UNITAID HIV Rapid Diagnostic Tests For Self-Testing

TECHNOLOGY LANDSCAPE
HIV RAPID DIAGNOSTIC TESTS

FOR SELF-TESTING
2nd Edition
1 July 2016
© 2016 UNITAID
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Design and layout:
2 | UNITAID Technology Landscape

TECHNOLOGY LANDSCAPE
HIV RAPID DIAGNOSTIC TESTS

FOR SELF-TESTING
2nd Edition
1 July 2016
Technology Landscape UNITAID | 3

Table of Contents
6 Acknowledgements
7 Abbreviations
9 Executive summary
12 Background
12 Public health problem
12 The potential for HIV self-testing (HIVST)
19 Technology landscape
19 Technologies available to diagnose HIV
20 Professional use of RDTs
23 HIVST target product profile
26 Current market of HIV RDTs for self-testing
32 Global HIVST demand
32 Current and estimated HIVST demand
37 Enabling environment
42 Summary and conclusions
42 Key considerations for countries, national programmes

and regional bodies
43 Key considerations for donors
44 Key considerations for manufacturers

47 Annex 1. Specification sheets for HIV self-test
products in the market
48 autotest VIH®
50 BioSURE HIV Self Test
51 OraQuick® In-Home HIV Test
53 INSTI HIV self-test
57 Annex 2. Specification sheets for HIV self-test

products emerging in the market
58 Atomo HIV Self-Test
60 Aware™ HIV-1/2 OMT Oral HIV Self Test
61 OraQuick® HIV Self-Test
62 Exacto® HIV Screening Test
64 To be named – Chembio Diagnostic Systems Inc.
67 References

Acknowledgements
This landscape was assembled in partnership with Carmen Pérez Casas and Olawale
Ajose (UNITAID); Rachel Baggaley, Cheryl Johnson, Carmen Figueroa, Anita Sands,
Mercedes Pèrez Gonzalez, Irena Prat, Willy Urassa, Robyn Meurant and Boniface
Dongmo Nguimfack (World Health Organization); Petra Stankard, Karin Hatzold,
Nina Hasen, Yasmin Madan, Patrick Aylward and Shannon Rosenberg (Population
Services International).
Financial support for this work came from the UNITAID secretariat and the Bill &
Melinda Gates Foundation.
The development of this work was coordinated by Carmen Pérez Casas, Olawale
Ajose, Rachel Baggaley, Cheryl Johnson and Petra Stankard under the supervision of
Philippe Duneton (UNITAID Secretariat) and Gottfried Hirnschall (WHO Department
of HIV).

Abbreviations
ART antiretroviral therapy
ARV antiretrovirals
CDC Centers for Disease Control and Prevention
CE European Conformity
DNA deoxyribonucleic acid
ERPD Expert Review Panel for Diagnostics
FDA United States Food and Drug Administration
GHTF Global Harmonization Task Force
Global Fund Global Fund to Fight AIDS, Tuberculosis and Malaria
HIV human immunodeficiency virus
HIVST HIV self-testing
IFU instructions for use
IPV intimate partner violence
IVD in vitro diagnostic
ISO International Organization for Standardization
mL mililitre
µL microlitre
NA Not available
NAT nucleic acid testing

NGO nongovernmental organization
PEP post-exposure prophylaxis
PEPFAR President’s Emergency Program for AIDS Relief
PLHIV people living with HIV
PMA pre-market approval
PQ prequalification
PrEP pre-exposure prophylaxis
PSI Population Services International
RDT rapid diagnostic test
RNA ribonucleic acid
STI sexually transmitted infection
TGA Therapeutic Goods Administration
UN United Nations
UNAIDS Joint United Nations Programme on HIV/AIDS
UNICEF United Nations Children’s Fund
USA United States of America
USAID United States Agency for International Development
US$ United States dollar
VMMC voluntary medical male circumcision
WHO World Health Organization

Executive summary
This report presents HIV self-testing (HIVST) as an innovative strategy with great
potential to contribute to achieving the United Nations (UN) 90–90–90 targets by
2020. It provides updates on the landscape of technologies for HIVST originally
presented in the first edition of the UNITAID/WHO Landscape on HIV self-testing
(December 2015), as well as a summary of the existing and emerging market and
projections of the demand for, and supply of, HIV rapid diagnostic tests (RDTs) for
self-testing. The information in this report is intended for manufacturers, donors,
national programmes, researchers and other global health stakeholders who are
exploring the potential role of HIVST.
HIVST is a potential approach to expand access to HIV testing services and

reach those at high risk for HIV who may not otherwise test, including men, young
people and key populations. The World Health Organization (WHO) defines HIVST
as a specific process in which a person collects his or her specimen (oral fluid
or fingerstick/blood) and then performs a test and interprets the result, often in
private or with someone they trust. All individuals with a reactive self-test result
must receive further testing with a complete validated testing algorithm for
diagnosis from a trained provider.
The first edition of this landscape identified 52 HIV RDTs on the market, the vast
majority (48) of which used fingerstick/whole blood specimens. As of June 2016,
24 HIV RDTs for professional use were identified as eligible for procurement by
major donors, as they are either approved by WHO or the Global Fund to Fight
AIDS, Tuberculosis and Malaria (Global Fund). Between 2012 and 2014, a total
of 243 million HIV RDTs for professional use were reportedly procured by public
agencies, averaging about 81 million HIV RDTs per year. The actual volume is likely
to be much larger, as these estimates do not include HIV RDTs procured directly
from manufacturers by country governments nor HIV testing services in the private
and/or informal sector. Prices for HIV RDTs for professional use range from US$
0.50 to US$ 11.00 depending on the specimen-type, procurement volume and
buyer.
HIVST is a complementary approach to existing HIV testing services and the

majority of HIV RDTs for self-testing are based on HIV RDTs for professional use
that have been modified and repackaged. Currently, there are fewer HIV RDTs
for self-testing on the market than those emerging. As of July 2016, there are
only four HIV RDTs for self-testing on the market with approval by a founding

member of the Global Harmonization Task Force (GHTF) and thereby eligible
for procurement with major donor funding. This includes one oral fluid and three
fingerstick/whole blood products. However, prices to date are largely prohibitive for
use in low- and middle-income countries (US$ 7.50–48). The pipeline of products
for HIVST is much larger, with six fingerstick/whole blood-based, and three oral
fluid-based RDTs for self-testing under development. All products are serology
assays that use immunochromatographie (lateral flow). The majority are second
generation RDTs, require between five and seven steps and include a reading time
between 15 and 45 minutes.
Significant innovation would be required to meet the current HIV RDT for self-
testing target product profile. Potential for innovation includes adaptation of
tests with greater seroconversion sensitivity (third and fourth generation RDTs)
and modifications of test kits to be more “user friendly”. These modifications
may include reducing the number of steps (e.g. one step), simplifying specimen
collection and transfer, achieving a faster time to results, ensuring results remain
stable for a longer period, improving the clarity of the space where the result
appears and is read to strengthen accurate result interpretation, and optimizing
packaging and instructions for use (IFU). Innovations in support tools for referral
and linkage could also improve test performance as well as ensure linkage to
further testing, prevention, treatment and care. Such modifications may not only
benefit those who self-test, but also health workers and lay providers who often
provide HIV testing services in a variety of settings where they may lack adequate
training, support and supervision and who deal with challenges such as poor
visibility, inadequate lighting and limited time and supplies.
Global demand for HIVST is largely uncertain. In high-income markets where HIV
RDTs for self-testing are approved for use, it is estimated that 1.6 million RDTS
for HIVST have been sold since 2012. Based on this information and current
data about uptake and use of HIVST in low- and middle-income countries, global
demand is estimated to be at least 4.8 million HIV RDTs by 2018. Work is currently
under way to refine this estimate using population-level data. These estimates will
focus on the African market and are planned for release in December 2016.
Despite this lack of clarity, global procurement in 2015 and the first half of 2016
significantly outpaced prior years. As of June 2016, several large buyers are
signalling increased interest in HIVST; and the President’s Emergency Fund for
AIDS Relief (PEPFAR), the Global Fund and the Bill & Melinda Gates Foundation
have all initiated procurement to support growing demand for implementation
research. Furthermore, policy development at the national level gained traction
in several countries since the first published landscape. Sixteen countries
report the existence of a policy supportive of HIVST, while another eight are
under development. WHO guidelines, a critical tool for further advancing policy
development, are also expected in late 2016.

Approval pathways are also becoming more concrete. Guidelines and a sample
dossier for WHO prequalification of HIV RDTs for self-testing are expected in
2016 and the Global Fund Expedited Review Panel has recently expressed
interest in reviewing dossiers for HIV RDTs for self-testing for temporary approval.
The establishment of these approval channels will bring more certainty to the
market and further enable market entry. However, clarification of country-level
policy and regulatory frameworks are urgently needed.
The growing pipeline of HIV RDTs for self-testing indicates a growing market
supply, while more concrete developments in approval, policy and regulatory
pathways, as well as increased procurement indicate an increasingly healthy
environment in which the market demand for HIVST can flourish. However, risks
that may slow market development remain, such as unanswered operational
research questions, limited product innovation and unclear country-level policy
and regulatory frameworks. To maximize the potential and continue to expand this
market, country governments, donors and manufacturers can all take critical steps
to address these risks and support further market development.

Background
Public health problem

A person’s knowledge of their HIV status is essential to the success of the HIV
response. HIV testing services are the gateway to treatment, prevention and care.
Antiretroviral therapy (ART), voluntary medical male circumcision (VMMC), prevention
of mother-to-child transmission, pre-exposure prophylaxis (PrEP) and post-exposure
prophylaxis (PEP) all contribute to reducing HIV transmission and HIV-related
morbidity and mortality. ART is highly effective in reducing HIV-associated morbidity
and mortality and can prevent onward transmission of HIV (1–3). Thus, in October
2015, the World Health Organization (WHO) recommended ART be offered to all
people living with HIV (PLHIV) immediately following diagnosis, regardless of clinical
assessment (4). The United Nations (UN) issued fast-track targets that could enable
the end of the HIV/AIDS epidemic, by aiming to have diagnosed, by 2020, 90% of
all PLHIV, for 90% of people diagnosed with HIV to receive ART, and for 90% of
those on ART to have a suppressed viral load (5). The first 90 – diagnosis of HIV – is
both essential and a key challenge facing the HIV response today.
To date, the global scale-up of HIV testing services has been significant. From
2010 to 2014, more than 600 million people received HIV testing services in 122
low- and middle-income countries (6). An estimated one half of PLHIV in Africa are
now aware of their HIV status (7), an increase from 2005 when only 10% of PLHIV
were aware of their status (8). These gains have been made possible through the
expanded use of rapid diagnostic tests (RDTs), implementation of routine testing in
health facilities (primarily in antenatal care and tuberculosis clinics), and expansion
of community-based HIV testing and task-sharing initiatives enabling trained lay
providers to perform HIV testing services. With the widespread availability of ART
and the widespread use of RDTs, which in a validated testing algorithm can often
provide a same-day diagnosis, HIV testing is now routinely provided with pre-test
information without the requirement for pre-test counselling (9).
Despite achievements in scaling up HIV testing, substantial gaps remain, as an

estimated 44% of PLHIV in Africa and 43% of all PLHIV globally have yet to be
diagnosed (7). Depending on the local epidemiology and the approaches used to
deliver HIV testing, the proportion of HIV-positive test results varies considerably.
In many settings where there has been a growing number of HIV tests every year,

these tests do not necessarily reach PLHIV who are unaware of their status and
others who are at high risk for HIV infection (9). For instance, although 150 million
HIV tests were performed in 2014 in 129 low- and middle-income countries, in this
same period 81 of these countries reported that only 3% of all HIV tests performed
were HIV-positive (6).
Source: PATH Viet Nam, Kimberly Green
HIV testing uptake and coverage for men continues to be lower than those for
women in most countries (10). Nearly 70% of adult HIV tests reported in 76 low-
and middle-income countries in 2014 were among women (10). Global reporting
suggests this is because HIV testing is integrated successfully within reproductive
health services, including antenatal care, but not consistently in other relevant
clinical settings, and that male partner testing is not widely implemented or taken
up (10,11). Thus, many men remain untested and those with HIV often continue to
be diagnosed late.
Among key populations, who are disproportionately affected by HIV and comprise
approximately 40% of the 2 million new HIV infections every year (12), testing
coverage remains low and existing reports of coverage are likely overestimates
due to limited data that are not representative. Low uptake of HIV testing services
among key populations is not only related to availability, but also depends on
acceptability and is impacted by unfriendly services, fear of stigma, discrimination
and criminalization of behaviour (12).

Young people and adolescents, particularly girls and young women, are
also at a significant risk of HIV infection and yet, in sub-Saharan Africa, adolescents
are less likely than adults to be tested for HIV. It is estimated that fewer than one of
every five girls (aged 15–19) are aware of their HIV status (11,13). Uptake of HIV
testing among adolescents is often low in settings with the highest HIV incidence
and services for adolescents are sometimes of poor quality; uptake is further
constrained due to laws and policies, for example, age of consent laws that prevent
adolescents from accessing HIV testing services (14).
Source:UNITAID/Eric Gauss
In addition to scaling up HIV testing services, maintaining the quality of HIV testing
is critical. A systematic review identified several reports of poor quality HIV testing
practices, such as poor product performance, improper storage of test kits and
supplies, clerical or transcription errors, user errors in performing the test and/or
interpreting the test result, lack of training, improper use of the testing strategy and/
or algorithm, lack of supportive supervision and training, lack of standard operating

procedures and poor documentation and recordkeeping practices, some of which
resulted in misdiagnosis of HIV status (9). To address these problems, effective
quality assurance systems and post-market surveillance systems must expand along
with the expanded delivery of HIV testing services.
These challenges require a new focus and new approaches to reach PLHIV who
remain undiagnosed early in their infection. Many countries and programmes are
considering innovative approaches to delivering HIV testing services to adequately
reach these people and achieve national and global testing targets.
The potential for HIV self-

testing (HIVST)
HIVST has been proposed as an additional approach to help countries expand
access to HIV testing services and reach those at high risk who may not
otherwise test. WHO defines HIVST as a specific process in which a person
collects his or her specimen (oral fluid or fingerstick/whole blood) and then
performs a test and interprets the result, often in private or with someone they
trust (9). All individuals with a reactive self-test result must receive further testing
with a complete validated testing algorithm for diagnosis from a trained provider
(9). Self-testing is not a new concept. It is in use in the management of various
health conditions, such as pregnancy, bowel cancer and diabetes. In this way,
HIVST represents another step in line with task sharing initiatives and efforts to
increase patient autonomy, decentralize services and create demand for existing
services.
There are many models for implementing HIVST, which vary in the level of support
provided and how and where HIV self-test kits are distributed. Models include
support from health workers, distribution or sale in the community or a health facility,
as well as sale in pharmacies, kiosks, vending machines and through the Internet.
Direct or indirect assistance may also be available through a demonstration on how
to self-test via an instructional video, telephone hotlines and printed instructions
for use (IFU) or other package inserts (9). Notably, accuracy of HIV RDTs used
for self-testing can be high, particularly when using validated tests and clear and
concise IFU, as well as other support tools (e.g. demonstration on how to self-test).
According to a systematic review of 21 reports that assessed the performance of
HIV RDTs, sensitivity ranged from 65% (95% CI 33.6–87.2%) to 98.8% (95% CI
92–99.8%) and specificity ranged from 94.7% (95% CI 84.9–98.3%) to 100%

(95% CI 99.9–100%) (15). While there is a wide range in reported sensitivity, only
2/21 reports reported sensitivity less than 80% and 15/21 reported sensitivity
of 90% or more (15). Furthermore, there was no difference between approaches
offering direct assistance compared to those that did not (15).
Despite good performance, it is important to note no single HIV RDT can provide
an HIV-positive diagnosis. However, a person with a nonreactive self-test result
does not need to have this result confirmed (9). It is recommended, as for all testing
services, to provide retesting messages for people with high ongoing or recent risk
exposure(s) (e.g. key populations; serodiscordant couples) (9).
There are many possible advantages to HIVST. It has been shown to be a discreet
and convenient approach that is also empowering and acceptable for diverse
populations in various contexts who may test less frequently or not otherwise test
at all (9,16–18). For those with a reactive self-test result, HIVST may lead to early
access to health services to establish an HIV diagnosis and link to prevention,
treatment and care. For those with a nonreactive test result, HIVST may support
increased uptake of prevention interventions, such as VMMC, PrEP and PEP, where
the requirement for HIV testing at the time of seeking prevention services is reported
as a barrier (19–21). For example, in Kenya, HIVST was reported to facilitate access
to PEP among health workers because accessing existing testing at their facility
was a barrier (20) and studies in Malawi, Zambia and Zimbabwe are under way to
evaluate the utility of HIVST to increase uptake of VMMC (22). HIVST may also lead
to increased frequency of testing, which is particularly relevant for individuals at high
ongoing risk for HIV and who are advised to test every three or every six months.
Several reports and models find that men who have sex with men would test more
frequently if self-testing were available (18,23) and that increased frequency would
have a public health benefit, particularly where testing coverage is low (24,25). In
addition, HIVST may ease the implementation and reduce the cost of interventions,
such as PrEP, where retesting is recommended every three months (26,27).
HIVST may also lead to cost savings and galvanize testing scale-up in settings with
low coverage and where there are health worker shortages. While the cost of an
HIV RDT for self-testing is higher compared to an HIV RDT for professional use, the
total cost of self-testing may be less than the total cost of standard facility-based
or community-based HIV testing. The potential cost savings of self-testing has also
been highlighted by a Zimbabwe-based cost-effectiveness model that states that
if HIVST were delivered for US$ 3 per test over a 20-year period, Zimbabwe would
save US$ 75 million and avert 7000 disability adjusted life-years (28). However,
since costs are highly variable across settings, further market research and cost-
effectiveness analysis is needed.
HIVST has also been shown to be safe in several studies. For example, in Malawi, a
two-year cluster randomized trial reported no suicides, self-harm or intimate partner
violence (IPV) and while a few reports of “coercion” were documented, nearly all
16 | UNITAID Discussion Paper

Source: WITS RHI, Mohamed Majam
were among men and nearly all reported they would recommend self-testing to
others (29). Nevertheless, it is important to note violence can occur in the context of
any intervention, including existing HIV testing services, and that providing messages
to mitigate risk for potential misuse and harm and implementing monitoring and
reporting systems are key (9). To date, only one study, where 41% of participants
reported IPV 12 months prior to the intervention, has identified a case of IPV
following HIVST (30).
Using existing evidence-based strategies, such as home-based assessment or care

(31) and couples and partner testing (30), has been shown to facilitate linkage
to further testing and onward prevention, treatment and care. Identifying tools and
strategies that support and facilitate linkage is an important area of research and
several studies are under way to assess effectiveness of different tools.
Box 1 highlights tools that could potentially enhance linkage to further testing,
prevention, treatment and care following HIVST.
Discussion Paper UNITAID | 17

BOX 1
Interventions and tools to support linkage to prevention, treatment and care
for HIVST
Home-based treatment initiation with support and active follow-up by community-based

networks has been shown to be an effective way to support linkage to care (31).
• Package inserts can be included in HIVST kits that explain the importance of further testing,
and where and how to obtain prevention, treatment and care services.
• Telephone hotlines can be set up for people to call before or after self-testing to obtain
information, including psychosocial and technical support as well as referrals and linkage to
prevention, treatment and care and other non-medical services (i.e. legal support; redress for
violence).
• Mobile phone services, which can operate like hotlines, can also provide reminders, videos and
other messages and information to encourage linkage to prevention, treatment and care.
• Internet and computer-based programmes can support self-testers. Some approaches have
included online two-way audio or video counselling services and programmes that offer step-by-
step instructions on what to do following a reactive self-test result including descriptions of where
and how to obtain further testing, prevention, treatment and care.
• Vouchers, coupons, financial incentives

or rebates could assist linkage to further
HIV testing, prevention, treatment and care,
particularly among populations that face
structural barriers to accessing services, such as
long distance and costly transportation.
• Referral or appointment cards that provide

a contact, date and/or time for an appointment
for follow-up services, including HIV testing
and other HIV prevention, treatment and care
services could also be utilized to facilitate
linkage.
• Partner HIVST may increase linkage to

care and encourage male involvement (30).
Depending on the context, offering HIVST
within voluntary partner notification
services could also promote linkage to
prevention, treatment and care Source: UNITAID/Eric Gauss

Technology
landscape
Technologies available to
diagnose HIV
There are two key categories of testing technologies that can be used at the
point of care to diagnose HIV-1/2 infection: HIV RDTs and nucleic acid testing
(NAT) technologies.
HIV RDTs are serology assays that detect HIV-1/2 antibodies and/or HIV-1 p24
antigen. HIV RDTs generally provide results between 5 and 20 minutes and are
in the form of lateral flow strips or cassettes or flow through devices. When used
within a national validated testing algorithm, they can accurately provide same
day diagnosis. They are relatively easy to use, can be performed using capillary
whole blood or oral fluid specimens, contain built-in quality controls and can be
administered by trained non-laboratory personnel.
NAT is a molecular technology for detecting the presence of HIV in RNA and/or
DNA in plasma, venous and capillary whole blood or dried blood spot specimens.
Currently, there are few NAT technologies that can be used at the point of care
in resource-limited settings. Those that are available are primarily used for early
infant diagnosis.
Depending on which assays are used, HIV infection can be detected between 10
and 50 days following the initial infection (Figure 1). HIV RDTs currently in use
can be classified into three groups (second, third and fourth generation) based
on how quickly they can detect HIV following an exposure.
• NAT technologies detect HIV in RNA or DNA and have been shown to
detect HIV infection in the acute infection stage. Compared to other point-
of-care HIV tests, they have the shortest window period compared to other
testing technologies and can detect HIV beginning 10 days after an exposure.
• Fourth generation HIV RDTs can detect both HIV-1/2 antibodies and
p24 antigen. These RDTs can identify an infection beginning 14 days after an
exposure. While theoretically they may be able to detect acute HIV infection using
p24 antigen, field evaluations suggest that this does not occur in practice (32).

• Third generation HIV RDTs only detect HIV-1/2 antibodies and have been
shown to have good seroconversion sensitivity. This type of test is widely
used in resource-limited settings and can typically detect HIV beginning 21
days after an exposure.
• Second generation HIV RDTs only detect HIV-1/2 antibodies and have
the longest window period compared to other generations as they can
typically detect HIV beginning 28 days after an exposure.
FIGURE 1
Detecting HIV-infection with various formats and generations of IVDs over the natural
history of infection
Days post infection
0 10 14 21 28 35 48
Eclipse period
Window period
Acute infection
HIV nucleic acid detected

No HIV assay detects
HIV infection at this HIV-1/2 antibodies detected
stage
NAT
HIV p24 antigen
4th generation
3th generation
2th generation
1st generation
Sources: WHO 2015 (9); Rosenberg 2015 (33).
Professional use of RDTs

The market of professional use RDTs for HIV is large. A review performed
for the first edition of this report in December 2015a identified 52 HIV RDTs
available for professional use, the majority of which (48) use fingerstick/whole
blood specimens and only four that use oral fluid specimens. As of June 2016,
24 HIV RDTs for professional use are eligible for procurement by main donors,

as per WHOb or the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global
Fund)c listing. Of those listed, 13 fingerstick/whole blood-based RDTs and two
oral fluid-based RDTs are WHO prequalified; and 9 other fingerstick/whole
blood products are undergoing the WHO prequalification process.d
Between 2012 and 2014, a total of 243 million HIV RDTs for professional use
were reportedly procured by the Global Fund, the Partnership for Supply Chain
Management Systems (SCMS), the United Nations Children’s Fund (UNICEF)
and WHO, averaging about 81 million HIV RDTs per year. In total, more than
242.2 million HIV RDTs using fingerstick/whole blood were procured, averaging
about 80.7 million annually. During the same period, nearly 750 000 HIV RDTs
using oral fluid were procured, averaging about 250 000 annually.
The volume is likely to be much larger, as these estimates reflect what is

reported by donor agencies and do not include HIV RDTs procured directly
from manufacturers by countries and HIV testing services that take place in the
private and/or informal sector.
In 2014, the cost of HIV RDTs for professional use ranged from US$ 0.95 to
US$ 1.08 per test, using volume weighted average prices per smallest unit
per year across the Global Fund, SCMS, UNICEF and WHO (excluding any
distributor markups and assuming ex-works). However, ranges were wide: the
cost per HIV RDT for professional use procured by the Global Fund ranged from
about US$ 0.50 per test to about US$ 3.30 per fingerstick/whole blood test,
whereas the cost of HIV RDTs using oral fluid ranged from US$ 4.00 to US$
11.00. See Table 1 and Table 2 for summary of products listed by WHO or the
Global Fund.
TABLE 1
Summary table of WHO prequalified HIV RDTs for professional use (oral fluid)
Assay name (manufacturer) Sensitivity* Specificity* Approval status
DPP® HIV 1/2 Assay

100% 99.9% WHO PQ
(Chembio Diagnostic Systems Inc., USA)
OraQuick® HIV 1/2 Rapid Antibody Test

99.1% 99.8% WHO PQ
(OraSure Technologies Inc., USA)
* sensitivity and specificity estimates for oral fluid as a specimen type
a
NITAID/WHO Landscape on HIV RDTs for self-testing. First edition, November 2015: http://unitaid.org/
U
images/marketdynamics/publications/HIV_ST_Landscape_Nov_2015-_UNITAID_WHO.pdf
b
HO Prequalification of IVDs Programme list of prequalified products 16 June 2016: http://www.who.int/
W
diagnostics_laboratory/evaluations/160615_prequalified_product_list.pdf?ua=1
c
Global Fund: http://www.theglobalfund.org/documents/psm/PSM_ProductsHIV-WHO_List_en/
d
HO Prequalification of IVDs Programme list of active applications products 16 June 2016: http://www.who.
W
int/diagnostics_laboratory/160608_rapid_test_v1.pdf?ua=1

TABLE 2
Summary table of WHO prequalified or Global Fund approved HIV RDTs for professional
use (fingerstick/whole blood)
Assay name (manufacturer) Approval

Sensitivity* Specificity*
status
ABON™ HIV 1/2/O Tri-Line Human Immunodeficiency

Virus Rapid Test Device 100% 99.7% WHO PQ
(ABON Biopharm (Hangzhou) Co. Ltd, China)
Alere Determine HIV-1/2

100% 99.4% WHO PQ
(Alere Medical Co. Ltd, Japan)
Alere HIV Combo

100% 99.72% CE marked
(Alere Medical Co. Ltd, Japan)
Anti-HIV 1/2
100% 10% CE marked
(Turk Lab, Turkey)
DIAQUICK HIV 1&2 Ab Cassette

100% 100% CE marked
(DIALAB GmbH, Austria)
First Response™ HIV 1-2-0 Card Test

100% 98.8% CE marked
(Premier Medical Corporation, Nani Daman, India)
Genie Fast HIV 1/2

(Bio-Rad Laboratories, Marnes La Coquette, France and 100% 99.9% CE marked
Steenvoorde, France)
Hexagon HIV
(Human Gesellschaft für Biochemica und Diagnostica 100% 99.9% CE marked
mbHGermany)
HIV 1/2 STAT-PAK® Dipstick

100% 99.7% WHO PQ
HIV 1/2 STAT-PAK™

99.3% 100% WHO PQ
ImmunoComb® II HIV 1&2 BiSpot

100% 99.4% WHO PQ
(Orgenics Ltd, Israel)
INSTI HIV-1/HIV-2 Antibody Test

100% 99.7% WHO PQ
(BioLytical Laboratories Inc., Canada)
Multispot HIV-1/HIV-2 Rapid Test

(Bio-Rad Laboratories, Marnes La Coquette, France and 100% 99.3% FDA/ PMA
Steenvoorde, France)
Multisure HIV Rapid Test

100% 99.12% CE marked
(MP Biomedicals Asia Pacific, Singapore)
ONE STEP Anti-HIV(1&2 ) Test

99.8% 99.23% CE marked
(InTec PRODUCTS INC., Haicang, Xiamen, China)
Rapid Test for Antibody to Human Immunodeficiency Virus

(HIV) (Colloidal Gold Device) 100% 98.48% WHO PQ
Beijing Wantai Biological Pharmacy Enterprise Co. Ltd, China)
SD Bioline HIV Ag/Ab Combo

100% 99.1% WHO PQ
(Standard Diagnostics Inc., Republic of Korea)
SD BIOLINE HIV/Syphilis Duo

100% 99.5% WHO PQ
SD BIOLINE HIV-1/2 3.0

99.8% 99.9% WHO PQ

Assay name (manufacturer) Approval
Sensitivity* Specificity*
status
SURE CHECK® HIV 1/2 Assay

99.8% 99.9% WHO PQ
Uni-Gold™ HIV
99.8% 99.9% WHO PQ
(Trinity Biotech Manufacturing Ltd, Ireland)
VIKIA HIV 1/2

99.4% 99.9% WHO PQ
(bioMérieux SA, France)
PMA: Pre-market approval
HIVST target product profile

The current technology utilized for HIVST is primarily adapted and repackaged versions
of HIV RDTs for professional use. There are many inherent characteristics of an HIV
RDT that may need adaptation to make it more suited for HIVST, but there are also
modifications to the packaging and IFU that further optimize a product for HIVST.
In 2014, PATH developed a target product profile for HIVST (34). The summary
below provides an overview of that profile, as well as some additional considerations
for the ideal HIV RDT for self-testing.
Test generation. At the moment, the self-testing products on, and emerging in,
the market are primarily second generation HIV RDTs. The use of second generation
HIV RDTs for self-testing has raised some concerns, as they reportedly have poorer
seroconversion sensitivity compared to third and fourth generation HIV RDTs. There
is one third generation HIV RDT for self-testing on the market currently, and another
that is emerging in the market.
Adapting tests that are highly sensitive, have high seroconversion sensitivity and
a shorter window period, including third and fourth generation RDTs and NAT
technologies that can be used at the point of care for self-testing, may be particularly
advantageous for populations that require frequent retesting and are at high risk
for HIV (e.g. high incidence). The development of third and fourth generation HIV
RDTs for self-testing is advancing, however, the development of self-operated NAT
technologies are not being developed at this stage.
In addition, possible concern about the use of second generation HIV RDTs for
self-testing should be weighed against several factors. First, NAT technologies and
fourth generation tests currently have limited availability in low- and middle-income
technologies. Where used, third and fourth generation tests may require volumes of
fingerstick/whole blood specimen, which is difficult for self-testers to collect, and
fourth generation tests may increase the risk of false-reactive results. Current NAT

Source: Atomo Diagnostics, Anna Wang
technologies are optimized for specificity, not sensitivity, which may also make them
less appropriate for a “test for triage” approach with self-testing.
Multiplex technology. There is also the potential for self-testing to improve

diagnosis for other sexually transmitted infections (STIs) through multiplex testing.
Combinations could include HIV, syphilis, hepatitis B and hepatitis C, among others.
Introducing multiplex self-testing for HIV and other STIs reduces the chance of
missed opportunities for STI screening outside facility-based settings. This could be
particularly beneficial for high-risk groups who are hard to reach, as described above.
At this time, the potential for multiplex self-testing has not been fully explored and
there are few multiplex RDTs for professional use. Only one HIV and syphilis RDT is
WHO prequalified. There are multiplex RDTs for HIV and hepatitis B and C, but none
is currently undergoing WHO prequalification. Despite the limited number of multiplex
RDTs that could be adapted for self-testing, if successful, they may be a way to reach
people at high risk and increase the public health impact of self-testing.
Reduced steps. Each step for HIV testing, from the specimen collection to
interpreting the final result, is critical for a correct result. The more steps, the greater
the risk is for user error that may then result in a greater risk of an incorrect test result.
Collecting and transferring specimen (either fingerstick/whole blood or oral fluid) has
been shown to be particularly prone to error for self-testers, resulting in test system
failures, invalid results and suboptimal performance (15). Thus, an HIV RDT for self-
testing with few steps, or ideally one single step, could substantially reduce the risk
of a number of user errors. Opportunities to develop integrated components, such as
specimen collection and transfer devices as well as integrated buffer systems may
be useful, including less painful lancets and other components that are automated to
regulate the volume of specimen collected and how the specimen is transferred.
Easy interpretation. Interpretation of test results can be challenging, particularly if

lines are faint or blurred, if the size of the read window is small, if the incubation time
is narrow and if the read time is lengthy. It is well documented that errors interpreting

RDT results occur among trained users, for example, incorrect interpretation of “faint
lines” and failure to read results within the stipulated time (15). It is likely that using
existing RDTs for self-testing will have similar challenges.
Current RDTs that are being used for self-testing should not be read for at least 15
minutes after the sample is applied and should not be read more than 60 minutes
afterward. This requirement may be challenging for individuals who do not have
timers readily available and result in misinterpretation of results by users reading too
early or too late (15). Settings where mobile phones or other timers and clocks are
available may minimize this problem.
To address these challenges, the ideal RDT for self-testing should provide a result in
one to five minutes and have stable incubation times where results are stable. Result
windows should be clear and easy to read, particularly to prevent faint lines that can
be especially challenging to interpret. Current HIV RDTs being used for self-testing,
however, do not have these characteristics and would need to be developed.
Robustness and durability. The product design for HIV RDTs for self-
testing should consider transport, use and storage in uncontrolled settings that
require a degree of robustness and durability. Products that can withstand high
temperatures, user errors and other conditions that promote product instability may
be an advantage for self-testers and those that distribute the test kits, particularly
in resource-limited settings. Lastly, while robustness and durability are critical,
packaging is also a key consideration to maximize product acceptability. Potential
users may find bulky or heavy packaging unattractive, particularly those seeking
privacy and discretion. The inclusion of multiple tests in a single pack may be desired
in order to facilitate repeat testing or partner testing.
Source: BioSure, Brigette Bard

IFU and support tools. Several studies have indicated that HIV RDTs for
self-testing perform best when IFU have been developed and validated among
intended user populations. Pictorial IFU are most ideal as literacy levels vary highly
across intended user populations and settings. Because of cultural and language
differences, special attention to detail will be needed as instructions will have to
be translated and validated before implementation. Other support tools such as
videos, telephone hotlines and demonstrations on how to self-test and interpret the
result can also improve performance. These tools can also be utilized to facilitate
linkage to prevention, treatment and care.
Disposal and waste management. In general, RDTs for self-testing should be

designed to be disposable as they will be designed for single use. Although RDTs
that use oral fluid specimens pose minimal biohazardous risk, concerns have been
raised about such risks with fingerstick/whole blood-based RDTs. However, no data
yet conclusively support this concern. Across all products for HIVST, lessons learnt
from blood glucose monitoring and other self-tests or self-monitoring devices should
be considered in order to minimize risk of exposure to biohazardous material.
Cost. HIV RDTs for self-testing are intended for a single use where all components
are individually packaged. Therefore, costs are typically higher than professional use
HIV RDTs that can be sold in bulk. While the test kit costs may be higher in some
cases, for comparison purposes the cost of the testing event should be considered,
for example, health worker time, facility costs and community outreach costs.
Second generation HIV RDTs for self-testing may be slightly lower cost than
third and fourth generation RDTs, and all RDT costs will be much lower than NAT
technologies at the point of care (estimated to be as much as US$ 20 per test
for professional use). Although NAT could be potentially more accurate and able
to diagnose HIV in the acute stage, a high cost for a self-use tool can lead to low
uptake of, and access to, HIVST.
Current market of HIV RDTs

for self-testing
Available and pipeline products. Currently, there is one oral fluid and three
whole blood-based RDTs for self-testing eligible for procurement with major donor
funds, including from the Global Fund and UNITAID. These products are registered
and approved for use by a founding member of the Global Harmonization Task Force
(GHTF). However, the pipeline is much larger, with six fingerstick/whole blood-based

and three oral fluid-based RDTs for self-testing under development. All products use
immunochromatographie (lateral flow) and serology. The majority are second generation
RDTs, with one third generation RDT on the market and one under development.
Current and emerging products require between five and seven steps and include
a reading time between 5 and 45 minutes. Significant product innovation would be
required to meet the target product profile description outlined above.
Tables 3A, 3B, 4A and 4B summarize the current pipeline. Detailed product
specifications can be found in Annex 1 and Annex 2.
TABLE 3A
Fingerstick/whole blood-based HIV RDTs for self-testing on the market
Approximate
Assay name (manufacturer) Generation Sensitivity Specificity Approval status price per test
(US$)
autotest VIH®
(AAZ Labs, France) CE marked; 25–28
2nd generation 100% 99.8%
submitted WHO PQ (to consumer)
Private sector version

BioSURE HIV Self Test 42–48
2nd generation 99.7% 99.9% CE marked
(BioSURE, United Kingdom) (to consumer)
Public sector version

BioSURE HIV Self Test 7.50–15
2nd generation 99.7% 99.9% CE marked
(BioSURE, United Kingdom) (to public sector)
INSTI HIV Self Test

(bioLytical Laboratories, 36
3rd Generation 100% 99.8% CE marked
Canada) (to consumer)
TABLE 3B
Oral fluid-based HIV RDTs for self-testing on the market
Approximate
Assay name (manufacturer) Generation Sensitivity Specificity Approval status price per test
(US$)
OraQuick® In-Home HIV Test 40

2nd generation 91.7% 98.7% FDA
(OraSure Technologies Inc., USA) (to consumer)
Completed CE
OraQuick® In-Home HIV Test
2nd generation 100% 99.8% procedure, pending NA
(OraSure Technologies Inc., USA)
CE certificate

TABLE 4A
Pipeline of fingerstick/whole blood-based HIV RDTs for self-testing emerging
in the market
Approximate
Approval
Assay name (manufacturer) Generation Sensitivity Specificity price per test
status
(US$)
Atomo HIV Self-Test

3rd generation NA NA No info NA
(AtomoDiagnostics, Australia)
Exacto® HIV Submitting

Screening Test 3rd generation NA NA dossier NA
(Biosynex Medtech, France) for CE mark
HemaDiagnostics Self-Test
(Hema Diagnostics NA NA NA No info NA
Systems LLC, USA)
To be named
(Chembio Diagnostics Systems 2nd generation NA NA No info NA
Inc., USA)
To be named
NA NA NA No info NA
(Alere, USA)
To be named (Trinity Biotech

NA NA NA No info NA
Manufacturing Ltd, Ireland)
TABLE 4B
Pipeline oral fluid-based HIV RDTs for self-testing emerging in the market
Approximate
Approval
Assay name (manufacturer) Generation Sensitivity Specificity price per test
status
(US$)
To be named
NA NA NA No info NA
(Sedia Biosciences, USA)
Aware™ HIV-1/2 OMT Oral

HIV Self Test
2nd generation NA NA No info NA
(Calypte Biomedical
Corporation, USA)
HIV Self-Test
Price available
(OraSure Technologies, 2nd generation NA NA No info
upon request
Bangkok, Thailand)

Market entry. HIV self-test products have launched in only a few countries. This
includes the United States Food and Drug Administration (FDA)-approved OraQuick® In-
Home HIV Test (OraSure Technologies, Bethlehem, PA, United States), an oral fluid-based
RDT, available in the United States, as well as two CE marked fingerstick/whole blood
RDTs available in France (autotest VIH®, AAZ Labs, Rungis Cedex, France) and the United
Kingdom (BioSURE HIV Self-Test, BioSURE Ltd, London, United Kingdom). Although the
OraQuick® In-Home HIV Test has completed CE mark procedures, it is not yet marketed
in Europe. In July 2016, the INSTI HIV Self-Test (bioLytical Laboratories, British Columbia,
Canada) was CE marked and will be launched in European markets in late 2016 .
Plans for future market introduction of RDTs for HIVST vary widely. The majority of
products, both oral fluid and whole blood, are intended for deployment in low- and
middle-income markets.
Currently, target markets in Africa routinely cited for both fingerstick/whole blood and
oral fluid-based HIVST include Kenya and South Africa. Interest in other African markets
is limited and inconsistent across manufacturers. Most manufacturers expect demand in
these African markets will come from the public sector (e.g. governments and international
donors) and that the private sector will comprise small volumes. Manufacturers’
interest outside of Africa is primarily in markets with concentrated epidemics and large
populations. Eastern Europe is of interest to manufacturers of both fingerstick/whole
blood and oral fluid products, particularly those already present in other European
countries or those pursuing CE-marking. The interest in this market may be particularly
important given evidence of increasing HIV incidence in Eastern Europe and the potential
for developed markets to drive innovation for low-income markets (35).
Source: AAZ Labs, Laure Poignant

While these targets markets suggest where interest in the market currently sits,
targets markets are in flux and are likely highly sensitive to any shift in demand.
At the moment, there is a high degree of uncertainty about the potential scope
of the target market and what the incentives for entering the HIVST market
might be (e.g. potential market size; profitability; demand). While there are many
drivers for this, one particularly cited by manufacturers is the uncertainty of and
not yet defined country-level regulatory and registration processes. Additionally,
there are also questions and concerns about the significant financial and human
resource investments needed to pursue registration for each country. For many
manufacturers, decisions about entering a specific market are being driven by
identification of markets with the most clear and conducive policy and regulatory
environments. Because there are few countries with clear policies and regulatory
standards, particularly in resource-limited settings where the need for HIV
testing is highest, the development of WHO guidelines and criteria for WHO
prequalification are viewed as a priority by manufacturers.
Pricing. HIV RDTs for self-testing that are currently available have a
recommended consumer price of between US$ 25 and US$ 48 in markets in
the United States and the European Union: (i) OraQuick® In-Home HIV Test
(OraSure Technologies, Bethlehem, PA, USA): US$ 40/test in the United States;
(ii) BioSURE HIV Self-Test (BioSURE Ltd, London, United Kingdom): US$ 42–48/
test in the United Kingdom; (iii) autotest VIH® (AAZ Labs, Rungis Cedex, France):
US$ 25–28/test in France; and INSTI HIV Self-Test® (bioLytical Laboratories,
British Columbia, Canada): US$36/test in European markets. In the United
Kingdom, BioSURE has also made a public sector version of its product, with a
different version of packaging, available at US$ 7.50–15 to the National Health
Service and nongovernmental organizations (NGOs). Price information for HIV
RDTs for self-testing outside these markets is limited and largely unreported. This
is because HIVST has not been widely implemented and is occurring informally
or in the context of research. HIV RDTs for self-testing used within the context of
research in low- and middle-income settings are priced at between US$ 3.15 and
US$ 16 per test. Pricing varies based on packaging requested, volumes procured,
country policies and regulation, importation taxes and fees, among other factors.
The cost of HIV RDTs for self-testing in informal markets also varies, particularly through
sale in private pharmacies and the Internet. Anecdotal reports from Kenya suggest
pricing as low as US$ 1 per test (36), while self-tests reportedly available in South Africa,
through pharmacies or online, retail for as much as US$ 10 (37). In Namibia, HIV self-
tests currently retail direct to consumers for US$ 4–12 (38). At the high end of this price
range, in both Namibia and South Africa, some products include multiple tests.
Manufacturers sense significant price pressure in the market – in both the

public and private sectors. In the public sector, manufacturers recognize growing
demands from donors and country governments to develop a lower-cost product
and there is consistent agreement that volumes may help reduce price.

However, costs associated with the development and the production of a single-use
product continues to limit manufacturer ability to reduce prices to levels cited as
targets by donors and country governments. Furthermore, the lack of clear demand
signals in low- and middle-income countries makes it difficult to forecast demand that
may indicate the volumes necessary to achieve further cost savings and reduce price.
Manufacturing capacity. Manufacturing capacity is not a barrier for meeting

current demand for HIV RDTs for self-testing where they are available on the
market. However, it is important to note that there is only one oral fluid-based RDT
manufacturer and two fingerstick/whole blood-based RDT suppliers and they
share the same source manufacturer. This suggests some risk to the sustainable
supply of product, if current demand was to increase exponentially or either
manufacturing site was to experience operational challenges.
Based on current reported manufacturing capacity and demand estimates, future

demand for HIV RDTs for self-testing can most likely be met. Analysis of available
data indicates manufacturing capacity is an unlikely barrier to the development of
the HIVST market in the short term, particularly because most HIVST products on
the market or in development are based upon an existing professional-use RDTs.
Thus, production lines for most professional-use RDTs have spare capacity that can
be easily used to meet HIVST demand. Only minor modifications to manufacturing
lines would be required for inclusion of tailored IFU and packaging. Furthermore, the
automation of existing lines may further expand capacity with minimal investment.
However, if demand increases considerably and at a quicker rate than regulatory
approvals of new products, this may become a challenge, particularly as user
preferences become more polarized (e.g. oral versus blood). Furthermore, the lead
time associated with current manufacturing lines has not been evaluated and will
need additional consideration as demand forecasts are clarified.
Critically, this analysis of manufacturing capacity assumes the use of re-purposed

HIV RDTs. If significant product innovation were to take place, bringing products in-
line with the target product profile, investments in manufacturing may be required.

Global HIVST
demand
Current demand for HIVST products remains low, as compared to its estimated potential.
It is estimated that since 2012, approximately 1.6 million RDTs for HIVST have been
sold. Procurement in 2015 and the first half of 2016 significantly outpaced prior years
and several large buyers are signalling increased interest in HIVST. Policy development
efforts gained traction in several countries since the first published landscape, and key
steps have been taken to formalize additional approval pathways. Combined, these
factors suggest the growth of a much healthier environment in which the market demand
for HIVST can flourish.
Current and estimated HIVST

demand
Demand estimates. The December 2015 WHO/UNITAID Landscape on HIV self-
testing estimated that the potential demand for HIVST could be at least 4.8 million by
2018 depending on the number of new users reached, the impact of HIVST on testing
frequency and the level of substitution in which users replace standard HIV testing
services with self-testing. The details of this analysis can be found at the following link:
http://unitaid.org/en/statements/1500-unitaid-and-who-review-emerging-landscape-
for-hiv-self-testing
Efforts are currently under way to refine this estimate, particularly in sub-Saharan Africa
where the need and demand for HIVST is likely to be highest. A more refined model is
under development and will estimate the HIVST market size in nine African countries –
Kenya, Malawi, Mozambique, Nigeria, South Africa, Uganda, United Republic of Tanzania,
Zambia and Zimbabwe. The model will begin by examining the potential market for
all HIV testing, disaggregated by age, sex and key population group. Using data on
existing HIV testing and emerging research on HIVST uptake across various distribution
models and populations, the model will estimate the adoption of HIVST among both new
and existing users across both existing (community and facility) and new (pharmacy)
channels. Estimates will be further refined to take into account estimated testing

Source: UNITAID/Eric Gauss
frequency, price and the presence of a range of factors in the enabling environment.
Estimates will be generated through 2020, and will be framed in the context of existing
HIV RDT procurement. These estimates will be formally released in 2016 and further
refinement of model assumptions will be undertaken when WHO normative guidance is
released.
Consumer demand. Efforts to estimate the size of the market for HIV RDTs
for self-testing draw heavily on the increasing body of evidence that suggests that
consumer demand for HIV self-test products can be high across a diversity of
channels.
In high-income settings (France, United Kingdom, United States), where HIVST

products are registered and available, the majority of distribution occurs through
the private sector. Between July 2012 (when the OraQuick® In-Home HIV Test was
FDA-approved) and June 2016, nearly 1.6 million HIV RDTs for self-testing products
have been sold in the private and public sectors of these markets.
• Nearly 1 million OraQuick® In-Home HIV Testse were sold in the United States,
primarily through over-the-counter pharmacy sales.
• Approximately 50 000 BioSURE HIV Self-Test kits were sold in the product’s
first year on the United Kingdom market between April 2015 and February
2016.f Most sales were through online retail outlets; no over-the-counter
product was available in the United Kingdom pharmacies and there was limited
distribution in the public sector. According to reports, as of February 2016,

among self-tests sold in the country, 75% were sold to men and 75% were sold
outside metropolitan areas. About 50% of users were first-time testers and 10%
ordered a test more than once (39).
• In France, AAZ Labs estimated that between 35 200 and 92 800 autotest
VIH® kits were sold between September 2015 and February 2016.g Sales of
the autotest VIH® are restricted to online retailers and pharmacies, supported
by government-led campaigns to promote HIV testing. One study of pharmacies
reporting sales of 900 kits found that 66% of purchasers were male and 42%
were first-time testers; 54% of users reported that they would not have tested if
a self-test was unavailable (40).
In developing markets where tests are not yet formally available, growing research
indicates high levels of consumer demand can be achieved through a variety of
channels. In Malawi, a study of community-based distribution of HIV self-test products
in Blantyre found a population-level uptake of 76.5% over a two-year period (29).
Uptake was highest among younger age groups, and 44% of participants were first-
time testers (29). Additionally, uptake among men was 68%, which is substantially
e
This is estimate is based on OraSure’s public reports from 2012 to present, divided by the estimated cost to distributers
(US$ 28). It also factors in publicly available procurement reports, as well as reports from contacts with past and ongoing
implementation projects.
f
Brigette Bard, BioSURE, personal communication, 29 June 2016.
g
Laure Poignant, AAZ Labs, personal communication, 27 June 2016.

higher than national estimates of testing coverage among men (29). In Zimbabwe, a
pilot of community-based distribution in one rural district found similarly high levels
of uptake, including high uptake among men. Importantly, distribution reached a high
proportion of PLHIV who were previously undiagnosed (41). Evaluations of secondary
test distribution, in which an individual is provided multiple self-test products for
distribution to their sexual partners, also suggest strong demand. In Kenya, women
attending antenatal and postpartum care, as well as female sex workers, were offered
a self-test kit for themselves and for their sexual partners. Between 75% and 91% of
participants reported secondary distribution of the test (30).
Additional studies are under way to generate further evidence of consumer uptake
of HIVST, including linkage to further testing, and prevention, treatment and care
following HIVST. This includes the UNITAID/ Population Services International (PSI)
HIV Self-Testing AfRica (STAR) Project, which is evaluating several HIVST distribution
models in Malawi, Zambia and Zimbabwe, including community-based models, facility-
based distribution in public and private clinics, and distribution through peer educators
to reach key population groups (22). Studies in Australia (43), Brazil (44), China (45),
Netherlands (46), Thailand (47), the United Kingdom (39,49), the United States
(48) and Viet Nam (50) are examining HIVST distribution among key populations,
while several studies in Kenya, South Africa, Uganda and Zambia are evaluating other
community- and facility-based distribution models to reach the general population,
as well as young people and key populations (51). Several planned and forthcoming
studies are also examining how uptake of HIVST may vary for blood-based tests
versus those with oral fluid. These data will be critical to the formulation of supportive
policies and implementation guidance for HIVST.
The potential for consumer demand through the private sector in developing countries,
particularly sub-Saharan Africa is unknown although several manufacturers are
interested in entering this market. Assessments and anecdotal reports of the informal
sale of HIV RDTs in the private sector indicate that HIV RDTs for self-testing have
been available informally for more than a decade in sub-Saharan Africa. In Namibia
and South Africa, it was reported that HIV RDTs for self-testing have been available
for sale in private pharmacies as of 2001 and 2002, respectively (52). Likewise, in
Kenya and other sub-Saharan African countries, a high proportion of health workers
are already self-testing for HIV(53,54). Outside of Africa, HIV RDTs for self-testing
are also reportedly available informally in private pharmacies and through the Internet,
including in China (55), Malaysia (58), Peru (57), the Philippines (59) and the Russian
Federation (56). None of these products are known to be quality assured and sell at a
range of prices, as outlined earlier in this report.
Although most private sector markets are informal and unregulated in resource-limited
settings, they indicate the potential to capture significant latent demand for self-testing.
However, formal work to evaluate potential demand in this sector remains limited,
particularly in sub-Saharan Africa (55). A small study of pharmacy distribution of HIVST
in Kenya is under way, but further work is needed to understand private sector demand
and inform the development of market entry strategies (36).

Government and donor-based procurement. In the last year, public procurement of

HIV self-test kits grew exponentially with support from several major HIV funding agencies.
• UNITAID is supporting the largest HIVST implementation study in Malawi, Zambia

and Zimbabwe. The focus of this study, as described above, is to identify the most
acceptable, ethical and effective approaches for delivering HIVST and reaching
populations at high risk who may not otherwise test, such as young people, men,
and female sex workers. Under this project, PSI and UNITAID procured 382 000
RDTs for HIVST in sub-Saharan Africa, as of June 2016. An additional 2.4 million
tests will be procured over the course of the project.
• President’s Emergency Fund for AIDS Relief (PEPFAR) is also supporting

ongoing and planned pilot programmes and operational research studies in Brazil,
Haiti, Lesotho, Mozambique, Namibia, Nigeria, Senegal, South Africa, Thailand, the
United Republic of Tanzania, Viet Nam, Zambia and Zimbabwe. Currently, PEPFAR
has been focusing HIVST implementation research in “DREAMS districts” to reach
adolescent girls and young women, as well as their male partners, key populations
and other vulnerable populations. Procurement of RDTs for self-testing is planned
to support these implementation studies. Further expansion of procurement
through PEPFAR is expected in the coming years.
• Bill & Melinda Gates Foundation is supporting several HIVST implementation

studies through the International Initiative for Impact Evaluation and WITS

Reproductive Health and HIV Institute, including pilot studies in Kenya, South
Africa, Uganda and Zambia. Other investments include work to understand the
HIVST market, including emerging supply and the potential market size for HIV
RDTs for self-testing. The Bill & Melinda Gates-funded work has resulted in the
procurement of more than 12 000 RDTs for HIVST.
• Global Fund currently supports one “assisted” HIVST project in Ukraine because
trained lay provider and community-based HIV testing is illegal. Since 2015, over
200 000 test kits have been procured for this project. Global Fund support for self-
testing is expected to increase after the March 2016 release of the Briefing note:
Operational research to improve implementation and uptake of HIV self-testing.
The note outlines key implementation considerations regarding HIVST to inform the
inclusion of HIVST pilot programmes in reprogramming or new applications.
This movement in the public sector market is critical to building a stable HIVST product
supply as discussions with manufacturers indicate that nearly all expect that bulk
procurement through the public sector will drive their revenue models.
Enabling environment
Approval pathways and eligibility for procurement. For many countries,
particularly low- and middle- income countries, evaluations and approvals by WHO,
the United States Agency for International Development (USAID), the United States
Centers for Disease Control and Prevention (CDC), the Global Fund and stringent
regulatory authoritiesh are utilized to guide local decisions in the absence of a national
mechanism or national regulation of in vitro diagnostics (IVDs). The procurement policies
of main international funders for HIV programmes (Global Fund, PEPFAR, UNITAID)
require IVDs to be manufactured according to the applicable International Organization
for Standardization (ISO) or equivalent standards and for the IVD to be reviewed and
approved or recommended by founding members of the GHTF and/or agencies listed
above. In addition, the Expert Review Panel for Diagnostics (ERPD), supported by
UNITAID and the Global Fund and hosted by WHO, provides expert recommendations
on the use of needed IVDs that have not yet obtained stringent approval or WHO
prequalification, leading to temporary eligibility for procurement by main donor institutions.
Similar to approvals from stringent regulatory authorities, WHO prequalification of an

HIV RDT for professional use involves an assessment of a product dossier that contains
comprehensive information provided by the manufacturer, supporting safety and
h
tringent regulatory authority refers to founding members of the GHTF, including the regulatory authorities from Australia,
S
Canada, the EU, Japan and the United States.

performance, and undertakes an onsite inspection, evaluating manufacturing quality and
risk management. The prequalification assessment relies on best international practices
and is based on globally accepted standards and guidance documents. In addition, the
WHO prequalification assessment includes a performance evaluation of sensitivity and
specificity, an assessment of invalid rates and inter-reader variability and an assessment
of operational aspects. In general, the other approval mechanisms of non-regulatory
authorities are usually comprised of an assessment of performance through a laboratory
evaluation in the hands of trained users in a controlled setting.
In addition to recognizing the assessment work of international bodies, such as those

noted above, some countries also have national-level product evaluation and approval
requirements. Evaluation requirements may call for an HIV RDT to be assessed in the
country setting or as part of a national algorithm before the IVD can be officially approved
for use. Ad hoc in-country evaluations are also often used, instead of pre-market
regulatory reviews, to inform product selection at the country level. Once approved for
use in a country, an IVD could be procured and dispensed through the public or private
sector. Lastly, within a national HIV testing policy there may also be generic regulations
on how and where HIV RDTs can be used and distributed as well as who can collect
specimens, perform the test, interpret the results and issue a diagnostic report.
Given the potential for the emergence of diverse and complex regulatory requirements
across markets, efforts to harmonize diagnostic regulation within specific regions may
be needed. Entities such as the Pan African Harmonisation Working Party and Asian
Harmonization Working Party could play an important role in standardizing approaches
across countries in order to streamline country registration processes and decrease
market entry barriers for manufacturers.
Approval for HIV RDTs for self-testing. At the time of this publication, no HIV
RDTs for self-testing have been approved for procurement by WHO, USAID or the
CDC or recommended for temporary procurement by ERPD. WHO is currently
developing the criteria and approval pathway for HIVST. While the products in Tables
3A and 3B are available and can be procured, current pricing is prohibitive to the public
sector and other low- and middle-income buyers. The establishment of these approval
channels is intended to bring more certainty to the market and drive greater demand
and market entry – enabling costs and prices to decrease.
The WHO Prequalification of IVDs Programme undertakes a comprehensive

assessment of individual IVDs through a standardized procedure aimed at determining
if the product meets WHO prequalification requirements on quality, safety and
performance. The prequalification assessment process includes three components:
• review of a product dossier;
• performance evaluation, including operational characteristics;
• manufacturing site(s) inspection.

BOX 1
Examples of approval pathways for HIV RDTs for self-testing
In high-income settings, there are examples of how HIV RDTs for self-testing were evaluated and then
licensed and registered for use. In the United States, the FDA pre-market approval of an HIV RDT for
self-testing required a three-phase clinical trial:
1. evaluation of the RDT in the hands of trained users in a controlled setting;
2a. observed evaluation of untrained users interpreting a panel of contrived test results in a
controlled setting;
2b. observed evaluation of untrained users, with high, unknown and low risk of HIV, performing the
RDT and interpreting the test results in a controlled setting;
3. established performance of the test system as a whole in the hands of untrained intended and
expected users in the actual intended use (in-home) setting as a measure of clinical utility (61).
In addition, a performance standard was established and a risk–benefit assessment was conducted to
determine the public health benefit (61).
In France and the United Kingdom, the conformity assessment conducted for the CE marking process
required the completion of both phase 2a and 2b studies in each country. For instance, the Medicines
and Healthcare Products Regulatory Agency (MHRA) guidance states no threshold for performance
and outlines that IVDs for self-testing will be evaluated in terms of usability and suitability for self-testing
population (e.g. validated IFU; labelling and packaging studies) (62).
In Australia, the Therapeutic Goods Administration (TGA) outlines guidance similar to that in France
and the United Kingdom, but specifies thresholds for sensitivity and specificity for professional use, and
states products for self-testing with a “user” sensitivity less than 90% would not be acceptable, whereas
user specificity between 90% and 95% “could be considered acceptable where evidence of significant
public health benefits can be demonstrated and where thorough risk mitigation strategies have been put
in place to minimise the risk of false negative and false positive results” (63).
All HIV RDTs with self-testing as the intended use submitted for WHO
prequalification will undergo a prequalification assessment, as per the process
described above. However, any WHO assessment that has already been
undertaken for HIV RDTs intended for professional use will be leveraged
according to a risk-based approach. The information required to support any

claim made by the manufacturer needs to be directly linked to the intended use
of the assay. In this instance, self-testing. Verification and validation data are,
therefore, required in the hands of both professional users and self-testers.
The WHO Prequalification of IVDs Programme released a sample dossier for an

IVD intended for HIVST in December 2015 and is currently drafting a Technical
Specifications Series for prequalification of HIV RDTs including both professional
and self-testing intended uses. The dossier and the Technical Specifications
Series guide outline the requirements and procedures for a dossier submission.
Formal release is expected in mid- to late-2016 (60).
To facilitate the procurement of quality tests while no product has yet been
found to meet WHO prequalification requirements, the Global Fund and UNITAID
launched an ERPD for HIV RDTs for self-testing. ERPD for HIV RDTs for self-
testing will not replace WHO prequalification, but instead act as an interim
solution, while a stringent review is under way. An invitation to manufacturers
to submit an expression of interest for consideration by ERPD was issued
in February 2016 and closed in April 2016. The results of this process are
expected in July 2016. It is likely that there will be additional ERPD’s which
include HIV RDTs for self-testing in 2016/2017. Under this ERPD review, HIV
RDTs for self-testing may be procured with the Global Fund and UNITAID’s
funds for a 12-month period. Box 2 summarizes examples of regulatory approval
pathways for HIVST.
National policy. Within national HIV testing policies, several countries permit
HIVST and outline standards for approval of RDTs, how they fit within the
national HIV strategy, how RDTs for self-testing should be distributed and who
can distribute or sell them. Only three countries (France, United Kingdom and
the United States) have a policy allowing self-testing and at least one product
approved for use. Some countries have a policy allowing HIVST, but do not
yet have a product with regulatory approval for use. Additionally, several other
countries report having a policy in development and/or informal sale and use of
RDTs for self-testing (Figure 2).
Key changes since the first landscape include data reported in the Global AIDS
Response Programme Reporting (WHO, UNAIDS, UNICEF) as of 23 June 2016
and the WHO review of more than 100 national policies and regulatory frameworks
(64). In particular, the pharmaceutical council in South Africa lifted the ban on the
sale of HIV self-test kits in private sector pharmacies; however, the Department
of Health is working to develop an official policy and the standards and criteria for
HIVST. In Brazil, an HIVST national policy was released in December 2015 and it
is planned for HIV self-test kits to be in private pharmacies by the end of 2016. To
continually track the evolving policy environment for HIVST, please reference
HIVST.org for the most up-to-date information.

FIGURE 2
Map of countries with policies supporting HIVST (n=16)
Countries with Policy Supporting HIVST

Australia, Belarus, Chad, China, Kenya, Lesotho, Malawi, Rwanda, South Africa, Spain, United
Republic of Tanzania
Countries with Policy Supporting HIVST & Products Approved For HIVST
France, United Kingdom, United States Of America
Australia, Malawi, Rwanda, Spain and the United Republic of Tanzania report that while there is a policy in place,
1
implementation has not yet begun.

2
Brazil plans to introduce a product for HIVST in pharmacies in late 2016.
While the South African Pharmaceutical Council lifted the ban on the sale of HIVST in May 2015, the Ministry of Health has
3
not provided official policy, criteria or standards.

Sources: Global AIDS Response Programme Reporting (WHO, UNAIDS, UNICEF) 23 June 2016; WHO, 2016 (64).

Summary and
conclusions
The demand for HIV testing to achieve the first 90 goal – diagnosis of 90% of all PLHIV
by 2020 – is of paramount importance to achieving global targets and stemming the
tide of the HIV epidemic. The additional approach of self-testing may have an important
impact on demand for HIV RDTs, particularly if uptake is high among new users not
previously reached and the frequency of testing increases among new and existing
users. Existing estimates of demand, however, remain limited and forthcoming size
estimates will be critical to understanding the potential for HIVST to shape or impact the
HIV RDT market and further maximize the public health impact of this approach.
Although more evidence is needed to fully understand the potential public health and
market impact of HIVST, this landscape provides a review of the existing and forthcoming
technologies, as well as a strategic summary of the supply and demand for HIVST. The
available data may inform strategic planning among diverse global health stakeholders
exploring the potential role of HIVST.
Key considerations
for countries, national
programmes and regional
bodies
• To facilitate the market for low-cost and quality-assured products for HIVST, it
is important for international and national policy to be implemented. Creation of
these policies and guides, which outline necessary approval channels, processes
and location of HIVST within the national algorithm and testing strategy, will build
confidence in demand estimates, providing greater certainty to manufacturers and
catalysing market entry in settings where barriers are few and market incentives
are many. There are several country examples of existing policies and regulations,
however, WHO guidance is essential, particularly for many low- and middle-income
countries.

• Countries and programmes should consider how HIVST can contribute to achieving
national testing targets, particularly in specific populations with low testing uptake,
high incidence and prevalence and high risk of infection. These decisions should
be reflected in national strategies to further inform demand forecasts and advance
implementation planning. This should include plans for establishment of strategies
that further optimize linkage, as already recommended by WHO for existing testing
services.
• While adapting existing professional use HIV RDTs for self-testing has many
benefits, it is important that countries, programmes and regional bodies work to
adapt and validate IFU, translations and other support materials to ensure they are
appropriate for their setting and context. Country governments should engage with
manufacturers to streamline processes for adaptation of IFU.
• Complex regulatory environments at the country level may pose a significant

constraint to market development. Country governments should move quickly to
outline clear and streamlined registration processes. These processes should ensure
entry of quality of products without imposing unnecessary requirements.
Key considerations for donors

• WHO guidelines are forthcoming in late 2016, however, key operational research
questions to guide implementation scale-up remain. This includes questions around
linkage to prevention, treatment and care and effective means for targeting HIVST to
reach those at highest risk. Operational research to answer these questions should
be supported in parallel with rapid adoption of WHO guidelines, development of
donor policies and scale-up of evidence-based approaches.
• To achieve scale-up in low- and middle-income markets, manufacturers must obtain

necessary approvals (USAID, Global Fund and WHO) for donor procurement.
Ensuring clear guidance and rapid review of applications will be crucial to ensure
rapid evolution of the HIVST market.
• HIV RDTs for self-testing may have a higher unit cost compared to HIV RDTs for
professional use. However, donors should consider the full cost of a testing event
and the potential cost savings and increased cost-effectiveness of self-testing.
Nevertheless given increased testing need and reduced donor budgets, it will be
critical to coordinate across donor agencies and take on collaborative efforts to
ensure the affordability of HIV RDTs for self-testing as the market evolves.

Key considerations for
manufacturers
• Existing technologies for HIVST still rely heavily upon adaptation of existing
technologies for professional use, notably second generation RDTs. In the
short term, this has some advantages, particularly to hasten market entry while
national and international policies and regulatory processes are still evolving.
Existing mechanisms, such as ERP-D and WHO prequalification should be
pursued as quickly as possible, particularly after WHO finalizes standards and
procedures, to speed entry in the public sector market. Engagement with country
governments regarding registration should also begin. However, in the medium
and long term, there is significant need to further optimize existing HIV RDTs
for self-testing, in line with the target product profile. These modifications may
translate into higher performing tests, greater uptake and frequency of testing
among users and thus a greater market size.
• There is significant potential for cross-over between markets for RDTs for
professional use and RDTs for self-test use. Investments in RDTs for self-testing
may catalyse optimization of existing, and development of new, HIV tests for
use by professionals, addressing the challenges facing professionals who work
in settings where conditions are poor, training and supervision are infrequent,
and resources and health worker time are limited. There may be greater market
incentives for manufacturers who can develop products that can unify the
market for decentralized HIV testing services, for example, in community-based
settings and low-level facilities and clinic settings, with the market for HIVST.
• IFU are likely to require significant adaptation across markets. Manufacturers

should work to develop pictorial instructions that minimize written text and that
may be easily tailored to various cultural context (e.g. replacement of photos with
individuals who reflect the intended user demographic or use of symbols in line
with the target market culture). Manufacturers should engage with governments
in target markets to establish streamlined process for adaptation.
• Many procurement decisions by countries and donors are driven by price,

particularly in low- and middle-income markets. Manufacturers who are able
to reduce price and shrink the gap between HIV RDTs for self-testing and
HIV RDTs for professional use may have a significant amount to gain. It
may be possible to achieve this by identifying innovation in product design,
manufacturing, packaging or shipment that could reduce product price.

ANNEX 1
SPECIFICATION SHEETS FOR HIV SELF-TEST
PRODUCTS IN THE MARKET

The following specification sheets provide information shared by manufacturers and
through public evaluations of HIV RDTs by a founding member of the GHTF.
Please note that sensitivity and specificity denotes the performance in the hands
of self-testers, and not the performance in the hands of professional users.
The information was provided by manufacturers and reflects what is stated in
manufacturer IFU and what is reported by recognized regulatory authorities (e.g.
FDA; CE; TGA) or other international approval systems (e.g. WHO prequalification;
Global Fund; USAID). Sensitivity and specificity reported in the literature, but not
recognized by a regulatory authority, is not reflected.
AUTOTEST VIH®
Product specification
Commercial name (trademark) autotest VIH®
Professional test basis

SURE CHECK® HIV-1/2
(commercial professional use name-trademark)
HIVST product photo
Approval status for professional use product CE, FDA, WHO prequalification
Company AAZ-LMB
Manufacturing site Rungis Cedex, France
Type of technology Immunochromatographie (lateral flow)
Generation (2nd, 3rd or 4th) 2nd

Synthetic: gp36,gp41,gp120
Antigen type
Control line: Protein A
Output Qualitative immunoassay, HIV-1/2 antibody detection
HIVST sensitivity 100%
HIVST specificity 99.8%
HIVST invalid rate 0.8%
Sample type Capillary whole blood
Volume of sample required 2.5 µL (integrated blood sampling system)
Capacity Single specimen – one-time use
150–200 µL (350 µL pre-measured enclosed in sealed

Volume of buffer required
buffer pot included)
Time to result 15 minutes
Read window Do not read after 60 minutes
1. Set up the stand and buffer

2. Remove lid from safety lancet and apply to finger
3. Sample collection (use end of barrel to collect sample)
Protocol complexity – steps requiredi
4. Push on test device through top of buffer to activate
migration
5. Interpretation of test result
Shelf life of test kit 24 months
8–30 °C – do not store in direct sunlight or open foil packet

Storage requirements
until ready to use the test
1 foil pouch containing test cassette, buffer cap, desiccant

Test kit components packet, bandage, safety lancet, test stand, disinfectant wipe,
sterile pad and IFU
Not included in test kit Timer
Wash hands and ensure they are clean and dry before testing
Do not open pouch until ready to perform test
Restrictions for use
Not intended for individuals with HIV-1 or HIV-2 who are on
ART
Test has an internal control (in the control line) to indicate

that human specimen has been added and that it has well
Controls migrated
Control specimens (e.g. test kit controls) are available but
sold separately
CE marked
Approvals for HIVST product
WHO prequalification dossier submitted in 2016
US$ 25–28 is the recommended consumer price in Europe;

HIVST pricing (US$/per test) US$ 8–15 for distributors and NGOs depending on format
(e.g. bulk; individual box), volume and conditions of payment.
Test kit has been evaluated formally among people using

ARV drugs for treatment and for prevention (e.g. PrEP
Additional details
or PEP) although the current product does not make an
intended use claim for people on PrEP or PEP
i
Steps are defined here as those beginning with the setup of the test kit and steps focused on specimen collection, specimen transfer, addition of buffer and ending
with interpretation of result.

BIOSURE HIV SELF TEST
Commercial name (trademark) BioSURE HIV Self Test

SURE CHECK® HIV-1/2/Stat-View HIV-1/2
HIVST product photo
Approval status for professional use product CE
Company BioSURE United Kingdom Ltd
Manufacturing site United Kingdom
Synthetic : gp36,gp41,gp120
Antigen type
HIVST sensitivity 99.7%
HIVST invalid rate 0.16%

Time to result Do not read before 15 minutes
1. Place pre-measured buffer pot into stand in box

3. Sample collection (place end of barrel onto drop of blood
to naturally collect sample)
Protocol complexity – steps required 4. Place test device into the buffer pot by pushing device tip
down firmly through foil lid to the bottom of the pot
5. Wait 15 minutes
6. Interpretation of test result through integrated section of
HIVST packaging
Shelf life of test kit 24 months after manufacture


until ready to use test
A carton or paper-based box including 1 foil pouch

(containing test device, safety lancet, bandage), IFU booklet,
Test kit components
integrated results reading booklet, disposal bag, product
insert
ART
Test has a control to indicate that human specimen has been

added
Controls
sold separately
Approval status for HIVST product CE
US$ 42–48 United Kingdom recommended retail price

(including tax) for direct to consumer sales via e-commerce
and United Kingdom private sector pharmacies
Pricing (US$/per test)
US$ 7.50–15 for sale to the public sector, including the
United Kingdom NGOs and the National Health Service
(NHS)
Test kit has not been evaluated formally among people using
Additional details
ARV drugs for prevention (e.g. PrEP or PEP)
ORAQUICK IN-HOME HIV TEST
Commercial name (trademark) OraQuick® In-Home HIV Test

OraQuick® ADVANCE® Rapid HIV-1/2
HIVST product photo
Approval status for professional use product FDA/CE

Company OraSure Technologies LLC
Manufacturing site Bethlehem, PA, USA
Synthetic peptides representing the HIV envelope region and

a goat anti-human IgG procedural control immobilized onto a
Antigen type
nitrocellulose membrane in the Test (T) zone and the Control
(C) zone
FDA: 91.7%
HIVST sensitivity
CE: 100%j
FDA: 99.98%
HIVST specificity
CE: 99.8%k
FDA: 1.1%
HIVST invalid rate
CE: 1.8%
Sample type Oral fluid
Volume of sample required NA
Volume of buffer required 1 mL
1. Remove cap of developer solution

2. Set buffer vial in stand
Protocol complexity – steps required 3. Collect sample (oral swab)
4. Insert sample in buffer
5. Interpret Result
Store at 2–27 °C – do not open foil packet until ready to use

test
Plastic package encasing a divided pouch (containing test

device, desiccant, developer solution vial), test/buffer stand,
Test kit components
pencil, disposal bag, IFU and informational booklets about
HIV
Do not eat, drink or chew gum for at least 15 minutes before

testing or use mouth cleaning products 30 minutes before
taking the test
Restrictions for use Do not open pouch until ready to perform test
ART
Operate at 15–37 °C
Addition of procedural quality control (band appears when

Controls human specimen is added and sample has flown up the
device)
FDA
Approval status for in-home HIV test product Formal CE mark pending as product has not yet been
launched in the EU

Distributor price not available

Pricing (US$/per test) US$ 40 is recommended consumer price in the USA;
recommended prices outside the USA not yet available
Detects HIV-1 seroconversion 2.5 days (95% CI: 1.2–3.8)

later than CE marked enzyme immunoassay (EIA)
Additional details
INSTI HIV SELF TEST
Commercial name (trademark) INSTI HIV Self Test

INSTI® HIV-1/HIV-2 Antibody Test
HIVST product photo
CE/FDA/HealthCanada/WHO prequalification
Approval status for professional use product CLIA Complexity: waived for fingerstick whole blood and
moderate for venous whole blood and plasma
Company bioLytical Laboratories
Manufacturing site Richmond, British Columbia, Canada
Type of technology Immunofiltration
Generation (2nd, 3rd or 4th) 3rd generation
gp41 and gp36 antigen

Antigen type
Control: Protein A
HIVST sensitivity 100%
HIVST invalid rate 0%
j
Note this is preliminary information, as the product has not yet been officially launched in Europe.
k
Note this is preliminary information, as the product has not yet been officially launched in Europe.

Sample type Fingerstick whole blood
Volume of sample required 50µL
1.5mL sample diluent, 1.5 mL colour developer, and 1.5 mL

Volume of Buffer required
of clarifying solution
Time to result Instant results after completion of procedure
1. Remove cap of sample diluent

2.Collect sample (fingerprick)
3.Insert sample into sample diluent
Protocol complexity – steps required
4. Sequentially invert and pour sample diluent, colour
developer and clarifying solution on to test device
5. Interpret Results
Store at 15 – 30°C.
The kit can be refrigerated (2-8oC) if required.
1 cardboard box containing test device, sample diluent, colour

developer, clarifying solution, IFU, HIVST Booklet, 2 sterile
Test kit components
single-use lancets, 2 pipettes, an adhesive bandage, and
disposal bag
Not included in test kit Not required
Not suitable for users who have a bleeding disorder

Not suitable for users below the age of 18
Not suitable for users who are taking ARV drugs for
treatment or prevention (i.e. ART, PrEP or PEP)
Not suitable for users who have participated in a HIV vaccine
study.
Built in procedural control of protein A which detects the

Controls human IGg antibodies.
Test kit quality controls available upon request.
Approval status for in-home HIV test product CE Marked
$36 is recommended consumer price in Europe

Pricing (US$/per test) Pricing information for distributors and NGOs available upon
request.
ARV drugs for prevention (e.g. PrEP or PEP).
Additional details
Extra pipette and lancet provided in the kit, but not required
for use.

ANNEX 2
SPECIFICATION SHEETS FOR HIV SELF-TEST
PRODUCTS EMERGING IN THE MARKET

The following specification sheets provide information shared by manufacturers
regarding products that are under development or are in the process of seeking
and receiving approvals by a founding member of the GHTF1 or through other
international approval systems (e.g. WHO prequalification; Global Fund; USAID).
Furthermore, these specification sheets are not comprehensive, as there are other
products under development for which available information was either inadequate or
confidential.
Please note all information and product characteristics described are subject to
change.
Please note that sensitivity and specificity is the performance in the hands of self-
testers, and not the performance in the hands of professional users. The information
was provided by manufacturers and reflects what is stated in manufacturer IFU and
what is reported by recognized regulatory authorities (e.g. FDA; CE; TGA) or other
international approval systems (e.g. WHO prequalification; Global Fund; USAID).
Sensitivity and specificity reported in the literature, but not recognized by a regulatory
authority, is not reflected.
ATOMO HIV SELF-TEST
Commercial name (trademark) Atomo HIV Self-Test

AtomoRapidTM HIV (1&2)
HIVST product photo
Approval status for professional use product CE; submitted dossier for WHO prequalification
Company Atomo Diagnostics
Manufacturing site Australia
Generation (2nd, 3rd or 4th) 3rd
1
Founding members of the GHTF include Australia, Canada, the European Union, Japan and the United States. Approval by these bodies is considered stringent
regulatory approval.

Antigen type Recombinant and synthetic peptides for HIV-1 and HIV-2
Qualitative immunoassay, HIV-1/2 antibody detection,

Output
including subtype O
HIVST sensitivity NA
HIVST specificity NA
HIVST invalid rate NA
Volume of sample required 10 uL
2–4 drops (sufficient mL to initiate fluid flow on the test

strip)
1. Pull green tab to remove lancet cap

2. Push grey button firmly to prick finger
3. Squeeze finger firmly to extract blood and touch blood to
Protocol complexity – steps requiredm tip of blood tube and fill tube
4. Flip blood tube over to the well
5. Add 2-4 drops of buffer solution
6. Interpret test results
2–30 °C; do not store in direct sunlight or open foil packet

IFUs, foil packet containing test cassette and desiccant,

Test kit components
buffer solution, disposable bag, care card
Not included in test kit Timer, bandage, sterile swab or tissue
The device has a self-contained internal control: if the purple

colour band (control line) is not visible within the result
window after performing the test, the result is considered
Controls invalid. However the test does not include a control for
human specimen.
sold separately
Wash your hands and ensure they are clean and dry before
starting the test
Restrictions of use Not suitable for blood donors or people with blood clotting or
bleeding disorders (e.g. haemophilia)
Not intended for people with HIV-1/2 using ART
Approval status for HIVST product None
Current or recommended price is not yet available for

Pricing (US$/per test)
distributors or for sale direct to consumers
Used or unused test should be placed in disposal bag, sealed

and disposed in general waste system
Additional details
m
Steps are defined here as those beginning with the setup of the test kit and steps focused on specimen collection, specimen transfer, addition of buffer and ending
with interpretation of result.

AWARE™ HIV-1/2 OMT ORAL HIV SELF TEST
Commercial name (trademark) Aware™ HIV-1/2 OMT Oral HIV Self Test
Commercial professional use name (trademark) Aware™ HIV-1/2 OMT, Oral HIV Rapid Test
HIVST product photo
Approval status for professional use product USAID waiver list; WHO prequalification application under review
Company Calypte Biomedical Corporation
Manufacturing site Thailand
Antigen type gp36,gp41
HIVST Sensitivity NA
HIVST Specificity NA
HIVST Invalid rate NA
Sample type Oral fluid (oral mucosal transudate)
Sample storage 2–30 °C
1. Insert test tube into stand

2. Remove test tube cap
3. Collect specimen by swabbing gum line
Protocol complexity – steps required 4. Transfer specimen to test tube containing buffer
5. Insert test strip into test tube
6. Remove test strip
7. Interpret test result
Shelf life of test kit 18 months (unopened); 7 days (opened)
2–30 °C – do not store in direct sunlight or open foil packet until

Storage requirements ready to use test
IFU, frequently asked questions, 1 foil pouch (containing 1 test

Test kit components strip, 1 desiccant, 1 capped test tube containing 1 mL of buffer, 1
collection swab and 1 test kit box (box also used as a stand)

Do not eat, drink or chew anything 10 minutes before testing

Not intended for people with HIV-1/2 using ART
Control specimens (e.g. test kit controls) are available but sold
separately
Controls All control specimens are derived from inactivated human plasma.
None of the controls were designed to produce an invalid test result.
Current or recommended price is not yet available for distributors or

Professional use pricing (US$/per test) for sale direct to consumers
Test kit has not been evaluated formally among people using ARV
Additional details drugs for prevention (e.g. PrEP or PEP)
ORAQUICK® HIV SELF-TEST
Commercial name (trademark) OraQuick® HIV Self-Test

OraQuick® Rapid HIV-1/2 Antibody Test
HIVST product photo
Approval status for professional use product WHO prequalification
Company OraSure Technologies LLC
Manufacturing site Thailand
Synthetic peptides representing the HIV envelope region and a goat

Antigen type anti-human IgG procedural control immobilized onto a nitrocellulose
membrane in the Test (T) zone and the Control (C) zone
HIVST sensitivity NA

HIVST specificity NA
HIVST invalid rate NA
Sample type Oral fluid
1. Remove cap of developer solution

2. Set buffer vial in stand
Protocol complexity – steps required 3. Collect sample (oral swab)
4. Insert sample in buffer vial
5. Interpret Result
Storage requirements Store at 2–27 °C– do not open foil packet until ready to use test
A divided pouch (containing test cassette, desiccant, vial of buffer),

Test kit components test/buffer stand and IFU
Do not eat, drink or chew gum for at least 15 minutes before testing
or use mouth cleaning products 30 minutes before taking the test
Not intended for individuals with HIV-1 or HIV-2 who are on ART
Operate at 15–37 °C
Test has a control to indicate that human specimen has been added
(i.e. band appears when human specimen is added)
Controls Control specimens (e.g. test kit controls) are available but sold
separately
Pricing (US$/per test) Pricing available from OraSure Technologies upon request
Test kit has not been evaluated formally among people using ARV
Additional details drugs for prevention (e.g. PrEP or PEP)
EXACTO® HIV SCREENING TEST
Commercial name (trademark) Exacto® HIV Screening Test

EXACTO® Test HIV

HIVST product photo
Approvals for professional use product CE
Company Biosynex Group
Manufacturing site France
Antigen type Synthetic: gp41,gp36
HIVST Sensitivity Not specified
HIVST Specificity Not specified
HIVST Invalid rate Not specified
Volume of sample required Not specified
Volume of buffer required 2 dropsn

2. Squeeze finger and use inverted cup/capillary tube to
collect sample
Protocol complexity – steps required 3. Add drop of blood to the test cassette where marked
“Blood”
4. Add buffer to the test cassette where marked “diluent”
5. Interpret result
Shelf life of test kit Not specified

1 foil pouch with test cassette and desiccant, 1 buffer

Test kit components solution, 1 bandage, 1 alcohol-wipe, 1 sterile pad, 1 lancet
and 1 inverted cup/capillary tube, IFU, disposal bag
n
Amount in mL not specified.

Test must be run immediately after the capillary blood has
been collected
ART
Test should be run in setting with 15–30 °C

added
Controls
sold separately
Approvals for HIVST product CE mark pending
HIVST pricing (US$/per test) Price to distributors and consumers not yet available
Validation study from CE mark; study did not provide

sensitivity and specificity but stated that 99.5% of
participants obtained interpretable result and 98% of the
Additional details
results were interpreted correctly
TO BE NAMED – CHEMBIO DIAGNOSTIC SYSTEMS INC.
Commercial name (trademark) To be named

SURE CHECK® HIV-1/2/Stat-View® HIV-1/2 assay
HIVST product photo NA
CE/FDA/WHO prequalification
Approvals for professional use product CLIA Complexity: waived for fingerstick and venous whole
blood/moderate for serum and plasma
Company Chembio Diagnostic Systems Inc.
Manufacturing site Medford, NY, USA
Synthetic: gp36,gp41,gp120
Antigen type
HIVST Sensitivity NA
HIVST Specificity NA
HIVST Invalid rate NA


Time to result Do not read until 15 minutes
1. Set up the stand and buffer

3. Sample collection (use end of barrel to collect sample)
Protocol complexity – steps required
4. Place test device on top of buffer
5. Push on test device through to activate buffer solution
6. Interpretation of test result
Shelf life of test kit 24 months from date of manufacture

1 foil pouch containing test cassette, buffer cap, desiccant

Test kit components
packet, bandage, safety lancet, test stand
ART

added
Controls
sold separately
None
Two private label version of the product are CE marked for
Approvals for HIVST product
self-testing in the European Union (BioSURE HIV Self-Test
and autotest VIH®)
Current or recommended price is not yet available for

HIVST pricing (US$/per test)
distributors or for sale direct to consumers
Additional details

66 | UNITAID Discussion Paper
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Discussion Paper UNITAID | 67

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TECHNOLOGY LANDSCAPE

HIV RAPID DIAGNOSTIC TESTS

Design and layout:

2 | UNITAID Technology Landscape

HIV RAPID DIAGNOSTIC TESTS

Technology Landscape UNITAID | 3

12 Public health problem

12 The potential for HIV self-testing (HIVST)

19 Technologies available to diagnose HIV

20 Professional use of RDTs

23 HIVST target product profile

26 Current market of HIV RDTs for self-testing

32 Global HIVST demand

32 Current and estimated HIVST demand

42 Summary and conclusions

42 Key considerations for countries, national programmes

43 Key considerations for donors

44 Key considerations for manufacturers

4 | UNITAID Technology Landscape

50 BioSURE HIV Self Test

51 OraQuick® In-Home HIV Test

53 INSTI HIV self-test

57 Annex 2. Specification sheets for HIV self-test

58 Atomo HIV Self-Test

60 Aware™ HIV-1/2 OMT Oral HIV Self Test

61 OraQuick® HIV Self-Test

62 Exacto® HIV Screening Test

64 To be named – Chembio Diagnostic Systems Inc.

Technology Landscape UNITAID | 5

6 | UNITAID Technology Landscape

ART antiretroviral therapy

CDC Centers for Disease Control and Prevention

DNA deoxyribonucleic acid

ERPD Expert Review Panel for Diagnostics

FDA United States Food and Drug Administration

GHTF Global Harmonization Task Force

Global Fund Global Fund to Fight AIDS, Tuberculosis and Malaria

HIV human immunodeficiency virus

HIVST HIV self-testing

IFU instructions for use

IPV intimate partner violence

IVD in vitro diagnostic

ISO International Organization for Standardization

NAT nucleic acid testing

Technology Landscape UNITAID | 7

PEP post-exposure prophylaxis

PEPFAR President’s Emergency Program for AIDS Relief

PLHIV people living with HIV

PMA pre-market approval

PrEP pre-exposure prophylaxis

PSI Population Services International

RDT rapid diagnostic test

RNA ribonucleic acid

STI sexually transmitted infection

TGA Therapeutic Goods Administration

UNAIDS Joint United Nations Programme on HIV/AIDS

UNICEF United Nations Children’s Fund

USA United States of America

USAID United States Agency for International Development