Serological evidence of HIV infection may be obtained by testing

OneStep for HIV antigens or antibodies. Antigen to HIV can be detected SPECIMEN COLLECTION AND PREPARATION
HIV 1+2 throughout virtually the total infection period, starting at or
shortly after the acute phase and lasting until the end stage of
Whole blood:
Wash your hands with soap and warm water. Choose a puncture
RapiCard™ InstaTest AIDS. Therefore, the use of highly sensitive antibody assays is the site on the fingertip. Clean the fingertip with Alcohol Prep Pad.
primary approach in serodiagnosis of HIV infection. Place a Safety Lancet on a selected puncture site. Forcefully press
Serum, WB, Plasma the tip of the Safety Lance against your fingertip. Wipe away the
first drop of blood with sterile gauze or cotton Using Disposable
TEST PRINCIPLE Pipette, collect blood from the puncture site. Alternatively - draw
Cat #177575-1-12 blood following laboratory procedure for obtaining venous blood.
This test employs chromatographic lateral flow device in a Do not test whole blood samples if older than 3days.
cassette format. Colloidal gold conjugated recombinant antigens
“Export Use Only” (Au-Ag) corresponding to HIV-1 gp120, gp41 and HIV-2 gp-36 Serum/plasma samples:
are dry-immobilized at the end of nitrocellulose membrane strip. Fresh serum or plasma samples can be used. No special patient
HIV 1+2 antigens are bond at the Test Zone (T) and rabbit anti- preparation required. Care should be taken to ensure blood full
HIV 1+2 monoclonal antibodies are bond at the Control Zone (C). clotting and any visible particulate matter in the sample should be
See external Label 40 Tests When the sample is added, it migrates by capillary diffusion removed by centrifugation or filtration. Avoid the use of highly
rehydrating the gold conjugate. If present in sample, HIV 1/2 hemolytic, turbid, microorganism contaminated samples or
antibodies will bind with the gold conjugated antigens forming samples stored for over 30days at 2-8 °C. Store samples at 2-8 °C.
Sensitvity 99% particles. These particles will continue to migrate along the strip Samples not required for assay within 3 days should be stored
Specificity 100% until the Test Zone (T) zone where they are captured by the HIV frozen (-20 °C or lower). Avoid sample deterioration by multiple
1+2 antigens generating a visible red line. If there are no HIV 1 or freeze-thaw cycles.
Generation 3rd Generation 2 antibodies in sample, no red line is formed in the Test Zone
(T).The gold conjugate will continue to migrate alone until it is Plasma: Collect whole blood into a collection tube (containing
captured in the Control Zone(C) by the rabbit anti-HIV 1+2 EDTA, citrate or heparin, respectively) by venipuncture. Separate
INTENDED USE antibodies aggregating in a red line, which indicates the validity the plasma by centrifugation.
of the test.
This test is a single use, rapid device for qualitative detection of Serum: Collect whole blood into a collection tube (containing no
antibodies to Human Immunodeficiency Viruses (HIV) in whole anticoagulants) by venipuncture. Allow the blood to clot. Separate
blood, serum and plasma samples.”Export Use Only” by centrifugation

SUMMARY AND EXPLANATION MATERIALS AND COMPONENTS

The Human Immunodeficiency Viruses type 1 and type 2 are Y HIV 1/2 Antibodies in sample.
etiological agents of the acquired immunodeficiency syndrome Ag1 Au-Ag in S (Sample Pad Window). Materials provided with the test kits
(AIDS). HIV has been isolated from patients with AIDS, AIDS Ag1-Y Au-Ag-HIV 1/2 Antibody Complex. 1. HIV (1+2) colloidal gold rapid test in white plastic cassette
related complex (ARC) and from healthy individuals at high risk Ag2 HIV 1/2 Antigens immobilized in the Test packed in foil pouch.
for (AIDS). Infection with HIV is followed by an acute flu-like Zone (T). 2. Instructions for use.
illness. This phase may remain unnoticed and the relationship to Ag1-Y-Ag2 Double Antigen Sandwich Complex in the 3. Diluent buffer.
HIV infection may not be clear in many cases. The acute phase is Test Zone (T). 4. The dilution buffer can be stored at room temperature. Stable
typically followed by an asymptomatic carrier, which progresses Ag1-YR Au-Ag-Rabbit anti-HIV complex in the for one month after opening.
to clinical AIDS in about 50% of infected individuals within 10 Control zone (C).
years after seroconversion.

COR CODE #12 Page 1 of 3

Materials required but not provided (5) 200 200 100anti-HCV 100
1. Clock or timer. (+) 2
2. Specimen collection container. 2 RF (+)
3. Centrifuge. (6) 50 49 10 Anti-HAV 10
4. Biohazard waste container. (+) 50
5. Sterile gauze or cotton. 50 HBsAg (+) 40
6. Single use only whole blood samples collection pipettes and 40 TP (+) 100
safety lancet. 100 N. sera
Total 670 666 2657 Error!
No book
POSITIVE NEGATIVE INVALID
ASSAY PROCEDURE mark
name
Procedure for whole blood samples: Open the pouch and pipette When the result of the test is positive, please contact your given
50µl of blood into the sample window (S). Add 50µl (or about one doctor. The positive result obtained with this Diagnostic
drop) of Diluent Buffer into the sample window. Procedure for Automation, Inc. HIV 1+2 Rapid Test alone cannot be the
serum/plasma samples: Open the pouch and add 80µl of serum or final diagnosis of HIV. Any positive result must be
plasma into the sample window (S). Avoid dropping sample or interpreted in conjunction with the patient clinical history
LIMITATIONS OF PROCEDURE
buffer in the observation window. Do not allow the sample to and another laboratory testing results. Follow-up and 1. Negative results do not exclude the possibility of HIV
overflow. Place the cassette on flat surface and read the results supplementary testing of all positive samples with other exposure or infection. Infection through recent exposure
within 10 to 30 minutes. A positive test line may appear after analytical system (e.g.ELISA, WB) is required to confirm any (seroconversion) to HIV may not be detectable. For positive
30minutes-this is a False Positive Result-do not read the results positive result. results, line intensity cannot be used to evaluate the anti-
after 30 minutes. HIV antibody levels. A test giving an invalid result should
be repeated. This HIV (1+2) Rapid Test does not
PERFORMANCE CHARACTERISTICS differentiate between recognition of HIV-1 antibodies and
RESULTS In a clinical evaluation of the performance of Diagnostic HIV-2 antibodies.
Automation, Inc. HIV 1/2 Rapid Test using 2657 confirmed 2. If, after retesting of the initially reactive samples, the test results

Quality Control: One red line will always appear next to the negative and 667 positive samples, sensitivity was 99.4% are negative, these samples should be considered as non-
Control Zone(C) indicating the validity of the test. If no red line (666/667) and specificity was 100% (2657/2657). The overall repeatable (false positive) and interpreted as negative. As with
appears, the test is invalid - discard the test and repeat with new agreement with the reference ELISA tests is 100%. Accuracy of many very sensitive rapid diagnostic tests, false positive results
sample and new cassette. 99% based on internal Quality Control standards. can occur due to the several reasons, most of which are related

Positive Results: One red line next to the Test Zone (T) but not limited to the quality of the sample and exposition of the
indicates that antibodies to HIV 1+2 have been detected using test to humidity
this HIV 1+2 Rapid Test. 3. This kit is intended ONLY for testing of individual samples.
Sites HIV pos.sera HIV neg.sera

Negative Results: No red line appears within 30 minutes next Do not use it for testing of cadaver samples, saliva, urine or
Total Positive Total Neative
to the Test Zone (T) indicating that no antibodies to HIV 1+2 other body fluids, or pooled (mixed) blood.
(1) 50 49 200 200
have been detected with this HIV 1+2 Rapid Test. However, this 4. This is a qualitative assay and the results can not be used to
(2) 119 119 61 anti-HCV 61
does not exclude the possibility from infection with HIV. measure antibodies concentrations.
(+) 113
113 HBsAg 110
(+) 1500
110 TP (+)
PRECAUTION
1500 n. sera For professional use only
(3) 149 147 173 173 1. This test is for In Vitro Use only
(4) 102 102 198 198

COR CODE #12 Page 2 of 3

2. All the waste and sample should be treated in case of 12. This test can be stored at room temperature (2-30 ºC do not freeze!)
transmitting disease and must be properly disinfected for 18 months from the date of manufacture (see label on strip pouch).
(autoclaving is preferred) before disposal. Use immediately after opening.
3. Once taking the cassette out of the pouch, carry out your
testing as early as possible (no more than 20 minutes) to
avoid moisture. The nitrocellulose membrane can absorb ISO 13485
water, which can affect the test chromatography ISO 9001
performance.
4. The performance characteristics of the test depend on
sample quality and preparation. For strong reactive samples,
the red line (corresponding to the Test Zone (T)) may appear
in 3-5 minutes after sample loading, but for weak reactive Diagnostic Automation/
samples, the red line may appear in 15 minutes. To obtain Cortez Diagnostics, Inc.
accurate assay results, the test results must be read within 30
minutes. Results obtained after 30 minutes can lead to
21250 Califa Street, Suite 102 and 116
incorrect interpretation. Woodland Hills, California 91367 USA

Date Adopted Cat # 177575-1-12

CORTEZ- OneStep
HIV 1 + 2
2011-01-01
RapiCard™ InstaTest -2015
Serum, WB,Plasma
Revision C Date: 2015-08-15

5. Make sure that the test is not expired (EXP Date indicated on
the kit box).
6. If automatic pipette is used, calibrate it frequently to assure
the accuracy of dispensing. Use different disposal pipette
tips for each specimen in order to avoid cross-
contaminations.
7. Do not modify the test procedure.
8. Do not reuse the test cassettes. Autoclave before disposal.
9. A test giving an invalid result should be repeated.
10. Blood that has been chemically treated, heated, diluted, or
otherwise modified may give inaccurate results.
11. The test kit can be stored at temperatures between 2 to 30ºC in the
sealed pouch to the date of expiration. The test kit should be kept
away from direct sunlight, moisture and heat.

COR CODE #12 Page 3 of 3