EN Q-NCOV-01G Cat. No.

: 09COV30D KIT CONTENTS

STANDARD Q

COVID-19 Ag STANDARD Q

COVID-19 Ag Test

2°C
(36°F)
30°C
(86°F) TM

STANDARDTM Q COVID-19 Ag Test

PLEASE READ CAREFULLY BEFORE YOU PERFORM THE TEST
Test device (individually in a Extraction Sterile
Nozzle cap Instructions for use
foil pouch with desiccant) buffer tube swab

PREPARATION

1 Carefully read instructions for using the

STANDARD Q COVID-19 Ag Test.
2 Check the expiry date at the back of the foil
pouch. Do not use the kit, if expiry date has
3 Check the test device and the desiccant pack in the foil pouch.

passed. COVID-19
Ag

Yellow
STANDARD Q

COVID-19 Ag Test

C
/ Item STANDARD Q COVID-19 Ag ① Result window
Green

T
/ REF No. Q-NCOV-01G
/ LOT No.
xxxxxxxxxxxx
/ MFG DATE YYYY.MM.DD.
/ EXP DATE YYYY.MM.DD.
#Buffer Lot : xxxxxxxxxx
30°C
(86°F) TM

② Specimen well
2°C
(36°F)

Yellow: Valid
Green: Invalid

<Foil pouch> <Test device> <Desiccant>

COLLECTION OF SPECIMEN
[Nasopharyngeal swab]

1 Insert a sterile swab into the nostril of

the patient, swab over the surface of the
2 Insert the swab into an extraction buffer
tube. While squeezing the buffer tube, stir
3 Remove the swab while squeezing the
sides of the tube to extract the liquid from
4 Press the nozzle cap tightly onto the tube.

posterior nasopharynx. Withdraw the the swab more than 5 times. the swab.
sterile swab from the nasal cavity.

x5

ANALYSIS OF SPECIMEN
[Specimens in transport media]

1 Using a micropipette, collect the 350µl

of specimen from the collection cup or
2 Press the nozzle cap tightly onto the tube.
1 Apply 3 drops of extracted specimen to
the specimen well of the test device.
2 Read the test result in 15-30 minutes.

VTM. Mix the specimen with an extraction

buffer.

Read
in 15-30 mins.
Do not read
after 30 mins.

15-30 mins
3 drops
C T
COVID-19

350µl • Do not read test results after 30 minutes.

It may give false results.
Ag

Few times mix

CAUTION

INTERPRETATION OF TEST RESULT

Positive Negative Invaild

COVID-19 COVID-19 COVID-19 COVID-19 COVID-19

Ag Ag Ag Ag Ag

“ C” Control Line
C

“T” Test Line

T

Ag Positive Negative Invalid

1. A colored band will appear in the top section of the result window to show that the test is working properly. This band is control line (C).
2. A colored band will appear in the lower section of the result window. This band is test line of SARS-CoV-2 antigen (T).
3. Even if the control line is faint, or the test line isn't uniform, the test should be considered to be performed properly and the test result should be interpreted as a positive result.
* The presence of any line no matter how faint the result is considered positive.
* Positive results should be considered in conjunction with the clinical history and other data available.
STANDARDTM Q COVID-19 Ag Test

EXPLANATION AND SUMMARY ANALYTICAL PERFORMANCE

[Introduction] 1. Limit of Detection (LoD) 3. Exogenous/Endogenous Interference Substances studies: There was no interference for potential interfering
Coronavirus is a single-stranded positive-sense RNA virus with an envelope of about 80 to 120 nm in diameter. Its The SARS-CoV-2 positive specimen was prepared by spiking Inactivated SARS-CoV-2 (2019-nCOV) NCCP substances listed below.
genetic material is the largest of all RNA viruses and is an important pathogen of many domestic animals, pets, 43326/2020/Korea strain to SARS-CoV-2 negative nasopharyngeal swab confirmed with PCR. LoD is determined ① Exogenous factor
and human diseases. It can cause a variety of acute and chronic diseases. Common signs of a person infected as 3.06 x 10 TCID50/ml by testing serially diluted the mock positive specimen.
2.2
Exogenous factor Interfering substances Test conc.
with a coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe
cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. The 2. Cross-Reactivity& Microbial interference Zanamivir (Influenza) 5 mg/ml
2019 new coronavirus, or “SARS-CoV-2 (COVID-19)”, was discovered because of Wuhan Viral Pneumonia cases There was no cross-reaction and interference with the potential cross-reacting microorganisms listed below Oseltamivir (Influenza) 10 mg/ml
in 2019, and was named by the World Health Organization on January 12, 2020, confirming that it can cause except SARS-COV.
colds and the Middle East Respiratory Syndrome (MERS) and more serious diseases such as acute respiratory Artemether-lumefantrine (Malaria) 50 µM
Potential cross reacting Concentration of potentially cross
syndrome (SARS). This kit is helpful for the auxiliary diagnosis of coronavirus infection. The test results are for Strain Doxycycline hyclate (Malaria) 70 µM
substance reacting substance
clinical reference only and cannot be used as a basis for confirming or excluding cases alone.  Relevant medicines
SARS-coronavirus Urbani 3.5 µg/ml Quinine (Malaria) 150 µM
[Intended use] MERS-Coronavirus Florida/USA-2_Saudi Arabia_2014 4 x 104 TCID50/ml Lamivudine (Retroviral medication) 1 mg/ml
STANDARD Q COVID-19 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of specific
229E 1 x 104.5 TCID50/ml Ribavirin (HCV) 1 mg/ml
antigens to SARS-CoV-2 present in human nasopharynx. This test is for administration by healthcare workers and
labs only, as an aid to early diagnosis of SARS-CoV-2 infection in patient with clinical symptoms with SARS-CoV-2 Human Coronavirus OC43 1 x 105 TCID50/ml Daclatasvir (HCV) 1 mg/ml
infection. It provides only an initial screening test result. This product is strictly for medical professional use only
NL63 1 x 104 TCID50/ml Acetaminophen 200 µM
and not intended for personal use. The administration of the test and the interpretation of the results should
Anti-inflammatory
be done by a trained health professional. The result of this test should not be the sole basis for the diagnosis; H1N1 Denver 1 x 105 TCID50/ml Acetylsalicylic acid 3.7 mM
medication
confirmatory testing is required. Ibuprofen 2.5 mM
H1N1 WS/33 1 x 105 TCID50/ml
[Test principle] Influenza A H1N1 Pdm-09 1 x 105 TCID50/ml Mupirocin 10 mg/ml
STANDARD Q COVID-19 Ag Test has two pre-coated lines, “C” Control line, “T” Test line on the surface of the Tobramycin 5 µg/ml
H1N1 New Caledonia 1 x 105 TCID50/ml
nitrocellulose membrane. Both the control line and test line in the result window are not visible before applying Antibiotic
any specimens. Mouse monoclonal anti-SARS-CoV-2 antibody is coated on the test line region and mouse H1N1 New jersey 1 x 105 TCID50/ml Erythromycin (antibiotic) 81.6 µM
monoclonal anti-Chicken IgY antibody is coated on the control line region. Mouse monoclonal anti-SARS-CoV-2
Ciprofloxacin (antibiotic) 31 µM
antibody conjugated with color particles are used as detectors for SARS-CoV-2 antigen device. During the test, Nevada/03/2011 1 x 105 TCID50/ml
SARS-CoV-2 antigen in the specimen interact with monoclonal anti-SARS-CoV-2 antibody conjugated with color Neo-Synephrine (Phenylephrine) 10% (v/v)
Influenza B B/Lee/40 1 x 104 TCID50/ml
particles making antigen-antibody color particle complex. This complex migrates on the membrane via capillary
Afrin Nasal Spray (Oxymetazoline) 10% (v/v)
action until the test line, where it will be captured by the mouse monoclonal anti-SARS-CoV-2 antibody. A colored
B/Taiwan/2/62 1 x 105 TCID50/ml Nasal sprays or drops
test line would be visible in the result window if SARS-CoV-2 antigens are present in the specimen. The intensity Saline Nasal Spray 10% (v/v)
of colored test line will vary depending upon the amount of SARS-CoV-2 antigen present in the specimen. If SARS- Type A 1 x 105 TCID50/ml
Respiratory syncytial virus Rhinocort
CoV-2 antigens are not present in the specimen, then no color appears in the test line. The control line is used for 10% (v/v)
Type B 1 x 105 TCID50/ml (Nasal corticosteroids - Budesonide)
procedural control, and should always appear if the test procedure is performed properly and the test reagents
of the control line are working. Human Metapneumovirus hMPV 3 Type B1 / Peru2-2002 1 x 10 TCID50/ml
5 Homeopathic Zicam Allergy Relief
5% (v/v)
(hMPV) Nasal Gel
hMPV 16 Type A1 / IA10-2003 1 x 105 TCID50/ml Homeopathic allergy relief
[Kit contents] medicine Sodium Cromoglycate 20 mg/ml
① Test device (individually in a foil pouch with desiccant) ② Extraction buffer tube ③ Nozzle cap Type 1 1 x 105 TCID50/ml
Olopatadine Hydrochloride 10 mg/ml
④ Sterile swab ⑤ Instructions for use Type 2 1 x 105 TCID50/ml
Parainfluenza virus Oral anaesthetic Anbesol (Benzocaine 20%) 5% (v/v)
Type 3 1 x 10 TCID50/ml
5

KIT STORAGE AND STABILITY Type 4A 1 x 105 TCID50/ml Throat lozenges

Strepsils (flurbiprofen 8.75mg ) 5% (w/v, 50mg/ml)
Store the kit at 2-30°C / 36-86°F out of direct sunlight. Kit materials are stable until the expiration date printed on Thoat candy (mint) 5% (w/v, 50mg/ml)
the outer box. Do not freeze the kit. A16 1 x 105 TCID50/ml
Rhinovirus Mucin: bovine submaxillary gland,
Type B42 1 x 10 TCID50/ml
4 100 µg/ml
Others type I-S
WARNINGS AND PRECAUTIONS Type 68 1 x 104 TCID50/ml Biotin 100 µg/ml
1. Do not re-use the test kit. Enterovirus
2. Do not use the test kit if the pouch is damaged or the seal is broken. (09/2014 isolate 4) 1 x 104 TCID50/ml
3. Do not use the extraction buffer tube of another lot. K 1 x 104 TCID50/ml ② Exogenous factor
4. Do not smoke, drink or eat while handling specimen. Endogenous factor Interfering substances Test Value
5. Wear personal protective equipment, such as gloves and lab coats when handling kit reagents. Wash hands Erdman 1 x 104 TCID50/ml
thoroughly after the tests are done. Mycobacterium tuberculosis HN878 1 x 10 TCID50/ml
4 802 ng/ml
6. Clean up spills thoroughly using an appropriate disinfectant. 375 ng/ml
7. Handle all specimens as if they contain infectious agents. CDC1551 1 x 104 TCID50/ml
8. Observe established precautions against microbiological hazards throughout testing procedures. H37Rv 1 x 104 TCID50/ml Human anti-mouse antibody 317 ng/ml
9. Dispose of all specimens and materials used to perform the test as bio-hazard waste. Laboratory chemical and Autoimmune disease
Type 1 3 x 10 TCID50/ml
5 69 ng/ml
biohazard wastes must be handled and discarded in accordance with all local, state, and national regulations.
10. Desiccant in foil pouch is to absorb moisture and keep humidity from affecting products. If the moisture Type 3 1.5 x 106 TCID50/ml 727.5 ng/ml
indicating desiccant beads change from yellow to green, the test device in the pouch should be discarded. Rheumatoid factor 3,480 IU/mL
Type 5 4 x 105 TCID50/ml
Whole Blood (human), EDTA
SPECIMEN COLLECTION AND PREPARATION Type 7 1.5 x 106 TCID50/ml
Serum protein anticoagulated
10% (w/w)
1. To collect a nasopharyngeal swab specimen, insert a sterile swab into the nostril of the patient, reaching the Adenovirus Type 8 4 x 105 TCID50/ml
surface of the posterior nasopharynx. Human serum albumin 60 mg/ml
Type 11 4 x 105 TCID50/ml
2. Using gentle rotation, push the swab until resistance is met at the level of the turbinate.
3. Rotate the swab a few times against the nasopharyngeal wall. Type 18 4 x 10 TCID50/ml
5

4. Remove the swab from the nostril carefully. LIMITATION OF TEST

Type 23 4 x 105 TCID50/ml 1. The test procedure, precautions and interpretation of results for this test must be followed strictly when testing.
5. Specimen should be tested as soon as possible after collection.
6. Specimens may be stored at room temperature for up to 1 hours or at 2-8°C/ 36-46°F for up to 4 hours prior to testing. Type 55 4 x 105 TCID50/ml 2. The test should be used for the detection of SARS-CoV-2 antigen in human nasopharyngeal swab specimens.
3. Neither the quantitative value nor the rate of SARS-CoV-2 antigen concentration can be determined by this
If the specimen storage condition is out of instructions as below, do not use. human immunodeficiency
BaL 10 µg/ml qualitative test.
1. The Nasopharyngeal swab is stored in extraction buffer for more than 4 hours at 5±3℃ or virus lysate 4. Failure to follow the test procedure and interpretation of test results may adversely affect test performance
CAUTION 1 hour at 20±5℃.
Haemophilus influenzae NCTC 4560 5 x 104 cells/ml and/or produce invalid results.
2. Freezing and thawing of Nasopharyngeal swab or the specimen in UTM is more than 1 cycle
5. A negative test result may occur if the level of extracted antigen in a specimen is below the sensitivity of the
or 3 cycles. Mutant 22 5 x 104 cells/ml test or if a poor quality specimen is obtained.
3. The Nasopharyngeal swab is stored in UTM for more than 12 hours at 5±3℃ or 8 hours at
FH strain of Eaton Agent [NCTC 6. For more accuracy of immune status, additional follow-up testing using other laboratory methods is recommended.
20±5℃. Mycoplasma pneumoniae 5 x 104 cells/ml
10119] 7. The test result must always be evaluated with other data available to the physician.
8. A negative result may occur if the concentration of antigen or antibody in a specimen is below the detection
M129-B7 5 x 104 cells/ml limit of the test or if the specimen was collected or transported improperly, therefore a negative test result does
[Transport medium] 4752-98 [Maryland (D1)6B-17] 5 x 104 cells/ml not eliminate the possibility of SARS-CoV-2 infection, and should be confirmed by viral culture or an molecular
Recommended Storage Condition assay or ELISA.
Virus Transport Medium(VTM) 178 [Poland 23F-16] 5 x 104 cells/ml 9. Positive test results do not rule out co-infections with other pathogens.
2℃ to 8℃ 25℃ Streptococcus pneumonia
262 [CIP 104340] 5 x 104 cells/ml 10. Negative test results are not intended to rule in other coronavirus infection except the SARS-CoV.
Copan UTM™ Universal Transport Media 12 hours 8 hours 11. Children tend to shed virus for longer periods of time than adults, which may result in differences in sensitivity
Slovakia 14-10 [29055] 5 x 104 cells/ml between adults and children.
BD™ Universal Viral Transport 12 hours 8 hours Typing strain T1 [NCIB 11841, 12. When using VTM, sensitivity can be reduced due to dilution.
Streptococcus pyrogens 5 x 104 cells/ml 13. Only Copan UTM, BD UTM and STANDARD™ Transport Medium have been validated with the assay.
STANDARD™ Transport Medium 12 hours 8 hours SF 130]
Bloomington-2 5 x 104 cells/ml
• When using viral transport medium (VTM), it is important to ensure that the VTM
Legionella pneumophila Los Angeles-1 5 x 104 cells/ml BIBLIOGRAPHY
containing the sample is warmed to room temperature. Cold samples will not flow 1. Clinical management of severe acute respiratory infection when novel coronavirus(nCoV) infection is
correctly and can lead to erroneous or invalid results. Several minutes will be required 82A3105 5 x 104 cells/ml suspected. Interim guidance. WHO.2020 
NOTE to bring a cold sample to room temperature. 2. Diagnostic detection of Wuhan coronavirus 2019 by real-time RT-PCR.2020
Candida albicans 3147 5 x 104 cells/ml
3. Diagnosis and treatment of pneumonia caused by new coronavirus (trial version 4) National Health
Bordetela pertussis NCCP 13671 5 x 104 cells/ml Commission. 2020

PERFORMANCE CHARACTERISTICS Moraxella catarrhalis N9 5 x 104 cells/ml

[Clinical evaluation] Pseudomonas aeruginosa R. Hugh 813 5 x 104 cells/ml
The prospective diagnostic evaluation of STANDARD Q COVID-19 Ag Test was conducted by FIND with collaborators
Staphylococcus epidermidis FDA strain PCI 1200 5 x 104 cells/ml
in Germany and Brazil with a total number of enrolled individuals of 1659.
The sensitivity and specificity of the STANDARD Q COVID-19 Ag Test was compared to the site-specific RT-PCR Streptococcus salivarius S21B [IFO 13956] 5 x 104 cells/ml
method.The pooled sensitivity in Germany was 76.6% (62.8-86.4%) and the pooled specificitywas 99.3%
(98.6-99.6%). The sensitivity observed in the testing clinic in Brazil was at 88.7% (81.3-93.4%)and the pooled Chlamydia pneumoniae TWAR strain TW-183 1 x 104 cells/ml
specificitywas97.6% (95.2-98.8%). Pooled human nasal wash N/A N/A
Country Germany Brazil *Human coronavirus HKU1 and Pneumocystis jirovecii (PJP) have not been tested. There can be cross-
Sample size 1259 400 reaction with Human coronavirus HKU1 and Pneumocystis jirovecii (PJP), even though the % identity of the
nucleocapsid protein sequence of HKU1 and PJP with the nucleocapsid protein sequence of SARS-CoV-2 was
Sensitivity 76.6% 88.7% 35.22% and 16.2% which is considered as low homology.
36/47 94/106
[% (95% CI)]|n/N (62.8-86.4%) (81.3-93.4%)
Specificity 99.3% 97.6%
1203/1212 287/294
[% (95% CI)]|n/N (98.6-99.6%) (95.2-98.8%)

L23COV3ENR8-W
Issue date: 2020.09

Manufactured by SD Biosensor, Inc.

Head office : C-4th&5th, 16, Deogyeong-daero
1556beon-gil, Yeongtong-gu,
Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA
Manufacturing site : 74, Osongsaengmyeong 4-ro,
Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do, 28161,
REPUBLIC OF KOREA

Authorized Representative

Altenhofstrasse 80 66386 St. Ingbert Germany

Phone : +49 6894 581020, Fax : +49 6894 581021

Please contact us for any complaints/inquiries/suggestions via email ([email protected]),

phone (+82-31-300-0400) or website (www.sdbiosensor.com).

To indicate the temperature limita�ons in Fulfill the requirements of

which the transport package has to be Direc�ve 98/79/EC on in vitro
kept and handled. diagnos�c medical devices
Reference number In vitro Diagnos�cs Consult Instruc�ons for Use Contains Sufficient Cau�on Note Do not re-use. Use by Batch code Manufacturer Date of manufacture Indicate that you should Keep away Do not use if packaging
for <n> Tests keep the product dry from sunlight is damaged