COVID-19 Antigen Rapid Test test result.

Substance Concentration Substance Concentration

3. The test is a presumptive test only. If you get a positive result, you must immediately seek a laboratory Mucin 2 mg/mL Fluticasone propionate 5 mg/mL
(For Self-testing) PCR test and follow-up clinical care. Whole blood 4% Dexamethasone 5 mg/mL
English 4. Negative results may occur if the level of antigen in the specimen is below the detection limit of the test. Zanamivir 5 mg/mL Tobramycin 5 μg/mL
Repeat testing after 1-2 days is recommended, if there is an ongoing suspicion of infection, being in a Ribavirin 5 mg/mL Mupirocin 10 mg/mL
Scan me for the how to use video high risk setting or where there is an occupational risk or have a known exposure to COVID-19. Arbidol 5 mg/mL Triamcinolone 10 mg/mL
For further support call +61 2 9986 2252 5. Negative results do not rule out SARS-CoV-2 infection, if you are experiencing COVID-like symptoms, Oseltamivir phosphate 10 mg/mL Histamine dihydrochloride 10 mg/mL
ISCOVu002-B001 1 you must immediately seek further laboratory PCR testing. Saline nasal spray 15% Benzocaine 5 mg/mL
ISCOVu002-B003 3 For additional language instructions please visit
6. A Negative result does not rule out infection with another type of respiratory virus. Oxymetazoline 15% Menthol 10 mg/mL
ISCOVu002-B005 5 https://apacsecurity.com/covid-19-antigen-test-
7. A Positive result cannot determine whether a person is infectious. Phenylephrine 15 mg/mL
resources/
8. Positive results do not rule out co-infections with other pathogens.
Please read these instructions for use before undertaking a test. 9. Positive results may occur, particularly in areas with low numbers of COVID-19 infections and
[Contact information]
confirmation with a PCR testing should be considered. Hangzhou Clongene Biotech Co., Ltd.
[Intended use] No.1 Yichuang Road, Yuhang Sub-district, Yuhang District, 311121 Hangzhou, China
The COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of [Frequently asked questions (FAQ)] https://en.clongene.com/
SARS-CoV-2 nucleocapsid antigens in nasal swabs from individuals suspected of being infected with How does the CLUNGENE COVID-19 Antigen Rapid Test work?
COVID-19 within the first 7 days of symptom onset. This test is intended for self-use by persons aged 15
AU REP APAC Security Pty Ltd
Unit 28, 19 Narabang Way, Belrose, NSW, 2085, Australia
The CLUNGENE COVID-19 Antigen Rapid Test is a type of test called an antigen test. When you have
years or above and also for an adult testing another person under 15 years of age. Individuals over 65 COVID-19, the SARS-CoV-2 virus (the virus that causes COVID-19) can be present in your nasal Tech support: +61 2 9986 2252, hours: 9am-7pm (AEST), 7 days per week
years of age should consider to seek assistance in performing the test. secretions. The CLUNGENE COVID-19 Antigen Rapid Test can detect small parts of SARS-CoV-2 virus Email: [email protected]
The test is an aid for diagnosis of COVID-19 and only provides a presumptive screening test result for the in your nasal secretions. These small parts of the SARS-CoV-2 virus are known as proteins or antigens. https://www.apacsecurity.com
SARS-CoV-2 virus. It is intended to be used in the home or similar environment by a lay person. In the event you are experiencing problems with the test, please contact our authorized representative in
Will this test hurt?
Confirmation of positive results is required by contacting your State or Territory Coronavirus testing Australia as above.
services to get a laboratory PCR test. A negative result does not mean a person does not have No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly
Additionally, you may wish to report poor performance or usability issues to the Therapeutic Goods
COVID-19. If you have symptoms, you should have a laboratory PCR test and follow medical advice. uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a doctor.
Administration (TGA) via the Users Medical Device Incident Report, email [email protected] or
What are the potential benefits and risks of this test? call 1800 809 361.
[When to use the test kit]
Potential risks include: To contact your local state/territory health department click on the following link:
Use this test: https://www.health.gov.au/about-us/contact-us/local-state-and-territory-health-departments
 Possible discomfort during sample collection.
✓ If you have COVID-like symptoms including headache, fever, a cough, sore throat, loss of sense of Local state and territory health departments
 Possible incorrect test results (see Limitations section).
smell or taste, shortness of breath, etc. Contact details and websites of the local state and territory health departments.
Potential benefits include:
✓ If you are concerned that you have been exposed to COVID-19.
 The results, along with other information, can help your doctor make informed recommendations Business hours: 02 5124 9213
Australian Capital Territory Coronavirus helpline (8am to 8pm daily): 02 6207 7244
Do not use this test: about your treatment/care. Department of Health
https://health.act.gov.au
X If you are prone to nosebleeds.  The results of this test may help limit the spread of COVID-19 to your family and others in your community.
General enquiries: 1300 066 055
New South Wales Department
[Warnings and precautions] What is the difference between a COVID-19 antigen, molecular, and antibody test? of Health
Coronavirus hotline (Service NSW, 24/7): 137 788
https://www.health.nsw.gov.au
1. For in vitro diagnostic use only. There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic General enquiries: 08 8922 8044
2. Do not use this test as the only guide to manage your illness. Please contact your State or Territory material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the Northern Territory Department Coronavirus hotline (National helpline): 1800 020 080
Coronavirus testing services to get a laboratory PCR test if your symptoms are persisting or virus, but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but of Health
https://health.nt.gov.au
worsening, or if you are concerned at any time. a negative result does not rule out infection. 13HEALTH: 13 432 584
3. The test is less reliable in the later phase of infection and in asymptomatic individuals. Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been Queensland Department of Coronavirus hotline: 134COVID, 134 268
Health
4. Negative results may occur if testing is not performed within the first 7 days of symptom onset. made by your immune system in response to a previous COVID-19 infection. Antibody tests are not https://www.health.qld.gov.au
5. If the test is to be used on a person under 15 years of age, the test must be undertaken by an adult. suitable to diagnose an active COVID-19 infection. General enquiries: 1300 232 272
South Australian Department of Coronavirus hotline (9am to 5pm daily): 1800 253 787
6. Keep out of reach of children to reduce the risk of accidentally drinking the extraction reagent or Health
[Performance characteristics] https://www.sahealth.sa.gov.au/
swallowing small parts.
7. Do not use this product after the expiration date. Clinical Performance General enquiries: 1300 135 513
Tasmanian Department of Public Health Hotline (coronavirus): 1800 671 738
8. Only use the test once and only with the provided parts. The clinical performance of CLUNGENE COVID-19 Antigen Rapid Test for self-testing was evaluated in a Health
https://www.health.tas.gov.au
9. Do not undertake testing in direct sunlight. prospective study in Greece between June 2021 and July 2021. A total of 578 laypersons (of which, 122
within 7 days post symptom onset) were sequentially enrolled. No additional training or instructions were Department of Health and Human Services: 1300 650 172
10. Avoid contact with Extraction Reagent. If the extraction reagent is accidentally exposed to a person’s Victorian Department of Health Victorian coronavirus hotline (24/7): 1800 675 398
provided. Self-sampling with nasal swabs and self-testing were conducted by participants using the
skin or eye, rinse with plenty of running water immediately. If irritation persists, seek medical assistance. https://www.dhhs.vic.gov.au
COVID-19 Antigen Rapid Test. For comparison, to each of the participants, an RT-PCR testing was
11. This test involves taking a sample from deep inside your nose. When doing the test, pay particular performed by professional sampling with nasopharyngeal swab. The COVID-19 Antigen Rapid Test
General enquiries: 08 9222 4222
Western Australian Department Coronavirus hotline: 13COVID (8am to 6pm, Mon–Fri), 1800 595 206
attention to the instructions on how to swab your nose. Incorrect swabbing may lead to an inaccurate showed a sensitivity of 95.1% (95% confidence interval: 89.7%-97.7%, N=122) and a specificity of 100% of Health
test result. https://www.healthywa.wa.gov.au
(95% confidence interval: 99.2%-100%, N=456) compared to RT-PCR.
12. The test cassette should remain in the sealed pouch until use.
Limit of Detection (Analytical Sensitivity)
13. Wash hands thoroughly before and after testing. Index of Symbol
14. Dispose all parts of the used test kit into the waste bag, then discard the waste bag in the general waste. The COVID-19 Antigen Rapid Test can detect SARS-CoV-2 virus as low as 570 TCID50/mL.
For in vitro diagnostic
Do not reuse Lot number Use by
[What is included in the test kit] Variants use only
30℃ Store
between
The performance of COVID-19 Antigen Rapid Test is not affected by Alpha, Beta, Gamma, Delta variants. Consult instructions Keep away from
Components ISCOVu002-B001 ISCOVu002-B003 ISCOVu002-B005 Caution
4℃ 4-30 ℃ for use sunlight
Cross Reactivity (Analytical Specificity)
1. Test Cassette 1x 3x 5x Catalogue Contains sufficient for
Cross reactivity was evaluated by testing 32 potential cross-reactive substances that may be present in Keep dry Manufacturer
2. Extraction Reagent Tube 1x 3x 5x number <n> tests
the nasal cavity.
3. Swab 1x 3x 5x No cross-reactivity was observed with recombinant MERS-CoV nucleocapsid protein when tested at the Do not use if package is damaged
4. Waste Bag 1x 3x 5x concentration of 50 μg/mL.
5. Instructions for Use 1x 1x 1x No cross-reactivity was observed with the following viruses when tested at the concentration of 1.0×106
PFU/mL: Influenza A (H1N1), Influenza A (H1N1pdm09), Influenza A (H3N2), Influenza B (Yamagata),
Influenza B (Victoria), Adenovirus (type 1, 2, 3, 5, 7, 55), Human metapneumovirus, Parainfluenza virus
[Storage and stability] Version No.: 2.2
(type 1, 2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human
 Store as packaged in the sealed pouch between 4–30 ℃. coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1. Effective Date: January 05, 2022
 The LOT and the expiration date were printed on the foil packaging and box. No cross-reactivity was observed with the following bacteria when tested at the concentration of 1.0×107
CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus
[Limitations] influenzae, Streptococcus pyogenes (group A), Streptococcus pneumoniae, Candida albicans,
1. The test should be used for the qualitative detection of SARS-CoV-2 antigens in nasal swab Staphylococcus aureus.
specimens only. The intensity of the T-line does not necessarily correlate to SARS-CoV-2 viral titer in Interference
the specimen.
The following potential interference substances were evaluated with the COVID-19 Antigen Rapid Test at
2. Failure to follow the instructions for use may adversely affect test performance and/or invalidate the
the concentrations listed below and were found not to affect test performance. Turn page
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[Preparing to do the test] 5. Swab the Right Nostril 11. Timing
1. Keep a clock, timer or stopwatch at hand. a. Remove the swab b. Firmly brush the Start the clock / stopwatch or timer.
2. Ensure that all test components are kept at room temperature (15-30 ℃). from the left nostril swab against the
and insert it into right inside of the nostril
3. Ensure that the packaging is intact; Do not use the test if there is visible damage of the foil 12. Wait 15 Minutes
packaging. nostril about 2.5 cm. in a circular motion
5 times or more. Read the test result at 15-20 minutes, DO NOT read the result after 20 minutes.
4. Open the box and you will get the components shown below:

CHECK!
You should swab both nostrils. Note: False results can occur if the test
Note: A false negative result may occur if sample collection is not thoroughly undertaken. results are read before 15 minutes or after 20
minutes.
Instructions for Use Swab Extraction Reagent Tube Waste bag 6. Insert the Swab into the Tube
Insert the nasal swab into the tube which
contains the extraction reagent. [Read result]
Note: Only open the foil packaging of the test cassette Positive Result
when you are ready to carry out the test. Use the test Two lines appear. One coloured line appears at the control region (C), and another appears at
cassette within one hour after opening.
the test region (T).
Test Cassette

[Before starting] Please look very closely!

The intensity of the T-line can be very faint.
Wash your hands in soapy water and dry 7. Rotate the Swab 5 Times
thoroughly. a. Rotate the swab at b. Let the tip of the
least 5 times while swab soak in the A positive test result indicates that you are likely to carry the COVID-19 disease. Contact your
pressing the swab tube for 1 minute. State or Territory Coronavirus testing services to get a laboratory PCR test as soon as possible,
tip against the and follow local guidelines for self-isolation to avoid spreading the virus to others.
[Step-By-Step Instructions]
bottom and the
1. Open Extraction Reagent Tube sides of the tube. Negative Result
Carefully tear off the sealed foil film on the One coloured line appears at the control region (C), and no line appears at the test region (T).
extraction reagent tube.

8. Remove the Swab

a. Remove the swab while squeezing the b. Cover the tube with
sides of the tube against the swab, to the provided cap
A negative test result indicates that you are unlikely to carry the COVID-19 disease.
release the liquid from the swab. tightly and insert
Even if you get a negative result, you still need to follow all public health advice on limiting the
the tube back into
spread of COVID-19.
2. Insert Tube into Box the box.
Please contact your State or Territory Coronavirus testing services to get a laboratory PCR test if
Gently press the tube through the perforated you develop symptoms or symptoms are persisting. If you suspect an infection, it is recommended
hole in the box. that you repeat testing after 1–2 days, as the virus cannot be precisely detected in all phases of an
infection.

Invalid Result
Control (C) line fails to appear.

9. Take out the Test Cassette from the pouch Note: If a C-line does not appear, the test
Open the sealed pouch and take out the test cassette. result is invalid regardless of the appearance of
3. Remove the Swab a T-line or not.
a. Open the swab b. Take out the
package at the stick swab. If a C-line does not appear, you need to retest with a new test cassette or contact your State or
end. Result Window — Territory Coronavirus testing services to get a laboratory PCR test.

[Dispose of the used test kit]

Note: Keep fingers Note: Test cassette must lay FLAT on the table during Sample Well —
away from swab tip. the entire testing.
—Swab Tip Collect all parts of the test kit and place in the waste bag that
can be placed in the general waste.

10. Add Sample to the Sample Well

4. Swab the Left Nostril Wash your hands thoroughly after handling.
a. Hold the tube vertically over the Sample b. Add 3 drops from the tube into the Sample
a. Gently insert the b. Firmly brush the
Well - not at an angle. Well by gently squeezing the sides of the tube.
entire tip of the swab, swab against the
app. 2.5 cm into the inside of the nostril
left nostril. in a circular motion Note 1: A false negative result may occur if less
5 times or more. than 3 drops of sample is used.
Scan the QR code to watch how to use the device and
Note 2: The result will not be affected if 1-2 access other resources.
more drops of sample are accidently added – For additional language instructions please visit
as long as you can read a C-line (see Read https://apacsecurity.com/covid-19-antigen-test-resources/
result below). For further support call +61 2 9986 2252,
(Approximately 1.5 times the length of the swab tip) hours: 9am-7pm (AEST), 7 days per week

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