V-CHEK COVID-19 Antigen Saliva Lollipop Test Instruction Manual

V-CHEK COVID-19 Antigen Saliva Lollipop Test

INTENDED USE

The COVID-19 Antigen Saliva Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in saliva specimens from individuals with symptoms or other symptoms that may suggest a COVID-19 infection. A positive result indicates the presence of viral antigens and additional testing is necessary. Positive results do not rule out bacterial infection or coinfection with other viruses. A negative result should be treated as presumptive and does not rule out COVID-19 infection.

Negative results should be considered in the context of a patient’s recent exposures. history, and the presence of clinical signs and symptoms consistent with COVID-19. If necessary, confirm with a molecular assay. The Test Card is intended for use in the first 7 days of symptom onset. The COVID-19 Antigen Saliva Test is intended for use by laypersons and enables self-testing at home or other locations. This is a screening test only. To confirm results take a laboratory PCR test.

PRINCIPLE

The COVID-19 Antigen Saliva Test is a qualitative membrane-based immunoassay for the detection of SARSCoY-2 antigens in human saliva samples. When the antigen in the sample reaches the Test area (T) of the membrane, it will form a coloured line. The absence of this coloured line suggests a negative result. To ensure the test is carried out properly, a coloured line will appear at the Control area (C), if the test has been performed correctly.

CONTENTS OF THE TEST KIT

‘Lollipop’ Saliva Swab, Test Cassette, Instructions For Use & Biosafe Disposal Bag

STORAGE

1.  Store the packaged test between 2-30’C.
2.  Keep away from direct sunlight, moisture and heat.
3.  Do not use the test kit past the expiration date as indicated on the outer packaging.
4.  DO NOT FREEZE.

WARNINGS AND PRECAUTIONS

1. Please read all of the information in the instructions for use carefully before using the test.
2. Do not swallow.
3.  Do not use the test kit past the expiration date as indicated on the outer packaging.
4.  Do not use test if pouch is damaged or not well sealed. Do not use any damaged test cassette or ‘lollipop’ saliva swab.
5.  Do not open the foil pouch of the test until it is ready for immediate use.
6.  Do not eat, drink or smoke prior to the test for at least 30 minutes,
7. To obtain accurate results, do not use visually bloody or overly soggy lollipop saliva swab samples.
8.  Do not bite the sponge of the saliva swab.
9. Do not reuse the used test card or saliva swab. They can only be used once.
10. Inadequate sample collection, processing, storage and transport may give a false positive or a false negative result.
11. The tests are less reliable in the later phase of infection and in asymptomatic individuals.
12. It is recommended to repeat listing within 1-2 days if there is an ongoing suspicion of infection.
13.  Keep out of reach of children.
14.  For ages 2 and above.
15.  Children taking the test should be supervised by an adult.
16. Wear a safety mask or other face-covering when collecting a saliva specimen from a child or another individual.
17. Use of Nitrile or Latex gloves is recommended when handling samples.
18.  Wash hands thoroughly after handling.
19. To reduce the risk of infection spreading. discard the used test in the Biosale Bag provided and dispose of it according to local regulations.

LIMITATIONS

1.  Tests are for screening purposes only and any positive results need to be confirmed by a laboratory PCR test.
2. Test Card performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.
3. Test Card performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.
4. The test must be at room temperature (15-30’C/59-86 ‘F) for 30 minutes before use, otherwise, the results may be incorrect.
5. A false-negative test result may occur if the level of antigen in a sample is below the limit of detection of the lest. Results need to be confirmed by a laboratory PCR test.
6. Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the least result.
7. Reading results in less than 10 minutes may lead to a false-negative result whilst reading results after more than 15 minutes may lead to a false-positive result.
8. Positive test results do not rule out co-infections with other pathogens.
9. Negative test results are not intended to rule out other infections.
10. Negative results should be treated as presumptive and confirmed with a laboratory PCR test.
11. Users should test saliva specimens as quickly as possible after the specimen has been collected.
12. If the sample volume is not enough, the test cannot be carried out successfully.

FREQUENTLY ASKED QUESTIONS

1. How accurate is the test? The performance of the Test Card was established with 243 samples collected from symptomatic patients, within 7 days of symptom onset.
   2019-Nov Ag Saliva Rapid Test Card (lmmlJJlOCN”tomato,a_phy)| Comparative RT-PCR Test Resit
   ---|---
   Positive

(•)

| Negative

(·)

| Total
Detected Positive| 110| 2| 112
D &tected N,et�| 5| 126| 131
Total| 115| 128| 243
Sensitivity| 95.65%, 95% Cl (90.22,98, 13)
Sf,acidity| 98.44%. 95% Cl (94.48. 99.57).
Aw.Jracy| 97.12%, 95% Cl (94.17.98.60)

A usability study was performed with 120 laypeople. The results show that the instructions provided with the test kit made it easy for the user to understand. The test is therefore suitable for lay users. Limit of Detection: The limit of detection for the V-Chek test is 200 TCID50/mL or less.

2. Can any substances interfere with the Test? No interference has been observed when testing the following substances: Whole Blood, Tamiflu (Oseltamivir), Ibuprofen, Naphthoxoline hydrochloride nasal drops, Tetracycline, Mucin, Chloramphenicol, Fisherman’s Friend, Erythromycin, Compound Benzocaine Gel, Tobramycin, Cromoglycate, Throat spray (Menthol). Sinex (Phenylephrine Hydrochloride). Mupirocin, Afrin (Oxymetazoline), Throat lozenge (Menthol) or Fluticasone propionate spray.
3. Can the test detect different variants of COVID-19? Yes, the following inactivated cultures of COVID-19 mutant variants can be detected by the V-Chek test:
   • Wuhan strain (SARS-CoV-2 Isolate: USA-Wal/2020), can be detected by the V-Chek test at concentrations of 100 TCID50/mL or more.
   •  Alpha (B.1.1. 7), Delta (B.1.617 .2) and Kappa (B.1.617 .1) variants can be detected by the V-Chek test at concentrations of 200 TCID50/ml or more. Please visit www.v-chek.net.au for the most up to date variant detection information.
4. How do I know that the test was run properly? A coloured line will appear in the control area (CJ of the test cassette ii the test has been properly performed – if this line is not visible, then the test has been incorrectly performed & you must run a new test or call the Customer Support Helpline on 1300 186 653.
5. What should I do if the result shows positive?
   • Note that you are currently suspected of COVI0-19 infection.
   • Contact the Customer Support Helpline on 1300 186 653.
   • DO A PCR TEST FOR CONFIRMATION
   • Comply with local sell-isolation guidelines.
6. What should I do if the result shows negative?
   • Continue to comply with all local applicable rules and protective measures.
   • Be aware that even if the test is negative, an infection may occur.
   • In case of suspicion, repeat the test after 1-2 days and comply with local self-isolation guidelines.
   • DO A PCR TEST FOR CONFIRMATION
7. What should I do if the result shows invalid?
   • Possibly caused by incorrect operation.
   • Repeat a lest using a new test.
   • If the test result is still invalid, contact the distributor or the store where you bought the product, or call the Customer Support Helpline on 1300 186 653 with the lot number.
8. Can the test be used more than once?
   • No. The test can only be used once.

ASSISTANCE PERFORMING THE TEST OR INTERPRETING RESULTS

Customer Support Helpline 1300 186 653 (24 Hours. 7 Days) W: www.v-chek.net.au

REFERENCES

1. Center for Disease Control and Prevention. Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19.May 22.
2. Wu F, Zhao S, Yu 8, et al. A new coronavirus associated with human respiratory disease in China. Nature. 2020;579:265-9.
3.  htlps://www.who.int/publicationslilitem/antigen-detection-in-thediagnosls-of-sars-co v-2infection-using-rapid-immunoassays.
4. Considerations on the use of sell-tests for COVID-19 in the EUIEEA. 17 March 2021.

INDEX OF SYMBOLS

1. Consult Instructions For use
2. Manufacturer
3. In Vitro Diagnostic Medical Device
4. Date of Manufacturer
5. catalogue Number
6. Store at 2•c-30’C
7. Batch code
8. Au1horized representative
9. Contains sufficient for tests
10. De no! use pouch is damaged
11. Use-by date
12. Do Not Reuse
13. Keep away from Sunlight
14. Keep Diy

COVID-19 Antigen Saliva Test (Lollipop Test)

Note: Use test only one time. Test within first 7 days of symptoms. Testing by adult only or under adult supervision

TEST KIT

‘LOLLIPOP’ SALIVA SWAB

TEST PROCEDURE STEPS

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