COVID CONFIRM Rapid Antigen Self-Test

Easy-to-use all-in-one design

For use on ages 2+ years

ARTG No.   XXXXXXX  Self-testing Use

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Product Code: OD-COV2S1T

This SARS-CoV-2 Antigen Kit (Saliva) is a lateral flow in vitro diagnostic rapid chromatographic immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human saliva specimens.

it is designed for self-testing in workplaces, home and schools.

Each test is in a single test package and can only be used once.

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Test Procedure


1. Remove the test from its package. Place the test on a clean, flat and dry surface. Label the test with patient ID number.
 

2.  To collect the saliva: Remove the blue cover from the test. Place the tip of the tongue against the root of the upper or lower jaw to enrich the saliva. Place the absorbent tip under the tongue and keep the lips closed tightly. Take out the test after 2 – 5 minutes to ensure that the absorbent tip has been soaked completely with saliva.
 

Note: Do NOT eat, drink, smoke or chew gum within the 30 minutes before giving your sample.

Note: Inadequate or improper sample collection may yield false negative results.
 

 

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3. Put the cover back onto the test.
 

4. Place the sample-loaded test flat on table. Read the results within 15 – 30 minutes.

Do not interpret the results after 30 minutes.
 

 

5. Place the used test into the waste bag. Seal the bag. Sanitize and dispose of the waste in your household garbage or rubbish bin.

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Interpretation of Results
 

The Control (C) line must appear for a test to be valid regardless of the appearance of the T line. Failure to observe the control line indicate the result is not reliable. When this occurs, check the operation procedure carefully, and test again with a new test. If the problem recurs, contact Onsite Diagnostics on 1300 667 107.
 

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Note that any visible T line is positive even if it is a FAINT line.

Possible reasons for false negative results: improper sample collection, use of incompatible extraction buffer, delayed sample transfer, low virus titer in the sample and not following the correct procedure.

Possible reasons for false positive results: improper sample collection, use of incompatible extraction buffer, cross-contamination of sample and not following the correct procedure.

Possible reasons for invalid results: incorrect sample volume, damaged package or used past expiry date.

Limitations

1.  The test is only for qualitative detection of the SARS-CoV-2 antigen in saliva samples.

2.  Results obtained with this kit should not be the sole basis for diagnosis and treatment of SARS-CoV-2 infection. The clinical symptoms, medical history, epidemiological information and other laboratory findings of patients should always be taken into consideration.

3.  A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.

4.  If testing is not performed within the first 7 days of symptom onset, there is a risk of a false negative result

5.  The test can be less reliable in the later stages of infection and in asymptomatic individuals

6.  The test does not differentiate between SARS-CoV-2 and SARS-CoV.

7.  Negative result with symptoms may indicate you have another type of virus.

View Usage Video

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What is coronavirus and how is it spread?
 

The term coronavirus refers to a family of viruses, some causing illness in people and others that circulate among animals. The SARS-CoV-2 strain was first identified in Wuhan, China in December 2019. Public health officials have identified the source of this virus in bats and are investigating its spread from animal to human and human to human. It is typically spread by respiratory droplets from coughs or sneezes, similar to the way flu and other respiratory viruses spread.

What is the incubation period for COVID-19?
 

Infectious disease experts have determined that symptoms can begin within 14 days of initial exposure to the virus.

What are the primary symptoms?
 

Primary symptoms are:

  • Cough

  • Fever

  • Shortness of breath
     

If you have any of the above symptoms, contact your healthcare provider right away.

ORDER ONLINE OR PLEASE PHONE 1300 667 107.

High stock turnover means we are able to provide product with a
long shelf life.
Expiry dates are generally 12-24 months from the date of purchase.