Clungene COVID-19 & Influenza A+B Antigen Combo Nasal Rapid Test 5 Pack

Clungene COVID-19 & Influenza A+B Antigen Combo Nasal Rapid Test 5 Pack

Description:

Test for the Flu and Covid19 all in one Test. Cassette is a side-by-side test kit.

The COVID-19/Influenza A+B combo Test is intended for the qualitative detection of SARS-CoV-2, influenza A and influenza B in nasal swab from persons suspected of being infected with COVID-19 or influenza.

The Test kit contains one nasal swab and two separate immunoassay tests, which allows the test person to separately test for COVID-19 and Influenza A+B. The main benefit of this Device is to find out whether a person carries the SARS-CoV-2/Influenza A+B virus during onset of COVID-19 or Influenza A+B. Recommended use is to test persons with COVID-19 and/or Influenza A+B symptoms.

For POSITIVE COVID-19 results: Follow the guidance from your local State or Territory Health Department for reporting of positive results and confirmation testing if necessary. If unwell, seek medical assistance.

For POSITIVE INFLUENZA results: If you have a positive result or are unwell, contact a medical practitioner for follow up clinical care.

Usage Directions:

Easy to use.

Sampling – The entire tip of the swab, app 2.5 cm, is inserted into the left nostril, where it is firmly brushed against the inside of the nostril in a circular motion 5 times or more. With the same swab, carry out the same procedure in the right nostril.

Extraction – After sampling the swab is inserted into a tube containing an extraction solution, where it is left for a minute.

Analysis – Three droplets of the extraction solution, now containing the sample, is added to both sample wells on the test cassette. Results are read after 15 minutes.

Warnings:

Always read the label and follow the directions for use. 

Do not use this test as the only guide to manage the test result(s) or your illness.

For POSITIVE COVID-19 results: Follow the guidance from your local State or Territory Health Department for reporting of positive results and confirmation testing if necessary. If unwell, seek medical assistance.

For POSITIVE INFLUENZA results: If you have a positive result or are unwell, contact a medical practitioner for follow up clinical care.

Negative test results do not exclude infection with SARS-CoV-2 (COVID-19), influenza A or influenza B; and face masks, social distancing and good hygiene practice must be maintained. Follow current government health messaging regarding confirmatory testing requirements.

If you have invalid results, you need to retest with a new test cassette and extraction reagent with a freshly collected sample.

The test is less reliable in the later phase of infection and in asymptomatic individuals.

Within the first 7 days of symptom onset for COVID-19 and within the first 4 days of symptom onset for Influenza when viral shedding is highest, the detection effect is good during this period.

False negative results may occur if testing is not performed within the first 7 days of symptom onset for COVID-19 and within the first 4 days of symptom onset for Influenza.

Repeat testing within 1-3 days is recommended if there is an ongoing suspicion of infection, high risk setting, occupational risk, or another requirement.

The device cannot differentiate between SARS-CoV-2 (COVID-19) and SARS-CoV-1 (SARS-coronavirus).

If the test is to be used on a person under 15 years of age, the test must be undertaken by an adult.

The test is not suitable for use in children aged < 2 years of age.

Keep out of reach of children to reduce the risk of accidents e.g drinking the extraction reagent or swallowing parts of the test kit.

Do not use this product after the expiration date.

Only use the test once and only with the provided parts. The kit components cannot be used interchangeably in different batches to avoid inaccurate test result.

Do not undertake testing in direct sunlight.

Avoid contact with Extraction Reagent. If the extraction reagent is accidentally exposed to a person’s skin or eye, rinse with plenty of running water immediately. If irritation persists, seek medical assistance.

This test involves taking a sample from deep inside your nose. When undertaking the test, pay particular attention to the instructions on how to swab your nose. Incorrect swabbing may lead to an inaccurate test result or damage to the donor.

The test cassette should remain in the sealed pouch until use.

Wash hands thoroughly before and after testing.

Dispose all parts of the used test kit into the waste bag, then discard the waste bag in the general waste.

Covid-19 fact sheet – explains what Covid-19 home use tests are (also known as Covid-19 rapid antigen self-tests), how they can be used at home and what to do when you get a result.