Description

COVID-19 and Influenza A+B Rapid Antigen Test 5 Pack

COVID-19 and Influenza A+B Rapid Antigen Test 5 Pack

Why choose the CLUNGENE COVID-19 and Influenza A+B Rapid Antigen Test 5 Pack?

Covid-19 and Influenza. Test persons with COVID-19 and/or Influenza A+B symptoms.
Home test. Can be offered to the general public.
Screening Results. In 15 – 20 minutes.
IVD Class 3. Listed with the TGA.

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.

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 and Precautions

For in vitro diagnostic use only.
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.
A negative result does not mean a person does not have COVID-19/Influenza A/Influenza B. If symptoms persist or if you feel unwell, please consult a medical practitioner for follow-up clinical care.
If you have invalid results, you need to retest with a new test cassette and extraction reagent with a freshly collected sample and contact the
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 other 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.

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COVID-19 and Influenza A+B Rapid Antigen Test 5 Pack

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