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.
The Clungene COVID-19/Influenza A+B Antigen Combo Rapid Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2, influenza A and influenza B viral nucleocapsid protein antigens in nasal swab from individuals suspected of being infected with COVID-19 within the first 7 days of symptom onset or influenza within the first 4 days of symptom onset.
Each Clungene COVID-19 & Influenza A+B Antigen Rapid Testing Kit includes:
- Test Cassette, which holds two seperate test strips, where detection of the SARS-COV-2 and Influenza A+B nucleocapsid antigen take place.
- Extraction Reagent Tube.
- Collection swab
- Waste bag
- IFU/Product insert
The Clungene COVID-19/Influenza A+B Antigen Combo Testing Kit is listed with the TGA – ARTG Identifier 404854
The Clungene COVID-19/Influenza A+B Antigen Rapid Screen Test is listed as and IVD Class 3 in the Australian Register of Therapeutic Goods, ARTG. APAC Security is registered as the sponsor of the testing kit.
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.
Interpretation of results
Results are read from the window of the Test Cassette, which is marked from top to bottom with C and T. Note that there are two detection windows; the left side is for the detection of SARS-CoV-2 and the right side for detection of Influenza A & B virus.
C is a control line, which must always be present at the time of analysis. No C-line means that the test is invalid and a new test should be performed.
T is a Test line indicating the presence of the SARS-CoV-2 and/or Influenza A & B virus. A line should be read as a presumptive positive test, indicating that the test person is likely to carry the COVID-19 or Influenza disease. No line should be interpreted as a negative test.
IMPORTANT – Even a faint T-line is an indication of a presumptive positive
Clinical Performance
The clinical performance of COVID-19/Influenza A+B Antigen Combo Rapid Test was established in prospective studies with nasal swabs collected from 918 individual patients (within 7 days post symptoms onset). For comparison, to each of the participants, an RT-PCR testing was performed by professional sampling with nasopharyngeal swab for detection of SARS-CoV-2, Influenza.
For COVID-19 Antigen Rapid Test:
Compared with RT-PCR, the COVID-19 Antigen Rapid Test showed a sensitivity of 95.3% (95% confidence interval: 92.0%-97.3%, N=256) and a specificity of 99.8% (95% confidence interval: 99.2%-100%, N=662), when testing symptomatic subjects within the first seven days after symptom onset.
For Influenza A+B Antigen Rapid Test:
Compared with RT-PCR, the Influenza A+B Antigen Rapid Test of influenza A showed a sensitivity of 94.4% (95% confidence interval: 88.3%-97.4%, N=107) and a specificity of 99.8% (95% confidence interval: 98.9%-100%, N=528), when testing symptomatic subjects within the first four days after symptom onset. Compared with RT-PCR, the Influenza A+B Antigen Rapid Test of influenza B showed a sensitivity of 92.6% (95% confidence interval: 82.5%-97.1%, N=54) and a specificity of 99.7% (95% confidence interval: 98.8%-99.9%, N=581), when testing symptomatic subjects within the first four days after symptom onset.
Shelf life & Storage conditions
The Clungene Covid-19 Antigen Rapid Self Test offers two years shelf life from date of manufacturing.
Storage temperature 4ºC – 30ºC.
The LOT number and expiration date are indicated on foil packaging and box
Warnings and Precautions
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- 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.
Resources:
For state and territory COVID information visit the relevant local state and territory health departments – here.
For other relevant information about COVID-19 visit the Commonwealth Department of Health website – here.
Download consumer fact sheet here. This 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.