Covid-19 Rapid Antigen Home RAT Test Kit (5 Tests/Pack)

Incoming Stock 50,000 tests only 09/02/2022 IN STOCK READY TO SHIP

Incoming Stock 50,000 tests only 17/02/2022 

• Suitable for home use 
• ARTG Approved Number: 333341
• Screening results within 15 to 20 minutes 
• The Clungene COVID-19 Antigen Rapid Screen Test is listed as and IVD Class 3 in the Australian Register of Therapeutic Goods, ARTG.
• Please ensure local healthcare guidelines are followed. If required a PCR test may be required as per state health policies. 
• We reserve the right to substitute brands of these tests in case of shortages. I f a brand is substituted please follow the instruction in the pack. We accept no liability whatsoever for any injury, harm or false test results as a company. 

Intended use:

The Clungene COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab or nasal swab from individuals who are suspected of COVID-19 within the first seven days of symptoms.

Each Clungene COVID-19 Antigen Rapid Testing Kit includes:

• Test Cassette, which holds the test strip where detection of the SARS-COV-2 nucleocapsid antigen take place.
• Extraction Reagent Tube.
• Collection swab
• Waste bag
• IFU/Product insert

The Clungene COVID-19 Antigen Testing Kit is listed with the TGA – ARTG Identifier 333341.

The Clungene COVID-19 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

1. 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.
2. Extraction – After sampling the swab is inserted into a tube containing an extraction solution, where it is left for a minute.
3. Analysis – Three droplets of the extraction solution, now containing the sample, is added to a sample well 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;

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 virus. A line should be read as a presumptive positive test, indicating that the test person is likely to carry the COVID-19 disease. No line should be interpreted as a negative test.

Clinical Performance

The clinical performance of CLUNGENE COVID-19 Antigen Rapid Test for self-testing was evaluated in a prospective study in Greece between June 2021 and July 2021. A total of 578 laypersons (of which, 122 within 7 days post symptom onset) were sequentially enrolled. No additional training or instructions were provided. Self-sampling with nasal swabs and self-testing were conducted by participants using the COVID-19 Antigen Rapid Test. For comparison, to each of the participants, an RT-PCR testing was performed by professional sampling with nasopharyngeal swab. The COVID-19 Antigen Rapid Test showed a sensitivity of 95.1% (95% confidence interval: 89.7%-97.7%, N=122) and a specificity of 100% (95% confidence interval: 99.2%-100%, N=456) compared to RT-PCR.

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.

Warnings and Precautions

• For in vitro diagnostic use only.
• Do not use this test as the only guide to manage your illness. Please contact your State or Territory
• Coronavirus testing services to get a laboratory PCR test if your symptoms are persisting or worsening, or if you are concerned at any time.
• The test is less reliable in the later phase of infection and in asymptomatic individuals.
• Negative results may occur if testing is not performed within the first 7 days of symptom onset.
• If the test is to be used on a person under 15 years of age, the test must be undertaken by an adult.
• Keep out of reach of children to reduce the risk of accidentally drinking the extraction reagent or swallowing small parts.
• Do not use this product after the expiration date.
• Only use the test once and only with the provided parts.
• 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 doing the test, pay particular attention to the instructions on how to swab your nose. Incorrect swabbing may lead to an inaccurate test result.
• 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.

Useful Links:

Rapid antigen test COVID in Perth

Covid-19 Home Test Kit in Perth

Covid-19 Rapid Antigen Home Test

Covid-19 Rapid Antigen Home Test Kit