InnoScreen Covid-19 Antigen Rapid Test Device (2 x Self Test Kits)

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  • Regular price $24.95


Rapid Antigen test Kit Nasal (2 tests per box)

The InnoScreen COVID-19 Antigen Rapid Test Device is an immunochromatographic membrane assay. It uses extremely sensitive monoclonal antibodies to detect SARS-CoV-2 viral nucleoprotein antigens in nasal swabs.

The InnoScreen COVID-19 Antigen Rapid Test Device (Self-test) is a rapid lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms suspecting a COVID-19 infection.

This test is for non-prescription home use on individuals aged 2 years or older suspected of COVID-19 by their healthcare provider in a non-laboratory setting.

If the test is being used for testing individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection, testing should be scheduled twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests.

Australian Made

Usage Directions

1) Unpack the test components. Do not discard the box. Ensure you have all components required. Do not use if they are expired or damaged.

2) Gently blow your nose into a tissue to remove excess mucus. Wash your hands with soap and water for at least 20 seconds or use hand sanitiser.

3) Remove the test cassette from the pouch and place it on a flat, clean surface. DO NOT TOUCH the test window

4) Insert the extration tube into the hole on the box. Unscrew the blue cap. Keep the cap aside, DO NOT DISCARD.

5) Open the swab from the end marked ‘Peel here’ and remove swab. DO NOT TOUCH the swab tips.

6) Gently insert the swab about 1-2cm into RIGHT nostril, rubbing against the nasal wall in a circular motion at least 5 times for total of 15 seconds. Remove the swab then repeat the same process with your LEFT nostril.

7) Place the swab into the extration tube. Break off the swab handle at the break point. Discard the break off handle.

8) Replace the blue cap on the tube. Squeeze the lower part of the tube against the swab tip inside the tube 15 times

9) Unscrew the white cap of the tube. Invert the tube then gently squeeze the tube to add 3 full drops of solution to the sample well marked “S” on the cassette.

10) Start timer and read results at 15 minutes as per INTERPRETING THE RESULTS as per the interpreting results section on this page. Results should not be read after 20 minutes.

11) After reading the result, place all the used components in the plastic bag provided and dispose into a general waste bin.

Interpreting Results

1) POSITIVE (Two coloured lines appear in control region and test region)

2) NEGATIVE (Only one coloured line appears in the control region)

3) INVALID (no coloured line appears in the control region)

Storage

Store between 2-30°C. Do not freeze. The kit contents are stable until the expiration dates marked on their outer packaging and containers. Once opened the device should be used immediately

Test Limitations

1. Negative results do not rule out SARS-CoV-2 and / or other types of virus infection, particularly in those who have been in contact with the virus or have symptoms. Follow-up testing with a confirmatory tests eg. PCR should be considered to rule out infection in these individuals.

3. Both viable and nonviable SARS-CoV-2 viruses are detectable with the COVID-19 antigen Rapid Test Device. Test performance depends on antigen load in the specimen and may not correlate with cell culture performed on the same specimen.

4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test but should only be made by the physician after all clinical and laboratory findings have been evaluated.

5. Failure to follow the TEST PROCEDURE and RESULT INTERPRETATION may adversely affect test performance and/or invalidate the test result.

6. A negative result may occur if the level of extracted antigen in a specimen is below the sensitivity of the test or if a poor-quality specimen is collected. Improper transport or storage of sample may also lead to false negative results.

7. A positive result can not necessarily determine whether a person is infectious. Confirmatory testing with a laboratory PCR test should be considered to confirm infection in these individuals for follow up clinical care.

8. Results obtained with this assay, particularly in case of weak test lines that are difficult to interpret, should be used in conjunction with other clinical information available to the physician.

9. The use of rapid antigen tests in screening asymptomatic individuals or on patients in late stage of infection (>7 days of onset of symptom) may produce false negative results due to low level of antigen presented in these samples. Please refer to clinical evaluation for details.

Warnings and Disclaimers

Please read the instructions carefully before performing the test.

If test results are positive the consumer must have a PCR test done and self isolate