The InnoScreen COVID-19 Rapid Antigen 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 approved for home self-use with self-collected direct anterior nasal swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older. Rapid Antigen testing is less reliable than PCR when testing an asymptomatic patient or testing patients after seven days of symptom onset as it may produce a false-negative result. Do not use the test for a child under two years old. An adult should perform the test for children 2-15 years old.
Suppose the test is being used for testing individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. In that case, testing should be scheduled twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests.
COVID-19 is the disease associated with SARS-CoV-2, first identified in China at the end of 2019. The virus is transmitted mainly via respiratory droplets that people sneeze, cough, or exhale. The incubation period for COVID-19 is estimated at between 2 and 14 days. Common symptoms of COVID-19 infection include fever, cough and respiratory symptoms such as shortness of breath and breathing difficulties. More severe cases develop severe pneumonia, acute respiratory distress syndrome, sepsis and septic shock that can lead to the patient’s death. People with existing chronic conditions seem to be more vulnerable to severe illness.
The InnoScreen COVID-19 Rapid Antigen Test Device is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect SARS-CoV-2 viral nucleoprotein antigens in nasal swabs.
Read the Package Insert before use. Directions should be read and followed carefully.
Children or teenagers aged 2 to 15 years old should have their samples collected and tested by an adult. Do not use the tests for anyone under two years of age.
Do not use the kit or components beyond the expiration date.
All kit components are single-use items. Do not use with multiple specimens. Do not reuse the used kit components.
Do not touch the swab tip when handling the swab sample.
Perform the test immediately after collecting the sample.
Excess blood or mucus on the swab specimen may interfere with test performance and yield a false-positive result. Avoid touching any bleeding areas of the nasal cavity when collecting samples.
Keep the test device on a flat surface during the testing.
Do not interpret the test result before 15 minutes and after 20 minutes of starting the test.
STORAGE AND STABILITY
Store the InnoScreen COVID-19 Rapid Antigen Test Device at 2-30°C.
DO NOT FREEZE.
Kit contents are stable until the expiration dates marked on their outer packaging and containers. Once opened, the device should be used immediately.
The following SARS-CoV-2 variants were tested on the InnoScreen COVID-19 Antigen Rapid Test Device. All the variants can be detected at above-mentioned limit of detection level.
SARS-CoV-2 Variants of Concern tested
B.1.1.7 Alpha United Kingdom
B.1.351 Beta South Africa
B.1.427/B.1.429 Epsilon United States
B.1.617.2 Delta India
P.1 Gamma Japan/Brazil
Negative Rapid Antigen test results do not exclude infection with SARS-CoV-2 (COVID-19); and
Positive test results or symptomatic persons require immediate confirmatory testing using a polymerase chain reaction (PCR) test.
Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements in your relevant State or Territory. https://www.health.gov.au/health-alerts/covid-19/testing
Negative test results do not exclude infection with COVID-19 (so face masks, social distancing and good hygiene practice must be maintained)
- Easy to use and interpret
- Non invasive and comfortable to use
- Direct detection of the virus
- Rapid results within 15 minutes
- TGA Approved
- Made in Australia