Description
Product Description
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 authorized 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.
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
Always read the label, follow directions of use, incorrect use could be harmful. If symptoms persist please consult your healthcare professional. Keep out of reach of children.
For in vitro diagnostic use only. Read the Package Insert prior to 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 2 years of age. • Do not use on anyone who is prone to nosebleeds or has had facial or head injury/surgery in the last 6 months. Leave the test device in the sealed pouch until just before use. Do not use the test device if pouch is damaged or open. • All kit components are single use items. Do not use with multiple specimens. Do not reuse the used kit components. • Do not mix components from different kit lots. • Do not touch 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 may yield a false-positive result. Avoid touching any bleeding areas of the nasal cavity when collecting specimens. • When collecting a nasal swab sample, use only the Nasal Swab provided in the kit
** SARS-CoV-2 variants
The following SARS-CoV-2 variants were tested on 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
