Intended Use:
Altremed is proud to announce our partner, BioCan Canada, new Tell Me Fast COVID-19 Antigen Test that is CE-marked and has been authorized by the UK for travelers using any of their ports of entry. It is a rapid qualitative membrane-based immunochromatographic in vitro assay intended for detection of SARS-CoV-2 (COVID19) antigens through human nasal swab, nasopharyngeal swab and throat (oropharyngeal) swabs.
Results are for the identification of SARS-CoV-2 antigen which is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results comparable to PCR, indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
Directions for Use:
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Take the extraction tube and add 10 drops (0.4ml) of extraction buffer solution into the extraction tube. Place the swab specimen collected from the patient into the specimen extraction tube. Tilt the tube sidewards so that the entire swab can dip in the extraction buffer and then swirl the swab 5-10 times while pressing the head against the bottom and side of the tube.
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Immediately dispose the used swab as per biohazard waste disposal procedures. Then fit the dropper tip on top of the extraction tube.
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Take the test strip out of the vail and place it on a clean flat surface. Transfer 2 drops solution from the extraction tube to the sample well of the test cassette.
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After 10-15 minutes interpret the results. Do not read the results after 20 minutes.
Interpretation of Results:
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NEGATIVE: Only one pink band appears on control line (C).
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POSITIVE: In addition to the pink control band, a pink band also appears on test line (T) which is located below the control line (C).
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INVALID: No band appears on the control line. A total absence of the control colored band (PINK) regardless the appearance or not of the test lines. Insufficient specimen volume, incorrect procedural techniques or deterioration of the reagents are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test.
NOTES ON INTERPREATION OF RESULTS:The intensity of the pink colored band in the result test line region (T) will vary depending on the concentration of antigens present in the specimen. However, neither the quantitative value, nor the rate of increase in antigens can be determined by this qualitative test.
Principle of the Test:
BioCan Canada’s Tell Me Fast COVID19 Antigen Test is a lateral flow chromatographic immunoassay. The test strip consists of a burgundy colored conjugate pad containing recombinant antigen conjugated with colloid gold (monoclonal mouse anti SARS-CoV-2 antibody conjugates) and rabbit IgG-gold conjugates and a nitrocellulose membrane strip containing test band (T bands) and a control band (C band). The T band is pre-coated with monoclonal mouse anti- SARS-CoV- 2 antibody for the detection of SARS-CoV-2 antigen, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample pad of the test strip, the specimen migrates by capillary action across the strip. SARS-CoV-2 virus if present in the specimen will bind to the monoclonal mouse anti- SARS-CoV-2 antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti- SARS-CoV-2 antibody, forming a pink colored T band, indicating a Covid-19 antigen positive test result. Absence of test band (T) suggests a negative result. The test contains an internal control (C band) which should exhibit a pink colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on of the test band. If the control line does not appear, the test result is not valid. The presence of this pink band serves as 1) verification that sufficient volume is added, 2) that proper flow is obtained and 3) as an internal control for the reagents.