Novel Coronavirus (COVID-19) Antigen Test

CE APPROVED

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Covid-19 Antigen Test

Now Available!

Biocan is an ISO 13485:2016 MDSAP certified manufacturer of various rapid in-vitro diagnostics tests made under stringent quality control in our facility near Vancouver, Canada.

As part of our corporate mission, we have launched the COVID-19 Antigen Test at a very reasonable cost to make it affordable to where it is needed most. We believe accessible testing is key to stop the spread of Novel Coronavirus, which has now affected many people worldwide and is spreading rapidly.

Our COVID19 Antigen Test is currently not approved for sale in Canada.

Intended Use:

 Biocan Tell Me Fast COVID-19 Antigen Test is a rapid qualitative membrane-based immunochromatographic in vitro assay intended for detection of SARS-CoV-2 (COVID19) antigens with human nasal swab, nasopharyngeal swab and throat (oropharyngeal) swabs. This test is intended for in vitro diagnostic use at point of care settings and laboratories and is a preliminary screening test and final diagnosis should be based after examination with other qualified assays like molecular diagnostics test.

 

 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 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. The agent detected may not be the definite cause of disease. Negative results, from patients with symptom onset beyond ten days, should be treated as presumptive and confirmation with a molecular assay if necessary, for patient management, may be performed. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.  

Principle of the Test:

 Biocan 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. 

Directions for Use:

Allow the tests, swabs and controls to reach to room temperature (15-30ºC) prior to testing. Do not open the package until ready to perform the assay. 

  1. 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. 

  2. Immediately dispose the used swab as per biohazard waste disposal procedures. Then fit the dropper tip on top of the extraction tube. 

  3. 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. 

  4.  After 10-15 minutes interpret the results. Do not read the results after 20 minutes. 

Interpretation of Results:

  • NEGATIVE: Only one pink band appears on control line (C). 

  • 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). 

  • 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. 

Product dispayed are not for sale in Canada Biocan Diagnostics Inc. © 2018. All rights reserved.