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Sales, R&D and Manufacturing Facility 55A & 53B Fawcett Road, Coquitlam BC V3K 6V2 Canada
Tell Me Fast COVID-19 Antigen Test Saliva/Nasal (Anterior & Mid Turbinate)
CE APPROVED
Now Available in:
- 20 Test pack
- Single Test Pack (OTC/Self Test)
Sensitivity & Speceficity:
LOD (Limit of Detection):
For the Saliva samples the LOD study was performed using cultured SARS-CoV-2 virus, which was β-propiolactone and heat inactivated and spiked into saliva specimen. The Limit of detection is 1.51 ˟10 TCID50/ml
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 saliva (oral fluid) and nasal swab (anterior nares or mid turbinate). 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 consists of a burgundy colored conjugate pad containing mouse monoclonal anti-SARS-CoV-2 nucleocapsid antibody conjugated to colloidal gold, rabbit IgG conjugated to colloidal gold and a nitrocellulose membrane containing test band (T bands) and a control band (C band). The T band is pre-coated with mouse monoclonal anti-SARS-CoV-2 nucleocapsid antibody for the binding and detection of SARS-CoV-2 nucleocapsid viral 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 well of the test cassette, the specimen migrates by capillary action across the cassette. SARS-CoV-2 virus, if present in the specimen, will bind to the mouse monoclonal anti- SARS-CoV-2 antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse monoclonal anti-SARS-CoV2 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 the pink control 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.
Sample collection
Saliva (Oral Fluids) Specimen:
The patient should rinse the mouth thoroughly before collection of saliva sample. Collect the saliva (oral fluid) specimen with the sterile swab provided by swabbing the upper and lower gums all the way from the back to the front twice. Process the swab as soon as possible after collecting the specimen by placing in the specimen extraction buffer vial.
Anterior Nasal Swab Specimen:
Insert the swab at least 1cm (0.5 inch) inside the nostril (naris) and firmly sample the nasal membrane by rotating the swab and leaving in place for 10 to 15 seconds. Sample both nostrils with same swab. Place swab, tip first, into the extraction buffer vail.
Mid Turbinate Swab Specimen:
Tilt patient’s head back 70 degrees. While gently rotating the swab, insert swab less than one inch (about 2 cm) into nostril parallel to the palate (not upwards) until resistance is met at turbinates. Rotate the swab several times against nasal wall and repeat in other nostril using the same swab. Place swab, tip first, into the extraction buffer vail.
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. Open the specimen extraction tube and place the swab 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 to 10 times while pressing the head against the bottom and side of the tube.
2. Break the swab from the break point and with the cap of the extraction tube press it down in the tube and close the specimen extraction tube and then shake it gently in a circular motion 5 to 10 times.
3. Take the test cassette out of the pouch and place it on a clean flat surface. Open the white top cap of the specimen extraction tube and transfer 3 drops solution from the extraction tube to the sample well of the test cassette.
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 INTERPRETATION 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.