Novel Coronavirus (COVID-19) IgG/IgM Antibody Test

CE APPROVED

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COVID-19

Covid19 Test Kit

Now Available!

Biocan is an ISO 13485:2016 MDSAP certified manufacturer of various rapid invitro 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 IgG/IgM Ab Rapid Test at a very reasonable cost to make it affordable to where it is needed most to stop the spread of this novel coronavirus, which has now affected a very large number of people worldwide and is spreading at a very fast rate.

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

Principle of the Test:

Biocan Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of a red colored conjugate pad containing recombinant COVID-19 antigen conjugated with colloid gold (SARS-CoV-2 conjugates), quality control antibody gold conjugates, nitrocellulose membrane strip containing two test lines (T1 and T2) and a control line (C). The T2 line is pre-coated with monoclonal anti-human IgG for the detection of IgG anti-SARS-CoV-2, the T1 line is pre-coated with reagents for the detection of IgM anti-SARS-CoV-2 and the C line is pre-coated with quality control antibody. When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. SARS-CoV-2 IgM antibodies if present in the specimen will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a red colored T1 line, indicating SARS-CoV-2 IgM positive test result. SARS-CoV-2 IgG antibodies if present in the specimen will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a red colored T2 line, indicating a SARS-CoV-2 IgG positive test result. Absence of any test lines (T1 and T2) suggests a negative result. The test cassette also contains a quality control line C. Regardless of the presence or absence of a detection band, the red quality control band C should appear. If the quality control band C does not appear, the test result is invalid, and the sample needs to be tested again with another test cassette.

Intended Use:

Biocan Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Rapid Test is a rapid, qualitative, membrane-based immunochromatographic in vitro assay intended for detection and differentiation of SARS-CoV-2 IgG & IgM in human serum, plasma (EDTA, citrate, Heparin) or venipuncture whole blood specimens (including finger prick) from patients suspected of COVID-19 infection by a healthcare provider, laboratories and point of care. Biocan Tell Me Fast Novel Coronavirus (COVID19) IgG/IgM Ab Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from this test should not be used as the sole basis for diagnosis.

Directions for Use:

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

  1. Place the test device on a clean and level surface.

  2. Pipette 10μL of serum, plasma or 20μL whole blood into the sample well of the test device.

  3. Add 2 drops of diluent buffer to sample well of the test device.

  4. Wait for the red lines to appear. The test result should be read between 10 and 15 minutes.

Interpretation of Results:

NOTE: Do not interpret the result after 20 minutes.

  •  IgM POSITIVE:  Two distinct red lines appear. The control line (C) and IgM (Test line 1) line are visible on the test cassette. The test is positive for SARS CoV 2 IgM antibodies.

  • IgG POSITIVE: Two distinct red lines appear. The control line (C) and IgG (Test line 2) line are visible on the test cassette. The test is positive for COVID-19 IgG antibodies.

  • IgM and IgG POSITIVE: Three distinct red lines appear. The control line (C), IgM (1) and IgG (2) lines are visible on the test cassette. The test is positive for COVID-19 IgM and IgG antibodies.

  • NEGATIVE: One distinct red line appears. The control line (C) is the only line visible on the test cassette. No COVID-19 IgG or IgM antibodies were detected.

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