Coronavirus (COVID-19) IgG/IgM Antibody Test
A rapid test for the qualitative detection and differentiation of novel coronavirus (COVID-19) IgG & IgM antibodies in human whole blood, serum and plasma samples. For presumptive preliminary screening and research use only. All results should be confirmed with other qualified assays.
Biocan Tell Me Fast Coronavirus (COVID-19) IgG/IgM Antibody Test is a rapid, qualitative, membrane-based immunochromatographic in vitro assay intended for detection and differentiation of novel coronavirus (COVID-19) IgG & IgM antibodies with human serum, plasma or whole blood samples. This test is intended for laboratory in vitro diagnostic use and is a preliminary screening presumptive test and final diagnosis should be based after examination with other qualified assays.
PRINCIPLE OF THE TEST:
Biocan Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of a pink colored conjugate pad containing recombinant COVID-19 antigen conjugated with colloid gold (COVID-19 conjugates) and quality control antibody gold conjugates and a nitrocellulose membrane strip containing two test lines (T1 and T2) and a control line (C). The T1 line is pre-coated with monoclonal anti-human IgG for the detection of IgG anti-COVID-19, T2 line is pre-coated with reagents for the detection of IgM anti-COVID-19 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. COVID-19 IgM antibodies if present in the specimen will bind to the COVID-19 conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a pink colored T2 line, indicating COVID-19 IgM positive test result. COVID-19 IgG antibodies if present in the specimen will bind to the COVID-19 conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a pink colored T1 line, indicating a COVID-19 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.
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.
- Place the test device on a clean and level surface.
- Pipette 10μL of serum, plasma or whole blood into the sample well of the test device.
- Add 2 drops of diluent buffer to sample well of the test device.
- Wait for the red lines to appear. The test result should be read between 10 and 15 minutes.
Note: Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
IgM POSITIVE: Two distinct red lines appear. The control line (C) and IgM (Test line 2) line are visible on the test cassette. The test is positive for COVID-19 IgM antibodies. IgG POSITIVE: Two distinct red lines appear. The control line (C) and IgG (Test line 1) 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 (M) and IgG (G) 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. INVALID: Control line fails to appear. The test results are INVALID, if no control line (C) is visible, regardless of the presence or absence of lines in the IgG (G) or IgM (M) region of the cassette. Repeat the test using a new cassette.