The 2019-nCoV (COVID-19) IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma specimens. For professional in vitro diagnostic use only.
This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in the IgG test line region. During testing, the specimen reacts with 2019-nCoV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to 2019-nCoV. A coloured line will appear in IgG test line region as a result of this. Similarly, anti-human IgM is coated in IgM test line region and if the specimen contains IgM antibodies to 2019-nCoV, the conjugate-specimen complex reacts with anti-human IgM. A coloured line appears in the IgM test line region as a result.
To serve as a procedural control, a coloured line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Pack Size: 25 Tests
- Sterile Lancets for Fingerstick whole blood collection
For serum or plasma:
- Specimen collection containers
- Capillary tubes
How does it work?
For Fingerstick Whole Blood specimen: To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill line and transfer 1 full drop (approx. 20μl of specimen to the sample well(S). Then add 2 drops of buffer (approximately 80 μl) and start the timer.
Wait for the coloured line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
IgG POSITIVE:* Two coloured lines appear. One coloured line should always appear in the control line region (C) and another line should be in the IgG line region.
IgM POSITIVE:* Two coloured lines appear. One coloured line should always appear in the control line region (C) and another line should be in the IgM line region.
IgG and IgM POSITIVE:* Three coloured lines appear. One coloured line should always appear in the control line region (C) and two test lines should be in the IgG line region and IgM line region.
*NOTE: The intensity of the colour in the test line regions may vary de
pending on the concentration of 2019-nCoV antibodies present in the specimen. Therefore, any shade of colour in the test line region should be considered positive.
NEGATIVE: One coloured line appears in the control line region (C). No line appears in the IgG region and IgM region.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test.
If the problem persists, discontinue using the test kit immediately and contact your local distributor.
The 2019-nCoV IgG/IgM Rapid Test Cassette will only indicate the presence of IgG and IgM antibodies to 2019-nCoV in the specimen and should not be used as the sole criteria for the diagnosis of 2019-nCoV infections.
As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of 2019-nCoV infection.
The test will show negative results under the following conditions: the novel coronavirus antibody has not appeared at the time of sample collection (Asymptomatic stage).