Rapid Antibody Test Kit ISO Qualitative Detection Rapid IgG IgM
Test
For professional and in vitro diagnostic use only.
| Product Name | Rapid Antibody Test Kit ISO Qualitative Detection Rapid IgG IgM
Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box |
| Storage | 2℃-30℃ |
[INTENDED USE]
The COVID-19 IgG/IgM Rapid Test device is a lateral flow
chromatographic immunoassay for the qualitative detection of
antibodies (IgG and IgM) to Novel coronavirus in human Whole
Blood/Serum/Plasma. It provides an aid in the diagnosis of
infection with Novel coronavirus.
[COMPOSITION]
The test contains a membrane strip coated with Mouse anti-Human IgM
antibody and Mouse anti-Human IgG antibody on the test line, and a
dye pad which contains colloidal gold coupled with Novel
coronavirus recombinant antigen.
The quantity of tests was printed on the labeling.
Materials Provided
• Test device •Package insert
• Buffer
Materials Required But Not Provided
• Specimen collection container •Timer
[INTERPRETATION OF RESULTS]
Positive: Control line and at least one test line appear on the membrane.
The
appearance of IgG test line indicates the presence of Novel
coronavirus specific IgG antibodies. The appearance of IgM test
line indicates the presence of Novel coronavirus specific IgM
antibodies. And if both IgG and IgM line appear, it indicates that
the presence of both Novel coronavirus specific IgG and IgM
antibodies. The IgM line appears a little weak, not as strong as
the IgG line, because the IgM antibody concentration is lower than
the IgG antibody in blood.
Negative: One colored line appears in the control region(C). No apparent
colored line appears in the test line 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 device.
