Self Test Diagnostic Kit For IgM Antibody To 2019-NCoV Rapid Test
INTENDED USE
The kit is used for the qualitative detection of novel coronavirus
(2019-nCoV) IgM antibodies in human serum and plasma samples in
vitro. It is only used as a supplementary detection index for
suspected negative cases of new coronavirus nucleic acid detection,
or in collaboration with nucleic acid detection in the diagnosis of
suspected cases, and can not be used as a basis for the diagnosis
and elimination of pneumonia caused by new coronavirus infection.
It is not suitable for screening in general population.
Only for medical institutions.
The test results are positive and need further confirmation.
Negative results can not exclude the possibility of infection.
This product is restricted to clinical use and emergency stockpile
during the period of new coronavirus pneumonia infection since
December 2019. It can not be used as a routine in vitro diagnostic
reagent. The results of this kit are for clinical reference only.
It is suggested that the disease be comprehensively analyzed
combined with clinical manifestations and other laboratory tests.
Laboratory testing of the COVID-19 should comply with “the
requirements of the laboratory guidelines for detection of
coronavirus pneumonia”, and do a good job in biosafety.
| Product details | Description |
| Test Time | 5-20 miuntes |
| Packaging Specifications | 5 test cards/ box, 20 test cards/ box, 40 test cards/ box |
| Exp | two years |
| Manufacturer | BIOVANTION |
| Preservation method | Normal temperature |
| Assification | Class1 |
| Package | carton/box |
| Sample Type | Pharyngeal |
Interpretation of test results
To develop color on C line only
To develop color on both C line and T line;
To develop color on T line only
If no C line is developed, the assay is invalid regardless of any
color in the T line.
Samples should be processed according to infectious contaminants
and samples should be collected again.
Sample requirements
- Serum and plasma samples were collected from the venous blood by
conventional method. The treatment of plasma sample: heparin
solution, sodium citrate solution and EDTA solution can be used to
anticoagulate blood.
- Serum or plasma samples can be stored at 2 ~ 8 ℃ if tests will be
done within 5 days, otherwise stored at -20 ℃. No more than 3 times
of freeze-thaw.
- The result of haemolysis sample test is invalid.
- Samples containing suspended fibrin or polymer are recommended for
centrifugation and supernatant for testing. Hemolytic samples can
not be detected.
- There should be no other microbial contamination in the samples to
be tested.
- The specimen transfer box should have special identification. After
removing the specimen from the sealed bag, it must be sterilized by
ultraviolet or 75% ethanol spray.
- Before use, the sample should be kept at room temperature for more
than 30 minutes, and the sample should be mixed before
freezing.
