Shenzhen Kisshealth Biotechnology Co., Ltd |
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Intended use:
This product is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM/IgG antibodies in human whole blood, serum,plasma or fingerstick whole blood specimen. The test is only to be used in conjunction with nucleic acid method in the diagnosis of suspected cases.
The test is not intended to be used for general population screening and only provides preliminary test results. Positive results need further confirmation and negative results cannot exclude the possibility of SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision.
Sample type:
whole blood, serum, plasma or fingertip whole blood specimen
Specifications:
1 Tests/Kit, 25Tests/Kit
Main Components:
Item | Component | Vol/Qty. | |
K601-1 | K601-25 | ||
1 | Test Cassette | 1 | 25 |
2 | Specimen Diluent | 0.5mL*1 | 3.0mL*1 |
3 | Lancet | 1 | 25 |
4 | Dropper | 1 | 25 |
5 | Alcohol Pad | 1 | 25 |
6 | Band-Aid | 1 | 25 |
7 | IFU | 1 | 1 |