Shenzhen Kisshealth Biotechnology Co., Ltd
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SARS-CoV-2 IgM/IgG Antibody Test Kit(Colloidal Gold) Antibody Detection Rapid Test
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.
The test is only for clinical use and emergency storage during pneumonia epidemic caused by SARS-CoV-2. It cannot be used as regular IVD product for clinical purpose. Test result is only for clinical reference. The test result should be interpreted by the physician along with other clinical findings and other laboratory test results.
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 |
Storage and stability:
The kit can be stored at room temperature or refrigerated (2-30°C).
The test device is stable through the expiration date printed on the sealed pouch.
The test device must remain in the sealed pouch until use.
DO NOT FREEZE.
Do not use beyond the expiration date.