Finecare™ 2019-nCoV IgM/IgG Test
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INTENDED USE
The Finecare™ 2019-nCoV lgM/lgG Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of IgG and IgM antibodies of novel coronaviruses (2019-nCoV) in human whole blood, serum and plasma specimen. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV.
The test provides preliminary test results. Negative results cannot exclude the possibility of 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision.
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STORAGE AND STABILITY
1. Store at 4-30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze.
2. The test device should be used within 1 hour after taking out from the foil envelope.
3. Keep away from sunlight, moisture and heat.
4. Kit contents are stable until the expiration date printed on the outer box.
SPECIFICATION
Description |
Cat. No. |
Sample Volume |
Specimen |
Reaction Time |
Storage Temperature |
Qualification |
W278 |
10μL |
Serum
Plasma
Whole Blood |
10 mins |
4-30℃ |
CE |
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