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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.
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.
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