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nCoV-19 IgG/IgM Rapid Test Device

The nCoV-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti-nCoV-19 virus and IgM anti-nCoV-19 virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with nCoV-19 viruses. Any reactive specimen with the nCoV-19 IgG/IgM Rapid Test must be confirmed with alternative testing method(s).

ASSAY PROCEDURE
Bring the specimen and test components to room temperature Mix the specimen well prior to assay once thawed. Place the test device on a clean, flat surface.
For capillary whole blood sample:
To use a capillary tube: Fill the capillary tube and transfer approximately 40 µL (or 1 drop) of fingerstick whole blood specimen to the specimen well (S) of the test device, then add 1 drop of Sample Diluent immediately into the sample well.
For whole blood sample:
Fill the dropper with the specimen then transfer 1 drop (about 40 µL) of specimen into the sample well. Making sure that there are no air bubbles. Then transfer 1 drop (about 40 µL) of Sample Diluent immediately into the sample well.
For Plasma/ Serum sample:
Fill the dropper with the specimen then transfer 1 drop (about 40 µL) of specimen into the sample well. The volume is around 80µL. Making sure that there are no air bubbles. Then transfer 1 drop (about 40 µL) of Sample Diluent immediately into the sample well.                 
Set up a timer. Read the result at 15 minutes. Don't read result after 30 minutes. To avoid confusion, discard the test device after interpreting the result