Intended Use
(COVID-19) IgM/IgG Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro diagnostic of COVID-19 IgM/IgG antibody in human serum, plasma, whole blood and fingertip blood.
This test kit can only be used as a supplementary indicator for novel coronavirus nucleic acid test negative suspected cases or in collaboration with nucleic acid test in the diagnosis of suspected cases. This test kit cannot be used as the basis for the diagnosis and exclusion of pneumonia infected by novel coronavirus. This test kit is only used in medical institutions, is not suitable for the screening of general population, and cannot be used for self-test. For professional use only.

Specifications

Main Components

1. IgM/IgG test strip in a sealed pouch with desiccant…………………25tests/50tests
2. Sample diluent…………………………………………………………1 piece/2 pieces
3. QR code card for calibration…………………………………………………1 piece
4. User manual…………………………………………………………………………1 piece
5. Plastic transfer pipette (Optional).
6. Alcohol pad (Optional).
7. Safety Blood Lancet (Optional).

Storage And Validity

1. Store the test kit at 4℃~30℃ up to the expiration date printed on package.
2. Test strip should be used within 1 hour once the foil pouch is opened.

Applicable Device

1. LS-1100 Dry Fluorescence Immunoassay Analyzer
2. LS-2100 Dry Fluorescence Immunoassay Analyzer
3. LS-4000 Dry Fluorescence Immunoassay Analyzer
4. LS-3000 Automatic Fluorescence Immunoassay Analyzer