Project Description

Rapid SARS-CoV-2 Antibody (IgM/IgG) Test®

Advanced Quality Medical Diagnostics



Intended Use

The Rapid SARS-CoV-2 Antibody (IgM/IgG) Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of IgG and/or IgM to SARS-CoV-2 in human whole blood (venous and fingerstick), serum or plasma specimens. This test is intended for use by healthcare professionals and trained healthcare workers as an aid in the diagnosis of SARS-CoV-2 infection.

94.4% Sensitivity

98% Specificity

· Specimen: whole blood, serum or plasma

· Test time: 15-20 minutes

· Storage temperature: 2-30℃

· Shelf life: 24 months

Technical files