STANDARD F COVID-19 IgM/IgG Combo FIA is the fluorescent immunoassay for the qualitative detection of specific antibodies to SARS-CoV-2 present in human serum and whole blood. STANDARD F COVID-19 IgM/IgG Combo FIA should be used with the STANDARD F Analyzers manufactured by SD BIOSENSOR. This test is for in vitro professional diagnostic use and intended as an aid to the diagnosis of SARS-CoV-2 infection in the convalescent phase of a patient with clinical symptoms of SARS-CoV-2 infection.

Advantage

• Total Antibody test (IgM and IgG)

• Superior sensitivity & specificity

• Suitable method for population antibody screening

Specification

Specimen Whole blood/Serum

Test time 15 minutes

Specimen volume 10 ul

Sensitivity 97.74% (130/133)

Sensitivity (≥7 days after symptom onset) 100% (119/119)

Specificity 95.33% (143/150)

Storage temperature 2-30℃ / 36-86℉