The COVID-19 Antibodies test from Diagnox is an FDA-EUA, C-FDA, CE-IVD, and A-TGA approved test for IgG and IgM antibodies. It is a rapid test device that utilizes lateral flow technology for the qualitative, differential detection of both anti-SARS-CoV-2 IgM (early marker) and IgG (late marker) antibodies. The test works with whole blood, serum, or plasma.
Features
Facilitates patient treatment decisions quickly
Detection window (IgM): 3-5 days for Symptomatic. 7 days for Asymptomatic
No clinical equipment or facilities needed
Dual-band results for simple interpretation
Multivariable analysis of immunoglobin IgG & IgM
Specifications
Format: Cassette
Time to results: 10 minutes
Specimen: Whole Blood/Serum/Plasma
Volume: 10 uL
Positive Percent Agreement: IgG 96.7% | IgM 86.7% | Overall 96.7%
Negative Percent Agreement: IgG 98.0% | IgM 99.0% | Overall 97.0%
Shelf life: 24 Months
Storage: Room temperature or refrigerated (2-30⁰C / 36-86⁰F)