Inova Diagnostics, San Diego, announced the emergency use authorization of Quanta Flash SARS-CoV-2 IgG by the FDA for use on the Bio-Flash random access chemiluminescent analyzer from Biokit, Barcelona, Spain.
The Quanta Flash SARS-CoV-2 IgG is a precise chemiluminescent immunoassay for the in vitro qualitative and semi-quantitative detection of IgG to the nucleocapsid and spike protein of SARS-CoV-2. This test has shown an excellent clinical performance with 100% specificity in patients with confounding conditions and a 100% sensitivity for COVID-19 in patients after ≥ 15 days of a positive RT-PCR result.
“We are excited about the emergency use authorization of our Quanta Flash SARS-CoV-2 IgG. Based on the high performance of the assay and the high automation level of the Bio-Flash system, Quanta Flash SARS-CoV-2 IgG represents a promising solution to detect antibodies to SARS-CoV-2,” says Michael Mahler, PhD, VP of research and development, Inova Diagnostics.
The Quanta Flash SARS-CoV-2 IgG test is performed using human serum or citrated plasma on the Bio-Flash instrument, which has a processing capacity of up to 60 samples per hour, stat capability, and time to first result of 30 minutes.
This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detection of IgG antibodies to SARS-CoV-2, not for any other viruses or pathogens.
Biokit Bio-Flash rapid response chemiluminescent analyzer for the autoimmune laboratory. (Courtesy: Inova Diagnostics)