Enzo Biochem announced that it has launched a SARS-CoV-2 IgG ELISA assay kit for serological detection of IgG antibodies against SARS-CoV-2 under Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration, the company said in a press release.

The assay permits the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and is designed to provide accurate results in a clinical laboratory setting with low- to high-throughput processing of specimens.

In a clinical study, performance of the SARS-CoV-2 ELISA Kit was compared with a molecular diagnosis (PCR) using serum samples from approximately 150 individuals. Positive percent agreement (PPA) and negative percent agreement (NPA) with a comparator PCR observed 96.5 percent specificity and 100 percent sensitivity. Clinical assays for antibodies must be reliable and have high specificity without cross-reactivity to related viruses.

The new test, which is built on Enzo’s proprietary ELISA platform, works with serum specimens and is formatted for both manual test-processing situations as well as automated, high-throughput clinical workflows. Enzyme-linked immunosorbent assay (ELISA) is an analytical, plate-based technique to detect the presence of a target analyte in a liquid sample using affinity reagents. 

Enzo’s high-throughput kit for IgG antibody utilizes a routine blood collection at a lab’s patient service center, a doctor’s office, or a hospital. All kits are manufactured at Enzo’s GMP certified production facilities. 

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