The BioMedomics COVID-19 IgG/IgM Rapid Test is a rapid, point-of-care (POC) lateral flow immunoassay (LFA) that detects antibodies to the SARS-CoV-2 spike protein receptor-binding domain (RBD). It detects both early (IgM) and late (IgG) marker antibodies in human finger-prick capillary blood, venous whole blood, serum, and plasma. Since its launch in March 2020, it has gone through several independent validations and is being used globally in hospitals, clinics, and government agencies.
Widespread deployment of POC testing for SARS-CoV-2 could transform the global COVID-19 response, helping individuals quickly understand whether they were previously infected or have developed a robust response to vaccination, and informing health officials on the level of community protection that may be present.
As their use extends beyond traditional clinical settings to help determine serostatus after infection or vaccination, evaluating test performance against laboratory assays at the POC, not just in controlled laboratory settings, is essential.
A recent study provides insight into how SARS-CoV-2 lateral flow assays are likely to perform in POC settings when used by individuals other than laboratory professionals.
When used 1 month after the onset of symptoms, the demonstrated robust sensitivity (90%) and complete specificity (100%) in a heavily exposed household cohort.
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