The US Food and Drug Administration (FDA) has issued a safety communication to alert caregivers regarding potential false-positive results with certain Ellume Covid-19 Home Test kits. The move came days after Ellume voluntarily recalled some batches of test kits due to similar concerns. The company also noted that it has identified the root cause and implemented additional controls. The FDA is now working with Ellume to resolve the issue.
The FDA has granted Emergency Use Authorization (EUA) for Euroimmun’s Anti-SARS-CoV-2 S1 Curve ELISA. This assay enables qualitative and semi-quantitative detection of IgG antibodies formed in human serum and plasma against the SARS-CoV-2 S1 antigen. The measurement of IgG antibodies can help in future discoveries as well as help in gaining insights on immune responses to Covid-19.
Covid-19 test kit manufacturers in the US, such as Abbott Laboratories, Quidel Corp and LumiraDX, are working to ramp up production to meet increasing demand, reports Reuters. This comes amid a shortage of rapid Covid-19 tests across several states.