NIAID
The group is developing an ELISA assay that uses phospholipids acquired by Borrelia burgdorferi, the Lyme bacterium, as biomarkers of disease.
FDA Validates Coronavirus Serology Test for First Time, Issues EUA for PerkinElmer's Euroimmun ELISA
The Euroimmun's Anti-SARS-CoV-2 ELISA test is the first serology test whose results were independently validated by the federal government.
NIH Kicks Off Study Investigating Coronavirus in Children
Among the study's aims is determining how rates of SARS-CoV-2 infection differ between healthy children and ones with asthma or other allergic conditions.
FDA Working With NCI, NIAID on SARS-CoV-2 Serology Test Validation Effort
The aim will be to establish the performance of serology tests for COVID-19 that are being marketed without FDA review and those seeking Emergency Use Authorization.
False Positives Could Undermine Utility of SARS-CoV-2 Serology Testing
Policymakers have touted such tests as key to easing shutdowns, but high specificity will be needed to avoid misinforming people about their infection status.