Test detects antibodies developed during a COVID-19 infection
QualTex Laboratories, a subsidiary of San Antonio-based nonprofit BioBridge Global, has begun offering the Ortho Diagnostics VITROS® Anti-SARS-CoV-2 IgG assay for use in detecting COVID-19 antibodies.
The assay helps health care professionals determine if a person’s immune system has developed antibodies to the virus that causes COVID-19. It was approved for Emergency Use Authorization for qualifying COVID convalescent plasma (CCP) by the Food and Drug Administration on Aug. 23.
Given the recent increase in COVID-19 cases and hospitalizations, the addition of the assay is a timely addition in the battle against the pandemic.
The FDA has issued an EUA for COVID convalescent plasma, which is donated by those who have recovered from COVID-19, for use in patients with active COVID-19 infections.
The Ortho IgG test has demonstrated 100% specificity and is currently the only assay approved by the FDA for COVID convalescent plasma qualification. The test runs on Ortho’s high-throughput, fully automated analyzers, and it measures IgG antibodies to the SARS-CoV-2 virus.
COVID Convalescent plasma is currently being used to save the lives of those most severely affected by COVID-19. This assay provides a powerful tool to identify those blood donors with the highest antibody concentrations to aid in COVID-19 treatment.