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 to the battle against the pandemic.

The FDA has issued a 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.

About QualTex Laboratories:

QualTex Laboratories provides state-of-the-art biologic testing services on whole blood, plasma, and human cells, tissue, and cellular- and tissue-based products for biotechnology and biopharmaceutical customers. It is one of the nation’s largest nonprofit testing laboratories with automation systems and has locations in Texas and Georgia. The center is a subsidiary of BioBridge Global, a nonprofit organization comprising services for regenerative medicine and research to help patients in South Texas, the United States, and worldwide. Visit us at qualtexlabs.org.

About BioBridge Global: 

BioBridge Global (BBG) is a San Antonio, Texas-based 501(c)(3) nonprofit corporation that offers diverse services through its subsidiaries – the South Texas Blood & Tissue Center, QualTex Laboratories, GenCure, and The Blood & Tissue Center Foundation. BBG provides products and services in blood resource management, cellular therapy, donated umbilical cord blood and human tissue as well as testing of blood, plasma and tissue products for clients in the United States and worldwide. BBG is committed to saving and enhancing lives through the healing power of human cells and tissue. It enables advances in the field of regenerative medicine by providing access to human cells and tissue, testing services and biomanufacturing and clinical trials support. Learn more at BioBridgeGlobal.org.