Ortho Clinical Diagnostics launches two COVID-19 antibody tests with 100% specificity

Study results show that even with 97% specificity, there is a chance of getting 30 false positive results out of 1,000

Ortho Clinical Diagnostics, OVID-19 antibody tests, VITROS Anti-SARS-CoV-2 Total, IgG tests, COVID-19, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare

Ortho Clinical Diagnostics has announced the launch of two COVID-19 antibody tests with 100% specificity.  Being 100% specificity-compliant, Ortho’s VITROS Anti-SARS-CoV-2 Total and IgG tests can help to identify, with great confidence, previously exposed individuals who have developed antibodies to SARS-CoV-2. When coupled with information from a molecular test that detects active infection, it can monitor the progression of the disease by measuring when antibodies appear in the blood.

Ortho’s 100% specificity-compliant antibody assay for Covid-19 testing — the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total and IgG Reagent Packs and Calibrators — have now been included in the updated list of approved Rapid/ CLIA/ ELISA kits the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, GoI.

With 6,287,771 confirmed cases worldwide and 379,941 deaths due to the novel coronavirus scourge —2,16,919 cases /5,815 deaths in India — healthcare professionals, researchers and government officials in the country and across the globe are racing against the clock to find solutions to better manage COVID-19 and save more lives and families.

Study results show that even with 97% specificity, there is a chance of getting 30 false positive results out of 1,000 and with 99.6%, 4 false positive results out of 1,000. “Only with 100% specificity can one be fully confident that the antibody positive test result is a true positive, such as with the one developed and launched recently by Ortho Clinical Diagnostics,” mentioned a statement issued by Ortho Clinical Diagnostics.

“Unlike many commercially available antibody test kits, Ortho’s high-throughput, automated VITROS Anti-SARS-CoV-2 antibody tests are highly reliable and have demonstrated 100% specificity in assay validation studies. The tests can help to identify with high accuracy a previously infected patient who can donate antibody-containing plasma to treat severe COVID-19 patients. This is important because any inaccurate test result could lead to a plasma therapy without antibodies to SARS-CoV-2, the active ingredients in the convalescent plasma therapy,” it stated.

Both VITROS Anti-SARS-CoV-2 antibody tests target the S1 subunit of the Spike (S) protein of SARS-CoV-2. The virus uses the S1 protein to bind to the angiotensin-converting enzyme 2 (ACE2) receptor to facilitate viral entry and infection.  Antibodies that can bind to S1 and block S1-ACE2 interaction can inhibit viral infection, which are called neutralizing antibodies.  The VITROS Anti-SARS-CoV-2 antibody tests can detect neutralizing antibodies that bind to the S1 protein.