Ortho Clinical Diagnostics, who specialize in blood-infection diagnostics, has developed a total antibody test for COVID-19, with over 99% sensitivity.  The VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack will be made available this month.

The test detects both IgG and IgM in the patient's blood, which requires a larger sample of blood than the blood drop. It is due to this increase in the volume of blood needed that Ortho Clinical Diagnostics says is how the test has such high sensitivity and can identify viable candidates for blood donation used in plasma therapy.

The test will run on Ortho's flagship analyzer, the VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, the VITROS® 5600 Integrated System and VITROS® ECi/ECiQ Immunodiagnostic Systems and can process approximately 150 tests in an hour.

The systems are designed to remove barriers and are adaptable for non-traditional laboratory environments because they don't require an external water supply to run and are already installed in more than 1,000 hospital and reference labs throughout the United States.

Ortho Clinical Diagnostics has stated in a recent press release “A limited quantity of tests kits have already been shipped to areas of the highest priority. Ortho will be in full production in the coming weeks and plans to manufacture several million SARS-CoV-2 antibody tests over the next month, with rapid production expansion following thereafter".

Serology tests used in the U.S. do not need to be granted EUA because they cannot be used as the sole basis for diagnosis. However Ortho's applied for FDA-EUA for its VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and was granted this on the 14th of April.

The test was developed at Ortho's Global Center of Excellence for R&D in Rochester, New York.