Roche nets FDA authorization for quantitative COVID-19 antibody test

Roche has received authorization from the FDA for a more accurate COVID-19 blood test capable of measuring the levels of specific antibodies that target the coronavirus’s cell-unlocking spike protein.

The company hopes the test can help track the success of vaccines as well as identify people who have recovered from an infection and could serve as convalescent plasma donors or assist in the development of new therapies.

The FDA green light for the Elecsys Anti-SARS-CoV-2 S quantitative antibody test, which runs on Roche’s cobas e analyzers, follows its September launch in Europe after receiving a CE mark.

“Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19,” Roche Diagnostics CEO Thomas Schinecker, Ph.D., said in a statement. “Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response.”

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The antibody test has shown to be very accurate in the 15 days after screening and diagnosis of an active infection with a molecular test, agreeing with positive PCR results 96.6% of the time and negative results 99.98% of the time, according to Roche. 

Studies of the test also showed the concentration of patients’ antibodies did not fall below a detectable range, from 0.40 U/mL to 250 U/mL, for at least 100 days following an infection.

The fully automated systems can provide a result in about 18 minutes, with a throughput of up to 300 tests per hour depending on the hardware.

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Roche first received FDA emergency authorization for its cobas e antibody test in early May, which only delivered a yes-or-no result.