FDA Grants Emergency Use to Roche SARS-CoV-2 Antibody Test

The test reports ≥99.8% specificity and 100% sensitivity at 14 days post-PCR confirmation, and could potentially better inform patient immunity and disease pathology.

The US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to a SARS-CoV-2 antibody test which reports a ≥99.8% specificity and 100% sensitivity at 14 days post-PCR confirmation.

The Elecys Anti-SARS-CoV-2 antibody test from Roche is designed to determine coronavirus 2019 (COVID-19) exposure, and whether the patient has developed antibodies against the virus.

The EUA led to the company’s statement that tens of millions of tests will be provided globally this month for countries accepting the CE mark, as well as the US. Developers hope the test’s functionality and availability is expanded as more is learned about the pathology and patient immunity to SARS-CoV-2.

The in-solution, double-antigen sandwich format-based immunoassay uses a blood sample to detect antibodies to the new coronavirus causing COVID-19 in patients—thereby potentially signaling whether a person has already been infected and may have developed an immunity to the virus.

The reported specificity of 99.81% is based on assessment in 5272 samples, in which no cross-reactivity to the 4 human coronavirus causing common cold were observed. Investigators believe this indicates potentially fewer false-positive results while improving distinction of SARS-CoV-2.

Hospitals and reference laboratories are able to run the new test on Roche’s branded cobas e analyzers, receiving results in approximately 18 minutes for a single test. Depending on the analyzer type, caregivers can run up to 300 tests per hour.

Roche leadership praised the work that went into contributing another regulated option for antibody assessment during the COVID-19 spread.

“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” Thomas Schinecker, chief executive officer of Roche Diagnostics, said in a statement.

Roche Group chief executive officer Severin Schwan praised the company’s capability in immediately delivering a great rate of high-accuracy tests to facilities worldwide.

”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis,” Schwan said.