Roche Diagnostics has developed a serology test for detecting antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19. According to a press release, the company plans to make the test (known as Elecsys Anti-SARS-CoV-2) available by early May in countries accepting the CE mark. In the United States, Emergency Use Authorisation is being sought from the Food and Drug Administration.
The test is an immunoassay using a subject’s serum and plasma to detect antibodies (including immunoglobulin G) to SARS-CoV-2. It is run on a Roche-manufactured platform (cobas e analyser) that is widely available in hospitals and reference laboratories around the world.
The company reports that the test can be quickly scaled up, and it anticipates that as production increases, the number of test units available will reach a level in the high double-digit millions by June.
The test has a fast turnaround time, and there is a high capacity for testing. Using the fully automated cobas e analyser, results are available in approximately 18 minutes. Depending on the analyser, test throughput can reach up to 300 tests/hour.
Detecting antibodies to SARS-CoV-2 can identify persons who have been infected with the virus, even if they have not shown any symptoms of the disease. Thus it provides important information for epidemiological research because it gives insight on disease spread in the population.
It is also considered to be potentially valuable for supporting priority screening of high-risk groups, including healthcare workers and individuals employed in other essential jobs. Although better understanding is needed to determine whether having antibodies to SARS-CoV-2 is a marker of immunity, the information provided by the test may be used to guide decisions on who may continue to work safely and/or who may return to work after COVID-19.
Earlier, Roche Diagnostics quickly responded to the COVID-19 pandemic with the introduction of a high-volume polymerase chain reaction test to diagnose active COVID-19 (cobas SARS-CoV-2 Test). The in vitro test uses a respiratory specimen that may be from a nasal, nasopharyngeal, or oropharyngeal swab for qualitative detection of nucleic acids from SARS-CoV-2.
It is designed to minimise the likelihood of false positive results. A negative result, however, does not rule out COVID-19.
Roche received FDA Emergency Use Authorization for the cobas SARS-CoV-2 test on March 12, 2020. It is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 and living in affected areas where SARS-CoV-2 is known to be present.
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