FDA has granted emergency use authorization to Roche’s test for antibodies to the coronavirus, and the Swiss diagnostics giant said Sunday it plans to produce in the “high double-digit millions” of the kits this month. Depending on the specific model of analyzer, Roche's cobas e systems can process up to 300 tests an hour and yield a result in 18 minutes.
A study of 5,272 samples run by Roche found the Elecsys test has a specificity of 99.8%, indicating low likelihood of false positives, and sensitivity of 100%, suggesting even better performance in not delivering false negatives, when used on samples taken 14 days after the confirmation of infection with the SARS-CoV-2 virus.
In a bid to improve accuracy of available serology tests for the coronavirus, FDA on Monday said it's changing how serology test developers submit EUAs and when validation data is required. It also outlined particular performance threshold recommendations for specificity and sensitivity for all developers of the serology tests.
Cellex became the first organization to receive EUA for an anti-SARS-CoV-2 antibody test at the start of April. By the end of April, nine other organizations had won EUAs for antibody tests. Offerings from Abbott and Bio-Rad Laboratories are reported to have specificity levels of just shy of 100%. In addition to Roche's EUA issued in May, FDA posted one for Euroimmun on Monday.
Other companies and labs brought antibody tests to market without first receiving emergency use authorization, thanks to leniency outlined in FDA's diagnostic policy for the coronavirus public health emergency. That move resulted in a proliferation of tests designed to detect evidence of an immune response against an earlier infection with SARS-CoV-2.
The accuracy of the tests is a concern, especially as officials may rely on immunity data as they make plans to reopen.
One recent study out of the University of California, San Francisco, of 12 different tests found the specificity of some tests is as low as 84%. Public health officials have since tried to regain greater oversight over quality of these tests. FDA issued a new umbrella letter of authorization April 28 for serology IVDs validated by the National Institutes of Health, National Cancer Institute, or another government agency designated by FDA.
FDA officials in a blog post Monday morning said that commercial manufacturers will have to submit EUA requests with validation data within 10 business days from when they notified the agency of their validation testing, or from the May 4 revisions to the policy — whichever is later.
Roche assessed the specificity of its test by using it to analyze 5,272 samples, most coming from routine diagnostic testing. Roche’s test detected anti-SARS-CoV-2 antibodies in 10 of the samples, resulting in a specificity of 99.81%. A study of 204 samples from 69 patients with SARS-CoV-2 infections found the test was 100% accurate 14 days after diagnosis, suggesting a zero to negligible rate of false negatives.
The figures match or exceed those generated on other tests. Roche has also studied its test more widely than some of its competitors. Abbott and Bio-Rad, for example, assessed the specificity of their tests by using them to analyze 1,070 and 687 negative samples, respectively.
At the same time, there remain doubts about whether the presence of antibodies means a person has immunity against SARS-CoV-2 given the early stages of the research into the virus.
Roche said Sunday it plans to produce the antibody test in the “high double-digit millions” for the U.S. and countries that accept the CE mark. The company said it has already begun shipping and noted it runs on the available cobas e instruments.
Roche's antibody test processing appears speedier and more extensive than Abbott's, which delivers results in 29 minutes and can process around 170 tests an hour.
The Swiss giant was the first company to get an EUA for a commercial diagnostic test for the coronavirus on March 13.
This story has been updated to reference a May 4 policy update from FDA.