Abbott Laboratories received FDA emergency use authorization (EUA) for its COVID-19 molecular test, which will run on the company's new Alinity m system, as well as its COVID-19 antibody blood test, which will run on the Alinity i system. The two actions bring to five the number of COVID-19 tests developed by the Abbott Park, Ill.-based company to receive EUAs.

“As a leader in infectious disease testing, Abbott is working to bring as many tests as possible across our platforms to customers and patients around the world,” John Hackett, divisional vice president of Applied Research and Technology for Abbott’s diagnostics business told BioWorld.

The Alinity m, Abbott’s newest molecular lab system, received FDA clearance for use with the company’s hepatitis C test in late March. The company is currently working with hospitals and health systems to launch the system in the U.S. to EUAs to help increase testing capacity during the pandemic. The system can process more than 1,000 tests in 24 hours and can run different types of test simultaneously without reducing throughput.

"Molecular lab tests play a critical role in detecting the virus for COVID-19. As a leader in diagnostics, we are pushing forward to develop high-performing tests across our platforms to help combat this pandemic," said Abbott’s President and CEO Robert Ford. "As we continue to develop and improve our testing technologies, we want to ensure they are meeting the needs of our customers – and right now that means having reliable tests for COVID-19 on all of our diagnostic instruments."

The latest EUA for Abbott’s SARS-CoV-2 lab-based serology blood test expands the systems on which the diagnostic test can be run. The emergency use authorizations enable labs to use the tests without having to wait for formal FDA clearance or approval.

Abbott plans to ship nearly 30 million antibody tests globally in May for use on its Architect and Alinity i platforms. By June, the company anticipates having capacity on the two systems for 60 million tests.

The company said it planned to submit this week for the CE mark for the Alinity i IgG antibody test and has already begun shipping tests for use on Architect systems in the U.K., Italy, Spain and India.

The three products previously granted EUA are the Abbott ID Now COVID-19 molecular test, the Abbott Realtime SARS-CoV-2 molecular test – which runs on Abbott's m2000 Realtime system – and a serology blood test for the detection of the antibody IgG on its lab-based Architect system.

So far, Abbott has shipped more than 7 million of the antibody tests and 2 million molecular COVID-19 tests for use in U.S., a company spokesperson told BioWorld.

The company expected to ship 4 million molecular tests for the m2000 in April, Ford said on an earnings call, and to produce 2 million tests per month for the ID Now platform by June.

"Having more options of highly reliable tests across our platforms will help health care workers and health officials as they conduct broad scale testing for COVID-19," said Ford.

High Reliability

In its efforts to make testing widely available very quickly, the FDA initially provided wide latitude for manufacturers of COVID-19 antibody tests, which led to the release of what the agency called “a concerning number” of inappropriately marketed and poorly performing tests.

On May 4, the FDA tightened its regulation of the tests, requiring manufacturers to submit EUA forms and data proving the tests work within 10 days of putting the test on the market. Of the more than 200 tests available, just 14 have received EUAs.

The antibody tests are designed to tell whether a person has COVID-19 and is recovering or has resolved the infection entirely. On a population level, they can help determine how widespread infection has been in a community, especially important with a disease like COVID-19 that has a high proportion of asymptomatic cases.

The revised regulation came after reports that some tests had false positive rates of up to 20% (specificity of 80%). The problem is that individuals who are told they have had the disease, but have not actually been infected, may take risks that increase their exposure.

On that score, the Abbott antibody tests have done very well. The FDA is currently targeting a specificity of 95% or a 5% rate of false positives.

Researchers at the University of Washington School of Medicine published a study in the Journal of Clinical Microbiology on May 8 that found that Abbott’s SARS-CoV-2 IgG lab-based serology blood test had 99.9% specificity and 100% sensitivity for detecting the IgG antibody in patients who had symptoms 17 days or more prior to testing.

The researchers validated the test on 1,020 patients.

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