New COVID-19 Tests Authorized by the U.S. FDA

A leader in serving science introduced two new SARS-CoV-2 antibody tests: the Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test, and the Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test. 

Thermo Fisher Scientific Inc. stated in a press release on October 12, 2020, that these new tests for detecting COVID-19 antibodies enable diagnostic laboratories to run the tests at customizable speed and throughput while using automated instruments already in place, minimizing initial costs and reducing the time needed to begin testing.

The OmniPATH COVID-19 Total Antibody ELISA test, developed in conjunction with the Mayo Clinic and WuXi Diagnostics as previously announced, has been granted U.S. FDA Emergency Use Authorization (EUA) for the qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and immunoglobulin G (IgG).

And, the EliA SARS-CoV-2-Sp1 IgG test is commercially available in accordance with the FDA's "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency". The EUA is currently under review by the FDA. 

The EliA test is designed for automated processing of up to 60 results per hour on the Thermo Scientific Phadia 250 instrument. The EliA test is quantitative within markets that accept the CE mark and semi-quantitative in the U.S. Individual IgM and IgA EliA tests are also available now for research use only.

Additionally, these tests are now available in Europe and countries accepting the CE Mark.

Marc N. Casper, chairman, president, and chief executive officer of Thermo Fisher Scientific stated: "The addition of COVID-19 antibody tests to our broad portfolio further enables our support of the pandemic response on multiple fronts."

As of October 9, 2020, the FDA had authorized 278 coronavirus diagnostic tests under EUAs, which include 217 molecular tests, 55 antibody tests, and 6 antigen tests during 2020.

The tests most people discuss are RT-PCR, the nasal-swab test that detects viral RNA, and various antibody tests, that detect if you have an immune response due to past exposure to the SARS-CoV-2 virus.

Recently the U.S. CDC reported that over 125 million coronavirus-related diagnostic tests had been conducted during 2020.

Furthermore, the CDC stated on August 24, 2020, 'Not everyone needs to be tested.’ 

‘However, people who have symptoms of COVID-19 disease should be tested. If you do get tested, you should self-quarantine/isolate at home pending test results and follow the advice of your healthcare provider,’ says the CDC.

PrecisionVaccinations publishes release-based diagnostic test development news.