Abbott to Distribute 1 Million Serology Test Kits This Week as Multiple COVID-19 Antibody Tests Receive FDA Emergency Use Authorization

According to statistics from Johns Hopkins University, the number of confirmed cases of coronavirus disease 2019 (COVID-19) worldwide has exceeded 2 million. In addition to posing a serious threat to public health, the COVID-19 pandemic has also imposed a heavy burden on the socio-economy and people’s lives. Therefore, under the pandemic circumstances, how to restore the normal functioning of society and people’s daily lives has become one of the issues of widespread concern.

Developing widely accessible serological tests could help restore normal societal operations. Serological tests identify individuals who have been or were previously infected with the novel coronavirus by detecting antibodies against the virus in their blood. Following infection, neutralizing antibodies against the novel coronavirus are produced in the bloodstream, providing temporary protection against reinfection, commonly referred to as immunity to the novel coronavirus. Identifying individuals who have developed such immunity may aid in designing targeted plans for resuming work and school activities.

Let’s now look at the latest advancements in the development of COVID-19 serological tests today.

Graphic by WuXi AppTec Content Team

Abbott Launches Serological Test Kits on a Large Scale

Abbott Announces Launch of Laboratory-Based Serological Blood Test to Detect IgG Antibodies Against the Novel CoronavirusOn the 16th, Abbott announced the launch of a laboratory-based serological blood test designed to detect IgG antibodies against the novel coronavirus. IgG antibodies are proteins produced by the body in the later stages of infection and may persist for months or even years after an individual has recovered. In addition to identifying individuals who have previously been infected with the novel coronavirus, this test will provide further insights into the virus, including the duration of antibody persistence in the body and whether they confer immunity. Such knowledge can help support the development of treatments and vaccines.

This antibody test will be run on Abbott’s ARCHITECT i1000SR and i2000SR laboratory instruments. More than 2,000 such instruments are in use in laboratories across the United States. These instruments can perform 100–200 tests per hour.

Abbott is significantly scaling up production of its antibody tests, with nearly 1 million test kits expected to be shipped immediately this week and a total of 4 million units scheduled for delivery in April. Abbott Laboratories will also expand its laboratory-based antibody testing capabilities in the near future to detect IgM antibodies against the novel coronavirus.

Currently, this test has not received Emergency Use Authorization (EUA) from the FDA. Abbott plans to submit an EUA application to the FDA and intends to apply for CE marking in the European Union.

FDA Grants Emergency Use Authorization for Two Antibody Testing Systems

On the 16th, the U.S. FDA announced that it had granted Emergency Use Authorization for Ortho Clinical Diagnostics’ COVID-19 total antibody test kit. This assay is among the first high-throughput, automated COVID-19 antibody tests to receive Emergency Use Authorization.

In addition to the aforementioned functions, this test can also help screen plasma donations for convalescent plasma therapy, thereby aiding critically ill patients in combating the virus.

These assays can be run on Ortho’s VITROS® XT 7600, 5600, and 3600 fully automated chemistry and immunoassay analyzers, and will soon be available on the VITROS® ECi/ECiQ fully automated clinical immunoassay systems. These systems are installed in more than 1,000 hospitals and laboratories across the United States. Ortho’s instruments can process up to 150 tests per hour.

Mr. Chris Smith, CEO of Ortho Clinical Diagnostics, stated: “The COVID-19 pandemic continues to impact individuals, families, and communities around the world. Ortho is committed to providing large-scale solutions that help people return to work, thereby alleviating the pressure on employees and the economy.”

Currently, a limited number of test kits have been shipped to the areas with the most urgent needs. Ortho will ramp up to full production in the coming weeks and plans to manufacture millions of test kits next month.

The FDA granted Emergency Use Authorization today to the DPP COVID-19 Assay System developed by Chembio Diagnostics. The DPP COVID-19 System is a serological point-of-care test that provides quantitative readings of IgM and IgG levels against SARS-CoV-2 within 15 minutes using a fingerstick whole blood sample. It is compatible with Chembio’s Micro Reader 1 and Micro Reader 2 analyzers.

References:

[1] Chembio Diagnostics Receives Emergency Use Authorization for DPP COVID-19 System for IgG and IgM Antibodies. Retrieved April 15, 2020, from https://finance.yahoo.com/news/chembio-diagnostics-receives-emergency-authorization-132623062.html

[2] Abbott Launches Third COVID-19 Test, a Laboratory-Based Antibody Blood Test That Will Ship in the U.S. Starting Tomorrow. Retrieved April 15, 2020, from https://www.prnewswire.com/news-releases/abbott-launches-third-covid-19-test-a-laboratory-based-antibody-blood-test-that-will-ship-in-the-us-starting-tomorrow-301041016.html

[3] Ortho's Total Antibody Test for COVID-19 Receives Emergency Use Authorization from FDA. Retrieved April 15, 2020, from https://www.prnewswire.com/news-releases/orthos-total-antibody-test-for-covid-19-receives-emergency-use-authorization-from-fda-301040690.html

Original Title: COVID-19 Serological Testing Update Today: Abbott Distributes 1 Million Test Kits This Week, Multiple Tests Receive FDA Emergency Use Authorization

▽Follow [WuXi AppTecDe】WeChat Official Account