The COVID-19 pandemic has moved rapidly over the past few weeks, and Ortho Clinical Diagnostics Inc. is doing its part to help during the crisis. To that end, the Raritan, N.J.-based company has worked to successfully secure an emergency use authorization (EUA) for its total antibody assay for COVID-19, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack and calibrators.

Specifically, Ortho's COVID-19 total antibody test can help determine who responsibly could go back to work by helping identify currently infected or previously exposed individuals who may have developed immunity.

Also of note, the test can help screen plasma donations for convalescent plasma therapy. When coupled with information from a molecular test, it can monitor disease progression by measuring when antibodies appear in the blood.

After its April 3 launch of the test under the U.S. FDA's notification pathway for serology tests, the company worked with the agency to secure additional review of the data under its EUA pathway. That action allowed the FDA to expedite review and authorization of SARS-CoV-2 diagnostic tests to expand testing capacity during the COVID-19 public health emergency.

The tests can be run on Ortho Clinical Diagnostics’ laboratory analyzer, the Vitros XT 7600 integrated system, the Vitros 3600 immunodiagnostic system, the Vitros 5600 integrated system and will soon be available on Vitros ECi/ECiQ immunodiagnostic systems.

Nearly 3,500 tests a day

"Ortho analyzers can run approximately 3,500 tests a day," C. Palani Palaniappan, chief innovation officer at Ortho Clinical Diagnostics, told BioWorld. "On average, we can have results in less than an hour for 150 samples in parallel."

When asked about the Ortho Clinical Diagnostics’ involvement with the FDA in this fight, Palaniappan highlighted the company's decades of experience interacting with the agency. That has given it "rich knowledge" in working effectively with the regulatory body. "The process in this situation has been similar, albeit predictably expedited," he acknowledged.

Clinical work

“When developing any antibody test, we need to select the right viral protein that can be used to detect antibodies the body creates in response to the infection,” Palaniappan explained when asked about the clinical work involved in this project. “However, the difficulty lies in experimenting with the viral protein to make sure the test is sensitive enough to detect even low levels of the antibodies and specific enough to only react with the specific antibodies that are developed against COVID-19.”

He added that the company’s R&D team worked doggedly to select the right viral protein and optimize the manufacturing processes and assay design to ensure accurate, reproducible results.

“Two different factors helped us expedite the process, the first being the unprecedented widespread nature of the pandemic,” he continued. “The global health community quickly came together to sequence the virus and publish it, making it easier than ever to gain information on [it].” Working with a global network of health care professionals “we had a leg up never before seen.” That, he added, permitted fast, effective action.

In addition, the company has deep experience developing antibody tests for infectious diseases. “The methodology is largely the same in creating a test for COVID-19 as it was for those we created for use in detecting antibodies to viruses, such as hepatitis.”

Following the selection of the viral protein and collection of blood samples from infected patients, the company applied its previously successful designs toward the COVID-19 tests, quickly resulting in high-quality assays.

A limited number of test kits has gone out to areas of highest priority, and the company plans to manufacture several million SARS-CoV-2 antibody tests over the next month, with rapid production expansion thereafter.

“Stay tuned!” replied Palaniappan when asked if he could discuss any other COVID-19-related work the company might pursue.

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