Roche Diagnostics launches Covid-19 precision immune antibody reagents

Roche Diagnostics said its Elecsys Anti-SARS-CoV-2 200T and 300T have received the Ministry of Food and Drug Safety’s approval as in vitro diagnostic medical devices that help confirm the formation of SARS-CoV-2 antibody.

Roche Diagnostics has released two Covid-19 precision immune antibody reagents, Elecsys Anti-SARS-CoV-2 200T and 300T. (Roche Diagnostics)

The products, the first Covid-19 precise immune antibody reagents in Korea, can confirm the production of SARS-CoV-2 antibodies by qualifying the total antibody of SARS-CoV-2 in human serum and plasma through electrochemiluminescence immunoassay, Roche Diagnostics said.

Researchers can use the reagent to checks the presence of an antibody targeting the Nucleocapsid (N) antigen, the most common protein in Covid-19 that does not show any mutations in human serum and plasma.

According to Roche Diagnostics, the approval has made it possible to use a precise immune antibody test in Korea to confirm previous Covid-19 infection, investigate the prevalence within the group, and distinguish between antibodies caused by natural infection and antibodies generated after vaccination.

As the reagent does not require a separate pre-treatment process, researchers can check the test result within 18 minutes. It is compatible with Cobas e411, e601, e602, and e801 automated immunization equipment installed in more than 500 hospitals, clinics, and laboratories nationwide.

The Elecsys Covid-19 antibody test, which uses the reagent, showed a specificity of 99 percent and a sensitivity of 100 percent two weeks after the polymerase chain reaction (PCR) confirmation through clinical studies.

The specificity associated with false positives was 99 percent in the analysis results of 200 samples. The company confirmed no false negatives related to sensitivity as a result of analyzing 90 samples of Covid-19 patients two weeks after the confirmation of the PCR test.

“We plan to apply for a new medical technology evaluation for the test method so that Korea can perform the precise immune antibody test smoothly,” Roche Diagnostics CEO Johnny Tse said. “We also hope that the test method will receive reimbursement soon.”