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Roche Diagnostics receives approval for COVID-19 test
Published : May 6, 2021 - 17:02
Updated : May 6, 2021 - 18:30
Roche Diagnostics cobas SARS-CoV-2 Test (Roche Diagnostics)


Roche Diagnostics Korea announced Thursday that the company has received approval for the cobas test, an assay used to specifically detect the severe acute respiratory syndrome coronavirus in laboratories settings.

According to Roche, the cobas test is capable of qualitative detection and differentiation between SARS-CoV-2, Influenza A and Influenza B present in nasal swab samples collected from individuals suspected of a respiratory infection.

Roche’s laboratory-based assay cobas SARS-CoV-2 test can be used in the multinational health care company’s automated molecular testing solutions, the cobas 6800/8800 Systems. The cobas 6800 System can provide up to 96 results in around three hours, and the cobas 8800 System could yield 960 results within eight hours.

The test sensitivity of Roche’s cobas SARS-CoV-2 test is over 97 percent, allowing it to accurately identify whether the virus is present or not, the firm said.

Roche said its test is expected to help deliver fast and accurate results to patients and also allow health care professionals to provide the right diagnoses and effective treatment plans for their patients.

Roche’s test received an emergency use authorization from the US Food and Drug Administration last September. Roche also received the CE marking that indicates it meets EU standards for the cobas SARS-CoV-2 test in the same month.

By Shim Woo-hyun (ws@heraldcorp.com)
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