[Photo provided by Celltrion Inc.]

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DiaTrust™ Covid-19 IgG/IgM Rapid Test, an in vitro diagnostic test based on an immunochromatographic assay, jointly developed by South Korea’s Celltrion and Humasis, has been cleared for emergency use by the U.S. Food and Drug Administration, Celltrion said on Monday.

DiaTrust is a product for healthcare professionals designed to recognize a specific surface antigen of the coronavirus for the diagnosis of infection within 15 minutes. It features maximized sensitivity based on a 'dual antigen' method that detects both antigens.

The company said the sensitivity of the clinical results was 93.3 percent, while the specificity was 99.1 percent.

In vitro test data showed DiaTrust can detect even Covid-19 variants identified in the U.K. and South Africa, Brazil, California and New York.

The product can also be used for serial testing, which takes place twice a week, once every three days, or every 24 to 36 hours. Serial testing allows follow-up of early asymptomatic patients, contributing to identification of infected patients earlier, the company said.

Celltrion’s U.S. subsidiary Celltrion USA will provide the product to Prime Healthcare Distributors, a New York-based diagnostic kits and personal protection equipment company, for local distribution. Celltrion USA signed a 240 billion won ($214.5 million) supply contract with Prime Healthcare last month.

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