Celltrion Bags FDA’s Emergency Approval for COVID-19 Rapid Test, Prepares to Ship Supply to the US


Image Courtesy: Celltrion Healthcare

The COVID-19 rapid test co-developed by Korea’s Celltrion and Humasis was granted emergency use authorization (EUA) by the FDA. Celltrion is now determined to amp up its manufacturing to honor its deal of providing diagnostic kits to the US.

93.9% Sensitivity and 99.1% Specificity

The test, also known as DiaTrust, is based on lateral flow immunoassay to detect nucleocapsid and receptor binding domains (RBDs) from the SARS-CoV-2 spike proteins in nasopharyngeal swab specimens (NPS). Celltrion announced that DiaTrust demonstrates 93.3% sensitivity and 99.1% specificity with a positive predictive value of 100% and a negative predictive value of 97%. What’s more, the test can deliver the result in 15 minutes and be stored between 2 to 30℃.

Celltrion DiaTrust™ COVID-19 Ag Rapid Test

Ability to Detect COVID-19 Variants

The test detects COVID-19 variants identified in the UK, South Africa, Brazil, California, and New York. Together with Humasis, Celltrion had conducted clinical trials in the US with 450 subjects and have also submitted those results.

DiaTrust is best to use in the first 7 days when an individual exhibits symptoms or is suspected to have been infected by COVID-19. In addition, the test can be used for serial testing as well with a 24 to 36 hours interval between two tests. It is allowed to be used twice in a week for follow-up observation and to minimize the virus infection when the subject is detected positive.

Humasis will provide the tests to Celltrion’s subsidiary, Celltrion Pharma USA in the US to fulfill the $220 million deal (240 billion won) signed in 2020 with New York-based Prime Healthcare Distributors for US distribution.

Celltrion has been a frontrunner in Korea for producing rapid test kits and antibodies. In February, The European Medicines Agency’s (EMA) regulators recommended Celltrion’s regdanvimab (CT-P59) for treating COVID-19.

Related Article: Celltrion Announces Positive Phase 1 Results for COVID-19 Antibody Therapy

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