Access Bio’s CareStart Real Time PCR COVID-19 Test Earns EUA

The test, which can be processed in 83 minutes or less, has shown 100% sensitivity and 100% specificity in clinical trials, according to the New Jersey company.

A doctor in a protective suit taking a nasal swab from a person to test for possible coronavirus infection
• Source: shutterstock.com

Access Bio, Inc. is launching its CareStart COVID-19 MDx RT-PCR molecular test to detect the SARS CoV-2 virus following receipt of an emergency use authorization (EUA) from the US Food and Drug Administration, the company announced on 23 July.

CareStart COVID-19 MDx RT-PCR detects nucleic acid sequences unique to SARS-CoV-2 that have been extracted, isolated, and purified from nasopharyngeal or oropharyngeal swab specimens. Specifically, it uses real-time reverse transcription-polymerase...

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