The US Food and Drug Administration has approved the first point-of-care test (POCT) to diagnose for COVID-19. The Emergency Use Authorization (EUA) from the FDA was granted to Cepheid for its Xpert® Xpress SARS-CoV-2 molecular test, which can be performed near the patient and can provide results within approximately 45 minutes. 

The test targets both N2 & E nucleic acid targets and can run on Cepheid's GeneXpert® systems 24/7, requiring no speciality training. This real-time RT-PCR test is intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in either nasopharyngeal swab and/or nasal wash/ aspirate specimens collected from individuals suspected of COVID-19 and is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

The GeneXpert Instrument Systems automates and integrates sample preparation, nucleic acid extraction and amplification, and detection of the target sequences in simple or complex samples using real-time PCR assays. The systems consist of an instrument, computer, and preloaded software for running tests and viewing the results. The systems require the use of single-use disposable cartridges that hold the RT-PCR reagents and host the RT-PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized.

The nasopharyngeal swab specimen and/or nasal wash/aspirate specimen is collected and placed into a viral transport tube containing 3 mL transport medium. The specimen is briefly mixed by rapidly inverting the collection tube 5 times. Using the supplied transfer pipette, the sample is transferred to the sample chamber of the Xpert Xpress SARS-CoV-2 cartridge. The GeneXpert cartridge is loaded onto the GeneXpert Instrument System platform, which performs the hands-free detection of viral RNA. 

Shipping is expected to begin this week.