FDA Approved the Rapid Coronavirus (SARS-CoV-2) Test

The US Food and Drug Administration (FDA) approved the Xpert® Xpress SARS-ÇoV-2 rapid molecular diagnostic test for use in detecting the novel coronavirus. The test was designed to run on the device system called "23.000 Cepheid Xpert", which operates in many parts of the world. With this system, a sputum sample can be tested for the virus in 45 minutes. One of the most important needs in the fight against the SARS-CoV-2 outbreak is for systems that can provide a rapid diagnosis. The Xpert*Xpress system offers fully automated, very rapid diagnosis. Sample preparation takes less than 1 minute.

How Does the Xpert- Xpress SARS COV 2 Test Work?

In this system, genomic sequences specific to SARS-CoV-2 are detected using polymerase chain reaction (PCR); this is therefore a rapid PCR test. In other words, this diagnostic system is based on a rapid, easy-to-use nucleic acid amplification test.

The Xpert system first separates the virus from the samples provided. It then isolates the virus's genomic material using sonication sound waves. Finally, it rapidly amplifies this genomic material using polymerase chain reaction. This process identifies the regions of the virus that are most clinically relevant. The test can provide results in as little as 45 minutes. Doctors can perform this test even in their own offices. It is important to emphasize that the FDA has granted this test emergency use authorization. It was announced that marketing would begin the following week. This system had previously been used successfully in the diagnosis of tuberculosis and HIV.

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