Molecular Test Distinguishes Respiratory Viruses

A rapid test that uses molecular techniques can detect and discriminate influenza A, influenza B, and respiratory syncytial virus (RSV) viral infections.

The tests employ real-time reverse transcription polymerase chain reaction (RT-PCR) to detect qualitatively ribonucleic acid (RNA) of the influenza A or B viruses or RSV in a patient's nasal or nasopharyngeal specimens.

The Simplexa Flu A/B and RSV test reports if a patient is positive or negative for infection with one or more of the three classes of viruses. The test does not require confirmation of test results by other time-consuming methods, such as culture. In addition, the time to perform the Simplexa test following RNA extraction from a specimen takes only about an hour, with results expected to be reported in less than three hours following receipt of a specimen.

The Simplexa assays are manufactured by Focus Diagnostics (Cypress, CA; USA), a subsidiary company of Quest Diagnostics Incorporated (Madison, NJ, USA). Quest Diagnostics, announced that the US Food and Drug Administration (FDA, Silver Spring, MD, USA) has issued 510(k) clearance to the Focus Diagnostics Simplexa Flu A/B & RSV test on the 3M Integrated Cycler (St. Paul, MN, USA). The test is designed for human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.

John G. Hurrell, PhD, vice president and general manager at Focus Diagnostics, said, "Our Simplexa test line can empower hospital, urgent care clinics and other laboratories to perform highly advanced molecular testing close to their patients, for faster reporting of results. For many physicians and laboratory administrators, it will eliminate the time-consuming step of sending a specimen to a reference laboratory for molecular testing to detect flu and RSV infection."

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Focus Diagnostics
Quest Diagnostics
FDA
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