Simplexa Direct Test Includes 53 New Virus Strains

The Simplexa test kit for select virus strains can detect a total of 92 influenza and respiratory syncytial virus (RSV) virus strains, more than any other officially cleared molecular test kit.

These include all four influenza strains that global health experts recommend be included in vaccines during the northern hemisphere’s 2015-2016 influenza season: A/Switzerland/9715293/2013 (H3N2)-like virus; A/California/7/2009 (H1N1)-like virus, B/Phuket/3073/2013-like virus, and B/Brisbane/60/2008-like virus.

In addition, the 46 new influenza strains include 20 avian influenza A and two swine influenza virus strains. These may be increasingly important to detect, as avian and swine influenza viruses can carry over into human populations. Influenza occurs globally, affecting an estimated 5% to 10% of adults and 20% to 30% of children, according to the World Health Organization (Geneva, Switzerland) statistics. Most seasonal flu activity in the Northern Hemisphere occurs between October and May, with peak season in the USA is between December and February.

The Simplexa Flu A/B & RSV Direct kit (Quest Diagnostics; Madison, NJ, USA) on the 3M Integrated Cycler (Focus diagnostics; Cypress, CA, USA) is a real-time reverse transcriptase polymerase chain reaction (RT-PCR) molecular test for the in vitro qualitative detection and differentiation of Influenza A virus, Influenza B virus, and respiratory syncytial virus (RSV) ribonucleic acid (RNA) in nasopharyngeal swabs from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors.

Classified as Clinical Laboratory Improvement Amendments (CLIA) moderate complexity, the test can report results in about an hour through a proprietary process that eliminates nucleic acid extraction, a time consuming technique typically employed by molecular tests. The tests have received from the US Food and Drug Administration (FDA, Silver springs, MD, USA) 510(k) initial clearance for combined molecular detection of influenza A, B and respiratory syncytial virus. Additional Simplexa tests aid in the detection and differentiation of influenza A, influenza B and RSV, Clostridium difficile, Group A Strep and Herpes simplex Virus (HSV) 1 and 2.

Related Links:
World Health Organization 
Quest Diagnostics 
Focus diagnostics