Molecular Diagnostic Test Detects Three Respiratory Viruses Simultaneously

Real-time technology provides distinct advantages over other molecular diagnostic techniques such as microbeads and microarrays because little hands-on time is required, risk of amplicon contamination is eliminated, equipment cost is relatively low, and inducement concerns are minimized.

The accuracy of the ProFlu+ assay was confirmed in a multi-site clinical study that compared results to traditional viral culture. A total of 826 patient samples were prospectively tested, and the assay demonstrated an overall clinical sensitivity and specificity of 98% and 83%, respectively. The decreased specificity was the result of the ProFlu+ assay detecting more positive samples than cultures. Further testing by genetic sequencing determined that 87 of the 103 samples that were positive by ProFlu+ but negative by culture were likely to have been true-positives

Prodesse, Inc., (Waukesha, WI, USA) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) to market the ProFlu+ assay.

"We are convinced that we made the right choice choosing real-time PCR as our core technology platform,” said Tom Shannon, CEO of Prodesse. "Laboratorians are telling us that the big box multiplex systems are cumbersome and more appropriate for epidemiological, not clinical, applications. ProFlu+ is the first in a lineup of real-time respiratory assays that we are in the process of clearing. All of these will use a common internal control so that a single nucleic acid extraction can be used with multiple assays. Our Pro hMPV+ for detection of human metapneumovirus is currently in clinical trials, and two additional products will shortly begin clinical trials: ProParaflu+, a multiplex assay for differentiating parainfluenza viruses and our first enteric product, ProGastro Cd for Clostridium difficile.

Prodesse focuses on the development, manufacture, and distribution of cost-effective, easy-to-use reagents for infectious disease agents.


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U.S. Food and Drug Administration