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Dx Focus: Roche's CMV Viral Load Test; Meridian's Illumigene Group A Strep Assay


Roche this week announced the commercial availability of a molecular test for cytomegalovirus viral load.

Physicians can use information from the test to help them manage patients diagnosed with the disease, especially patients whose immune systems have been suppressed for solid organ transplantation, Roche said.

The new test is based on real-time PCR and runs on Roche's fully automated Cobas AmpliPrep/Cobas TaqMan system for viral load monitoring of multiple infectious diseases. The system can be combined with the Cobas p 630 instrument, which provides integrated pre-analytical primary tube handling.

Roche said its new CMV viral load test standardizes CMV viral load monitoring with traceability to the World Health Organization international CMV standard.

The test received pre-market approval from the US Food and Drug Administration in July.

Meridian Bioscience has received clearance from the US Food and Drug Administration for its Illumigene assay for group A streptococcus.

The new test uses loop-mediated isothermal amplification technology to detect Streptococcus pyogenes in throat samples. The test procedure is simple and highly sensitive, requires no capital equipment, and can be performed in less than an hour, Meridian said. All reagents and disposables are contained in the test kit and can be stored at room temperature.

Acute pharyngitis is one of the most frequent illnesses for which pediatricians and other primary care physicians are consulted, with an estimated 15 million visits per year in the United States, Meridian said. Approximately 20 to 30 percent of children seeking physician care are diagnosed with Group A Strep pharyngitis, typically by rapid antigen testing or throat swab culture. Studies have shown that culture may miss up to 10 percent of true positives.