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Dx Focus Dec 17, 2009: Clinical and Regulatory PCR and Nucleic Acid Testing News


DxNA said this week that the US Food and Drug Administration has granted emergency use authorization for a 2009 H1N1 influenza virus test for use in the company's GeneSTAT PCR detection platform.

The platform, which weighs less than 10 pounds, is being targeted for use in hospitals and other locations "where disease outbreaks are suspected instead of sending patient samples to distant reference laboratories," DxNA said.

The company added that the GeneSTAT system "is inherently less costly than the PCR devices typical of large clinical laboratories," but did not provide details on pricing for the system.

AcroMetrix has launched OptiQual MSSA Positive Control, a standardized quality control for methicillin-sensitive Staphylococcus aureus molecular testing.

"Each lab can maintain CLIA compliance for qualitative PCR tests that detect MSSA by using the OptiQual MSSA Positive Control daily," the company said in a statement.

AcroMetix said that the control can also be used as a negative specificity control for MRSA DNA assays because it can monitor whether the assay is specific for the mecA gene that distinguishes MRSA from MSSA.

The control contains inactivated whole MSSA bacterial particles, "providing a safe method of monitoring the entire PCR process from extraction through amplification and detection."