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Dx Focus Feb 24, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


Longhorn Vaccines and Diagnostics said this week that it has been granted emergency use authorization from the US Food and Drug Administration for its influenza A/H1N1-09 Prime rRT-PCR assay.

The test was approved for use in high-complexity laboratories under the Clinical Laboratory Improvement Amendments act.

The Longhorn influenza test is a real-time, reverse transcriptase PCR assay that requires no mixing prior to use, Longhorn said.

The test has been authorized for use on the Applied Biosystems 7500 Fast real-time PCR system, which features a clinical collection and transport component that preserves released nucleic acids, including labile RNA for testing, and contains an internal positive control that can track sample degradation after collection.

"Sample integrity and the ease and economy of transporting collected samples are key components to testing during outbreaks," Longhorn CEO Gerald Fischer said in a statement.

Longhorn, based in San Antonio, Texas, will continue to develop the assay and expects to submit a separate 510(k) filing this year, the company said.

The clinical laboratory of the University of California-Davis Health System is now offering a reverse-transcriptase PCR respiratory viral panel test, UC Davis said last week.

The RVP test simultaneously detects 10 common respiratory viruses from patients with cold- and flu-like symptoms, providing definitive results within 24 to 36 hours, UC Davis said.

The new test is particularly beneficial for severely ill patients when a fast and accurate diagnosis is needed to determine the optimal course of treatment, the school said.

Physicians in the Sacramento area may request the RVP test by ordering it through the UC Davis Health System medical diagnostic service.

"Rather than limiting this test to UC Davis patients, we would like to make the RVP by RT-PCR [test] available to the entire Sacramento community, with the hope of improving diagnosis and care for as many patients as possible," Ralph Green, medical director of the health system's Medical Diagnostics group, said in a statement.

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