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RUO: Liat™ Influenza A/2009 H1N1 Assay

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2009 H1N1 Assay

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Fully automated sample-to-result detection of 2009 H1N1 influenza in 26 minutes!
Received FDA Emergency Use Authorization (since expired)

Emerging in April 2009, the 2009 H1N1 is a novel influenza A virus that has spread widely and has become the predominant circulating influenza strain in the U.S. Additionally, the World Health Organization raised the pandemic alert level to Phase 6 in June 2009 in response to the worldwide spread of this novel influenza.

The Liat Influenza A/2009 H1N1 Assay is a rapid, automated test for the qualitative detection and differentiation of 2009 H1N1 influenza viral RNA. Performed on the Liat™ Analyzer, the assay received FDA Emergency Use Authorization (since expired) for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests and in laboratories certified under CLIA to perform high complexity tests. The Liat Influenza A/2009 H1N1 Assay uses nasopharyngeal swab (NPS) specimens collected from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.

The Liat system refines the testing process to three simple steps: (1) collecting a raw biological sample into a Liat assay tube, (2) scanning the tube’s barcode to identify the test and track the patient sample, and (3) inserting the tube into the Liat Analyzer. The analyzer automatically executes all the required assay steps, including sample purification, nucleic acid amplification, and detection of the target sequence, and reports test results on the built-in touch screen. No manual reagent addition, operator intervention or data interpretation is required. Turnaround time for a test is only 26 minutes.

Related Links:
Liat Influenza A/2009 H1N1 Assay Package Insert
Healthcare Provider Fact Sheet
Patient Fact Sheet

Documents are provided for informational purpose only. FDA Emergency Use Authorization expired on June 23, 2010. Contact for more information.

For research use only. Not for use in diagnostic procedure.




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