Fda clearance for 20 mins liat influenza a b assay
IQuum, Inc. have received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the Liat™ Influenza A/B Assay and the Liat™ Analyzer. This molecular diagnostic test is an automated sample-to-result multiplex real-time RT-PCR assay for the detection and discrimination of influenza A and influenza B in approximately 20 minutes. The test is intended for use in laboratories certified under the CLIA to perform 'moderate complexity' tests, enabling its use in hospital labs or other near-patient settings.
'The Liat Influenza A/B Assay presents a revolutionary improvement in the speed and ease-of-use of nucleic acid testing,' said Dr. Shuqi Chen, Chief Executive Officer of IQuum, Inc. 'IQuum´s goal is to provide sophisticated nucleic acid tests that can be performed in near-patient settings and deliver accurate results to physicians and patients instantly. This regulatory clearance demonstrates the capability of the Liat system to realize this goal.'
Influenza A, including subtypes A/2009 H1N1 and H3N2, and influenza B, are considered to be the predominant seasonal influenza viruses. Current near-patient influenza testing is performed using rapid immunoassays. However, studies have shown that such immunoassays have a sensitivity of only 10-70%1.
The Liat Influenza A/B Assay is currently the only test that has equivalent or better sensitivity and specificity as current lab-based nucleic acid tests, while substantially matching the time-to-result and ease-of-use of rapid immunoassays. Having an operator hands-on time of less than 1 minute and a total time-to-result of approximately 20 minutes, the Liat test can be performed on-demand in hospital near-patient settings, providing physicians with accurate and timely results. The Liat system integrates multiple intelligent features, such as sample volume metering, on-board internal control, advanced error diagnostics, and automated data interpretation to ensure the quality of results when operated by minimally trained users.
The Liat Influenza A/B Assay and the Liat Analyzer are also available as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.
The development of the Liat Influenza A/B Assay was partially funded and supported by grants from the National Institute of Allergy and Infectious Diseases, National Institute of Health.
1. Hurt AC et al. Influenza & Other Respiratory Viruses 2009;3(4):171-76
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Posted on October 11, 2011