Molecular Diagnostic Detects and Discriminates Influenza A and B Viruses

An automated sample-to-result multiplex real-time polymerase chain reaction (RT-PCR) assay detects and discriminates between influenza A and influenza B viruses in approximately 20 minutes.

The Liat Influenza A/B assay and the Liat analyzer are intended for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform moderate complexity tests, enabling its use in hospital labs or other near-patient settings.

A product of IQuum (Marlborough, MA, USA), the Liat analyzer is a molecular diagnostic system that refines the testing process to three simple steps: collecting a raw biological sample into a Liat tube, scanning the tube’s barcode to identify the test and track the patient sample, and inserting the tube into the Liat analyzer. The analyzer automatically executes all the required assay steps and reports test results on a built-in touch screen. No manual reagent addition, operator intervention, or data interpretation is required.

Currently, near-patient influenza testing is performed using rapid immunoassays. However, studies have shown that such immunoassays have a sensitivity of only 10% to 70%. The Liat Influenza A/B assay 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.

IQuum, Inc. has received the US Food and Drug Administration (FDA; Silver Spring, MD, USA) 510(k) clearance to market the Liat Influenza A/B assay and the Liat analyzer. The assay and analyzer are also available as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.

Related Links:
IQuum
US Food and Drug Administration