Abbott adds new FDA-cleared test for Flu A/B and RSV to its molecular diagnostics menu

Sept. 19, 2013

Abbott has announced it will add a new U.S. Food and Drug Administration-cleared molecular diagnostic test for detection and differentiation of influenza A and influenza B and respiratory syncytial virus (RSV) to its broad infectious disease testing menu. The IMDx Flu A/B and RSV test developed by IntelligentMDx is performed on Abbott's m2000 molecular diagnostics system.

The IMDx Flu A/B and RSV for Abbott m2000 test is a qualitative, reverse transcription polymerase chain reaction (rT-PCR) test for rapid detection of influenza A and B and RSV. It is performed on nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The test is fully automated and can analyze up to 94 patient samples per run. Minimal hands-on time is required as results are obtained directly from an upper respiratory tract specimen from a symptomatic patient. The IMDx Flu A/B and RSV for Abbott m2000 test is capable of detecting at least 55 different strains of influenza A, influenza B, and RSV, including variant strains.

In 2011, Abbott and IMDx announced a global, multi-year distribution agreement through which IMDx designs, develops, obtains regulatory clearances, and manufactures real-time PCR assays for the Abbott m2000 instrument system.

Rapid and accurate detection of influenza A and influenza B and RSV with molecular diagnostic tests may allow doctors to expedite treatment with anti-viral medications and help prevent inappropriate antibiotic prescribing. Learn more about the new test.

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