4th February 2014 Content supplied by:
Alere™ i Provides Accurate, Molecular Results for Influenza in Under 15 Minutes
The Alere i Influenza A & B test is the first and only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes. The test is now commercially available in Austria, France, Spain, Switzerland, Germany, Italy and the UK.
Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, lab-accurate results in less than 15 minutes on a user-friendly platform.1 The proprietary technology utilizes isothermal nucleic acid amplification technology (iNAT), which, unlike PCR testing, does not require temperature cycling and can therefore deliver results more quickly – Molecular. In Minutes™ (MIM) – and to a broader range of settings.
Alere i tests for Strep A, C. difficile respiratory syncytial virus (RSV) and chlamydia / gonorrhoea are currently in development.
Alere i Influenza A & B is currently under regulatory review in the United States by the US Food and Drug Administration (FDA) and is not available in the US pending completion of such review.
1. The clinical performance of Alere i Influenza A & B was established in a multi-center, prospective study conducted at eight US trial sites during the 2012-2013 respiratory season. A total of 571 prospective nasal swab specimens, collected from patients of all ages presenting with influenza-like symptoms, were evaluated with Alere i Influenza A & B, and compared to viral culture. All discrepant samples were tested on an FDA-cleared RT-PCR assay at a central testing laboratory to confirm influenza status.
Alere i Influenza A & B Performance vs. Culture
Discrepant Results Resolved by RT-PCR
Resolved Sensitivity – 99.3%
Resolved Specificity – 98.1%
Resolved Sensitivity – 98.9%
Resolved Specificity – 99.6%
Date Published: 4th February 2014