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Multicenter clinical evaluation of the novel Alere? i Influenza A&B isothermal nucleic acid amplification test

tetano

Editor, Senior Moderator
J Clin Virol. 2014 Jun 7. pii: S1386-6532(14)00214-5. doi: 10.1016/j.jcv.2014.06.001. [Epub ahead of print]
Multicenter clinical evaluation of the novel Alere? i Influenza A&B isothermal nucleic acid amplification test.
Bell J1, Bonner A2, Cohen DM3, Birkhahn R4, Yogev R5, Triner W6, Cohen J6, Palavecino E7, Selvarangan R8.
Author information
Abstract
BACKGROUND:

Rapid detection of influenza infection is important for patient management and timely anti-viral therapy. Rapid antigen detection tests for influenza have inferior sensitivity when compared to nucleic acid-based amplification tests. An isothermal nucleic acid amplification test that offers the potential for rapid molecular testing at the clinical point-of-care with simple equipment can improve influenza detection rates.
OBJECTIVES:

To evaluate the performance of Alere? i Influenza A&B isothermal nucleic acid amplification test to detect influenza A and B in comparison to viral cell culture as reference method.
STUDY DESIGN:

A prospective, multicenter, clinical study to evaluate the clinical performance of the Alere? i Influenza A&B assay in a point-of-care setting using prospectively enrolled specimens from both children and adults was conducted in seven sites.
RESULTS:

In comparison with viral cell culture, the overall sensitivity and specificity of the Alere? i Influenza A&B assay was 97.8% and 85.6% for the detection of influenza A, and 91.8% and 96.3% for the detection of influenza B, respectively. Following resolution of discrepant results by real-time RT-PCR the sensitivity and specificity of the Alere? i Influenza A&B assay improved to 99.3% and 98.1% for influenza A, and 97.6% and 100% for influenza B, respectively.
CONCLUSIONS:

The Alere? i Influenza A&B isothermal nucleic acid amplification test is an ideal point-of-care test for influenza detection in children and adults due to its high sensitivity and specificity and ability to generate results within 15min from specimen receipt.

Copyright ? 2014. Published by Elsevier B.V.
KEYWORDS:

Alere? i Influenza; Influenza; Nucleic acid amplification; POC; RADT

PMID:
24973813
[PubMed - as supplied by publisher]

Free full text

http://www.ncbi.nlm.nih.gov/pubmed/24973813
 
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