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J Clin Virol. 2014 Sep;61(1):81-6. doi: 10.1016/j.jcv.2014.06.001. Epub 2014 Jun 7.

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

Author information

1
Children's Mercy Hospitals and Clinics, Kansas City, MO, United States; University of Missouri Kansas City School of Medicine, Kansas City, MO, United States.
2
Veritas, P.A., Belton, TX, United States.
3
Nationwide Children's and the Ohio State University, Columbus, OH, United States.
4
New York Methodist Hospital, Brooklyn, NY, United States.
5
Ann & Robert Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
6
Albany Medical College, Albany, NY, United States.
7
Wake Forest University Baptist Medical Center, Winston-Salem, NC, United States.
8
Children's Mercy Hospitals and Clinics, Kansas City, MO, United States; University of Missouri Kansas City School of Medicine, Kansas City, MO, United States. Electronic address: rselvarangan@cmh.edu.

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 15 min from specimen receipt.

KEYWORDS:

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

PMID:
24973813
DOI:
10.1016/j.jcv.2014.06.001
[Indexed for MEDLINE]
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