Jeremiah Bell1, Aleta Bonner2, Daniel M Cohen3, Robert Birkhahn4, Ram Yogev5, Wayne Triner6, Jason Cohen6, Elizabeth Palavecino7, Rangaraj Selvarangan8. 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.
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.
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