Joanna Merckx, MD, MSc; Rehab Wali, BSc, MBBS; Ian Schiller, MSc; Chelsea Caya, MScPH; Genevieve C. Gore, MLIS; Caroline Chartrand, MD, MSc; Nandini Dendukuri, PhD; Jesse Papenburg, MD, MSc
Acknowledgment: The authors thank Dr. Madhukar Pai, McGill University, for generously allowing the use of the EndNote libraries and data set from Chartrand and colleagues' 2012 review and Dr. Patricia Fontela, McGill University, for her thoughtful review of the manuscript.
Grant Support: In part by the Québec Health Research Fund and by an investigator-initiated study grant from BD Diagnostic Systems. Drs. Papenburg and Dendukuri are recipients of career awards from the Québec Health Research Fund.
Disclosures: Drs. Merckx, Wali, Chartrand, Dendukuri, and Papenburg and Ms. Gore report investigator-initiated study funding from BD Diagnostic Systems during the conduct of the study. Dr. Papenburg also reports a career award from Québec Health Research Fund during the conduct of the study; grants from AbbVie outside the submitted work; and personal fees from Cepheid, AbbVie, and RPS Diagnostics outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-0848.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: See Supplement. Statistical code: See Supplement. Data set: Full data set and codebook available on www.nandinidendukuri.com.
Requests for Single Reprints: Jesse Papenburg, MD, MSc, McGill University Health Centre, E05.1905, 1001 Décarie Boulevard, Montreal, Québec H4A 3J1, Canada; e-mail, email@example.com.
Current Author Addresses: Dr. Merckx: Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1020 Pine Avenue West, Montreal, Quebec H3A 1A2, Canada.
Dr. Wali: 3 Tullyhall Way, Lucan, Dublin K78 TH73, Ireland.
Mr. Schiller: Centre for Outcomes Research and Evaluation (CORE), 5252 Boulevard de Maisonneuve, Bureau 3C.07, Montreal, Quebec H4A 3S5, Canada.
Ms. Caya: McGill University Health Centre—Research Institute, EM3.3509, 1001 Décarie Boulevard, Montreal, Quebec H4A 3J1, Canada.
Ms. Gore: Schulich Library of Physical Sciences, Life Sciences, and Engineering, Macdonald-Stewart Library Building, 809 Sherbrooke Street West, Montreal, Quebec H3A 0C1, Canada.
Dr. Chartrand: CHU Sainte-Justine, Département de Pédiatrie, 3175 Chemin de la Côte Sainte-Catherine, Montreal, Quebec H3T 1C5, Canada.
Dr. Dendukuri: Centre for Outcomes Research and Evaluation (CORE), 5252 Boulevard de Maisonneuve, Bureau 3F.50, Montreal, Quebec H4A 3S5, Canada.
Dr. Papenburg: McGill University Health Centre, E05.1905, 1001 Décarie Boulevard, Montreal, Quebec H4A 3J1, Canada.
Author Contributions: Conception and design: J. Merckx, R. Wali, C. Chartrand, N. Dendukuri, J. Papenburg.
Analysis and interpretation of the data: J. Merckx, R. Wali, I. Schiller, C. Caya, C. Chartrand, N. Dendukuri, J. Papenburg.
Drafting of the article: J. Merckx, R. Wali, C. Caya, N. Dendukuri, J. Papenburg.
Critical revision of the article for important intellectual content: J. Merckx, C. Caya, N. Dendukuri, J. Papenburg.
Final approval of the article: J. Merckx, R. Wali, I. Schiller, C. Caya, G.C. Gore, C. Chartrand, N. Dendukuri, J. Papenburg.
Provision of study materials or patients: G.C. Gore, J. Papenburg.
Statistical expertise: J. Merckx, I. Schiller, C. Chartrand, N. Dendukuri, J. Papenburg.
Obtaining of funding: J. Papenburg.
Administrative, technical, or logistic support: J. Merckx, R. Wali, G.C. Gore.
Collection and assembly of data: J. Merckx, R. Wali, C. Caya, G.C. Gore, C. Chartrand, J. Papenburg.
Rapid and accurate influenza diagnostics can improve patient care.
To summarize and compare accuracy of traditional rapid influenza diagnostic tests (RIDTs), digital immunoassays (DIAs), and rapid nucleic acid amplification tests (NAATs) in children and adults with suspected influenza.
6 databases from their inception through May 2017.
Studies in English, French, or Spanish comparing commercialized rapid tests (that is, providing results in <30 minutes) with reverse transcriptase polymerase chain reaction reference standard for influenza diagnosis.
Data were extracted using a standardized form; quality was assessed using QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies 2) criteria.
162 studies were included (130 of RIDTs, 19 of DIAs, and 13 of NAATs). Pooled sensitivities for detecting influenza A from Bayesian bivariate random-effects models were 54.4% (95% credible interval [CrI], 48.9% to 59.8%) for RIDTs, 80.0% (CrI, 73.4% to 85.6%) for DIAs, and 91.6% (CrI, 84.9% to 95.9%) for NAATs. Those for detecting influenza B were 53.2% (CrI, 41.7% to 64.4%) for RIDTs, 76.8% (CrI, 65.4% to 85.4%) for DIAs, and 95.4% (CrI, 87.3% to 98.7%) for NAATs. Pooled specificities were uniformly high (>98%). Forty-six influenza A and 24 influenza B studies presented pediatric-specific data; 35 influenza A and 16 influenza B studies presented adult-specific data. Pooled sensitivities were higher in children by 12.1 to 31.8 percentage points, except for influenza A by rapid NAATs (2.7 percentage points). Pooled sensitivities favored industry-sponsored studies by 6.2 to 34.0 percentage points. Incomplete reporting frequently led to unclear risk of bias.
Underreporting of clinical variables limited exploration of heterogeneity. Few NAAT studies reported adult-specific data, and none evaluated point-of-care testing. Many studies had unclear risk of bias.
Novel DIAs and rapid NAATs had markedly higher sensitivities for influenza A and B in both children and adults than did traditional RIDTs, with equally high specificities.
Québec Health Research Fund and BD Diagnostic Systems.
Merckx J, Wali R, Schiller I, et al. Diagnostic Accuracy of Novel and Traditional Rapid Tests for Influenza Infection Compared With Reverse Transcriptase Polymerase Chain Reaction: A Systematic Review and Meta-analysis. Ann Intern Med. 2017;167:394–409. [Epub ahead of print 5 September 2017]. doi: https://doi.org/10.7326/M17-0848
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Published: Ann Intern Med. 2017;167(6):394-409.
Published at www.annals.org on 5 September 2017
Infectious Disease, Influenza, Pulmonary/Critical Care.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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