Diagnosis; Diagnostic techniques and procedures; Group A streptococcus; Meta-analysis; Molecular probe techniques; Pharyngitis; Sensitivity and specificity; Streptococcus pyogenes; Systematic review; Nucleic Acids; Humans; Sensitivity and Specificity; Nucleic Acid Amplification Techniques; Pharyngitis/diagnosis; Point-of-Care Testing; Microbiology (medical); Infectious Diseases
Abstract :
[en] [en] BACKGROUND: Acute pharyngitis is one of the most common conditions in outpatient settings and an important source of inappropriate antibiotic prescribing. Rapid antigen detection tests (RADTs) offer diagnosis of group A streptococcus at the point of care but have limited sensitivity. Rapid nucleic acid tests (RNATs) are now available; a systematic review of their accuracy is lacking.
OBJECTIVES: To evaluate the accuracy of RNATs in patients with pharyngitis; to explore test-level and study-level factors that could explain variability in accuracy; and to compare the accuracy of RNATs with that of RADTs.
DATA SOURCES: MEDLINE, Embase, Web of Science (1990-2020).
STUDY ELIGIBILITY CRITERIA: Cross-sectional studies and randomized trials.
PARTICIPANTS: Patients with pharyngitis.
INDEX TEST/S AND REFERENCE STANDARDS: RNAT commercial kits compared with throat culture.
METHODS: We assessed risk of bias and applicability using QUADAS-2. We performed meta-analysis of sensitivity and specificity using the bivariate random-effects model. Variability was explored by subgroup analyses and meta-regression.
RESULTS: We included 38 studies (46 test evaluations; 17 411 test results). RNATs were most often performed in a laboratory. The overall methodological quality of primary studies was uncertain because of incomplete reporting. RNATs had a summary sensitivity of 97.5% (95% CI 96.2%-98.3%) and a summary specificity of 95.1% (95% CI 93.6%-96.3%). There was low variability in estimates across studies. Variability in sensitivity and specificity was partially explained by test type (p < 0.05 for both). Sensitivity analyses limited to studies with low risk of bias showed robust accuracy estimates. RNATs were more sensitive than RADTs (13 studies; 96.8% versus 82.3%, p 0.004); there was no difference in specificity (p 0.92).
CONCLUSIONS: The high diagnostic accuracy of RNATs may allow their use as stand-alone tests to diagnose group A streptococcus pharyngitis. Based on direct comparisons, RNATs have greater sensitivity than RADTs and equal specificity. Further studies should evaluate RNATs in point-of-care settings.
Disciplines :
Pediatrics
Author, co-author :
Dubois, Constance; Université de Paris, Centre of Research in Epidemiology and Statistics (CRESS), INSERM, Paris, France
Smeesters, Pierre R; Academic Children Hospital Queen Fabiola, Université libre de Bruxelles, Department of Paediatrics, Brussels, Belgium, Molecular Bacteriology Laboratory, Université libre de Bruxelles, Brussels, Belgium
Levy, Corinne; Association Clinique et Thérapeutique Infantile du Val-de-Marne, ACTIV, Créteil, France
Bidet, Philippe; Robert Debré Hospital, APHP, Université de Paris, Department of Microbiology, Paris, France
Cohen, Robert; Association Clinique et Thérapeutique Infantile du Val-de-Marne, ACTIV, Créteil, France
Chalumeau, Martin; Université de Paris, Centre of Research in Epidemiology and Statistics (CRESS), INSERM, Paris, France, Necker-Enfants malades Hospital, APHP, Université de Paris, Department of General Paediatrics and Paediatric Infectious Diseases, Paris, France
Toubiana, Julie; Necker-Enfants malades Hospital, APHP, Université de Paris, Department of General Paediatrics and Paediatric Infectious Diseases, Paris, France, Institut Pasteur, Biodiversity and Epidemiology of Bacterial Pathogens, Paris, France
Cohen, Jérémie F ; Université de Paris, Centre of Research in Epidemiology and Statistics (CRESS), INSERM, Paris, France, Necker-Enfants malades Hospital, APHP, Université de Paris, Department of General Paediatrics and Paediatric Infectious Diseases, Paris, France. Electronic address: jeremie.cohen@inserm.fr
REFES, Yacine Marc ; University of Luxembourg > Faculty of Science, Technology and Medicine (FSTM) > Department of Life Sciences and Medicine (DLSM) > Medical Education
External co-authors :
yes
Language :
English
Title :
Diagnostic accuracy of rapid nucleic acid tests for group A streptococcal pharyngitis: systematic review and meta-analysis.
Turun Yliopisto University of Cincinnati Universiteit van Amsterdam
Funding text :
We thank Dr Ivaska (University of Turku, Finland), Dr Jayaratne (McMaster University, Canada), Dr Mortensen (University of Cincinnati, USA), Dr Rao (Scott and White Medical Center, Temple, USA) and Dr Sickler (Roche Diagnostics) for having shared additional and unpublished information about their studies. We thank Dr Leeflang (University of Amsterdam, the Netherlands) for having provided valuable comments on a draft version of this work.
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