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Diagnostic accuracy of rapid nucleic acid tests for group A streptococcal pharyngitis: systematic review and meta-analysis
Affiliation:1. Department of Neurological Surgery, Oregon Health & Science University, Portland, Oregon, USA;2. Department of Neurosurgery, University of California, Los Angeles, California, USA;3. Division of Cardiothoracic Surgery, Department of Surgery, Oregon Health & Science University, Portland, Oregon, USA;4. Division of Cardiothoracic Surgery, Department of Surgery, University of California−Davis, Sacramento, California, USA;1. Tropical Diseases Research Group, Murdoch Children''s Research Institute, Melbourne, VIC, Australia;2. Epigenetics Research Group, Murdoch Children''s Research Institute, Melbourne, VIC, Australia;3. Clinical Epidemiology and Biostatistics Unit, Murdoch Children''s Research Institute, Melbourne, VIC, Australia;4. Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia;5. Infectious Diseases Unit, Department of General Medicine, Royal Children''s Hospital Melbourne, Melbourne, VIC, Australia;6. Paediatric Department, Academic Children Hospital Queen Fabiola, Université Libre de Bruxelles, Brussels, Belgium;7. Molecular Bacteriology Laboratory, Université Libre de Bruxelles, Brussels, Belgium;8. Unidad de Investigación Médica en Inmunoquímica, Hospital de Especialidades del Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico;9. School of Chemistry and Molecular Biosciences and Australian Infectious Diseases Research Centre, The University of Queensland, Brisbane, QLD, Australia;10. School of Medicine, The University of Queensland, Brisbane, QLD, Australia;11. Department of Molecular Medicine and Pathology, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand;12. Department of Cardiology, The Alfred Hospital, Melbourne, VIC, Australia;13. Infection Prevention and Healthcare Epidemiology Unit, The Alfred Hospital, Melbourne, VIC, Australia;14. Imaging Research, Baker Heart and Diabetes Institute, Melbourne, VIC, Australia;15. Department of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia;p. School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia;q. Nucleus Network, Melbourne, VIC, Australia;r. Department of Medicine, University of Cambridge, Cambridge, UK;s. Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Perth, WA, Australia;t. Faculty of Health and Medical Sciences, University of Western Australia, Perth, WA, Australia;u. The Institute for Glycomics, Griffith University, Gold Coast, QLD, Australia;v. Department of Family Medicine, McGill University, Montreal, QC, Canada;w. Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK;x. National Institute for Health Research, Oxford Biomedical Research Centre, Oxford, UK;y. QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia;z. Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA;11. Department of Paediatric Infectious Diseases, Perth Children''s Hospital, Perth, WA, Australia
Abstract:
BackgroundAcute 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.ObjectivesTo 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 sourcesMEDLINE, Embase, Web of Science (1990–2020).Study eligibility criteriaCross-sectional studies and randomized trials.ParticipantsPatients with pharyngitis.Index test/s and reference standardsRNAT commercial kits compared with throat culture.MethodsWe 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.ResultsWe 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).ConclusionsThe 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.
Keywords:Diagnosis  Diagnostic techniques and procedures  Group A streptococcus  Meta-analysis  Molecular probe techniques  Pharyngitis  Sensitivity and specificity  Systematic review
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