NDLI: Diagnostic accuracy of a rapid nucleic acid test for group A streptococcal pharyngitis using saliva samples: protocol for a prospective multicenter study in primary care

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Diagnostic accuracy of a rapid nucleic acid test for group A streptococcal pharyngitis using saliva samples: protocol for a prospective multicenter study in primary care

Content Provider	Springer Nature : BioMed Central
Author	Touitou, Robert Bidet, Philippe Dubois, Constance Partouche, Henri Bonacorsi, Stéphane Jung, Camille Cohen, Robert Levy, Corinne Cohen, Jérémie F.
Abstract	Background Group A streptococcus is found in 20–40% of cases of childhood pharyngitis; the remaining cases are viral. Streptococcal pharyngitis (“strep throat”) is usually treated with antibiotics, while these are not indicated in viral cases. Most guidelines recommend relying on a diagnostic test confirming the presence of group A streptococcus before prescribing antibiotics. Conventional first-line tests are rapid antigen detection tests based on throat swabs. Recently, rapid nucleic acid tests were developed; they allow the detection of elements of the genome of group A streptococcus. We hypothesize that these rapid nucleic acid tests are sensitive enough to be performed on saliva samples instead of throat swabs, which could be more convenient in practice. Methods This is a multicenter, prospective diagnostic accuracy study evaluating the performance of a rapid nucleic acid test for group A streptococcus (Abbott ID NOW STREP A2) in saliva, compared with a conventional pharyngeal rapid antigen detection test (EXACTO PRO STREPTATEST, lateral flow assay, comparator test), with a composite reference standard of throat culture and group A streptococcus PCR in children with pharyngitis in primary care (i.e., 27 primary care pediatricians or general practitioners). To ensure group A streptococcus is not missed, the salivary rapid nucleic acid test requires a minimally acceptable value of sensitivity (primary outcome) set at 80%. Assuming 35% of participants will have group A streptococcus, we will recruit 800 consecutive children with pharyngitis. Secondary outcomes will include difference in sensitivity between the pharyngeal rapid antigen detection test and the salivary rapid nucleic acid test; variability in sensitivity and specificity of the salivary rapid nucleic acid test with the level of McIsaac score; time to obtain the result of the salivary rapid nucleic acid test; patient, physician, and parents satisfaction; and barriers and facilitators to using rapid tests for group A streptococcus in primary care. Ethics and dissemination Approved by the Institutional Review Board “Comité de protection des personnes Ile de France I” (no. 2022-A00085-38). Results will be presented at international meetings and disseminated in peer-reviewed journals. Trial registration number ClinicalTrials.gov: NCT05521568.
Related Links	https://diagnprognres.biomedcentral.com/counter/pdf/10.1186/s41512-023-00150-4.pdf
Ending Page	8
Page Count	8
Starting Page	1
File Format	HTM / HTML
ISSN	23977523
DOI	10.1186/s41512-023-00150-4
Journal	Diagnostic and Prognostic Research
Issue Number	1
Volume Number	7
Language	English
Publisher	BioMed Central
Publisher Date	2023-07-13
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Acute pharyngitis Sore throat Rapid antigen detection tests Rapid nucleic acid tests Group A streptococcus Primary care Saliva Diagnostic accuracy Sensitivity Specificity Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Pathology and Forensic Medicine Clinical Biochemistry

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