Bibliographic Details
| Title: |
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 |
| Authors: |
Robert Touitou, Philippe Bidet, Constance Dubois, Henri Partouche, Stéphane Bonacorsi, Camille Jung, Robert Cohen, Corinne Levy, Jérémie F. Cohen |
| Source: |
Diagnostic and Prognostic Research, Vol 7, Iss 1, Pp 1-8 (2023) |
| Publisher Information: |
BMC, 2023. |
| Publication Year: |
2023 |
| Collection: |
LCC:Medicine (General) |
| Subject Terms: |
Acute pharyngitis, Sore throat, Rapid antigen detection tests, Rapid nucleic acid tests, Group A streptococcus, Primary care, Medicine (General), R5-920 |
| More Details: |
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. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2397-7523 |
| Relation: |
https://doaj.org/toc/2397-7523 |
| DOI: |
10.1186/s41512-023-00150-4 |
| Access URL: |
https://doaj.org/article/9421b4f4007b42f4b9e1db0343ef73ea |
| Accession Number: |
edsdoj.9421b4f4007b42f4b9e1db0343ef73ea |
| Database: |
Directory of Open Access Journals |
