Diagnostic Accuracy of Rapid Molecular Tests for Group A Streptococcal Pharyngitis Using Saliva Samples

Centre Hospitalier Intercommunal Creteil

Status: Completed

Conditions: Streptococcal Pharyngitis

Treatments: Diagnostic Test: Comparator test: Rapid antigen detection test (usual care); Diagnostic Test: Reference standard test: Composite of culture and PCR-based tests based on a throat swab; Diagnostic Test: Index test: Abbott ID NOW STREP A 2

Study type: Observational

Funder types: Other

Identifiers

NCT05521568

PREDISTREP IX

Details and patient eligibility

About

Observational study evaluating the diagnostic accuracy of rapid point-of-care molecular Group A strep diagnostic tests in saliva as compared to standard culture- and PCR-based techniques for the management of children aged 3-15 years of age presenting with sore throat to primary care.

Full description

Group A streptococcus (GAS) is found in 20% to 40% of cases of childhood pharyngitis; the remaining cases are viral. Streptococcal pharyngitis ('strep throat') deserves antibiotics, while these are not indicated in viral cases. Because signs and symptoms of streptococcal and viral cases overlap, most guidelines recommend relying on a diagnostic test to identify Group A streptococcus to select who should receive antibiotics. In most settings, the first-line test to detect Group A Streptococcus is a rapid antigen detection test based on a throat swab, and the reference standard to identify streptococcal cases is throat culture. Recently, new rapid tests were developed. They use molecular techniques, such as rapid PCRs or LAMP, based on throat swabs. We hypothesize that these new molecular tests are sensitive enough to be performed on saliva swabs instead of throat swabs. Collecting saliva is less invasive and could be done by personnel with limited training.

Enrollment: 800 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children 3-15 years
• seen in primary care (general practitioner or primary care pediatrician)
• with a diagnosis of acute pharyngitis defined as an inflammation of the pharynx and/or tonsils (erythema with or without exudate) or acute sore throat (even if without local signs of pharyngeal inflammation)
• non-opposition of the accompanying parent(s)

Exclusion criteria

• children who received antibiotics within 7 days before inclusion
• children already enrolled in the study for the same episode of pharyngitis

Trial design

800 participants in 3 patient groups

Index test : Abbott ID NOW STREP A 2

Treatment:

Diagnostic Test: Index test: Abbott ID NOW STREP A 2

Reference standard test : Composite of culture and PCR-based tests based on a throat swab

Treatment:

Diagnostic Test: Reference standard test: Composite of culture and PCR-based tests based on a throat swab

Comparator test : Rapid antigen detection test (usual care)

Treatment:

Diagnostic Test: Comparator test: Rapid antigen detection test (usual care)