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

NCT05521568 | Completed

• 1 other identifier: PREDISTREP IX
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Streptococcal Pharyngitis

Keywords

sore throat, rapid tests, molecular tests, saliva, sensitivity, specificity

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the Abbott ID NOW STREP A 2 rapid molecular test on saliva samples.

  Immediatly after the test

Secondary Outcomes (1)

• Difference in sensitivity between the rapid molecular tests on saliva and the classical rapid antigen detection tests on throat swabs

  Immediatly after the test

Other Outcomes (4)

• Variability in sensitivity and specificity of rapid molecular tests on saliva according to the McIsaac score (modified Centor score)

  Immediatly after the test

• Time needed to perform the rapid molecular test on saliva and obtain the results

  Immediatly after the test

• Satisfaction of the physician, the child, and the accompanying parent(s) withe a questionnaire

  Through study completion, an average of 1,5 year

Study Arms (3)

Index test : Abbott ID NOW STREP A 2

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

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)

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

Interventions

Index test: Abbott ID NOW STREP A 2 DIAGNOSTIC_TEST

The test under evaluation ('index test') is the rapid molecular test for Group A streptococcus Abbott ID NOW STREP A 2 (performed on saliva samples instead of throat swabs). This test was chosen because of its ease of use and several previous evaluations showing high diagnostic accuracy on throat swabs. The test gives a result after 2 to 6 minutes and will be performed by primary care practitioners participating in the study, in their office, using salivary swabs instead of throat swabs. Investigators will receive one session of specific training prior to the study. Saliva samples will be collected using the cotton swab that comes within the test packages. Index test results will not be used for patient management. Clinicians performing the rapid saliva test will not be blinded to clinical information.

Index test : Abbott ID NOW STREP A 2

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

Throat samples will be obtained by use of a double-swab collection-transportation system : * Swab #1 will be used to perform the rapid antigen detection test (see below) * Swab #2 will be held at ambient temperature and sent within 72 hours to Robert Debre Hospital microbiology laboratory. Throat swabs will be used to perform throat cultures using standard techniques (PMID: 22768060). Throat swabs will also be used to perform a PCR specific for Group A streptococcus (PMID: 23465407). Samples with a positive culture and/or a positive PCR test result will be classified as reference-standard-positives. Samples with a negative culture and a negative PCR will be classified as reference-standard-negatives. Investigators will be blinded to clinical data, including the result of the rapid antigen detection test and the rapid saliva test.

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

Comparator test: Rapid antigen detection test (usual care) DIAGNOSTIC_TEST

As per usual care, all children will undergo a rapid antigen detection test (StreptAtest, Biosynex), using Swab#1 (see above). This rapid antigen detection test is the one used in France and is the only commercial kit that is officially recommended by the National Health Insurance system. It detects Lancefield's Group A antigen, which is specific to Group A Streptococcus. The test will be performed by investigators, during consultation time. Clinicians performing the rapid antigen detection test will not be blinded to clinical information.

Comparator test : Rapid antigen detection test (usual care)

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children (3 to 15 years) with acute pharyngitis in primary care

You may qualify if:

• 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)

You may not qualify if:

• children already enrolled in the study for the same episode of pharyngitis

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Hôpital Necker-Enfants Malades: collaborator
• University Hospital, Paris: collaborator
• Groupe Hospitalier Diaconesses Croix Saint-Simon: collaborator
• Association Clinique Thérapeutique Infantile du val de Marne: collaborator

Study Sites (1)

ACTIV

Saint-Maur-des-Fossés, France

Location

Related Publications (1)

• Touitou R, Bidet P, Dubois C, Partouche H, Bonacorsi S, Jung C, Cohen R, Levy C, Cohen JF. 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. Diagn Progn Res. 2023 Jul 13;7(1):13. doi: 10.1186/s41512-023-00150-4.

  PMID: 37443047 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Double throat swabs will be taken from each participant. One will be used during consultation to perform the rapid antigen detection test. One will be sent to the microbiology laboratory to perform the reference standard test. If the throat swab grows Group A Streptococcus on culture, the strain will be stored at -80°C for 5 years. Below we describe 3 Groups to allow a sufficiently detailed description of all tests, but the index test, the reference standard, and the comparator test will be performed on all study participants (i.e., 'single-gate' design).

MeSH Terms

Conditions

Pharyngitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 30, 2022
• Study Start: January 31, 2023
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)