Diagnosis and antibiotic treatment of group a streptococcal pharyngitis in children in a primary care setting: impact of point-of-care polymerase chain reaction
- PMID: 30651115
- PMCID: PMC6335697
- DOI: 10.1186/s12887-019-1393-y
Diagnosis and antibiotic treatment of group a streptococcal pharyngitis in children in a primary care setting: impact of point-of-care polymerase chain reaction
Abstract
Background: To compare the sensitivity and specificity of the recommended 2-step rapid antigen detection test (RADT) with confirmatory culture vs the point-of-care (POC) polymerase chain reaction (PCR) Roche cobas® Liat® Strep A test for detection of group A Streptococcus (GAS) in pediatric patients with pharyngitis, and to investigate the impact of these tests on antibiotic use in a large pediatric clinic.
Methods: This prospective, open-label study was conducted at a single site during fall/winter 2016-2017. A total of 275 patients aged 3 to 18 years with symptoms of pharyngitis had a throat-swab specimen analyzed using RADT, POC PCR, and culture. The sensitivity, specificity, and percentage agreement (95% CI) between assays and a laboratory-based nucleic acid amplification test were calculated. DNA sequencing was used to adjudicate discrepancies. The RADT or POC PCR result was provided to clinicians on alternating weeks to compare the impact on antibiotic use.
Results: A total of 255 samples were evaluated; 110 (43.1%) were GAS positive. Sensitivities (95% CI) for POC PCR, RADT, and culture were 95.5% (89.7-98.5%), 85.5% (77.5-1.5%), and 71.8% (62.4-80.0%), respectively. Specificities (95% CI) for POC PCR, RADT, and culture were 99.3% (96.2-99.98%), 93.7% (88.5-97.1%), and 100% (97.5-100%), respectively. Compared with RADT, POC PCR resulted in significantly greater appropriate antibiotic use (97.1% vs 87.5%; P = .0065).
Conclusion: Under real-world conditions, RADT results were less specific and culture results were less sensitive than found in established literature and led to increased rates of inappropriate antibiotic use. POC PCR had high sensitivity and specificity and rapid turnaround times, and led to more appropriate antibiotic use.
Trial registration: ID number ISRCTN84562679 . Registered October 162,018, retrospectively registered.
Keywords: Cobas Liat strep a assay; Group a Streptococcus; Molecular point-of-care testing; Rapid antigen detection test.
Conflict of interest statement
Ethics approval and consent to participate
All subjects or their guardians provided written informed consent to participate in the study, and the study protocol and informed consent form were approved by the Baylor Scott and White Institutional Review Board (Temple, TX) prior to study initiation.
Consent for publication
Not applicable.
Competing interests
S.T., U.C., D.D., and J.S. are employees of Roche Molecular Systems. The other authors declare no conflicts of interest. Support for third-party writing assistance, furnished by Andrew Luber, PharmD, was provided by Roche Molecular Systems.
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