Abstract

BackgroundTo 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.MethodsThis 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.ResultsA 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).ConclusionUnder 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 registrationID number ISRCTN84562679. Registered October 162,018, retrospectively registered.

Highlights

  • 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

  • The current study evaluated the feasibility of replacing the current standard of care (SOC) algorithm – the 2-step RADT with confirmatory culture – with POC PCR testing using the cobas Liat Strep A test

  • A total of 110 samples were determined to be positive for GAS, with an overall incidence of 43.1%: 46.1% (70/152) in the RADT arm and 38.8% (40/103) in the POC PCR arm

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Summary

Introduction

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. Infection with Streptococcus pyogenes (group A betahemolytic streptococci; GAS) is the most common bacterial cause of acute pharyngitis and is responsible for an estimated 20–30% of sore throat cases in children [1, 2]. Acute pharyngitis can be a result of either bacterial or viral pathogens and, as such, current clinical guidelines encourage the use of antibiotics only for confirmed cases of GAS[4]. Despite these recommendations, and the overall rates of documented GAS infections (5–30% of sore throat visits), antibiotics are often prescribed in as many as 60% of patient visits for sore throat [3, 5, 6]. Greater awareness of the development of bacterial resistance resulting from the overprescribing of antibiotics is increasing the urgency to move away from empiric antibiotic treatment for common respiratory infections

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