Evaluation of the Lyra Direct Strep Assay To Detect Group A Streptococcus and Group C and G Beta-Hemolytic Streptococcus from Pharyngeal Specimens

Boyanton, Bobby L.; Darnell, Elizabeth M.; Prada, Anne E.; Hansz, Dana M.; Robinson-Dunn, Barbara

doi:10.1128/jcm.02405-15

Cited by 10 publications

(4 citation statements)

References 14 publications

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“…After 7 days, any residual specimens were stored at Ϫ70°C for PCR testing. Additional PCR testing for GAS and group C/G streptococci (Lyra Direct Strep kit; Quidel Corporation, San Diego, CA) was performed for the study per the manufacturer's recommendation (28).…”

Section: Methodsmentioning

confidence: 99%

Prevalence of Fusobacterium necrophorum in Children Presenting with Pharyngitis

Van

Cox

Cox³

et al. 2017

J Clin Microbiol

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, an obligate anaerobic bacterium, was recently reported to be an important cause of bacterial pharyngitis with a prevalence as high as that of group A (GAS) in adolescents and young adults. Importantly, is the primary causative agent of the life-threatening Lemierre's syndrome, and screening of pharyngeal samples may be warranted for its early detection and prevention. The aim of this study was to determine the prevalences of and groups A and C/G streptococci as agents of bacterial pharyngitis in children. Pharyngeal samples ( = 300) were collected from pediatric patients presenting to the emergency department with signs and symptoms of pharyngitis. Overall, 10 (3.3%), 79 (26.3%), and 4 (1.3%) patients were PCR positive for , GAS, and group C/G streptococci, respectively. The prevalence of was significantly higher in patients between the ages of 14 and 20 years at 13.5% than in patients aged 14 years and younger (1.9%, < 0.001). All positive patients presented with signs and symptoms similar to GAS pharyngitis. Our data demonstrated a potential role for as a pathogen of pharyngitis among young adults, but suggests that the prevalence of is low in preadolescent patients.

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Section: Methodsmentioning

confidence: 99%

Prevalence of Fusobacterium necrophorum in Children Presenting with Pharyngitis

Van

Cox

Cox³

et al. 2017

J Clin Microbiol

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“…The illumigene group A Streptococcus (Meridian Bioscience, Inc.) utilizes loop-mediated isothermal amplification (LAMP) technology and has reported sensitivity and specificity of 82% to 99% and 93% to 99.6%, respectively (20,21). The Quidel Corporation has the Solana Strep Complete assay for group A and group C/G detection and the Solana GAS assay (sensitivity, 91 to 98%; specificity, 97 to 98% [22,23]) that utilize helicasedependent amplification for GAS detection, and the Lyra Direct Strep assay, which is a multiplex real-time PCR assay for detection of group A and C or G Streptococcus (sensitivity and specificity, 100%) (24). The Alere i Strep A and Alere i Strep A2 assays (Abbott Laboratories) use the isothermal nicking enzyme amplification reaction (NEAR) and have reported sensitivity and specificity of 96% to 100% and 91.3% to 100%, respectively (25)(26)(27).…”

Section: Discussionmentioning

confidence: 99%

Multicenter Clinical Evaluation of the Automated Aries Group A Strep PCR Assay from Throat Swabs

Kanwar

Crawford

Ulen³

et al. 2019

J Clin Microbiol

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Group A Streptococcus (GAS) is one of the leading causes of bacterial pharyngitis. Early GAS diagnosis is critical for appropriate antibiotic administration that reduces the risk of GAS sequelae and limits spread of the infection. The Aries Group A Strep (GAS) assay (Luminex, Austin, TX) is a fully automated PCR assay for direct detection of GAS in throat swab specimens in less than 2 h with minimum hands-on time. This multicenter prospective study evaluated the clinical performance of the Aries GAS assay compared to that of Streptococcus pyogenes culture. Subjects with symptoms consistent with pharyngitis were enrolled across four sites in the United States, and a throat swab in liquid Amies medium was obtained. Aries and reference testing was performed within 72 and 48 h after sample collection, respectively. Of 623 throat swab specimens from patients with pharyngitis (93.6% <18 years old, 54.3% female), the reference method yielded valid results for 618 specimens. Reference and Aries assay testing showed GAS-positive results for 160 (25.9%) and 166 (26.9%) specimens, respectively. Compared to the reference method, Aries assay sensitivity was 97.5% (95% confidence interval [CI], 93.7% to 99.0%), specificity was 97.8% (95% CI, 96.0 to 98.8%), positive predictive value was 94.0% (95% CI, 89.3% to 96.7%), and negative predictive value was 99.1% (95% CI, 97.7% to 99.7%). There were 10 false-positive and four false-negative detections with the Aries assay. Discrepant analysis with bidirectional sequencing yielded concordant results with the Aries assay for nine of 14 discordant samples. The Aries assay had high sensitivity and specificity for qualitative detection of group A Streptococcus from patients with pharyngitis.

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“…Nucleic acid testing offers an alternative way to improve speed and accuracy in GAS pharyngitis diagnosis and has been shown to have superior sensitivity and specificity compared to conventional throat cultures and clinical diagnosis [4,5].…”

Section: Introductionmentioning

confidence: 99%

“…Distribution of non-group A beta-hemolyticStreptococcus isolated from primary culture Large-colony forming beta-hemolytic S. dysgalactiae isolates have been shown to cause streptococcal pharyngitis; however, if untreated do not increase the risk of post-streptococcal sequelae[5] …”

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confidence: 99%

Prospective Evaluation of Xpert® Xpress Strep A Automated PCR Assay vs. Solana® Group A Streptococcal Nucleic Acid Amplification Testing vs. Conventional Throat Culture

et al. 2021

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In our laboratory, the negative rapid group A streptococcal (GAS) antigen assays are backed up by the Solana® GAS Assay by Quidel instead of a Group A streptococcal throat culture. Another FDA cleared RT-PCR assay is the Xpert® Xpress Strep A, which detects Streptococcus pyogenes DNA, and is performed on the Cepheid GeneXpert instrument. Three hundred seventy-five positive and negative specimens were randomly selected from 5489 throat specimens that had been tested by the Solana® GAS Assay during January 2018 and were tested with the Xpress Strep A assay. A throat culture was also set up (sheep blood agar at 35 °C in 5% CO2). All beta-hemolytic streptococci were purified and identified by MALDI-TOF mass spectrometry. Of the 375 samples, 185 were positive by Solana® GAS Assay, and 187 were positive by the Xpress Strep A. The total agreement between the Solana® GAS Assay and the Xpert® Xpress Strep A was 99.5%. The agreement of the Xpert® Xpress Strep A assay with culture was 90.1%. The sensitivity and specificity for Xpress Strep A versus culture were 100% and 83.5%, respectively. The Xpert® Xpress Strep A assay's performance was equivalent to the Solana® GAS Assay, and was highly sensitive. The lower specificity was likely due to the Xpress Strep A assay having higher sensitivity as compared to throat culture.

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Evaluation of the Lyra Direct Strep Assay To Detect Group A Streptococcus and Group C and G Beta-Hemolytic Streptococcus from Pharyngeal Specimens

Cited by 10 publications

References 14 publications

Prevalence of Fusobacterium necrophorum in Children Presenting with Pharyngitis

Prevalence of Fusobacterium necrophorum in Children Presenting with Pharyngitis

Multicenter Clinical Evaluation of the Automated Aries Group A Strep PCR Assay from Throat Swabs

Prospective Evaluation of Xpert® Xpress Strep A Automated PCR Assay vs. Solana® Group A Streptococcal Nucleic Acid Amplification Testing vs. Conventional Throat Culture

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