Detection of Group B Streptococcus Directly from Collected ESwab Samples by Use of the BD Max GBS Assay

Silbert, Suzane; Rocchetti, Talita Trevizani; Gostnell, Alicia; Kubasek, Carly; Widen, Raymond

doi:10.1128/jcm.00445-16

Cited by 24 publications

(25 citation statements)

References 20 publications

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“…Available GBS testing includes culture, with or without the aid of a chromogenic medium, and NAATs. After enrichment, culture-based methods can take from 24 to 48 h for a final result, in contrast to molecular-based tests that are faster and less labor-intensive than culture (5).…”

Section: Discussionmentioning

confidence: 99%

“…The CDC also recommends "optional" direct broth testing using antigen detection (i.e., if chromogenic broth is used, then GBS may be confirmed by latex agglutination) or nucleic acid amplification tests (NAATs). Several U.S. Food and Drug Administration (FDA)-cleared tests have been commercialized and provide results at least 1 day earlier than culture (5).…”

mentioning

confidence: 99%

“…The system, when loaded to capacity, can process 288 specimens without any user intervention, with a time to first result of ϳ60 min for DNA assays, such as the NeuMoDx GBS assay. The NeuMoDx GBS assay and system join an expanding list of NAAT technologies and instrumentation available for GBS detection (5,8). Indeed, many systems have been recently FDA cleared and commercialized, generating results at least 1 day earlier than the traditional CDC culture method (5).…”

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confidence: 99%

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Multicenter Evaluation of NeuMoDx Group B Streptococcus Assay on the NeuMoDx 288 Molecular System

et al. 2019

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Group B Streptococcus (GBS) is the leading cause of neonatal sepsis and meningitis in developed countries. Recommendations for antepartum GBS detection include enriched culture with several options for identifying GBS, some of which are time-consuming. To reduce the time for identification and determination of the maternal GBS colonization status, rapid nucleic acid amplification technologies have been developed and commercialized. For rapid detection of GBS, a three-site clinical study was conducted to evaluate the NeuMoDx GBS assay, a real-time PCR test performed for vaginal/rectal swab specimens in Lim broth enrichment culture on the NeuMoDx 288 molecular system (NeuMoDx system); these data were used to a support 510(k) submission. A total of 1,250 eligible remnant samples were prospectively enrolled and tested during the study. The results of the PCR assay were compared to the results of the Centers for Disease Control and Prevention (CDC)-recommended enriched-culture method, which served as the gold standard reference method for the study. The NeuMoDx GBS assay results yielded a sensitivity of 96.9% (95% confidence interval [CI] = 94.1 to 98.4), specificity of 96.0% (95% CI = 94.6 to 97.1), and a total agreement with the reference method of 96.2% (95% CI = 93.8 to 98.3). NeuMoDx GBS assay results were also compared to results obtained using the BD MAX GBS assay on the BD MAX system. The two systems demonstrated a total percent agreement of 98.0% (95% CI = 95.5 to 100.0). The performance of the NeuMoDx GBS assay implemented on the NeuMoDx system compared favorably to the CDC enriched-culture method and to the BD MAX GBS assay.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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Multicenter Evaluation of NeuMoDx Group B Streptococcus Assay on the NeuMoDx 288 Molecular System

et al. 2019

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“…) . An aliquot of 200 μL of liquid transport medium was also inoculated into Todd‐Hewitt broth (Asan Pharm) supplemented with colistin (10 μg/dL) and nalidixic acid (15 μg/dL), and this mixture was enriched by incubating it for ≥18 h at 36°C according to CDC recommendations . Following enrichment, 50 μL of Todd‐Hewitt broth was inoculated onto both BAP and CA after vortexing.…”

Section: Methodsmentioning

confidence: 99%

Detection and genomic analysis of genital group B streptococcus in pregnant Korean women

Lee

Kim

Park

et al. 2018

J of Obstet and Gynaecol

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“…These measures have been effective, with current rates of EO-GBS disease in the United States at record lows (i.e., 0.3 per 1,000 live births) (6). Several U.S. Food and Drug Administration (FDA)-cleared NAATs can be used to detect GBS in enrichment broth, and at least one FDA-cleared test can be used directly on vaginal/rectal swabs without broth enrichment for intrapartum testing (7)(8)(9)(10)(11)(12)(13). Intrapartum testing results are critical for women who present in labor prior to 35 weeks, who failed to have the surveillance cultures performed before time of delivery, or who do not have other indications for antimicrobial therapy to prevent EO-GBS disease (10).…”

mentioning

confidence: 99%

Streptococcus agalactiae Strains with Chromosomal Deletions Evade Detection with Molecular Methods

Tickler¹,

Tenover

Dewell³

et al. 2019

J Clin Microbiol

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Surveillance of circulating microbial populations is critical for monitoring the performance of a molecular diagnostic test. In this study, we characterized 31 isolates of Streptococcus agalactiae (group B Streptococcus [GBS]) from several geographic locations in the United States and Ireland that contain deletions in or adjacent to the region of the chromosome that encodes the hemolysin gene cfb, the region targeted by the Xpert GBS and GBS LB assays. PCR-negative, culturepositive isolates were recognized during verification studies of the Xpert GBS assay in 12 laboratories between 2012 and 2018. Whole-genome sequencing of 15 GBS isolates from 11 laboratories revealed four unique deletions of chromosomal DNA ranging from 181 bp to 49 kb. Prospective surveillance studies demonstrated that the prevalence of GBS isolates containing deletions in the convenience sample was Ͻ1% in three geographic locations but 7% in a fourth location. Among the 15 isolates with chromosomal deletions, multiple pulsed-field gel electrophoresis types were identified, one of which appears to be broadly dispersed across the United States.

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Detection of Group B Streptococcus Directly from Collected ESwab Samples by Use of the BD Max GBS Assay

Cited by 24 publications

References 20 publications

Multicenter Evaluation of NeuMoDx Group B Streptococcus Assay on the NeuMoDx 288 Molecular System

Multicenter Evaluation of NeuMoDx Group B Streptococcus Assay on the NeuMoDx 288 Molecular System

Detection and genomic analysis of genital group B streptococcus in pregnant Korean women

Streptococcus agalactiae Strains with Chromosomal Deletions Evade Detection with Molecular Methods

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