Multicenter diagnostic accuracy evaluation of the luminex aries real-time PCR assay for group B streptococcus detection in LIM broth-enriched samples

D. R. Hernandez, Donna Wolk, K. L. Walker, S. Young, R. Dunn, S. A. Dunbar, A. Rao

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

The vertical transmission of group B Streptococcus (GBS) strains causing neonatal sepsis is one of the leading reasons for neonatal mortality worldwide. The gold standard for GBS detection is enriched culture with or without the aid of chromogenic agars. Given the high risk for morbidity and mortality in this population, high assay sensitivity is required to prevent the personal and economic costs of GBS disease. Nucleic acid amplification tests (NAATs) allow for objective determination of GBS colonization with a sensitivity and a specificity higher than those of traditional culture methods. In this study, we determined the analytical and clinical performance of the Aries GBS assay compared to those of the enrichment culture method, biochemical identification, and the NAATs used at the study sites. Remnant Lim broth samples were used to perform the Aries assay and reference testing. Upon first testing using enriched culture as the reference standard, the Aries GBS assay identified GBS with a 96.1% sensitivity (95% confidence interval [CI], 91.2 to 98.7%) and a 91.4% specificity (95% CI, 88.8 to 93.6%). The test performed with 100% positive agreement (95% CI, 83.2 to 100%) compared to the results of the BD Max GBS assay and 98.0% positive agreement (95% CI, 89.2 to 99.9%) compared to the results of the Cepheid Xpert GBS LB test. Repeatability and reproducibility were maintained in intra- and interlaboratory testing, regardless of the instrument, module, or user who performed the test. The Aries GBS assay can be set up in less than 5 min and produces results in 2 h. The easy setup, with minimal hands-on time, and high assay sensitivity and specificity make this a useful testing option for GBS screening in pre-partum women.

Original languageEnglish (US)
Article numbere01768-17
JournalJournal of Clinical Microbiology
Volume56
Issue number8
DOIs
StatePublished - Aug 1 2018
Externally publishedYes

Fingerprint

Streptococcus agalactiae
Real-Time Polymerase Chain Reaction
Nucleic Acid Amplification Techniques
Confidence Intervals
Sensitivity and Specificity
Infant Mortality
Agar
Economics
Morbidity

Keywords

  • Aries
  • GBS
  • Group B Streptococcus
  • Luminex
  • Molecular methods
  • Streptococcus

ASJC Scopus subject areas

  • Microbiology (medical)

Cite this

Multicenter diagnostic accuracy evaluation of the luminex aries real-time PCR assay for group B streptococcus detection in LIM broth-enriched samples. / Hernandez, D. R.; Wolk, Donna; Walker, K. L.; Young, S.; Dunn, R.; Dunbar, S. A.; Rao, A.

In: Journal of Clinical Microbiology, Vol. 56, No. 8, e01768-17, 01.08.2018.

Research output: Contribution to journalArticle

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abstract = "The vertical transmission of group B Streptococcus (GBS) strains causing neonatal sepsis is one of the leading reasons for neonatal mortality worldwide. The gold standard for GBS detection is enriched culture with or without the aid of chromogenic agars. Given the high risk for morbidity and mortality in this population, high assay sensitivity is required to prevent the personal and economic costs of GBS disease. Nucleic acid amplification tests (NAATs) allow for objective determination of GBS colonization with a sensitivity and a specificity higher than those of traditional culture methods. In this study, we determined the analytical and clinical performance of the Aries GBS assay compared to those of the enrichment culture method, biochemical identification, and the NAATs used at the study sites. Remnant Lim broth samples were used to perform the Aries assay and reference testing. Upon first testing using enriched culture as the reference standard, the Aries GBS assay identified GBS with a 96.1{\%} sensitivity (95{\%} confidence interval [CI], 91.2 to 98.7{\%}) and a 91.4{\%} specificity (95{\%} CI, 88.8 to 93.6{\%}). The test performed with 100{\%} positive agreement (95{\%} CI, 83.2 to 100{\%}) compared to the results of the BD Max GBS assay and 98.0{\%} positive agreement (95{\%} CI, 89.2 to 99.9{\%}) compared to the results of the Cepheid Xpert GBS LB test. Repeatability and reproducibility were maintained in intra- and interlaboratory testing, regardless of the instrument, module, or user who performed the test. The Aries GBS assay can be set up in less than 5 min and produces results in 2 h. The easy setup, with minimal hands-on time, and high assay sensitivity and specificity make this a useful testing option for GBS screening in pre-partum women.",
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