Multicenter Diagnostic Accuracy Evaluation of the Luminex Aries Real-Time PCR Assay for Group B Streptococcus Detection in Lim Broth-Enriched Samples

Journal of Clinical Microbiology
D R HernandezArundhati Rao

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...Continue Reading

References

Sep 1, 1996·Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine·N M Buderer
Dec 1, 2007·Proteomics. Clinical Applications·Federico GoodsaidHarald Mischak
Sep 25, 2014·Diagnostic Microbiology and Infectious Disease·Caroline JoubrelHélène Réglier-Poupet
Oct 10, 2015·Pathogens and Disease·Javier Rodriguez-GrangerManuel Rosa-Fraile
Apr 8, 2016·Journal of Clinical Microbiology·Suzane SilbertRaymond Widen

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Citations

Sep 8, 2021·Annals of Clinical Microbiology and Antimicrobials·Meng-Yi HanXu-Guang Guo

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Methods Mentioned

BETA
PCR
nucleic acid extraction
reverse transcription-PCR
electrophoresis

Software Mentioned

Aries
BLAST
SYNCT UDP
Windows
Sequencing Analysis
3730xl Data Collection
SAS

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