Diagnostic Accuracy of Loop-Mediated Isothermal Amplification Assay for Group B Streptococcus Detection in Recto-Vaginal Swab: Comparison with Polymerase Chain Reaction Test and Conventional Culture

Abstract

A rapid method for obtaining group B streptococcus (GBS) screening results has been required in the obstetric field. We aimed to determine the diagnostic performance of the Loop-Mediated Isothermal Amplification (LAMP) assay is acceptable compared to the existing polymerase chain reaction (PCR) assay. The study involved 527 pregnant women aged 19 to 44 years. Rectovaginal swabs were collected between 35 and 37 weeks of gestation or prior to impending preterm births or term labor without GBS screening. We presented the diagnostic performance of the LAMP assay with a 95% confidence interval (CI) compared to the PCR and microbiological culture. In total, 115 (21.8%), 115 (21.8%) and 23 (4.4%) patients showed positive results using the LAMP, PCR assay and microbiological culture method, respectively. The LAMP assay showed 100% sensitivity (95% CI, 96.8–100.0), 100% specificity (95% CI, 99.1–100.0) and 100% diagnostic accuracy (95% CI, 99.3–100.0) with the reference being the PCR assay. Meanwhile, the LAMP assay showed 87.0% sensitivity (95% CI, 71.0–100.0), 81.2% specificity (95% CI, 77.6–84.7), and 81.4% diagnostic accuracy (95% CI, 78.0–84.8) with the microbiological culture as a reference. This study presented the LAMP assay as an acceptable method for GBS screening with a similar performance to the existing PCR method.