Abstract
Purpose
Streptococcus agalactiae remains a major pathogen in human health, especially in neonatal infection. Detection in pregnant women is essential to initiate intrapartum antibiotic prophylaxis. This study compared the HiberGene loop-mediated isothermal amplification (LAMP) assay to culture, the reference method, for the detection of group B Streptococcus (GBS) in pregnant women.
Methods
This was a prospective multicenter study conducted in four French hospitals. Three hundred fifty-four non-redundant routine care vaginal swabs were analyzed by both methods, LAMP assay and culture. Clinicians and patients were blinded to the results of the LAMP assay.
Results
Three hundred thirty-seven samples presented concordant results, 15 presented discordant results, and 2 were invalid using the LAMP assay (excluded from the study). Compared to culture, the LAMP assay had a sensitivity of 87.7%, a specificity of 98%, a negative predictive value of 97.6%, and a positive predictive value of 89.3%.
Conclusion
The HiberGene GBS LAMP assay is an easy test that possesses good performances compared with the reference method, culture. It could be used in case of emergency when a quick result is needed.
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Acknowledgements
We would like to thank the company AirDiag, which provided us with the kits and all reagents, along with the devices to carry out this comparison of methods.
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Philippe Lanotte and Asmaa Tazi contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Coralie Lemaire, Mélinda Cheminet, Claire Duployez, Mathilde Artus, Yassine Ballaa, Laura Devos, Asmaa Tazi, and Philippe Lanotte. The first draft of the manuscript was written by Coralie Lemaire, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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Lemaire, C., Cheminet, M., Duployez, C. et al. A LAMP-based assay for the molecular detection of group B Streptococcus.. Eur J Clin Microbiol Infect Dis 42, 1245–1250 (2023). https://doi.org/10.1007/s10096-023-04656-z
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DOI: https://doi.org/10.1007/s10096-023-04656-z