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Start Over Topic sensitivity and specificity Language english
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1. Performances of two rapid LAMP-based techniques for the intrapartum detection of Group B Streptococcus vaginal colonization.

Author

Charfi R, Guyonnet C, Untrau M, Giacometti G, Paper T, Poyart C, Plainvert C, and Tazi A

Subjects
Humans, Female, Pregnancy, Infant, Newborn, Adult, Nucleic Acid Amplification Techniques methods, Streptococcus agalactiae genetics, Streptococcus agalactiae isolation & purification, Streptococcal Infections diagnosis, Streptococcal Infections microbiology, Vagina microbiology, Pregnancy Complications, Infectious diagnosis, Pregnancy Complications, Infectious microbiology, Sensitivity and Specificity, Molecular Diagnostic Techniques methods
Abstract

Purpose: Group B Streptococcus (GBS) is the leading cause of invasive infections in newborns. The prevention of GBS neonatal disease relies on the administration of an intrapartum antibiotic prophylaxis to GBS-colonized women. In recent years, rapid intrapartum detection of GBS vaginal colonization using real-time nucleic acid amplification tests (NAATs) emerged as an alternative to antenatal culture screening methods., Methods: We compared the performances of two loop-mediated isothermal amplification (LAMP) tests, the Ampliflash® GBS and the PlusLife® GBS tests, to standard culture for GBS detection in vaginal specimens from pregnant women. The study was conducted from April to July 2023 in a French hospital of the Paris area., Results: A total of 303 samples were analyzed, including 85 culture-positive samples (28.1%). The Ampliflash® GBS test and the PlusLife® GBS tests gave a result for 100% and 96.3% tests, respectively. The performances of the tests were as follows: sensitivity 87.1% (95% confidence interval (CI) 78.3-92.6) and 98.7% (95% CI 93.0-99.8), specificity 99.1% (95% CI 96.7-99.8), and 91.9% (95% CI 87.3-95.0), respectively. False negative results of the Ampliflash® GBS test correlated with low-density GBS cultures. Time-to-results correlated with GBS culture density only for the PlusLife® GBS test (p < 0.001)., Conclusion: Both techniques provide excellent analytical performances with high sensitivity and specificity together with a short turnaround time and results available in 10 to 35 min. Their potential to further reduce the burden of GBS neonatal disease compared with antenatal culture screening needs to be assessed in future clinical studies., (© 2024. The Author(s).)

Published
2024
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2. Underestimation of Leptospirosis Incidence in the French West Indies

Author

Sylvie Cassadou, Martine Ledrans, Pascale Bourhy, Philippe Quénel, Martina Escher, Claude Flamand, Jacques Rosine, Mathieu Picardeau, Institut de Veille Sanitaire (INVS), Cellule de l'Institut de Veille Sanitaire en régions Antilles Guyane, Cellule Interrégionale d'Epidémiologie Antilles-Guyane, Cellule interrégionale d'épidémiologie Antilles-Guyane [CIRE], Unité d'Epidémiologie, Institut Pasteur de la Guyane, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP), Centre National de Référence de la Leptospirose-Centre Collaborateur FAO/OMS pour l'épidémiologie de la leptospirose-Biologie des Spirochètes, Institut Pasteur [Paris], Institut de recherche, santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CIRE Antilles-Guyane - Gourbeyre, Centre Collaborateur FAO/OMS pour l'épidémiologie de la leptospirose, Centre National de Référence de la Leptospirose - National Reference Center Leptospirosis (CNR), Biologie des Spirochètes / Biology of Spirochetes, CIRE Antilles-Guyane - Fort de France, The authors received specific funding only from the Institut de Veille Sanitaire, their institution. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Conceived and designed the experiments: SC JR CF ME ML PB MP PQ. Performed the experi- ments: SC JR ME PB. Analyzed the data: SC JR CF. Contributed reagents/materials/analysis tools: PB MP. Wrote the paper: SC JR CF ME ML PB MP PQ. Organized and strenghtened the partners network: PQ ML., Jean-Baptiste Adrien, Hélène Bazus, Sylvie Boa, Fabrice Boulard, André Cabié, Arnaud Duthilly, Emilie Gaubert-Maréchal, Stéphanie Guyomard, Cécile Herrmann, Patrick Hoche- dez, Isabelle Lamaury, Claude Olive, Marion Petit-Sinturel, Raphaelle Théodose, the public health nurses of the CVAGS, all the General Practitionners of the two sentinel networks in Guadeloupe and Martinique, the ambulatory labs, the hospital labs, the hospital medical staffs, the Pasteur Institute of Guadeloupe, the Pasteur Institute of Paris and Jude Sweeney for the revision of the English text., Institut Pasteur [Paris] (IP), and École des Hautes Études en Santé Publique [EHESP] (EHESP)

Subjects
0301 basic medicine, Male, [SDV]Life Sciences [q-bio], Antibodies, Protozoan, Disease, Polymerase Chain Reaction, Dengue fever, 0302 clinical medicine, Environmental protection, Epidemiology, Enzyme-linked immunoassays, Child, Guadeloupe, Aged, 80 and over, Disease surveillance, Incidence (epidemiology), Incidence, lcsh:Public aspects of medicine, Middle Aged, Leptospirosis, Hospitals, 3. Good health, [SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology, Infectious Diseases, Child, Preschool, Female, France, Martinique, Adult, medicine.medical_specialty, lcsh:Arctic medicine. Tropical medicine, Adolescent, lcsh:RC955-962, 030231 tropical medicine, 030106 microbiology, Enzyme-Linked Immunosorbent Assay, Sensitivity and Specificity, 03 medical and health sciences, Young Adult, Environmental health, Agglutination Tests, medicine, Humans, Aged, Demography, business.industry, Public Health, Environmental and Occupational Health, Infant, Newborn, Outbreak, Infant, Correction, lcsh:RA1-1270, DNA, Protozoan, medicine.disease, Public and occupational health, Immunoglobulin M, business
Abstract

BACKGROUND:Leptospirosis is a neglected zoonosis affecting mainly tropical and subtropical regions worldwide, particularly South America and the Caribbean. As in many other countries, under-reporting of cases was suspected in the French West Indies because of inadequate access to diagnostic tests for the general population. METHODOLOGY/PRINCIPAL FINDINGS:In order to estimate the real incidence of leptospirosis in Guadeloupe and Martinique, a study was performed in 2011 using the three prevailing available biological tests for diagnosis: Microscopic Agglutination Test (MAT), IgM ELISA and PCR. The study investigated inpatients and outpatients and used active case ascertainment from data provided by a general practitioners' sentinel network. The epidemiology of the disease was also described in terms of severity and demographic characteristics. Leptospirosis incidence was estimated at 69.4 (95%CI 47.6-91.1) and 60.6 (95%CI 36.3-85.0) annual cases per 100,000 inhabitants in Guadeloupe and Martinique, respectively, which was 3 and 4 times higher than previous estimations. CONCLUSION/SIGNIFICANCE:Inclusion of PCR and IgM ELISA tests for diagnosis of leptospirosis resulted in improved sensitivity in comparison with MAT alone. Our results highlighted the substantial health burden of the disease in these two territories and the importance of access to appropriate laboratory tests. Based on our results, PCR and IgM ELISA tests have now been included in the list of tests reimbursed by the national system of social security insurance in France. Our results also underline the relevance of implementing an integrated strategy for the surveillance, prevention and control of leptospirosis in the French West Indies.

Published
2016