Multicenter Performance Evaluation of the Revogene
Journal
Molecular diagnosis & therapy
ISSN: 1179-2000
Titre abrégé: Mol Diagn Ther
Pays: New Zealand
ID NLM: 101264260
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
accepted:
28
05
2023
medline:
18
8
2023
pubmed:
20
7
2023
entrez:
20
7
2023
Statut:
ppublish
Résumé
This study aimed to evaluate the performance and ease of use of the Revogene Between April and August 2019, 398 women who gave birth in one of the three maternities participating in this study agreed to the collection of a vaginal swab when they arrived in the labor ward. The samples were immediately sent to the adjacent laboratory where they were discharged into the buffer provided with the Revogene The Revogene The easy-to-use Revogene
Identifiants
pubmed: 37470972
doi: 10.1007/s40291-023-00660-3
pii: 10.1007/s40291-023-00660-3
doi:
Types de publication
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
611-620Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Références
Verani JR, McGee L, Schrag SJ, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC) (2010) Prevention of perinatal group B streptococcal disease—revised guidelines from CDC, 2010. MMWR Recomm Rep 59 (RR-10):1–36.
Melin P. Neonatal group B streptococcal disease: from pathogenesis to preventive strategies. Clin Microbiol Infect. 2011;17:1294–303. https://doi.org/10.1111/j.1469-0691.2011.03576.x .
doi: 10.1111/j.1469-0691.2011.03576.x
pubmed: 21672083
Madrid L, Seale AC, Kohli-Lynch M, et al. Infant GBS disease investigator group infant group B streptococcal disease incidence and serotypes worldwide: systematic review and meta-analyses. Clin Infect Dis. 2017;65:160–72. https://doi.org/10.1093/cid/cix656 .
doi: 10.1093/cid/cix656
Lopez Sastre JB, Fernandez Colomer B, Coto Cotallo GD, et al. Trends in the epidemiology of neonatal sepsis of vertical transmission in the era of group B streptococcal prevention. Acta Paediatr. 2005;94:451–7. https://doi.org/10.1111/j.1651-2227.2005.tb01917.x .
doi: 10.1111/j.1651-2227.2005.tb01917.x
pubmed: 16092460
Barcaite E, Bartusevicius A, Tameliene R, Kliucinskas M, Maleckiene L, Nadisauskiene R. Prevalence of maternal group B streptococcal colonisation in European countries. Acta Obstet Gynecol Scand. 2008;87(3):260–71. https://doi.org/10.1080/00016340801908759 .
doi: 10.1080/00016340801908759
pubmed: 18307064
Hansen SM, Uldbjerg N, Killian M, Sørensen UBS. Dynamics of Streptococcus agalactiae colonization in women during and after pregnancy and in their infants. J Clin Microbiol. 2004;42:83–9. https://doi.org/10.1128/JCM.42.1.83-89.2004 .
doi: 10.1128/JCM.42.1.83-89.2004
pubmed: 14715736
pmcid: 321715
Raabe VN, Shane AL. Group B Streptococcus (Streptococcus agalactiae). Microbiol Spectr. 2019. https://doi.org/10.1128/microbiolspec.GPP3-0007-2018 .
doi: 10.1128/microbiolspec.GPP3-0007-2018
pubmed: 30900541
Skoff TH, Farley MM, Petit S, et al. Increasing burden of invasive group B streptococcal disease in non pregnant adults, 1990–2007. CID. 2009;49:85–92. https://doi.org/10.1086/599369 .
doi: 10.1086/599369
Ferrieri P, Cleary PP, Seeds AE. Epidemiology of group B streptococcal carriage in pregnant women and newborns infants. J Med Microbiol. 1977;10:103–14. https://doi.org/10.1099/00222615-10-1-103 .
doi: 10.1099/00222615-10-1-103
pubmed: 320335
Ancona RJ, Ferrieri P, Williams PP. Maternal factors that enhance the acquisition of group B streptocci by newborn infants. J Med Microbiol. 1980;13:273–80. https://doi.org/10.1099/00222615-13-2-273 .
doi: 10.1099/00222615-13-2-273
pubmed: 6991698
Schrag SJ, Zywicki S, Farley MM, et al. Group B streptococcal disease in the era of intrapartum antibiotic prophylaxis. N Engl J Med. 2000;342:15–20. https://doi.org/10.1056/NEJM200001063420103 .
doi: 10.1056/NEJM200001063420103
pubmed: 10620644
Nanduri SA, Petit S, Smelser C, et al. Epidemiology of invasive early-onset and late-onset group B streptococcal disease in the United States, 2006 to 2015: multistate laboratory and population-based surveillance. JAMA Pediatr. 2019;173:224–33. https://doi.org/10.1001/jamapediatrics.2018.4826 .
doi: 10.1001/jamapediatrics.2018.4826
pubmed: 30640366
pmcid: 6439883
Puopolo KM, Madoff LC, Eichenwald EC. Early-onset group B streptococcal disease in the era of maternal screening. Pediatrics. 2005;115:1240–6. https://doi.org/10.1542/peds.2004-2275 .
doi: 10.1542/peds.2004-2275
pubmed: 15867030
Poyart C, Réglier-Poupet H, Tazi A, et al. Invasive Group B Streptococcal Infections in Infants France. Emerg Infect Dis. 2008;14(10):1647–9. https://doi.org/10.3201/eid1410.080185 .
doi: 10.3201/eid1410.080185
pubmed: 18826837
pmcid: 2609873
Creti R, Imperi M, Berardi A, et al. Neonatal group B streptococcus infections: prevention strategies, clinical and microbiologic characteristics in 7 years of surveillance. Pediatr Infect Dis J. 2017;36(3):256–62. https://doi.org/10.1097/INF.0000000000001414 .
doi: 10.1097/INF.0000000000001414
pubmed: 27870810
Boyer KM, Gotoff SP. Prevention of early-onset neonatal disease with selective intrapartum chemoprophylaxis. N Engl J Med. 1986;314:1665–9. https://doi.org/10.1056/NEJM198606263142603 .
doi: 10.1056/NEJM198606263142603
pubmed: 3520319
Homer CS, Scarf V, Catling C, Davis D. Culture-based versus risk-based screening for the prevention of group B streptococcal disease in newborns: a review of national guidelines. Women Birth. 2014;27(1):46–51. https://doi.org/10.1016/j.wombi.2013.09.006 .
doi: 10.1016/j.wombi.2013.09.006
pubmed: 24239269
Belgian Superior Health Council (2003) Prevention of perinatal group B Streptococcal infections, guidelines from the Belgian Health Council, 2003 (SHC 7721). https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/4448391/Prevention%20of%20perinatal%20group%20B%20streptococcal%20infections%20%28April%202003%29%20%28SHC%207721%29.pdf . Accessed 11 October 2022.
Schrag SJ, Zell ER, Lynfield R, et al. Active Bacterial Core Surveillance Team. A population-based comparison of strategies to prevent early-onset group B streptococcal disease in neonates. N Engl J Med. 2002;347(4):233–9. https://doi.org/10.1056/NEJMoa020205 .
doi: 10.1056/NEJMoa020205
pubmed: 12140298
Benitz WE, Gould JB, Druzin ML. Risk factors for early onset group B streptococcal sepsis: estimation of odds ratios by critical literature review. Pediatrics. 1999;103: e77. https://doi.org/10.1542/peds.103.6.e77 .
doi: 10.1542/peds.103.6.e77
pubmed: 10353974
Darlow BA, Voss L, Lennon DR, Grimwood K. Early-onset neonatal group B streptococcus sepsis following national risk-based prevention guidelines. Aust N Z J Obstet Gynaecol. 2016;56(1):69–74. https://doi.org/10.1111/ajo.12378 .
doi: 10.1111/ajo.12378
pubmed: 26172580
Ko DW, Zurynski Y, Gilbert GL. Group B streptococcal disease and genotypes in Australian infants. J Paediatr Child Health. 2015;51:808–14. https://doi.org/10.1111/jpc.12830 .
doi: 10.1111/jpc.12830
pubmed: 25656648
Di Renzo GC, Melin P, Berardi A, et al. Intrapartum GBS screening and antibiotic prophylaxis: a European consensus conference. J Matern Fetal Neonatal Med. 2015;28(7):766–82. https://doi.org/10.3109/14767058.2014.934804 .
doi: 10.3109/14767058.2014.934804
pubmed: 25162923
Meex C, Devey A, Defêche J, et al. Evaluation of the Revogene
doi: 10.1016/j.diagmicrobio.2021.115616
pubmed: 34974352
Plainvert C, El Alaoui F, Tazi A, et al. Intrapartum group B Streptococcus screening in the labor ward by Xpert® GBS real-time PCR. Eur J Clin Microbiol Infect Dis. 2018;37(2):265–70. https://doi.org/10.1007/s10096-017-3125-2 .
doi: 10.1007/s10096-017-3125-2
pubmed: 29082442
Ke D, Ménard C, Picard FJ, et al. Development of conventional and real-time PCR assays for the rapid detection of group B streptococci. Clin Chem. 2000;46:324–31. https://doi.org/10.1093/clinchem/46.3.324 .
doi: 10.1093/clinchem/46.3.324
pubmed: 10702518
Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998;17:857–72. https://doi.org/10.1002/(sici)1097-0258(19980430)17:8%3c857::aid-sim777%3e3.0.co;2-e .
doi: 10.1002/(sici)1097-0258(19980430)17:8<857::aid-sim777>3.0.co;2-e
pubmed: 9595616
Wilson EB. Probable inference, the Law of succession, and statistical inference. J Am Stat Assoc. 1927;22:209–12. https://doi.org/10.1080/01621459.1927.10502953 .
doi: 10.1080/01621459.1927.10502953
El Helali N, Nguyen JC, Ly A, Giovangrandi Y, Trinquart L. Diagnostic accuracy of a rapid real-time polymerase chain reaction assay for universal intrapartum group B streptococcus screening. Clin Infect Dis. 2009;49(3):417–23. https://doi.org/10.1086/600303 .
doi: 10.1086/600303
pubmed: 19580414
Mueller M, Henle A, Droz S, et al. Intrapartum detection of Group B streptococci colonization by rapid PCR-test on labor ward. Eur J Obstet Gynecol Reprod Biol. 2014;176:137–41. https://doi.org/10.1016/j.ejogrb.2014.02.039 .
doi: 10.1016/j.ejogrb.2014.02.039
pubmed: 24680393
Al-Soud WA, Rådström P. Purification and characterization of PCR-inhibitory components in blood cells. J Clin Microbiol. 2001;39(2):485–93. https://doi.org/10.1128/JCM.39.2.485-493.2001 .
doi: 10.1128/JCM.39.2.485-493.2001
pubmed: 11158094
pmcid: 87763
Sidstedt M, Hedman J, Romsos EL, et al. Inhibition mechanisms of hemoglobin, immunoglobulin G, and whole blood in digital and real-time PCR. Anal Bioanal Chem. 2018;410(10):2569–83. https://doi.org/10.1007/s00216-018-0931-z .
doi: 10.1007/s00216-018-0931-z
pubmed: 29504082
pmcid: 5857286
Valkenburg-van den Berg AW, Houtman-Roelofsen RL, Oostvogel PM, et al. Timing of group B streptococcus screening in pregnancy: a systematic review. Gynecol Obstet Invest. 2010;69:174–83. https://doi.org/10.1159/000265942 .
doi: 10.1159/000265942
pubmed: 20016190
Towers CV, Rumney PJ, Asrat T, et al. The accuracy of late third-trimester antenatal screening for group B streptococcus in predicting colonization at delivery. Am J Perinatol. 2010;27:785–90. https://doi.org/10.1055/s-0030-1254237 .
doi: 10.1055/s-0030-1254237
pubmed: 20458663
Haberland CA, Benitz WE, Sanders GD, et al. Perinatal screening for group B streptococci: cost-benefit analysis of rapid polymerase chain reaction. Pediatrics. 2002;110:471–80. https://doi.org/10.1542/peds.110.3.471 .
doi: 10.1542/peds.110.3.471
pubmed: 12205247
El Helali N, Giovangrandi Y, Guyot K, et al. Cost and effectiveness of intrapartum group B streptococcus polymerase chain reaction screening for term deliveries. Obstet Gynecol. 2012;119(4):822–9. https://doi.org/10.1097/AOG.0b013e31824b1461 .
doi: 10.1097/AOG.0b013e31824b1461
pubmed: 22433346
El Helali N, Habibi F, Azria E, et al. Point-of-care intrapartum group b streptococcus molecular screening: effectiveness and costs. Obstet Gynecol. 2019;133(2):276–81. https://doi.org/10.1097/AOG.0000000000003057 .
doi: 10.1097/AOG.0000000000003057
pubmed: 30633130