{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T01:14:55Z","timestamp":1772500495094,"version":"3.50.1"},"reference-count":32,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2022,9,9]],"date-time":"2022-09-09T00:00:00Z","timestamp":1662681600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Streptococcus agalactiae is a leading cause of sepsis and meningitis in newborns and young infants. Screening programs and intrapartum antibiotic prophylaxis have reduced early neonatal onset of disease. The aim of this study was to evaluate a molecular assay with lyophilized and ready-to-use reagents: VIASURE\u00ae\u00a0Streptococcus B Real Time PCR detection kit (CerTest Biotec) (Viasure qPCR assay) compared to both the GBS culture and a molecular assay with separated and frozen reagents: Strep B Real-TM Quant (Sacace Biotecnologies\u00ae) (Sacace qPCR assay). A total of 413 vaginal\u2013rectal swabs from women between the 35th and 37th weeks of pregnancy were processed. GBS culture was firstly achieved through Granada medium and Columbia CNA agar at 35 \u00b0C in aerobic conditions. Then, nucleic acid extraction was performed for subsequent molecular analysis using both commercial assays. Discordant results were resolved via bidirectional Sanger sequencing. Viasure qPCR assay clinical sensitivity was 0.97 (0.92\u20130.99) and specificity 1 (0.98\u20131). This retrospective study demonstrated the good clinical parameters and the strong overall agreement (99.3%) between the Viasure qPCR assay and both reference assays. Finally, the added value observed of the assay under study was the stabilized and ready-to-use format, reducing the number of time-consuming steps, permitting the storage at room temperature, facilitating transport, being environmentally respectful, and reducing additional costs.<\/jats:p>","DOI":"10.3390\/diagnostics12092189","type":"journal-article","created":{"date-parts":[[2022,9,9]],"date-time":"2022-09-09T04:54:41Z","timestamp":1662699281000},"page":"2189","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Retrospective Study for the Clinical Evaluation of a Real-Time PCR Assay with Lyophilized and Ready-to-Use Reagents for Streptococcus agalactiae Detection in Prenatal Screening Specimens"],"prefix":"10.3390","volume":"12","author":[{"given":"Mar\u00eda Paz","family":"Peris","sequence":"first","affiliation":[{"name":"Health Research Institute Arag\u00f3n, 50009 Zaragoza, Spain"},{"name":"Department of Animal Pathology, Faculty of Veterinary, University of Zaragoza, 50009 Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gloria","family":"Mart\u00edn-Saco","sequence":"additional","affiliation":[{"name":"Health Research Institute Arag\u00f3n, 50009 Zaragoza, Spain"},{"name":"Miguel Servet University Hospital, Microbiology, 50009 Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Henar","family":"Alonso-Ezcurra","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Paediatrics, Radiology, and Public Health, Faculty of Medicine, University of Zaragoza, 50009 Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Escolar-Mi\u00f1ana","sequence":"additional","affiliation":[{"name":"Department of Animal Production and Food Science, Faculty of Veterinary, University of Zaragoza, 50009 Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"Rezusta","sequence":"additional","affiliation":[{"name":"Health Research Institute Arag\u00f3n, 50009 Zaragoza, Spain"},{"name":"Miguel Servet University Hospital, Microbiology, 50009 Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4917-8550","authenticated-orcid":false,"given":"Raquel","family":"Acero","sequence":"additional","affiliation":[{"name":"Department of Design and Manufacturing Engineering, School of Engineering and Architecture, University of Zaragoza, 50009 Zaragoza, Spain"},{"name":"Instituto de Investigaci\u00f3n en Ingenier\u00eda de Arag\u00f3n (I3A), University of Zaragoza, 50009 Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Milagro-Beamonte","sequence":"additional","affiliation":[{"name":"Health Research Institute Arag\u00f3n, 50009 Zaragoza, Spain"},{"name":"Miguel Servet University Hospital, Microbiology, 50009 Zaragoza, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2022,9,9]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"160","DOI":"10.1093\/cid\/cix656","article-title":"Infant GBS Disease Investigator Group. 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