000119736 001__ 119736 000119736 005__ 20240319081024.0 000119736 0247_ $$2doi$$a10.3390/diagnostics12092189 000119736 0248_ $$2sideral$$a129789 000119736 037__ $$aART-2022-129789 000119736 041__ $$aeng 000119736 100__ $$0(orcid)0000-0001-5750-3643$$aPeris, María Paz$$uUniversidad de Zaragoza 000119736 245__ $$aRetrospective 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 000119736 260__ $$c2022 000119736 5060_ $$aAccess copy available to the general public$$fUnrestricted 000119736 5203_ $$aStreptococcus 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® Streptococcus 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®) (Sacace qPCR assay). A total of 413 vaginal–rectal 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 °C 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 (0.92–0.99) and specificity 1 (0.98–1). 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. 000119736 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000119736 590__ $$a3.6$$b2022 000119736 592__ $$a0.67$$b2022 000119736 591__ $$aMEDICINE, GENERAL & INTERNAL$$b64 / 169 = 0.379$$c2022$$dQ2$$eT2 000119736 593__ $$aClinical Biochemistry$$c2022$$dQ2 000119736 594__ $$a3.6$$b2022 000119736 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000119736 700__ $$aMartín-Saco, Gloria 000119736 700__ $$0(orcid)0000-0003-2742-8827$$aAlonso-Ezcurra, Henar 000119736 700__ $$aEscolar-Miñana, Cristina$$uUniversidad de Zaragoza 000119736 700__ $$0(orcid)0000-0001-7294-245X$$aRezusta, Antonio$$uUniversidad de Zaragoza 000119736 700__ $$0(orcid)0000-0002-4917-8550$$aAcero, Raquel$$uUniversidad de Zaragoza 000119736 700__ $$aMilagro-Beamonte, Ana 000119736 7102_ $$12008$$2640$$aUniversidad de Zaragoza$$bDpto. Produc.Animal Cienc.Ali.$$cÁrea Nutrición Bromatología 000119736 7102_ $$11009$$2773$$aUniversidad de Zaragoza$$bDpto. Patología Animal$$cÁrea Sanidad Animal 000119736 7102_ $$11011$$2630$$aUniversidad de Zaragoza$$bDpto. Microb.Ped.Radio.Sal.Pú.$$cÁrea Microbiología 000119736 7102_ $$15002$$2515$$aUniversidad de Zaragoza$$bDpto. Ingeniería Diseño Fabri.$$cÁrea Ing. Procesos Fabricación 000119736 773__ $$g12, 9 (2022), 2189 [9 pp.]$$tDiagnostics$$x2075-4418 000119736 8564_ $$s281548$$uhttps://zaguan.unizar.es/record/119736/files/texto_completo.pdf$$yVersión publicada 000119736 8564_ $$s2760846$$uhttps://zaguan.unizar.es/record/119736/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000119736 909CO $$ooai:zaguan.unizar.es:119736$$particulos$$pdriver 000119736 951__ $$a2024-03-18-16:34:28 000119736 980__ $$aARTICLE