{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T00:35:46Z","timestamp":1759970146756,"version":"build-2065373602"},"reference-count":38,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2025,1,15]],"date-time":"2025-01-15T00:00:00Z","timestamp":1736899200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Bill &amp; Melinda Gates Foundation","award":["INV-007007"],"award-info":[{"award-number":["INV-007007"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background\/Objectives: Conventional live oral poliovirus vaccines (OPVs) effectively prevent poliomyelitis. These vaccines are derived from three attenuated Sabin strains of poliovirus, which can revert within the first week of replication to a neurovirulent phenotype, leading to sporadic cases of vaccine-associated paralytic poliomyelitis (VAPP) among vaccinees and their contacts. A novel OPV2 vaccine (nOPV2) with enhanced genetic stability was developed recently; type 1 and type 3 nOPV strains were engineered using the nOPV2 genome as a backbone by replacing the capsid precursor polyprotein (P1) with that of Sabin strains type 1 and type 3, respectively. The nOPV vaccines have a high degree of sequence homology with the parental Sabin 2 genome, and some manufacturing facilities produce and store both Sabin OPV and nOPV. Therefore, detecting Sabin virus contaminations in nOPV lots is crucial. Methods: This study describes the development of pan quantitative reverse transcription polymerase chain reaction (panRT-PCR) and multiplex one-step RT-PCR (mosRT-PCR) assays for the straightforward detection and identification of contaminating Sabin viruses when present in significantly higher amounts of nOPV strains. Results: The two assays exhibit high specificity, reproducibility, and sensitivity to detect 0.0001% and 0.00001% of Sabin viruses in nOPV, respectively. Additionally, an analysis of 12 trivalent nOPV formulation lots using both methods confirmed that the nOPV lots were free from Sabin virus contamination. Conclusions: The results demonstrated that the RT-PCR assays are sensitive and specific. These assays are relevant for quality control and lot release of nOPV vaccines.<\/jats:p>","DOI":"10.3390\/vaccines13010075","type":"journal-article","created":{"date-parts":[[2025,1,15]],"date-time":"2025-01-15T10:00:01Z","timestamp":1736935201000},"page":"75","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development of RT-PCR Assays for Simple Detection and Identification of Sabin Virus Contaminants in the Novel Oral Poliovirus Vaccines"],"prefix":"10.3390","volume":"13","author":[{"given":"Olga","family":"Singh","sequence":"first","affiliation":[{"name":"Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hasmik","family":"Manukyan","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erman","family":"Tritama","sequence":"additional","affiliation":[{"name":"Research and Development Division, PT. BioFarma, Bandung, West Java 40161, Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0819-0569","authenticated-orcid":false,"given":"Shwu-Maan","family":"Lee","sequence":"additional","affiliation":[{"name":"Center for Vaccine Innovation and Access, PATH, Seattle, WA 98121, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerry P.","family":"Weir","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0110-5504","authenticated-orcid":false,"given":"Majid","family":"Laassri","sequence":"additional","affiliation":[{"name":"Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,1,15]]},"reference":[{"key":"ref_1","unstructured":"Plotkin, S.A.O.W., and Offit, P.A. 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