دورية أكاديمية
أعرض في EDS

High throughput AS LNA qPCR method for the detection of a specific mutation in poliovirus vaccine strains.

التفاصيل البيبلوغرافية
العنوان: High throughput AS LNA qPCR method for the detection of a specific mutation in poliovirus vaccine strains.
المؤلفون: Opmeer L; Batavia Biosciences B.V., Bioscience Park Leiden, Zernikedreef 16, 2333CL Leiden, The Netherlands., Gazzoli I; Batavia Biosciences B.V., Bioscience Park Leiden, Zernikedreef 16, 2333CL Leiden, The Netherlands., Ballmann M; Batavia Biosciences B.V., Bioscience Park Leiden, Zernikedreef 16, 2333CL Leiden, The Netherlands., Willemsen M; Batavia Biosciences B.V., Bioscience Park Leiden, Zernikedreef 16, 2333CL Leiden, The Netherlands., Voshol GP; GenomeScan B.V., Plesmanlaan 1d, 2333 BZ Leiden, The Netherlands., Grudniewska-Lawton M; GenomeScan B.V., Plesmanlaan 1d, 2333 BZ Leiden, The Netherlands., Havenga M; Batavia Biosciences B.V., Bioscience Park Leiden, Zernikedreef 16, 2333CL Leiden, The Netherlands., Yallop C; Batavia Biosciences B.V., Bioscience Park Leiden, Zernikedreef 16, 2333CL Leiden, The Netherlands., Hamidi A; Batavia Biosciences B.V., Bioscience Park Leiden, Zernikedreef 16, 2333CL Leiden, The Netherlands., Gillissen G; Batavia Biosciences B.V., Bioscience Park Leiden, Zernikedreef 16, 2333CL Leiden, The Netherlands., Bakker WAM; Batavia Biosciences B.V., Bioscience Park Leiden, Zernikedreef 16, 2333CL Leiden, The Netherlands. Electronic address: w.bakker@bataviabiosciences.com.
المصدر: Vaccine [Vaccine] 2024 Apr 02; Vol. 42 (9), pp. 2475-2484. Date of Electronic Publication: 2024 Mar 19.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Country of Publication: Netherlands NLM ID: 8406899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-2518 (Electronic) Linking ISSN: 0264410X NLM ISO Abbreviation: Vaccine Subsets: MEDLINE
أسماء مطبوعة: Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
مواضيع طبية MeSH: Poliomyelitis*/prevention & control , Poliovirus*/genetics , Oligonucleotides*, Humans ; Poliovirus Vaccine, Oral/genetics ; Poliovirus Vaccine, Inactivated ; Mutation ; Quality Control
مستخلص: Sabin Inactivated Poliovirus Vaccine (sIPV) has become one of the preferred vaccination options for the last step in the Poliovirus eradication program. Sequencing of poliovirus samples is needed during the manufacturing of poliovirus vaccines to assure the safety and immunogenicity of these vaccines. Next-generation sequencing analysis is the current costly and time-consuming gold standard for monitoring the manufacturing processes. We developed a low-cost and quick, highly sensitive, and allele-specific locked nucleic acid-probe-based reverse transcription quantitative PCR alternative that can accurately detect mutations in poliovirus vaccine samples during process development, scaling up, and release. Using the frequently in vitro occurring and viral replication-impacting VP1-E 295 K mutation as a showcase, we show that this technology can accurately detect E 295 K mutations in poliovirus 2 samples to similar levels as NGS. The qPCR technology was developed employing a synthetic dsDNA fragment-based standard curve containing mixes of E 295 K-WT (wildtype) and Mut (mutant) synthetic dsDNA fragments ranging from 1 × 10 7 copies/µL to 1 × 10 2 copies/µL to achieve a linear correlation with R 2  > 0.999, and PCR efficiencies of 95-105 %. Individual standard concentration levels achieved accuracies of ≥92 % (average 96 %) and precisions of ≤17 % (average 3.3 %) RSD. Specificity of locked nucleic acid (LNA)-probes was confirmed in the presence and absence of co-mutations in the probe-binding region. Application of the developed assay to Sabin Poliovirus type 2 production run samples, illustrated a linear relationship with an R 2 of 0.994, and an average accuracy of 97.2 % of the variant (allele)-specific AS LNA qPCR result, compared to NGS. The assay showed good sensitivity for poliovirus samples, containing E 295 K mutation levels between 0 % and 95 % (quantification range). In conclusion, the developed AS LNA qPCR presents a valuable low-cost, and fast tool, suitable for the process development and quality control of polio vaccines.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
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فهرسة مساهمة: Keywords: AS LNA qPCR; Mutations; NGS; Quality control; Sabin Poliovirus 2; VP1-E295K; Vaccine; qPCR; sIPV
المشرفين على المادة: 0 (Poliovirus Vaccine, Oral)
0 (locked nucleic acid)
0 (Poliovirus Vaccine, Inactivated)
0 (Oligonucleotides)
تواريخ الأحداث: Date Created: 20240319 Date Completed: 20240408 Latest Revision: 20240425
رمز التحديث: 20240425
مُعرف محوري في PubMed: PMC11007389
DOI: 10.1016/j.vaccine.2024.01.103
PMID: 38503660
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-2518
DOI:10.1016/j.vaccine.2024.01.103