RT Journal Article T1 Development and Clinical Validation of a Pangenotypic PCR-Based Assay for the Detection and Quantification of Hepatitis E Virus (Orthohepevirus A Genus). A1 Frias, Mario A1 Lopez-Lopez, Pedro A1 Zafra, Ismael A1 Caballero-Gomez, Javier A1 Machuca, Isabel A1 Camacho, Angela A1 Risalde, Maria A A1 Rivero-Juarez, Antonio A1 Rivero, Antonio K1 HEV RNA K1 RT-PCR K1 Limit of detection K1 Pangenotypic K1 Performance K1 Primers K1 Probe AB The objective of this study was to design a pangenotypic PCR-based assay for the detection and quantification of hepatitis E virus (HEV) RNA from across the entire spectrum of described genotypes belonging to the Orthohepevirus A genus. The optimal conditions and the performance of the assay were determined by testing the WHO standard strain (6219/10) and the WHO HEV panel (8578/13). Similarly, performance comparisons were made with two commercial assays (Real Star HEV RT-PCR 2.0 and ampliCube HEV 2.0 Quant) to detect HEV RNA at concentrations below 1,000 IU/ml with viral strains from the WHO and to test samples from 54 patients with acute hepatitis. The assay presented in this study was able to detect the entire spectrum of described genotypes belonging to the Orthohepevirus A genus, demonstrating better performance than both commercial kits. This procedure may represent a significant improvement in the molecular diagnosis of HEV infection. PB American Society for Microbiology YR 2020 FD 2020-10-22 LK http://hdl.handle.net/10668/16547 UL http://hdl.handle.net/10668/16547 LA en NO Frías M, López-López P, Zafra I, Caballero-Gómez J, Machuca I, Camacho Á, et al. Development and Clinical Validation of a Pangenotypic PCR-Based Assay for the Detection and Quantification of Hepatitis E Virus (Orthohepevirus A Genus). J Clin Microbiol. 2021 Jan 21;59(2):e02075-20 NO This study was supported by the Fundación Progreso y Salud, Consejería de Saludde la Junta de Andalucía (PIN-0477/2017 and PI0187/2013); the Fundación para laInvestigación en Salud (FIS) del Instituto Carlos III (PI15/01017); and the Red deInvestigación en SIDA de España ISCIII-RETIC (RD16/0025/0034). A.R.-J. and M.F. arerecipients of postdoctoral perfection grants from the Spanish Ministry of Science,Innovation and Universities of Spain (CD18/00111 and CD18/00091, respectively).J.C.-G. is supported by a grant from the Spanish Ministry of Education, Culture andSport (FPU17/01319) DS RISalud RD Apr 9, 2025