Frias, MarioLopez-Lopez, PedroZafra, IsmaelCaballero-Gomez, JavierMachuca, IsabelCamacho, AngelaRisalde, Maria ARivero-Juarez, AntonioRivero, Antonio2023-02-092023-02-092020-10-22Frías 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):e02075-20http://hdl.handle.net/10668/16547The 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.enHEV RNART-PCRLimit of detectionPangenotypicPerformancePrimersProbeHepatitis EHepatitis E virusHumansPolymerase chain reactionRNA, viralSensitivity and specificityresearch article33148702open accessARN viralReacción en cadena de la polimerasaSensibilidad y especificidadVirus de la Hepatitis E10.1128/JCM.02075-201098-660XPMC8111163https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8111163https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8111163/pdf