Evaluation of an automated platform for the detection of HEV RNA in plasma and stool

Pauline Sottil; Sébastien Lhomme; Karine Saune; Soheil El Hayani; Kévin Oliveira-Mendes; Jean-Marie Peron; Nassim Kamar; Jacques Izopet; Florence Abravanel

doi:10.1016/j.jviromet.2024.114920

Evaluation of an automated platform for the detection of HEV RNA in plasma and stool

J Virol Methods. 2024 Apr 3:327:114920. doi: 10.1016/j.jviromet.2024.114920. Online ahead of print.

Authors

Pauline Sottil¹, Sébastien Lhomme², Karine Saune², Soheil El Hayani¹, Kévin Oliveira-Mendes¹, Jean-Marie Peron³, Nassim Kamar⁴, Jacques Izopet², Florence Abravanel⁵

Affiliations

¹ CHU Toulouse, Hôpital Purpan, Laboratoire de Virologie, National Reference Center for Hepatitis E, Toulouse 31300, France.
² CHU Toulouse, Hôpital Purpan, Laboratoire de Virologie, National Reference Center for Hepatitis E, Toulouse 31300, France; Inserm UMR 1291 - CNRS UMR5051 - Université Toulouse III, Toulouse, France.
³ CHU Toulouse, Hôpital Purpan, Département de Gastroentérologie, 31300, France.
⁴ CHU Toulouse, Hôpital Rangueil, Département de Néphrologie, Dialyse et Transplantation multi-organe, 31300, France.
⁵ CHU Toulouse, Hôpital Purpan, Laboratoire de Virologie, National Reference Center for Hepatitis E, Toulouse 31300, France; Inserm UMR 1291 - CNRS UMR5051 - Université Toulouse III, Toulouse, France. Electronic address: abravanel.f@chu-toulouse.fr.

PMID: 38574772
DOI: 10.1016/j.jviromet.2024.114920

Abstract

Introduction: We evaluated the performance of the automated Altostar HEV RNA platform for detecting HEV RNA.

Methods and results: Clinical performance was determined by testing 81 plasma samples and 10 fecal samples manually quantified previously with the Realstar RT-PCR assay using the Magnapure instrument for extraction. The assays were concordant for 79/81 plasma samples (97.5%) and 10/10 (100%) fecal samples. The two plasma samples that tested negative with the Altostar assay had a very low HEV RNA concentration (1.6 and 1.4 log₁₀ IU/ml). Quantitative results obtained with the automated platform and the manual workflow were highly correlated (ρ= 0.98, p<0.01). The intra-run and inter-run standard deviation were 0.09 IU/ml and 0.13 IU/ml respectively. The assay was linear from 2 to 6 log IU/ml. The limit of detection determined by Probit analysis with the WHO HEV RNA standard was 7.6 [95% CI: 4.4-52.5] IU/ml.

Conclusions: The Altostar platform enables highly accurate testing for the detection of HEV RNA in stool and the quantification of HEV RNA in plasma. This allowed us to shorten turnaround times and to save time for the technical staff.

Keywords: Altostar; HEV; Plasma; Stool.