Development and characterization of secondary standards for nucleic acid amplification technology (NAAT) assays for detection of hepatitis E virus.

ABSTRACT:

Background

To harmonize assays for detection of HEV RNA, a World Health Organization International Standard (WHO IS) was established. The WHO IS represents the highest order standard for HEV RNA but is limited in quantity. Secondary standards are needed to limit the use of WHO IS and minimize the need to replace it.

Objective

Establish secondary standards for HEV NAAT assays and to calibrate these against the WHO IS.

Methods

Stocks of genotype 3 HEV were prepared using both cell lysates and cell culture supernatants to produce non-enveloped and quasi-enveloped virus stocks, respectively. Both stocks were heat-inactivated, diluted in negative human plasma, and lyophilized to produce two candidate secondary standards: HEV-RR (non-enveloped virus) and HEV-RR.1 (quasi-env

SUBMITTER: Fares-Gusmao R 

PROVIDER: S-EPMC9714074 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature