Evidence map›Paper›PMID 36395548›Full record

ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2022

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

Rafaelle Fares-Gusmao, Zhen Jiang, Sakthivel Subramaniam, Bryan J Visser, Alysia Scott, Yuji Ishida, Takeshi Saito, Sally A Baylis, David R McGivern, HEV Standard Calibration Study Group

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 44% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 4 countries.

Rafaelle Fares-GusmaoCenter for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Zhen JiangCenter for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Sakthivel SubramaniamCenter for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Bryan J VisserCenter for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Alysia ScottCenter for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Yuji IshidaDepartment of Medicine, Division of Gastrointestinal and Liver Diseases, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.; Research and Development Department, PhoenixBio, Co., Ltd, Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan.
Takeshi SaitoDepartment of Medicine, Division of Gastrointestinal and Liver Diseases, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.; Department of Molecular Microbiology and Immunology, University of Southern California, Keck School of Medicine, Los Angeles, California, USA.
Sally A BaylisViral Safety Section, Paul-Ehrlich-Institut, Langen, Germany.
David R McGivernCenter for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.. Electronic address: David.McGivern@fda.hhs.gov.
HEV Standard Calibration Study Group
Center for Biologics Evaluation and Research · USIstituto Superiore di Sanità · ITPaul Ehrlich Institut · DEUniversity of Southern California · USHiroshima University · JP

Funding

Innate Defense Program against HCVR01DK101773 · NIDDK · UNIVERSITY OF SOUTHERN CALIFORNIA · PI SAITO, TAKESHI · 2015 to 2019
$1.9M
Impact of Occult Hepatitis C Virus Infection in Progression of Liver DiseasesR21AI139954 · NIAID · UNIVERSITY OF SOUTHERN CALIFORNIA · PI SAITO, TAKESHI · 2018 to 2019
$454k
NIAID NIH HHS R21 AI139954NIDDK NIH HHS R01 DK101773
6 · The paper itself

Abstract

backgroundTo 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.

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

methodsStocks 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-enveloped virus). Both candidate standards were characterized and calibrated against the WHO IS for HEV RNA in an international collaborative study.

resultsThe collaborative study returned a total of 15 data sets, with different RNA extraction and amplification methods. The estimated mean values relative to the WHO IS (250,000 IU/ml) are 229,000 IU/ml and 355,000 IU/ml for HEV-RR and HEV-RR.1, respectively.

conclusionWe have established two secondary standards for HEV RNA calibrated against the WHO IS. These standards are non-infectious and stable under different storage temperatures.

Indexed as

Hepatitis E virusHumansInternational CooperationReference StandardsRNA, ViralTechnologyRNA, ViralBiological standardsHepatitis E virusMolecular testingNucleic acid testsSecondary standardsStandardization

Identifiers

PMID36395548
PMCPMC9714074
OpenAlexW4308388278

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.