Evidence map›Paper›PMID 26141063›Full record

ArticleVirology journal2015

Standardization of the methods and reference materials used to assess virus content in varicella vaccines.

JiYoung Hong, Ho Jung Oh, Naery Lee, Do-Keun Kim, Heui-Seong Yoon, Yeon-Tae Kim, Seokkee Chang, Jae-Hak Park, Hyejoo Chung

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in Virology journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 33% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

9 authors at 2 institutions in 3 countries.

JiYoung HongVaccines division, National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, 363-700, Republic of Korea. eca_dee@hanmail.net.
Ho Jung OhVaccines division, National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, 363-700, Republic of Korea. ohojung@korea.kr.
Naery LeeVaccines division, National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, 363-700, Republic of Korea. cosmos0925@korea.kr.
Do-Keun KimVaccines division, National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, 363-700, Republic of Korea. dickykim@korea.kr.
Heui-Seong YoonVaccines division, National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, 363-700, Republic of Korea. h3035@korea.kr.
Yeon-Tae KimVaccines division, National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, 363-700, Republic of Korea. potpol1770@naver.com.
Seokkee ChangVaccines division, National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, 363-700, Republic of Korea. skchang@korea.kr.
Jae-Hak ParkDepartment of Laboratory Animal Medicine, College of Veterinary Medicine, Seoul National University, Seoul, 151-742, Republic of Korea. pjhak@snu.ac.kr.
Hyejoo ChungVaccines division, National Institute of Food & Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju-si, 363-700, Republic of Korea. hjchung58@korea.kr.
Ministry of Food and Drug Safety · KRNational University College · PR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Korea, every vaccine lot is tested by the National Center for Lot Release (NCLR) in accordance with the national lot release procedures to ensure the safety and efficacy of vaccines. These quality tests examine the virus content in varicella vaccines via plaque assays (either the agar overlay method [AOM] or plaque staining method [PSM]), according to the procedures suggested by the Korean Reference Material for the Varicella Vaccine (KRMVV) or the manufacturer's standard in-house protocol.

aimTo standardize the virus content tests, viral titers in the KRMVV were measured using the PSM at four participating laboratories in a collaborative study. With the aim of developing a standardized method using the KRMVV as a positive control, we compared the ability of the two test methods, AOM and PSM, to accurately and reproducibly determine the virus content of two commercial varicella vaccines.

resultsThe results showed that the standardized method (PSM) was more suitable for quality control analysis of the varicella vaccine.

conclusionUse of a standardized method (PSM) according to the Korean reference material will improve the reliability and objectivity of lot release testing.

Indexed as

Chickenpox VaccineHumansReproducibility of ResultsRepublic of KoreaTechnology, PharmaceuticalViral LoadViral Plaque AssayChickenpox Vaccine

Identifiers

PMID26141063
PMCPMC4491273
OpenAlexW1514472446

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.