Evidence map›Paper›PMID 40918206›Full record

ArticleBiosafety and health2025

Development of an identity test for COVID-19 mRNA vaccines using SARS-CoV-2 NAT standard.

Miran Jo, Eunjo Lee, Ho Jung Oh, Jin Tae Hong, Kyung Hee Sohn

Abstract read
In one paragraph

Article in Biosafety and health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Miran JoNational Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju 28159, Republic of Korea.
Eunjo LeeNational Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju 28159, Republic of Korea.
Ho Jung OhKorea Regulatory Science Center, Seoul 04535, Republic of Korea.
Jin Tae HongCollege of Pharmacy, Chungbuk National University, Cheongju 28160, Republic of Korea.
Kyung Hee SohnNational Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju 28159, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Despite the development of messenger ribonucleic acid (mRNA) vaccines for the infectious novel coronavirus 2 (SARS-CoV-2), further research on test methods is required to ensure their quality as well as rapid and effective approval for release to the market. During the current national lot release testing, identity tests cannot be conducted on other products using primers, probes, and in-house reference materials provided by the manufacturer and specific to one vaccine, because their sequences do not match. When key reagents and reference materials are dependent on the manufacturer in this way, difficulties in national lot release approval-which serves as an additional step for the government to verify product quality-arise if the manufacturer does not provide them. In this study, we aimed to develop a quantitative polymerase chain reaction (qPCR) assay by using commercially available nucleic acid amplification test (NAT) reference material and a dye instead of a probe along with primers that were newly designed in this study. It can be applied to both vaccines. This study suggests a test method that can be applied when the in-house reference standard for the identity test, a major step to confirm the quality of vaccines, is not secured.

Indexed as

Coronavirus disease 2019 (COVID-19)Identity testLot releaseMessenger ribonucleic acid (mRNA) vaccineQuality controlQuantitative polymerase chain reaction (qPCR)

Identifiers

PMID40918206
PMCPMC12412394

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.