Evidence map›Paper›PMID 33753180›Full record

ArticleVirus research2021

Novel indel mutation in the N gene of SARS-CoV-2 clinical samples that were diagnosed positive in a commercial RT-PCR assay.

Sanghoo Lee, DongJu Won, Chang-Ki Kim, Jinwoo Ahn, Youngkee Lee, Hyeongkyun Na, Yun-Tae Kim, Mi-Kyeong Lee, Jong Rak Choi, Hwan-Sub Lim and 1 more

Open access · greenAbstract read
In one paragraph

Article in Virus research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.7field-weighted citation impact, top 29% 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

8 citing papers in PubMed, 10 citations in OpenAlex.

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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

11 authors at 2 institutions in 1 country.

Sanghoo LeeCenter for Companion Biomarker, Seoul Clinical Laboratories Healthcare Co., Ltd, Gyeonggi-do, Republic of Korea. Electronic address: sprout30@scllab.co.kr.
DongJu WonDepartment of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Chang-Ki KimCenter for Clinical Trial, Seoul Clinical Laboratories, Gyeonggi-do, Republic of Korea.
Jinwoo AhnCenter for Companion Biomarker, Seoul Clinical Laboratories Healthcare Co., Ltd, Gyeonggi-do, Republic of Korea.
Youngkee LeeCenter for Companion Biomarker, Seoul Clinical Laboratories Healthcare Co., Ltd, Gyeonggi-do, Republic of Korea.
Hyeongkyun NaCenter for Companion Biomarker, Seoul Clinical Laboratories Healthcare Co., Ltd, Gyeonggi-do, Republic of Korea.
Yun-Tae KimCenter for Technology Innovation, Seoul Clinical Laboratories, Gyeonggi-do, Republic of Korea.
Mi-Kyeong LeeDepartment of Molecular Diagnostics, Seoul Clinical Laboratories, Gyeonggi-do, Republic of Korea.
Jong Rak ChoiDepartment of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Hwan-Sub LimDepartment of Molecular Diagnostics, Seoul Clinical Laboratories, Gyeonggi-do, Republic of Korea.
Kyoung-Ryul LeeCenter for Companion Biomarker, Seoul Clinical Laboratories Healthcare Co., Ltd, Gyeonggi-do, Republic of Korea; Department of Molecular Diagnostics, Seoul Clinical Laboratories, Gyeonggi-do, Republic of Korea; Center for Technology Innovation, Seoul Clinical Laboratories, Gyeonggi-do, Republic of Korea; Center for Clinical Trial, Seoul Clinical Laboratories, Gyeonggi-do, Republic of Korea. Electronic address: dkrlee@scllab.co.kr.
Seoul Medical Center · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Commercially available reverse transcription-polymerase chain reaction (RT-PCR) kits are being used as an important tool to diagnose SARS-CoV-2 infection in clinical laboratories worldwide. However, some kits lack sufficient clinical evaluation due to the need for emergency use caused by the current COVID-19 pandemic. Here we found that a novel insertion/deletion mutation in the nucleocapsid (N) gene of SARS-CoV-2 samples is a cause of negative results for the N gene in a widely used assay that received emergency use authorization (EUA) from US FDA and Conformite Europeenne-in vitro diagnostics (CE-IVD) from EU. Although SARS-CoV-2 is diagnosed positive by other target probes in the assay, our findings provide an evidence of the genetic variability and rapid evolution of SARS-CoV-2 as well as a reference in designing commercial RT-PCR assays.

Indexed as

INDEL MutationCoronavirus Nucleocapsid ProteinsCOVID-19COVID-19 Nucleic Acid TestingFalse Negative ReactionsGenes, ViralHumansMass ScreeningPandemicsReverse Transcriptase Polymerase Chain ReactionRNA, ViralSARS-CoV-2Coronavirus Nucleocapsid ProteinsRNA, ViralDifferent geographical originsIndel mutationNucleocapsid geneSARS-CoV-2Viral genome sequencing

Identifiers

PMID33753180
PMCPMC7977010
OpenAlexW3139381338

What OpenQuestion holds

Textmetadata
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.