Evidence map›Paper›PMID 34800690›Full record

ArticleInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2022

Nationwide external quality assessment of SARS-CoV-2 nucleic acid amplification tests in Japan.

Satomi Asai, Akira Seki, Yasumasa Akai, Hiromitsu Tazawa, Hidehumi Kakizoe, Mend-Amar Ravzanaaadii, Hayato Miyachi

Open access · goldAbstract read
In one paragraph

Article in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 26% 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

4 citing papers in PubMed, 13 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

7 authors at 3 institutions in 1 country.

Satomi AsaiDepartment of Laboratory Medicine, Tokai University School of Medicine, Isehara Kanagawa, Japan. Electronic address: sa@is.icc.u-tokai.ac.jp.
Akira SekiDepartment of Laboratory Medicine, Tokai University School of Medicine, Isehara Kanagawa, Japan. Electronic address: akira-seki@jccls.org.
Yasumasa AkaiScientific Research, Scientific Affairs, Sysmex corporation, Kobe, Japan. Electronic address: Akai.Yasumasa@sysmex.co.jp.
Hiromitsu TazawaClinical Bioresource Center, Kyoto University Hospital, Kyoto, Japan. Electronic address: tazawa@kuhp.kyoto-u.ac.jp.
Hidehumi KakizoeDepartment of Laboratory Medicine, Tokai University School of Medicine, Isehara Kanagawa, Japan. Electronic address: kh553821@tsc.u-tokai.ac.jp.
Mend-Amar RavzanaaadiiDepartment of Laboratory Medicine, Tokai University School of Medicine, Isehara Kanagawa, Japan. Electronic address: mendamar.r@gmail.com.
Hayato MiyachiDepartment of Laboratory Medicine, Tokai University School of Medicine, Isehara Kanagawa, Japan. Electronic address: miyachi@is.icc.u-tokai.ac.jp.
Tokai University · JPKyoto University Hospital · JPSysmex (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesWe conducted a nationwide external quality assessment (EQA) study of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid amplification testing in Japan.

methodsA total of 563 public health and private sector laboratories participated. The EQA samples comprised 6 RNA and full-process controls.

resultsThe overall agreements were 99.3% and 97.9% for the RNA and full-process controls, respectively. A total of 530/563 (94.1%) laboratories reported correct results; public health laboratories had the highest accuracy. Thirty-three laboratories reported at least one incorrect result (26 laboratories of medical facilities, 5 commercial laboratories, 1 public health laboratory, and 1 other). Sixteen laboratories of medical facilities that used a fully automated assay system failed to detect the presence of the full-process control, due to inherent insufficiency in the limit of detection (LOD). Other causes of incorrect results included failure to ensure the LOD (n = 13), error in result judging or reporting (n = 3), and error in sample handling (n = 1).

conclusionsPerformance was mostly dependent on the laboratory category and assay evaluation, particularly the LOD. Guidance should be developed based on these results, particularly in the phase of new entry into laboratory services for SARS-CoV-2.

Indexed as

COVID-19SARS-CoV-2HumansJapanNucleic Acid Amplification TechniquesSensitivity and SpecificityCOVID-19diagnosticsexternal quality assessmentmolecularSARS-CoV-2

Identifiers

PMID34800690
PMCPMC8595969
OpenAlexW3213240512

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.