Evidence map›Paper›PMID 36196490›Full record

ArticleJournal of clinical laboratory analysis2022

Performance comparison of two nucleic acid amplification systems for SARS-CoV-2 detection: A multi-center study.

Chan Mo, Kamfai Lo, Ying He, Bo Peng, Feifan Guo, Zhou Zheng, Ruiwei Jiang, Yihua Cai, Yumin Li, Dongyue Guo and 4 more

Abstract readMulticenter Study
In one paragraph

Article in Journal of clinical laboratory analysis, 2022. 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
–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

2 citing papers in PubMed.

  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

14 authors.

Chan MoMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.
Kamfai LoThe University of Hong Kong-Shenzhen hospital, Shenzhen, Guangdong, China.
Ying HeThe Eighth Affiliated Hospital of Sun Yat-sen University, Shenzhen, Guangdong, China.
Bo PengShenzhen Center for Disease Control and Prevention, Shenzhen, Guangdong, China.
Feifan GuoMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.
Zhou ZhengMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.
Ruiwei JiangMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.ORCID https://orcid.org/0000-0002-5668-7281
Yihua CaiMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.
Yumin LiMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.
Dongyue GuoMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.
Bing ZhangMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.
Tong OuMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.
Dan XiongMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.
Xiuming ZhangMedical Laboratory of the Third Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China.ORCID https://orcid.org/0000-0002-7971-6444

Funding

Science and Technology Planning Project of Shenzhen City of China JCYJ20180306172209668Science and Technology Planning Project of Shenzhen City of China JCYJ20190812171816857Shenzhen Key Medical Discipline Construction SZXK054
6 · The paper itself

Abstract

backgroundMany rapid nucleic acid testing systems have emerged to halt the development and spread of COVID-19. However, so far relatively few studies have compared the diagnostic performance between these testing systems and conventional detection systems. Here, we performed a retrospective analysis to evaluate the clinical detection performance between SARS-CoV-2 rapid and conventional nucleic acid detection system.

methodsClinical detection results of 63,352 oropharyngeal swabs by both systems were finally enrolled in this analysis. Sensitivity (SE), specificity (SP), and positive and negative predictive value (PPV, NPV) of both systems were calculated to evaluate their diagnostic accuracy. Concordance between these two systems were assessed by overall, positive, negative percent agreement (OPA, PPA, NPA) and κ value. Sensitivity of SARS-CoV-2 rapid nucleic acid detection system (Daan Gene) was further analyzed with respect to the viral load of clinical specimens.

resultsSensitivity of Daan Gene was slightly lower than that of conventional detection system (0.86 vs. 0.979), but their specificity was equivalent. Daan Gene had ≥98.0% PPV and NPV for SARS-CoV-2. Moreover, Daan Gene demonstrated an excellent test agreement with conventional detection system (κ = 0.893, p = 0.000). Daan Gene was 99.31% sensitivity for specimens with high viral load (C

conclusionsWhile showing an analytical sensitivity slightly below than that of conventional detection system, rapid nucleic acid detection system may be a diagnostic alternative to rapidly identify SARS-CoV-2-infected individuals with high viral loads and a powerful complement to current detection methods.

Indexed as

COVID-19Nucleic AcidsClinical Laboratory TechniquesCOVID-19 TestingHumansRetrospective StudiesSARS-CoV-2Nucleic Acidsclinical detection performancemulti-center studynucleic acid detection systemSARS-CoV-2

Identifiers

PMID36196490
PMCPMC9701884

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Registered trials

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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.