Evidence map›Paper›PMID 36401275›Full record

ArticleVirology journal2022

Comparison of the performance of two real-time fluorescent quantitative PCR kits for the detection of SARS-CoV-2 nucleic acid: a study based on large real clinical samples.

Yiting Wang, Xuewen Li, Yifei Wang, Zheyu Tu, Jiancheng Xu, Junqi Pan, Qi Zhou

Abstract read
In one paragraph

Article in Virology journal, 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
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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.

Yiting WangDepartment of Laboratory Medicine, First Hospital of Jilin University, 1 Xinmin Street, Changchun, 130021, China.ORCID 0000-0001-5977-5407
Xuewen LiDepartment of Laboratory Medicine, First Hospital of Jilin University, 1 Xinmin Street, Changchun, 130021, China.ORCID 0000-0001-9880-571X
Yifei WangDepartment of Laboratory Medicine, First Hospital of Jilin University, 1 Xinmin Street, Changchun, 130021, China.ORCID 0000-0002-1784-7916
Zheyu TuDepartment of Laboratory Medicine, First Hospital of Jilin University, 1 Xinmin Street, Changchun, 130021, China.
Jiancheng XuDepartment of Laboratory Medicine, First Hospital of Jilin University, 1 Xinmin Street, Changchun, 130021, China.ORCID 0000-0001-8796-271X
Junqi PanUniversity of Melbourne, Grattan Street, Parkville, VIC, 3010, Australia.
Qi ZhouDepartment of Pediatrics, First Hospital of Jilin University, 1 Xinmin Street, Changchun, 130021, China. zhou_qi@jlu.edu.cn.ORCID 0000-0002-5084-8697

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe global pandemic of coronavirus disease 2019 (COVID-19) has led to the development of multiple detection kits by national manufacturers for severe acute respiratory syndrome coronavirus 2 viral nucleic acid testing. The purpose of this study is to evaluate the performance of different kits (i.e., Maccura kit and Sansure kit) in real clinical work using clinical samples, which will help with the optimization of the test kits.

methodDuring the past three months (March-May 2022), 1399 pharyngeal swabs from suspected COVID-19 patients have been initially screened using the Maccura kit in Jilin, China, and the test results were verified using the Sansure kit. The cycle threshold (Ct) values generated by the two kits were compared at different viral load levels. Correlation and consistency of the Ct values were investigated using Spearman correlation, Deming regression, and Bland-Altman plots. The cut-off Ct values of the Maccura kit were recalculated by referencing the result of the Sansure kit as a standard. Furthermore, another 163 pharyngeal swabs from suspected COVID-19 patients were collected to verify the new cut-off values.

resultsAs a result of the Maccura kit testing, 1192 positive cases and 207 suspected COVID-19 cases were verified. After re-examination by the Sansure kit, 1118 positive cases were confirmed. The difference between the Ct values provided by the two kits was statistically significant, except for the N gene at high viral load. The Ct values obtained from the two kits presented a linear positive correlation. The Maccura kit used new cut-off Ct values of 35.00 (ORF1ab gene) and 35.07 (N gene). Based on that, the validation pass rate for the new cut-off Ct values was 91.41%.

conclusionSince the Maccura kit is found to have false positives in actual clinical work, recalculation of the cut-off values can reduce this occurrence. In order to improve the accuracy of the testing, laboratories should use two kits for COVID-19 testing, and the adjusting and optimizing of the kits for their situation are needed.

Indexed as

COVID-19Nucleic AcidsCOVID-19 TestingHumansReagent Kits, DiagnosticReal-Time Polymerase Chain ReactionSARS-CoV-2Nucleic AcidsReagent Kits, DiagnosticCoronavirus disease 2019Maccura kitReverse transcription-polymerase chain reactionSansure kitSevere acute respiratory syndrome coronavirus 2

Identifiers

PMID36401275
PMCPMC9675236

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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.