Abstract
Objectives
Detection of Syndecan 2 (SDC2) methylation in stool DNA is a novel method for the auxiliary diagnosis of early colorectal cancer (CRC). Currently, this method has been widely applied; however, its accuracy and reliability have not been determined. The objective of this pioneering study was to evaluate the performance of clinical laboratories in China for their ability to detect SDC2 methylation from stool DNA.
Methods
We generated a sample panel consisting of clinical and cell samples. The clinical samples were stool specimens from patients with or without CRC, including four positives (prepared by serial dilution from one stool specimen), one negative and one interferential sample. Two cell samples, with positive or negative methylated SDC2, were used as controls. The panel was distributed to 32 clinical laboratories for analysis of SDC2 methylation, and the results were compared and scored.
Results
The sample panel was compatible with commercially available assays and it showed appropriate stability to be an external quality assessment material. There were four false results; one hospital laboratory and one commercial diagnostic laboratory had a false-positive and a false-negative result, respectively, and one commercial diagnostic laboratory had both a false-positive and false-negative result. Among the 32 participating laboratories, 29 (90.62%) obtained an acceptable or better performance score, while 3 (9.38%) laboratories required improvement.
Conclusions
Our results demonstrate that the detection of SDC2 methylation from stool DNA was satisfactory in China. Additionally, the importance of external quality assessment was highlighted for monitoring the performance of clinical laboratories.
Funding source: Natural Science Foundation of Shanghai
Award Identifier / Grant number: (No. 21ZR1455900)
Funding source: Shanghai Municipal Health Commission
Award Identifier / Grant number: (No. 201940264)
Funding source: Shanghai Centre for Clinical Laboratory
Award Identifier / Grant number: (Nos. 2021ZXKT-01, 2021ZXKT-02)
Funding source: Youth Medical Talents-Clinical Laboratory Practitioner Program of Shanghai “Rising Stars of Medical Talents” Youth Development Program
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Research funding: This study was supported by grants from Natural Science Foundation of Shanghai (No. 21ZR1455900), Shanghai Municipal Health Commission (No. 201940264), Shanghai Centre for Clinical Laboratory (Nos. 2021ZXKT-01, 2021ZXKT-02) and Youth Medical Talents-Clinical Laboratory Practitioner Program of Shanghai “Rising Stars of Medical Talents” Youth Development Program. The funding organizations played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: Research involving human subjects complied with all relevant national regulations, institutional policies and is in accordance with the tenets of the Helsinki Declaration (as revised in 2013), and has been approved by the Ethical Committee of Shanghai Centre for Clinical Laboratory (202203).
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Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0206).
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