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Small-scale external quality assessment of methylated SHOX2 and RASSF1A detection in China: findings from 2023-2024
Chengxiang Chu1,2, Xiaoyu Fan3, Chunli Shi3
1Department of Quality Control Material R&D, 608229 Shanghai Center for Clinical Laboratory , Shanghai, China.
Objectives:
DNA methylation in short homeobox gene 2 (SHOX2) and RAS association domain family protein 1 (RASSF1A) shows significant auxiliary diagnostic value for early-stage lung cancer. However, the detection accuracy is frequently compromised because of the complexity of the analytical procedures. This pilot external quality assessment (EQA) study evaluated the performance of methylated SHOX2 (mSHOX2) and methylated RASSF1A (mRASSF1A) detection across clinical laboratories in China.
Methods:
A sample panel was prepared containing two mSHOX2-positive samples, one mRASSF1A-positive sample, one mSHOX2 and mRASSF1A double-positive sample, and one negative sample. The panel was randomly coded and distributed to clinical laboratories for mSHOX2 and mRASSF1A detection in 2023 and 2024. The returned results were compared and scored to evaluate laboratory performance.
Results:
The sample panel demonstrated sufficient stability and applicability. Results were collected from 21 laboratories in 2023 and 29 laboratories in 2024. Approximately 90.5 % (19/21) and 75.9 % (22/29) laboratories achieved correct results in 2023 and 2024, respectively. Out of the 105 results in 2023 and 145 results in 2024, 1 false negative and 3 false positives were observed in 2023 and 6 false negatives and 12 false positives in 2024.
Conclusions:
This two-round EQA study in China emphasizes the need for improvement in the performance of mSHOX2 and mRASSF1A methylation detection. These results underscore the critical role of EQA schemes in monitoring and improving the detection quality in clinical laboratories. To address the challenges in mSHOX2 and mRASSF1A detection, targeted recommendations are proposed to enhance detection accuracy and reliability.
