Chung Jae Hoon, Park Minsu, Cho Hyun, Song Wan, Kang Minyong, Sung Hyun Hwan, Jeon Hwang Gyun, Jeong Byong Chang, Seo Seong Il, Lee Hyun Moo, Jeon Seong Soo
Samsung Medical Center, Department of Urology, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.
Department of Statistics, Keimyung University, Daegu 42403, Korea.
Biology (Basel). 2021 Apr 5;10(4):297. doi: 10.3390/biology10040297.
There is controversy over the usefulness of prostate-specific antigen (PSA) as a prostate cancer (PCa) biomarker. This controversy arises when there are differences in the results of PSA assay modalities. In this study, which aimed to evaluate a proper validation between the two PSA assay modalities, the agreement between the results of the two modalities was analyzed. PSA examinations were conducted using two PSA assay modalities in 4810 patients. The intra-class correlation coefficient (ICC) and weighted kappa analysis were used to evaluate the agreement between the two assay modalities. A linear regression was performed to evaluate the association between the two assay modalities. According to ICC values (ICC: 0.999, < 0.001) and weighted kappa analysis values (kappa: 0.951, alpha's standard error (ASE): 0.001, < 0.0001), the agreement between the assay modalities was rated as excellent. However, the strength of agreement was poor in the following PSA sub-groups: 0.05-0.1 ng/mL (ICC: 0.281, = 0.0860); 0.15-0.2 ng/mL (ICC: 0.288, = 0.0036); 1.5-2.0 ng/mL (ICC: 0.360, = 0.0860); and 2.0-2.5 ng/mL (ICC: 0.303, = 0.0868). In linear regression analysis, when modality B PSA yielded a value of 0.2 ng/mL, the expected value for modality A was 0.258 ng/mL (95% CI: 0.255-0.260), and when modality B PSA yielded a value of 4 ng/mL, the expected value for modality A was 3.192 ng/mL (95% CI: 3.150-3.235). The difference in the PSA values between the two PSA assay modalities is confirmed, and this difference may be clinically meaningful.
前列腺特异性抗原（PSA）作为前列腺癌（PCa）生物标志物的有用性存在争议。当PSA检测方法的结果存在差异时，就会引发这种争议。在本旨在评估两种PSA检测方法之间适当验证的研究中，分析了两种方法结果之间的一致性。对4810例患者使用两种PSA检测方法进行PSA检查。采用组内相关系数（ICC）和加权kappa分析来评估两种检测方法之间的一致性。进行线性回归以评估两种检测方法之间的关联。根据ICC值（ICC：0.999，<0.001）和加权kappa分析值（kappa：0.951，α的标准误差（ASE）：0.001，<0.0001），检测方法之间的一致性被评为优秀。然而，在以下PSA亚组中一致性强度较差：0.05 - 0.1 ng/mL（ICC：0.281，= 0.0860）；0.15 - 0.2 ng/mL（ICC：0.288，= 0.0036）；1.5 - 2.0 ng/mL（ICC：0.360，= 0.0860）；以及2.0 - 2.5 ng/mL（ICC：0.303，= 0.0868）。在线性回归分析中，当方法B的PSA值为0.2 ng/mL时，方法A的预期值为0.258 ng/mL（95%置信区间：0.255 - 0.260），当方法B的PSA值为4 ng/mL时，方法A的预期值为3.192 ng/mL（95%置信区间：3.150 - 3.235）。证实了两种PSA检测方法之间PSA值的差异，并且这种差异可能具有临床意义。
