一种国产PD-L1诊断试剂盒与进口同类产品的临床一致性比对研究

A comparison study of consistency between a domestic PD-L1diagnostic kit and an imported same kind product

为研究PD-L1在宫颈癌(cervical cancer,CC)组织中的表达情况,并分析国内外PD-L1检测试剂结果的一致性,采用多中心研究,收集2019年5月—2020年7月于河南省肿瘤医院、河南省人民医院和中国科学院大学附属肿瘤医院(浙江省肿瘤医院)病理科接收的CC患者样本共1102例,使用国产PD-L1(WD160)试剂盒以及美国丹科北美有限公司PD-L1(22C3)试剂盒分别对组织样本进行PD-L1免疫组织化学染色,统计不同肿瘤分期CC患者组织中PD-L1的阳性率。结果显示:(1)两种PD-L1试剂盒在CC组织中的表达阳性符合率为100.00%,阴性符合率为83.81%,总符合率为96.42%,K值为0.8896(P<0.05);(2)国产PD-L1(WD160)试剂盒检测阳性率在Ⅰ、Ⅱ期CC患者中没有显著差异,但在Ⅲ期患者中显著降低(P=0.03,P=0.005,P总=0.015)。因此,国产PD-L1(WD160)试剂盒能够有效识别CC组织PD-L1阳性患者,可用于肿瘤免疫抑制剂类药物的伴随诊断。另外,PD-L1阳性率在不同肿瘤分期中的差异提示肿瘤微环境在疾病发生不同时期的变化,这种变化可能对CC的免疫治疗效果产生影响。

To examine the expression of PD-L1in cervical cancer(CC)and to analyze the consistency between a domestic PD-L1kit(WD160)and an imported same kind PD-L1kit(22C3),1102CC patient tissue samples were collected from Henan Provincial Cancer Hospital,Henan Provincial People's Hospital and Cancer Hospital of The University of Chinese Academy of Sciences(Zhejiang Cancer Hospital)from May 2019to July 2020.PD-L1(WD160)and PD-L1(22C3)kits were used for immunohistochemistry staining respectively,and the expression levels of PD-L1from different disease stages samples were analyzed.The results showed that,(1)The positive coincidence rate of the two PD-L1kits was 100.00%,the negative coincidence rate was 83.81%,the total coincidence rate was 96.42%,and K value was 0.8896(P<0.05);(2)There was no difference in PD-L1staining between the stageⅠandⅡpatients,but a significant decrease from the stageⅢpatients(P=0.03,P=0.005,Ptotal=0.015).In conclusion,PD-L1kit(WD160)has a high consistency with PD-L1kit(22C3)and can effectively distinguish PD-L1positive CC patients,which could be used as accompanying diagnostic reagent for tumor immunoinhibitory drugs.Furthermore,the difference in PD-L1expression level at different disease stages may reflect the change of tumor microenvironment,which could affect the outcome of anti-tumor immunosuppressive drugs for CC treatment.