癌胚抗原定量測定試劑盒（化學發光免疫分析法）的臨床性能評價

梁麗萍　李志雄　董志寧　李　明　吳英松★

癌胚抗原定量測定試劑盒（化學發光免疫分析法）的臨床性能評價

梁麗萍1李志雄1董志寧1李明2吳英松2★

［摘要］目的對自制的癌胚抗原定量測定試劑盒（化學發光免疫分析法）進行臨床應用研究及臨床性能評價。方法用自制試劑盒檢測采集到的血清1 156例和101例血漿，以羅氏公司癌胚抗原定量測定試劑盒（電化學發光法）為對照試劑，雅培公司癌胚抗原測定試劑盒（化學發光微粒子免疫檢測法）作為復核試劑，對自制試劑盒的一致性和相關性等指標進行計算分析。結果同羅氏試劑盒相比，自制試劑盒異常符合率達96．1%，正常符合率達97．8%，總符合率達97．3%，Kappa值達0．931（P＜0．01）。從定量測定值分析，與羅氏試劑盒測值相比，自制試劑盒測值的線性回歸方程為Y＝0．091＋1．009X，相關系數為0．987（P＜0．01），相關性良好。結論本試劑盒檢測性能滿足臨床應用的需要。

［關鍵詞］癌胚抗原；臨床研究；化學發光免疫分析法

作者單位：1．廣州市達瑞生物技術股份有限公司，廣東，廣州510665 2．南方醫科大學生物技術學院，廣東，廣州510515

The clinic research of the carcinoembryonic antigen (CEA) quantitative diagnostic kit by chemiluminescent immunoassay (CLIA)

LIANG Liping1, LI Zhixiong1, DONG Zhining1, LI Ming2, WU Yingsong2★
(1. Darui Biotechnology Co., Ltd., Guangzhou, Guangdong, China, 510665; 2. School of Biotechnology, Southern Medical University, Guangzhou, Guangdong, China, 510515)

[ABSTRACT] Objective To investigate the clinic research of the carcinoembryonic antigen (CEA) quantitative diagnostic kit by chemiluminescent immunoassay (CLIA) (CEA-CLIA).Methods 1 156 cases of serum and 101 cases of plasma were detected with the self-made kit. Roche carcinoembryonic antigen quantitative determination kit (ECL) were used as control agents, and Abbott carcinoembryonic antigen determination kit (CMIA) were used as a reagent in review. Consistency and correlation were calculated. Results The positive accordant ratio, the negative accordant ratio,the Kappa value was 96.1%,97.8%, 0.931 (P<0.01), respectively. Compared to Roche's kit in the quantitative analysis, the linear regression equation of the reagent was Y=0.091+1.009X.The correlation coefficient was 0.987 (P<0.01). And the correlation coefficient was satisfy. Conclusion CEA-CLIA was a valuable diagnostic kit for clinic application.

[KEY WORDS] Carcinoembryonic antigen (CEA); Clinic research; Chemiluminescent Immunoassay (CLIA)

癌胚抗原（carcinoembryonic antigen，CEA）是一種分子量為175 kDa～200 kDa糖蛋白抗原，1965年首先由加拿大學者Gold和Freedman從胎兒及結腸癌組織中發現［1］。胚胎期主要存在于胃腸道、肝臟和胰腺等器官，出生后含量很低。其濃度與多種腫瘤尤其是消化道腫瘤相關，如結腸癌、直腸癌、胃癌、胰腺癌、膽管癌等，肺、乳腺及泌尿生殖系統的惡性腫瘤也升高［2］。在臨床中CEA常與多個腫瘤標志物聯合檢測，用于肺癌、胃癌、結直腸癌等多種腫瘤的早期診斷、療效和預后評價［3－5］，在臨床上已作為一項常規的檢查項目?！?br>