總前列腺特異性抗原定量測定試劑盒（化學發光免疫分析法）的性能驗證

方婉仙　李志雄　董志寧　李　明　吳英松★

總前列腺特異性抗原定量測定試劑盒（化學發光免疫分析法）的性能驗證

方婉仙1李志雄1董志寧1李明2吳英松2★

［摘要］目的對自制的總前列腺特異性抗原（total prostate specific antigen，tPSA）定量測定試劑盒（化學發光免疫分析法）進行性能驗證，判斷自制試劑盒是否滿足產品行業標準要求。方法參照產品行業標準要求，對自制試劑盒的準確度、最低檢測限、線性、重復性、批間差、穩定性、配對抗體等克分子反應性進行考察。結果自制試劑盒的最低檢測限為0．0022 ng／mL，線性相關系數r＝0．9998，重復性為2．82%和1．96%，批間差為5．55%，配對抗體等克分子反應小于15%，均符合產品標準的要求。對剛過12個月有效期的產品進行以上項目檢測，也符合產品標準要求，說明效期內試劑質量穩定。結論自制試劑盒的各項性能指標符合行業標準要求，在線性、最低檢測限和檢測范圍方面比臨床常用的羅氏tPSA電化學發光試劑盒更優，可替代國外昂貴試劑應用于臨床檢測。

［關鍵詞］總前列腺特異性抗原（tPSA）；化學發光免疫分析法（CLIA）；性能驗證

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 verification of the performance of total prostate specific antigen (tPSA) quantitative diagnostic kit (chemiluminescent immunoassay)

FANG Wanxian1, 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]ObjectiveTo verify the performance of total prostate specific antigen (tPSA) quantitative diagnostic kit (CLIA) in order to know whether the kit is fit for industrial standard.Methods Refering to tPSA quantitative diagnostic kit (CLIA) industrial standard, the kit accuracy, sensitivity, linearity, repeatability, precision between different assays, stability and equal gram molecular reaction of matching antibodies were studied. ResultsThe sensitivity of the kit was 0.0022 ng/mL．The linear coefficient (r) was 0.9998．Repeatability were 2.82% and 1.96%．And the precision between different assays was 5.55%．Equal gram molecular reaction of matching antibodies was less than 15%. All results were in line with the requirements of industrial standard. The same analysis was performed with the kits which were one month over the expiration date and all the analysis results were in line with industrial standard.ConclusionAll analytic performance results of the kit meet industrial standard.The detection index of linearity, detection limit, detection range are better than that of the tPSA kit from Roche, which can replace foreign expensive reagent for clinical testing and basic medical researh.

[KEY WORDS]Total prostate specific antigen (tPSA); Chemiluminescent immunoassay(CLIA); Performance verification

當前，人口老齡化日益加劇，前列腺疾病患者數量不斷增長，其中前列腺癌已成為嚴重危害人類健康的主要疾病之一［1］，如何及時正確診斷該類疾病是目前臨床與醫藥科學研究的熱點。前列腺特異性抗原（prostate specific antigen，PSA）是一種含有237個氨基酸、側鏈含有7%～8%碳水化合物且具有糜蛋白酶樣活性的絲氨酸蛋白酶，其分子量約為30 000道爾頓?！?br>