鳞状细胞癌抗原试剂盒的应用及评价

目的：探讨鳞状细胞癌抗原（SCC）在临床中的应用价值,并对瑞典康乃格公司生产的SCC试剂盒从灵敏度、精密度、准确度、特异性等方面进行评价。方法：采用ELISA法测定30例正常人和40例宫颈癌患者血清中的SCC水平。结果：SCC试剂盒最小生物检测限为0．625μg/L,批内、批间变异系数分别为2．3％和4．6％,回收率为97．3％。30例正常人血清中SCC水平为（0．88±0．49）μg／L,全部在正常范围内;40例宫颈癌患者,其中10例Ⅲ期患者血清SCC水平为（10．85±7．61）μg／L,阳性率为70％,30例Ⅳ期患者血清SCC水平为（16．07±6．8）μg／L,阳性率高达90％。经t检验健康组与宫颈癌组比较P〈0．01,差异有统计学意义;宫颈癌Ⅲ期组与宫颈期癌Ⅳ组比较P〈0．05,差异有统计学意义。结论：鳞状细胞癌抗原试剂盒的灵敏度、重复性、准确性和特异性较好,它对宫颈癌的辅助诊断和临床疗效观察有很好的应用价值。

Application and evaluation of Squamous Cell Carcinoma Antigen reagent kit

Objective：To investigate the clinical application value of squamous cell carcinoma （SCC） and evalu ate the SCC reagent kit produced by CanAg company of Sweden from its sensitivity, repeatability, accuracy, and specificity. Method：Serum SCC level of 30 healthy persons and 40 patients with cervical carcinoma were detected by ELISA. Result：The minimal biological detection limit of the SCC reagent kit was 0. 625μg/L. The intra--batch and inter--batch coefficients of variation were 2.3% and 4. 6%, respectively. The recovery rate was 97.3%. The average serum SCC level of healthy persons was（0.83±0.49）μg/L,which were all normal. Among patients with cervical carcinoma , the average SCC level of 10 patients with Ⅲ cervical carcinoma was（10. 35±7. 61） μg/L （positive rate 70%）, and the average SCC level of 30 patients of Ⅳ cervical carcinoma was （16.07±6. 8）μg/L （positive rate 90%）. The SCC positive rate between patients with cervical carcinoma Ⅲ and Ⅳ had significant difference. Conclusion：The SCC reagent kit had good sensitivity, repeatability, accuracy, and specificity, which has great clinical value for assistant diagnose and treatment efficacy observation of cervical carcinoma.