摘要
目的建立CA50的时间分辨荧光免疫分析法(CA50-TRFIA),并对其方法学及肿瘤诊断临床应用价值进行评价。方法用稀土离子铕(Eu3+)标记CA50单克隆抗体,以微孔板为载体,固相夹心法建立CA50-TRFIA。通过对76例恶性肿瘤患者、47例良性疾病患者以及213例健康人血清CA50的测定,应用临床诊断试验评价方法,对CA50TRFIA方法学和临床应用价值进行评价。结果CA50TR-FIA检测灵敏度为1.08×103u/L,批内和批间CV分别为2.6%和3.5%,平均回收率为108.61%,与IR-MA法测定值的相关系数为0.904,可测范围为(1.08～140)×103u/L,良性疾病组与对照组比较差异无统计学意义(P>0.05)。卵巢肿瘤组、消化道肿瘤组、肺癌组分别与良性疾病组和对照组比较差异均有统计学意义(P<0.01)。结论CA50时间分辨荧光免疫分析(TRFIA)法具有良好的特异性、准确度、稳定性,且无放射污染,可作为肿瘤的辅助诊断指标。
Objective To establish a time resolved fluoroimmunoassay （TRFIA） for detecting the carbo- hydrate antigen CA50 and evaluating its diagnostic and clinical application in the treatment of malignant tumor. Methods A solid-phase sandwich TRFIA of CA50 was established. The europium （Eu3＋ ） was labelled on the monoclonal antibody （McAb） against CA50 and then coated on the mieroplate as a carrier. The serum contents of CA50 in 76 patients with malignant tumor, 47 patients with carcinoids and 213 normal controls were measured using clinical diagnostic methods to evaluate the clinical application of CA50 TRFIA in the diagnosis of tumor. Results The sensitivity of the CA50 TRFIA was l. 08 x 103 U/ L. The intra- and inter- assay CV were 2. 6% and 3. 5% , respectively. The recovery rate was 108. 61 %. Its correlation coefficient to IRMA was 0. 904. The measurement range was （1.08% 140） % 103 u/L. There was no significant difference between the patient group with carcinoids and the normal control group （P〉0. 05）. Compared with the patient group with careinoids and the normal control group, the patient group with ovarian tumor, alimentary canal carcinoids and lung cancer exhibited statistical signifi- cant difference （P〈0. 01）. Conclusion The established sandwich TRFIA for CA50 measurement is an exceedingly specific, accurate and steady assay. It is also radiation free which can be served as an auxiliary index in the diagnosis of tumor.
出处
《肿瘤防治研究》
CAS
CSCD
北大核心
2009年第9期762-765,共4页
Cancer Research on Prevention and Treatment
作者简介
作者简介：强新晨（1974～），男，本科，主管检验师，主要从事肿瘤实验诊断工作
通讯作者：肖华龙，E-mail：qxcjswx@yahoo．com.cn
