前S1抗原方法学性能验证的评价和分析  

Evaluation and analysis on the performance of methodology using Pre-S1 Ag

作　　者：傅芳美 王智华 

机构地区：[1]解放军第九二医院检验科,福建南平353000

出　　处：《现代预防医学》2014年第8期1485-1486,1489,共3页Modern Preventive Medicine

摘　　要：目的评价乙肝病毒前S1抗原ELISA试剂盒的方法学性能。方法 (1)取前S1弱阳性质控血清的原始浓度及+20%、-20%浓度的标本,进行连续20 d检测,统计分析其日间精密度CV及灰区标本符合率;(2)取80例随机样本及近2年收集的20例特殊样本[HBsAg阴性(-),HBeAg阴性(-),而试剂2检测前S1抗原阳性(+)的标本]用两种ELISA试剂进行符合率实验,并将20例特殊样本进行HBV-DNA检测,进行正确性验证。结果 (1)试剂1检测前S1抗原日间精密度CV=5.65%;-20%浓度样本的结果 97.6%阴性(-),+20%浓度样本的结果 100%阳性(+),样本吸光度均值为0.216 8,95%CI为(0.195 5;0.238 1)。(2)两种试剂对80例随机样本检测,符合性100%,20例特殊样本用试剂1检测结果均为阴性(-),HBV-DNA检测也为阴性(-)。结论 (1)试剂1的检出限、精密度及cut off计算公式符合试剂说明书中规定标准;(2)试剂1与试剂2符合率较好,试剂1与HBV-DNA的符合性较试剂2好;(3)评价方案简单易行,各临床实验室应建立自己的分析性能指标,选择合适的实验方法,以提高结果的灵敏度和特异性。Objective The aim of this study was to evaluate the performance of methodology using ELISA kit for hepatitis B virus Pre-S1 Ag. Methods First, the concentrations of weakly positive Pre-S1Ag control serum specimens, and samples with ＋20% and -20% concentration were measured for continuous 20 days, followed by statistical analysis on the day precision CV and gray zone specimens coincidence rate. Second, two ELISA kits were used to analyze samples from 80 random cases and special samples （HB- sAg negative, HBeAg negative, and reagent 2 detection of Pre-S1Ag positive specimens） from 20 cases collected in recent two years. The coincidence rate experiments were performed, and correctness verification tests were carried out by HBV-DNA detection on the special samples from 20 cases. Results First, the first reagent detection rate for Pre-S1Ag day precision CV was 5.65%. The result for sample with -20% concentration was 97.6% negative and the result for sample with ＋20% concentration was 100% positive. The mean absorbance for sample was 0.2168, 95% CI （0.1955; 0.2381）. Second, the compliance of the two reagents detecting samples from 80 random cases was 100%. The results of both the reagent test and HBV-DNA test for samples from 20 special cases were negative. Conclusion First, the detection limit, precision and cut-off formula for reagent one were in line with the standard instruc- tions of the prescribed reagent. Second, the consistent rates for both reagent one and two were good, while results for reagent one conformed better with the results for HBV-DNA than the results for reagent two. Third, the evaluation program is simple and easy. Each clinical laboratory should establish its own analysis on performance indicators and select suitable experimental methods in or- der to improve the sensitivity and specificity of the results.

关 键 词：前S1抗原 性能验证 方法学评价 HBV-DNA 

分 类 号：R181.24[医药卫生—流行病学]