ANYTEST2000时间分辨荧光免疫分析仪的使用方法学评价

目的比较时间分辨荧光免疫分析（TRFIA）、酶联免疫吸附试验（ELISA）两种方法在测定乙肝病毒标志物（HBV—M）时结果的符合程度、灵敏度、特异性，并通过内质控的定量分析，对TRFIA法的方法学进行客观评价，了解TRFIA法测定HBVM的准确性和可行性为其在临床上广泛应用提供依据。方法对200份随机标本同时用TRFIA及ELISA法作表面抗原（HBsAg）的测定；并以HBsAg为例，对系统探测灵敏度，低、中、高质控血清的批内和批间精密度，线性范围等进行定量测定和描述。结果HBsAg阴性阳性结果，经配对资料的卡方检验，无显著性差异，P〉0．05，HBsAg的最小测定值为0．02ng／mL，低、中、高三种质控血清的批内和批间CV均小于5％，线性r=0．999。结论TRFIA法测定HBVM特异性、灵敏度及结果符合率较ELISA法高，TRFIA作为定量的方法，可为临床疗效观察提供依据，能较好的为临床检测服务。

Technology evaluation of ANYTEST2000 time-resolved fluoroimmunoassay

Objective To compare the consistent extent, sensitivity, specificity of time-resolved fluoroimmunoassay （TRFIA） and enzyme linked immunosorbent assay （ELISA） in detecting hepatitis B virus marker（HBV-M）, evaluate the technology of TRFIA objectively by the quantitative analysis with inside control, and comprehend the accuracy and feasibility of TRFIA in detecting HBVM to provide basis for it＇s wide use clinically. Methods Detect the surface antigen （HBsAg） of 200 random samples with TRFIA and ELISA at the same time; and quantitatively detect and describe the sensitivity of the system, intra-batch and inter-batch precision of low, middle, high quality control serum, linear range. Results There is no statistic difference between the negative and positive results of HBsAg by chi-square criterion of pairing data （P〉0.05）, the minimum value of HBsAg is 0.02ng/mL, intra-batch and inter-batch CVs of low, middle, high quality control serum are less than 5%, linearity r=-0.999. Conclusion Sensitivity, specificity and consistent extent of TRFIA in detecting HBVM are higher than ELISA, as a quantitive method, TRFIA can provide basis for clinical therapeutic effect observation and serve clinical detection better.