化学发光法检测低水平HBsAg性能及临床应用评价

Performance and Clinical Application of Chemiluminescent Assay for Detecting of Low Levels of HBsAg

目的评估化学发光法检测低水平乙型肝炎病毒表面抗原性能及临床价值。方法采用酶联免疫吸附试验（ELISA）检测西安市中心医院2010年5月～2012年6月间门诊及住院的8408例患者的乙型肝炎病毒表面抗原患者，初筛出少见模式标本438例。再次对初筛标本进行化学发光法检测，化学发光检测过程中采用乙型肝炎表面抗原低水平标准物质进行质量控制和性能评估，检出的低水平乙型肝炎表面抗原标本再进行中和确认试验。结果438例初筛标本经化学发光法分23次不同批次检测出27例低水平HBsAg分布于4种乙型肝炎模式中，其中包含21例原ELISA检测为HB—sAg阴性标本。测定中标准物质阳性符合率和阴性参考品符合率均为100％，化学发光法与ELISA法两者符合率为94．7％，化学发光法和ELISA法检测HBsAg的最低灵敏度分别为0．1μg／L，0．4μg／L。结论化学发光法产品性能指标符合临床要求。灵敏度高、特异性好的化学发光法联合酶联免疫吸附试验有助于低水平HBsAg的检出，对低水平HBsAg的人群的诊断、治疗、流行病学研究有重要意义。

Objective To evaluate the chemiluminescent method for the detection of low levels of hepatitis B virus surface an- tigen and its clinical value performance. Methods Colleted （ELISA） 8 408 patients with hepatitis B in Xi＇ an central hospital from May 2010 and June 2012 and detecred hepatitis B virus surface antigen in the patients by enzyme-linked immunosorbent assay （ELISA）. Screening out rare model in 438 cases, again on the screen specimens were detected by chemiluminescence, chemiluminescence detection was used in the process of hepatitis B surface antigen low level standard substance for quality control and performance ev/duation,detecting of low levels of hepatitis B surface antigen specimens then neutralization con- firmatory test. Results 438 cases of screening specimens by chemiluminescence method in 23 different batches were detected 27 cases of low levels of HBsAg distribution in four kinds of hepatitis B model,including 21 cases of ELISA for the detection of HBsAg negative samples. Determinationof standard material in positive coincidence rate and negative reference coincidence rate was 100%. Chemiluminescence method and ELISA coincidence rate was 94.7 %, chemiluminescence method and ELISA method for the detection of HBsAg minimum sensitivity were 0.1 μg/L,0.4 μg/L respectively. Conclusion The chemilumi- nescence product performance indicators met the clinical requirements. High sensitivity,good specificity chemiluminescence method combined with enzyme linked immunosorbent assay contribute to low levels of HBsAg detection. Low level of HB- sAg populations in diagnosis, treatment, epidemiological study has important significance.