摘要
国产HBV和HCV感染检测试剂与国外同类试剂相比,存在过度追求操作简便化和定量检测缺乏量值溯源等问题.将HBsAg的双抗体夹心ELISA试剂的"一步法"改为"两步法",并保证足够的温育时间;同时,选择多个单抗作为包被抗体,不但可以避免"钩状效应"或HBsAg变异造成的假阴性结果,而且将改善试剂的测定下限.将HBV和HCV核酸检测试剂的标本处理由简单的煮沸裂解改为核酸纯化,并增加用于核酸提取的标本量和提取后扩增加样量,同时加入内标,不但可以改善测定下限和检测重复性,而且可以有效地监控假阴性结果的出现.定量检测试剂标准品系列与国家或国际标准物质的量值溯源,可使不同试剂得到的检测结果具有可比性.
Compared with commercial reagents manufactured by foreign companies for detection of HBV and HCV infection, domestic reagents have poorer performance because of the over-pursuit of easy operation and lack of metrological traceability in quantitative measurement. If "two-step" sandwich ELISA model and multiple monoclonal coating antibodies were used, false-negative results caused by the hook-effect and HBsAg mutant would be avoided. Moreover, sufficient incubation time in each step would improve the detection-limit of the reagents. By replacing the boiling lysis with nucleic acid purification in sample preparation and increasing the sample volume of nucleic acid purification and amplification detection could improve the detection-limit and reproducibility of HBV and HCV nucleic acid testing. The use of internal control could effectively monitor the of false negative results as well Application of international or national reference materials for metrological traceability of calibrators in reagents also plays an important role in assuring result concordance among different commercial reagent kits, methods and clinical laboratories.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2010年第10期901-904,共4页
Chinese Journal of Laboratory Medicine
关键词
肝炎病毒
乙型
肝炎病毒属
聚合酶链反应
指示剂和试剂
参考标准
Hepatitis B virus
Hepacivirus
Polymerase chain reaction
Indicators and reagents
Reference standards