摘要
依据《体外诊断试剂注册管理办法》和乙型肝炎病毒核酸分型试剂自身特点,提出对HBV基因分型检测试剂性能研究的特殊要求。对该类试剂的参考品和质控品研制、阳性/阴性参考品符合率、最低检测限、分析特异性、精密度、基因混合型研究、携带污染率等方面进行了详细解析。阐述了乙型肝炎病毒基因分型类体外诊断试剂的性能研究要点。为从事该类产品注册申报前性能研究的行业人员提供参考。
In accordance with IVD Registration Regulation and the Hepatitis B Virus Genotyping Detection Reagent＇ s own characteristics, the special requirements for the product performance evaluation were analyzed. Detailed analysis such reagents reference materials and quality control materials, positive/negative reference product compliance rate, the lowest sensitivity, analytical specificity, precision, hybrid genetic research and carry-over study were carried out. The main points of product performance of the hepatitis B virus genotype detection reagents were discussed. The results provided the reference information for the relevant personnel conducting performance evaluation study before submitting the registration application.
出处
《标记免疫分析与临床》
CAS
2016年第1期110-112,共3页
Labeled Immunoassays and Clinical Medicine
关键词
HBV基因型
性能研究
Hepatitis B Virus Genotype
Performance evaluation
