《日本血吸虫抗体检测标准酶联免疫吸附试验法》解读

Interpretation of Criteria for Detection of Antibody against Schistosoma japonicum—Enzyme-linked Immunosorbent Assay

遵循《卫生标准管理办法》相关规定,按照《标准化工作导则第1部分:标准化文件的结构和起草规则》(GB/T 1.1—2020)体例,编制《日本血吸虫抗体检测标准酶联免疫吸附试验法》。标准全文由六章组成,包括范围、规范性引用文件、术语和定义、仪器设备、试剂或材料、检测步骤。另附有2个资料性附录(主要试剂材料制备方法,检测步骤示意图和注意事项)。该标准已由国家卫生健康委员会发布通告(国卫通[2021]11号),定于2022年5月1日起实施。该标准的实施将进一步推进我国血吸虫病检测技术规范化进程,为全国实现消除血吸虫病目标提供重要的技术支撑。

The criteria compilation for the detection of antibodies against Schistosoma japonicum using enzyme linked immunosorbent assay was performed based on the documents of Management Measures for Health Criteria and Directives for standardization-Part 1.Rules for the structure and drafting of standardizing documents(GBT1.1—2020).The criteria are composed of six chapters which include the range of applications,normative reference documents,terms and definitions,instruments and equipment,reagent or materials and detection steps.Two informa-tive appendices(including preparation method of main reagent materials,and schematic diagram of detection steps and points for attention)is appended along with the criteria.The criteria was issued by the National Health Com-mission of the People’s Republic of China through No.11 of Chinese Health Announcement and had implemented since May 1,2022.The criteria will further promote the standardization process of schistosomiasis detection technolo-gy and provide important technical support for achieving the goal of schistosomiasis elimination in China.