CAJ | 학술논문

目的对风疹病毒IgM抗体检测试剂盒进行国家监督抽验，评价其质量现状。方法采用法定检验结合探索性研究，对阴阳性符合率、检测限和重复性项目进行检验，结果法定检验显示16批次中15批次合格（93.8%），不合格项目为阴性符合率；探索性研究中仅11批次满足行业标准要求（68.8%），不合格项为阳性样本符合率、检测限和重复性。结论目前上市的风疹病毒IgM抗体检测试剂盒存在一定的质量问题，建议今后在注册检验中，统一采用行业标准和国家参考盘，以促进企业改进产品质量。
목적대풍진병독IgM항체검측시제합진행국가감독추험，평개기질량현상。방법채용법정검험결합탐색성연구，대음양성부합솔、검측한화중복성항목진행검험，결과법정검험현시16비차중15비차합격（93.8%），불합격항목위음성부합솔；탐색성연구중부11비차만족행업표준요구（68.8%），불합격항위양성양본부합솔、검측한화중복성。결론목전상시적풍진병독IgM항체검측시제합존재일정적질량문제，건의금후재주책검험중，통일채용행업표준화국가삼고반，이촉진기업개진산품질량。
Objective To evaluate the quality status of rubel a virus IgM diagnostic kits by national supervising sampling. Methods Using legal inspection combining with exploratory study, the positive and negative coincidence rate, detection limit and repeatability of kits were verified. Results The results showed that 15 of 16 batches of kits were qualified using legal inspection, and the passing rate was 93.8%. The unqualified item was negative coincidence rate. In exploratory study, only 11 batches (68.8%) complied with industry standard. The unqualified items were negative coincidence rate, detection limit and repeatability. Conclusion At present, rubel a virus IgM diagnostic Kits have some quality problems in the market. It is recommended that we adopt industry standard and national reference panel in the registration inspection for the future, which wil prompt enterprises to improve quality.