Discussion on the Application of SARS-CoV-2 for Nucleic Acid Detection
新冠病毒核酸检测室内质控品应用探讨

摘要

目的 按照《CNAS-CL02-A009医学实验室质量和能力认可准则在分子诊断领域的应用说明》对于定性检测项目质控物的要求，进行新冠核酸病毒检测的质量控制，探讨不同质控品在新冠病毒核酸检测中的应用效果,为常规及应急状态下的新冠核酸检测质量保证提供依据。方法 根据试剂盒阳性质控检测ct值将试剂盒阳性对照品进行稀释，达到检测限1.5~3倍的浓度作为自配的弱阳性质控品使用。结果 试剂盒阳性对照稀释后作为自配质控品稳定性较好，但不能监测样本提取步骤，用于日常样本检测时质量控制受限于各试剂盒厂家，不能通用于不同厂家的试剂盒。结论 试剂盒阳性对照稀释作为弱阳性质控品使用可临时用于新的项目或应急情况使用，实验室进行长期的质量控制推荐使用自配质控品和第三方质控品联合应用的方式。

Abstract

Objective The quality control of coronavirus detection was carried out in accordance with the requirements of quality control materials for qualitative detection items in the "Instructions on the Application of CNAS-CL02-A009 Medical Laboratory Quality and Capability Accreditation Criteria in the Field of Molecular Diagnosis"，then explore the application effect of different quality control substances in the nucleic acid detection of SARS-CoV-2，to provide a basis for the quality assurance of SARS-CoV-2 testing under routine and emergency conditions. Method The positive control substance of the kit was diluted according to the CT value of the positive quality control test of the kit, and the concentration reached 1.5~3 times of the detection limit was used as the self-formulated weakly positive quality control substance.
Results the positive control of the kit can be used as the self-matched quality control product with good stability after it was diluted, but the sample extraction steps cannot be monitored. The quality control of the kit used in daily sample testing is limited by each kit manufacturer, and it cannot be used in the kit of different manufacturers.
Conclusion  s The positive control dilution of the kit can be used as a weakly positive quality control product, which can be used temporarily for new projects or emergency situations. For long-term quality control in the laboratory, it is recommended to use self-supplied quality control product and third-party quality control product combined application.