International Journal of Medicine and Data

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. Conclusions 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.

Self-matched Quality Control Products; Third Party Quality Control; SARS-CoV-2; Combined Detection