Establishment of national standard for enterovirus 71 nucleic acid detection kit
10.13200/j.cnki.cjb.004510
- VernacularTitle:肠道病毒71型核酸检测试剂国家标准品的建立
- Author:
HAO Xiaotian
- Publication Type:Journal Article
- Keywords:
Enterovirus 71(EV71);
Nucleic acid detection;
Standard;
Limit of detection(LOD)
- From:
Chinese Journal of Biologicals
2025;38(06):659-663
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish the first national standard for enterovirus 71(EV71) nucleic acid detection kit for quality evaluation of related kits.Methods EV71 virus isolation culture was collected,diluted and lyophilized after inactivation to prepare the national standard for EV71 nucleic acid detection kit.Eleven laboratories were selected to evaluate the standard by digital PCR.The concentration of standard was determined according to the evaluation results,and the homogeneity,stability and applicability were analyzed.Results It was determined that the concentration of the national standard for EV71nucleic acid detection kit was(6.7±0.3) log10U/mL(k=2).The homogeneity of the standard met the requirements.The stability was not affected when the standard was stored at 4℃ for 7 days or at room temperature(25℃) for 3 days.The applicability study results confirmed that the standard could accurately evaluate the limit of detection(LOD) and other performances of the detection kit.Conclusion The first national standard for EV71 nucleic acid detection kit was established,which provides physical standard and basis for quality control and evaluation of performance indicators such as LOD of related kits.
