Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang Province, China.
Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang Province, China.
Diagn Microbiol Infect Dis. 2022 Nov;104(3):115766. doi: 10.1016/j.diagmicrobio.2022.115766. Epub 2022 Jul 20.
The COVID-19 pandemic has necessitated the rapid expansion of laboratories that conduct SARS-CoV-2 tests. A provincial external quality assessment (EQA) scheme on SARS-CoV-2 tests was organized by Zhejiang Provincial CDC to assess the accuracy of the tests in individual CDC municipal and county laboratories in Zhejiang Province, China. Three positive samples in high, medium, and low concentrations, respectively, were prepared using the serial dilutions from the culture with the viral titer concentration of 1×10 TCID50/mL, and one negative sample were included. A total of 93 laboratories participated, contributing results from 36 distinct combinations of nucleic acid extraction methods and PCR reagents. There was 100% concordance among all laboratories for all EQA samples, and no false-positive or false-negative results were observed. The EQA survey provides confidence in the identification of infected individuals or asymptomatic populations and assurance for clinical and public health decision-making based on test results.
新型冠状病毒肺炎疫情促使进行 SARS-CoV-2 检测的实验室迅速扩张。浙江省疾病预防控制中心组织了一项省级 SARS-CoV-2 检测外部质量评估（EQA）计划，以评估中国浙江省各疾病预防控制市级和县级实验室检测的准确性。使用病毒滴度浓度为 1×10 TCID50/mL 的培养物进行连续稀释，分别制备了高、中、低浓度的三个阳性样本，并包含一个阴性样本。共有 93 家实验室参加，提供了 36 种不同核酸提取方法和 PCR 试剂组合的结果。所有实验室对所有 EQA 样本的检测结果完全一致，没有出现假阳性或假阴性结果。EQA 调查为识别受感染个体或无症状人群提供了信心，并为基于检测结果进行临床和公共卫生决策提供了保证。
