Bankamp Bettina, Anderson Raydel, Hao Lijuan, Lopareva Elena, Chen Min-Hsin, Kim Gimin, Beard R Suzanne, Mori Yoshio, Otsuki Noriyuki, Ryo Akihido, Rota Paul A
Centers for Disease Control and Prevention, 1600 Clifton Road N.E., Atlanta, GA 30329, USA.
Department of Virology III, National Institute of Infectious Diseases, Tokyo 208-0011, Japan.
Vaccines (Basel). 2024 Jul 23;12(8):824. doi: 10.3390/vaccines12080824.
More than 100 laboratories in the World Health Organization Global Measles and Rubella Laboratory Network (GMRLN) perform nucleic acid-based methods for case confirmation of measles or rubella infections and/or strain surveillance (genotyping). The quality of laboratory data is critical to ensure that diagnostic results and country reports to regional verification committees are based on accurate data. A molecular External Quality Assurance (mEQA) program was initiated by the US-CDC in 2014 to evaluate the performance of laboratories in the network. The inclusion of testing for measles and rubella viruses, with a focus on detection and genotyping, plus the diversity of assays and platforms employed required a flexible and comprehensive proficiency testing program. A stepwise introduction of new evaluation criteria gradually increased the stringency of the proficiency testing program, while giving laboratories time to implement the required changes. The mEQA program plays an important role in many processes in the GMRLN, including informing plans for the training of laboratory staff, access to reagents, and the submission of sequence data to global databases. The EQA program for Local Public Health Institutes in Japan is described as an example for national mEQA programs. As more laboratories initiate molecular testing, the mEQA will need to continue to expand and to adapt to the changing landscape for molecular testing.
世界卫生组织全球麻疹和风疹实验室网络（GMRLN）中的100多个实验室采用基于核酸的方法对麻疹或风疹感染进行病例确认和/或毒株监测（基因分型）。实验室数据的质量对于确保诊断结果以及向区域验证委员会提交的国家报告基于准确数据至关重要。美国疾病控制与预防中心（US-CDC）于2014年启动了一项分子外部质量保证（mEQA）计划，以评估该网络中各实验室的性能。纳入麻疹和风疹病毒检测，重点是检测和基因分型，再加上所采用检测方法和平台的多样性，需要一个灵活且全面的能力验证计划。逐步引入新的评估标准逐渐提高了能力验证计划的严格程度，同时给实验室留出时间来实施所需的变革。mEQA计划在GMRLN的许多流程中发挥着重要作用，包括为实验室工作人员培训计划提供信息、获取试剂以及向全球数据库提交序列数据。日本地方公共卫生机构的质量保证计划被作为国家mEQA计划的一个例子进行了描述。随着越来越多的实验室开始进行分子检测，mEQA将需要继续扩展并适应分子检测不断变化的形势。
