网络出版日期: 2020-05-11
Current status of institutional capabilities of officially accredited and approved laboratories in detecting parasites-parasitic diseases in China
Online published: 2020-05-11
通过我国政府各管理部门官方网站获取检验检测机构资质认定、实验室认可及检测项目、检测方法和检测标准等相关信息,用Excel数据透视表对国家认证认可实验室寄生虫和寄生虫病检测能力的现状进行描述性统计分析。结果显示,截至2019年6月底,在全国各级疾病预防控制中心共3 457个机构中,同时通过资质认定（CMA）和实验室认可（CNAS）的82个（2.4%）;82个认证认可实验室开展寄生虫/寄生虫病检测的有47个（57.3%）,获批的寄生虫检测项目/参数共607项,室均检测项目数7.4项。以检测对象分,疾病控制类463项（76.3%）、生活饮用水51项（8.4%）、食品47项（7.7%）和实验动物46项（7.6%）。同时具有与人体寄生虫病直接相关的疾病控制类、生活饮用水和食品等3类样品检测能力的实验室只有7个（14.9%,7/47）;以检测方法分,病原学方法检查的有403项（66.4%）,免疫学方法检测的有178项（29.3%）,分子生物学检测的26项（4.3%）。同时具有病原学、免疫学和分子生物学检测能力的实验室有11个（23.4%,11/47）;607个检测项目中,在用的检测依据共计75个。使用国标和行标的项目数为437项（72.0%）,使用非标的项目数为170项（28.0%）;非标项目中,有可用标准但未使用的为89项（52.4%）。提示我国疾病预防控制体系内获得认证认可的实验室数量较少,室均检测项目数尚不足以覆盖常见寄生虫,有可用标准但未使用的检测项目较多。有必要加强认证认可实验室的建立和能力提升的指导、培训和能力验证等方面工作,进一步提升国家认证认可实验室的寄生虫（病）检测能力。
关键词： 疾病预防控制; 寄生虫（病）; 检测能力; 检验检测机构资质认定; 实验室认可
江莉 , 黄浦雁 , 吴寰宇 , 王真瑜 , 郑彬 , 郭常义 . 我国疾病预防控制机构国家认证认可实验室寄生虫（病）检测能力的现状分析[J]. 中国寄生虫学与寄生虫病杂志, 2020 , 38(2) : 224 -233 . DOI: 10.12140/j.issn.1000-7423.2020.02.015
Based on the information of officially qualified laboratories undertaking examination and detection service, the current status of operational capacity in detecting parasites-parasitic diseases was descriptively analyzed using the Excel PivotTable tool. The information analyzed were obtained from relevant official websites of government administrations, comprising institution accreditation, laboratory approval, test items, test method, and test standard. The results showed that by the end of June 2019, there were 3 457 testing laboratories at all levels of disease control and prevention centers in China, and 82 (2.4%) of them have been qualified by both China Inspection Body and Laboratory Mandatory Approval (CMA) and China National Accreditation Service for Conformity Assessment (CNAS). 47 of 82 certification and accreditation laboratories detect the parasites (parasitical diseases), accounting for 57.3%. A total of 607 parasitical detection items/parameters were approved (7.4 items/laboratory on average). With regard to the type of testing object, there were 436 items concerning disease control (76.3%), 51 for tap water testing (8.4%), 47 for food inspection (7.7%) and 46 for experimental animal testing (7.6%). Only seven laboratories (14.9%, 7/47) were capable of testing specimens for disease control, as well as tap water and food specimens, which are directly related to human parasitic diseases. With regard to the testing method, there were 403 items (66.4%) using pathogenic methods, 178 items (29.3%) using immunological methods, and 26 items (4.3%) using molecular biological methods. Eleven laboratories (23.4%, 11/47) were qualified being capable of pathogenic, immunological and molecular testings at the same time. Of 607 test items, 75 reference standards were in current use; 437 items (72.0%) using national and trade standards, and 170 items (28%) using non-standard references. Of the 170 items with non-standard references, 89 items (52.4%) have the reference standards available but not befing used. These results suggested that the number of CMA accredited and CNAS qualified laboratories in the disease prevention and control system is low, the average number of testing items per laboratory is not sufficient to cover common parasites, and a considerable number of testing items have not used the standard references, although these standards are already available. To CMA-CNAS laboratories, it is necessary to strengthen the guidance on the development and capacity building, training and capacity validation, in order to further enhance the capabilities of detecting parasite (parasitic disease).
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