CHINESE JOURNAL OF PARASITOLOGY AND PARASITIC DISEASES ›› 2020, Vol. 38 ›› Issue (2): 224-233.doi: 10.12140/j.issn.1000-7423.2020.02.015

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Current status of institutional capabilities of officially accredited and approved laboratories in detecting parasites-parasitic diseases in China

Li JIANG1,*(), Pu-yan HUANG1, Huan-yu Wu1, Zhen-yu WANG1, Bin ZHENG2, Chang-yi GUO1   

  1. 1 Shanghai Municipal Center for Disease Control and Prevention, Shanghai Institutes of Preventive Medicine, Shanghai 200336, China
    2 National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention; Chinese Center for Tropical Diseases Research; WHO Collaborating Centre for Tropical Diseases; National Center for International Research on Tropical Diseases, Ministry of Science and Technology; Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai 200025, China
  • Online:2020-04-30 Published:2020-05-11
  • Contact: Li JIANG E-mail:jiangli@scdc.sh.cn

Abstract:

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).

Key words: Disease Control and Prevention, Parasite(Parasitic disease), Detecting capability, CMA, CNAS

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