Investigation On The Development And Application Of Reference Materials In The Field Of Environmental Health

Objectives:To compare the general situation on the development of reference material in the field of environmental health between China and other developed countries,and to grasp the statues of reference material production,usage and demand of reference materials in the field of environmental health in China,as well as the hardness and difficulties in related research.To analyze the problems and challenges faced by the development of reference material,and to provide supports for the development of new varieties of reference materials in the future.Methods:To search academic data bases such as PubMed,CNKI,Wanfang Database,as well as websites related to reference material research organizations to collect information on reference material research organizations,the category and amount of reference material,the process and standards of reference materials production,and the usage of reference materials,and to compare the difference between China and other countries.In total of 32 provinces,autonomous regions and municipality cities in China were selected,3 cities were selected randomly in each provinces and,and 3 districts/counties were selected in each cities.Choose Jiangsu province and Gansu province as the key points to carry out questionnaire survies.The questionnaire survey was carried out among the laboratory personnel of disease prevention and control institutions in selected sites.The results of the questionnaire were input in Epidata 3.1 and the data were analyzed by SPSS 22 software.Pearson test was used to analyze the relationship between the usage of reference materials and different regions and institutes,as well as that of the purchase factors of reference materials.The top purchase factor of reference materials were analyzed by Friedman test and Kendall test.In order to adjust the results of data research and questionary,interview experts of reference material producers and users to acknowledge the development statues and difficu ties of reference materials in China.Results:According to the acdemic survey results,the 9 ISO guides issued by the International Organization for Reference Material Committee(ISO/REMCO)are the basis for the standardization of reference materials in various countries.At present,countries with more developed reference materials include the United States,the United Kingdom,Germany and the European Reference Material(ERM)created by the European Joint Research Center,Japan,South Korea,etc.All countries have followed the ISO guides to produce reference materials.And reference materials producers are mainly research institutions at the national level.Due to the long history of development and the relatively developed economic development,the United States,the European Union,the United Kingdom,and Japan all have plenty of environmental reference materials.Refernce material in China is divided into two systems:reference materials and refernce samples.There are differences in the management,definition and classification of the two systems.The reference material/sample production equivalently adopted the ISO guidels,and the producers are composed of research institutions and enterprises that have passed the national qualification approval.However,due to the late start of the development of China's reference materials/samples,the amount of mixed standard gases in environmental reference materials/samples is small,organic substances,inorganic substances,microbial indicators,active ingredients in disinfectants,standard substances/samples required for cosmetics testing and related hygiene is poor.A total of 360 questionnaires were distributed in the questionnaire survey,and 354 valid questionnaires were returned.Respondents were aware of the reference materials/samples,with 29.9%(106/354)of respondents aged 6-10 years.Respondents indicated that work was most often done using standard materials/samples to draw calibration curves.59%of respondents only used domestic reference materials/samples,39.6%of respondents used domestic and imported reference materials/samples,and 1.4%used only imported reference materials/samples.Respondents believe that domestic reference materials/samples are cheap and easy to purchase,but the catagories are incomplete;while the imported reference materials are complete in variety,traceable,expensive,and cumbersome to purchase.They will prefer national reference material/sample producers to purchase reference materials.The respondents'reference materials/samples that encountered difficulties in their daily work,including matrix reference materials and various mixed reference materials,were consistent with the results of expert interviews.Between 2011 and 2016,the average annual cost of respondents purchasing refence substances/samples showed an upward trend,and the difference between the average annual cost and the region was not statistically significant,and was statistically significant between the level of the institutes(P = 0.00,P<0.05).Respondents indicated that the specific components of the reference material/sample were first considered when purchasing the reference material/sample,which is consistent with the results of the expert interview.Conclusion:Due to the late start of China's reference materials/samples,the development in the environmental field is not as comprehensive as foreign countries,and there are differences between the management system and foreign countries.The reference material/sample producer has low production technology,high development cost,long development cycle and access to imported reference materials are the reasons for the slow development of China's reference materials/samples.China should strengthen the supervision of reference materials/samples,control the reference material/sample market,mobilize the enthusiasm of producers,and develop portable and stable low-concentration environmental reference materials/samples to provide data support and quantity transfer for national environmental pollution monitoring work.