查看更多>>摘要：目的 分析2006 - 2023年全国地方病防治机构氟化物检测实验室外质控考核情况，掌握全国各省、市、县级地方病防治机构氟化物检测实验室氟检测外质控能力，确保全国地方性氟中毒监测数据的准确性和可靠性。 方法 采用回顾性分析，对2006 - 2023年，所有全国地方病防治机构氟化物检测实验室外质控考核结果进行汇总分析。其中2006 - 2008年的考核结果，采用Grubbs法检验异常值；Cochran法检验方差齐性，剔除不合格实验室的考核数据，计算总平均值和总标准差；Z比分法检验实验室考核情况，采用│Z│ < 3的结果进行统计和判定。2009 - 2023年的考核结果来自所有实验室，其中2010年按上、下半年进行两次，其余年份每年1次。采用稳健统计，分别计算各实验室的Z比分数，当│Z│≤2时，考核结果为合格；当2 <│Z│ < 3时，考核结果为基本合格；当│Z│≥3时，考核结果为不合格，公议值来自所有参加考核的实验室。 结果 从2006年质控运行之初到2023年,参加外质控考核的实验室数量明显增加。其中参加水氟考核的实验室由2006年的30个增加到2023年的1 277个，参加尿氟考核的实验室由29个增加到497个；参加砖茶氟考核的实验室由2014年的43个增加到2023年的193个。考核结果显示，当│Z│ < 3时，全国地方病防治机构氟化物检测实验室水氟外质控总合格率为95.2%，其中最低是2008年为87.1%（27/31）最高是2014年为100.0%（394/394）；当│Z│≤2时，总的反馈合格率为88.4%，其中2010年上半年最低，为79.3%（288/363），2014年最高，为99.5%（392/394）。考核结果显示，当│Z│ < 3时，全国地方病防治机构氟化物检测实验室尿氟外质控总合格率为98.0%，其中2006、2007年最低，均为86.2%（25/29），是2014年最高，为100.0%（68/68）；当│Z│≤2时，总合格率为93.7%,其中最低是2010年下半年为86.5%（64/74），最高是2014年为100%（68/68）。考核结果显示，当│Z│ < 3时，全国地方病防治机构氟化物检测实验室砖茶氟外质控总合格率为95.4%，其中最低是2023年为85.0%（164/193），2014、2015、2016年最高，为100.0%（43/43、51/51、79/79）；当│Z│≤2时，总合格率为89.2%，其中2017年最低，为72.7%（32/44），2014年最高，为100.0%（43/43）。2009 - 2023年水氟检测考核全部合格的省级实验室共21个，其中市、县级实验室全部合格的省份共3个；尿氟检测考核全部合格的省级实验室共11个，其中市、县级实验室全部合格的省份仅1个；2014 - 2023年茶氟检测考核全部合格的省级实验室共5个，无市、县级实验室全部合格的省份。 结论 2006 - 2023年，参加外质控考核的氟化物检测实验室数量逐年增加，大部分省、市、县级实验室均具有较好的氟化物检测能力，能够满足地方病防治监测的检测需求；对于部分存在问题的实验室，要有针对性地进行整改，提高检测质量，以期为地方性氟中毒病区监测工作提供更好的技术保障。 Objective To analyze the external quality control assessment results of fluoride testing laboratories in endemic disease prevention and control institutions nationwide from 2006 to 2023, investigate the quality control capabilities of these laboratories in various provinces, prefectures, cities, and counties nationwide, and ensure the accuracy and reliability of surveillance data on endemic fluorosis nationwide. Methods Using retrospective analysis, the external quality control assessment results of all participating fluoride testing laboratories of national endemic disease prevention and control institutions from 2006 to 2023 were summarized and analyzed. The assessment results from 2006 to 2008 were tested for outliers using Grubbs method, homogeneity of variance using Cochran method, excluding the assessment data of unqualified laboratories, calculating the total mean and total standard deviation, Z-score method was used to test the assessment of laboratories, and statistical analysis and judgment were done when the result of │Z│ < 3. The assessment results from 2009 - 2023 were obtained from all laboratories. In 2010, two tests were conducted in the first and second half of the year, and the Z-ratio scores of each laboratory were calculated using robust statistics. When │Z│≤2, the assessment was qualified when 2 < │Z│ < 3, the assessment was basically qualified when│Z│≥3, the assessment was unqualified, and the consensus value came from all participating laboratories in the assessment. Results From the beginning of quality control operation in 2006 to 2023, the number of laboratories participated in external quality control assessments had significantly increased. The number of laboratories participated in water fluoride assessment increased from 30 in 2006 to 1 277 in 2023, and the number of laboratories participated in urine fluoride assessment increased from 29 to 497. The number of laboratories participated in the brick tea fluorine assessment had increased from 43 in 2014 to 193 in 2023. The assessment results showed that when │Z│ < 3, the total qualified rate of fluoride external quality control in fluoride testing laboratories of national endemic disease control institutions was 95.2%, with the lowest being 87.1% (27/31) in 2008 and the highest being 100.0% (394/394) in 2014. When │Z│≤2, the total feedback pass rate was 88.4%, with the lowest being 79.3% (288/363) in the first half of 2010 and the highest being 99.5% (392/394) in 2014. The assessment results showed that when │Z│ < 3, the total pass rate of urine fluoride external quality control in fluoride testing laboratories of national endemic disease control institutions was 98.0%, with the lowest being 86.2% (25/29) in 2006 and 2007, respectively, and the highest being 100.0% (68/68) in 2014. When │Z│≤2, the total qualification rate was 93.7%, with the lowest being 86.5% (64/74) in the second half of 2010 and the highest being 100.0% (68/68) in 2014. The assessment results showed that when│Z│ < 3, the total pass rate of extra-fluoride quality control of brick tea in fluoride testing laboratories of national endemic disease control institutions was 95.4%, with the lowest being 85.0% (164/193) in 2023, and the highest being 100.0% (43/43, 51/51, 79/79) in 2014, 2015 and 2016, respectively. When │Z│≤2, the total pass rate was 89.2%, with the lowest being 72.7% (32/44) in 2017 and the highest being 100.0% (43/43) in 2014. From 2009 to 2023, there were a total of 21 provincial-level laboratories that passed the water fluoride detection assessment, including 3 provinces where all prefecture level and county-level laboratories were qualified. The assessment results of urinary fluorine showed that there were 11 qualified provincial-level laboratories and 1 prefecture-level laboratory. From 2014 to 2023, the assessment results of brick-tea fluorine showed that there were 5 provincial-level laboratories that passed the tea fluorine testing assessment and no prefecture-level laboratory. Conclusions Conclusion: From 2006 to 2023, the number of fluoride testing laboratories participating in external quality control assessment has increased year by year, and most provincial, municipal and county-level laboratories have good fluoride testing capabilities, which can meet the testing needs of endemic disease prevention and monitoring. For some laboratories with problems, targeted rectification should be carried out to improve the quality of detection, in order to provide better technical support for the monitoring of endemic fluorosis areas.
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