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[目的]调研河南省AIDS筛查实验室工作的现实状况,发掘技术上及管理中存在的问题,以提高检测质量。[方法]抽取河南省108家艾滋病筛查实验室,对质量保证、实验室规范化建设、人力资源及培训情况、SOP文件、实验室质量控制等8个方面进行现场调查,以统一的调查评分表打分,统计分析分数。[结果]按评分标准统计,本次调查的实验室中3.7%(4/108)不合格(≤60分),5.6%(6/108)合格(61～80分),40.7%(44/108)良好(81～90分),50.0%(54/108)优秀(≥91分)。不规范的项目主要为:76.9%(83/108)质控图签字不规范,48.2%(52/108)无失控分析及纠错记录,45.4%(49/108)仪器校准不规范,34.3%(37/108)未规范使用外部质控品,31.5%(34/108)的ELISA原始记录不规范,各实验室对发现的问题立即进行整改。[结论]河南省AIDS筛查实验室存在一些问题,应加强实验室技术培训和质量控制方面的工作。
[Objective] The research aimed to investigate the current situation of AIDS screening laboratories in Henan Province and explore the technical and management problems in order to improve the quality of testing. [Methods] A total of 108 AIDS screening laboratories in Henan Province were drawn and field survey was conducted on 8 aspects of quality assurance, standardized laboratory construction, human resources and training, SOP documents, and laboratory quality control. A unified questionnaire Scoring, statistical analysis of scores. [Results] According to the grading standards, 3.7% (4/108) failed (≤60 points), 5.6% (6/108) qualified (61-80 points), 40.7% (44 / 108) were good (81-90), 50.0% (54/108) excellent (≥91). The non-standard items mainly include: 76.9% (83/108) Quality Control Chart Signing Unqualified, 48.2% (52/108) No Control Analysis and Error Correction Records, 45.4% (49/108) Instrument Calibration Not Standardized, 34.3% (37/108) Unconventional external controls were used, and 31.5% (34/108) of the original ELISA records were not standardized. The laboratories rectified the problems immediately. [Conclusion] There are some problems in AIDS screening laboratory in Henan Province, we should strengthen laboratory technical training and quality control work.