上海市临床实验室梅毒血清学检测质量的评估

发布时间：2018-06-17 11:18

本文选题：上海市 + 临床　；参考：《复旦大学》2010年硕士论文

【摘要】：梅毒是由梅毒螺旋体引起的一种慢性疾病,它主要是通过性接触进行传播。近几年来,梅毒的发病率逐年增高已经成为一个严重的社会问题。梅毒的诊断主要依靠病史,临床症状和实验室检查。实验室检查是梅毒诊断的重要指标,其结果的可靠性直接影响梅毒诊断,治疗及疗效的判定,关系到病人的生命健康,因此提高检验结果的准确性十分重要。血清学实验是诊断梅毒的主要手段。一类是以快速血浆试验(RPR)或甲苯胺红不加热血清试验(TRUST)为代表的非梅毒螺旋体实验,通常称筛查试验；一类是以梅毒螺旋体明胶凝集实验(TPPA)为代表的梅毒螺旋体特异性试验,称确诊试验。目前尚未有对上海市梅毒血清学检测情况的分析或报道。本研究针对上海市开展梅毒血清学检测的临床实验室进行评估,了解上海市梅毒血清学检测的质量情况,寻找影响质量的原因并对临床实验室进行干预,以提高上海市梅毒血清学检测质量。第一部分上海市59家三级医院和区中心医院梅毒血清学筛查试验检测情况分析目的了解上海市59家三级和区中心医院临床实验室梅毒血清学筛查试验检测情况,分析影响梅毒血清学筛查试验检测质量的因素。方法2004年10月对上海市59家三级和区中心医院实验室进行现场调查,发放梅毒血清质控样品进行检测。对调查结果进行分析,寻找影响梅毒筛查试验检测质量因素。结果59家医院总体合格率为89.8%,梅毒筛查使用的仪器仅有40家(67.8%)合格,试剂48(98%)家单位合格,人员也都符合标准。筛查试验对于高滴度标本,不同的试剂测定的筛查结果(滴度)有差异F=4.498,p=0.038。合格的仪器能提高样品检测的准确性,x2=7.11 p=0.03。结论上海市59家三级和区中心医院梅毒筛查试验总体情况良好。高滴度标本使用不同的试剂检测时可能会得到不同的结果,仪器是否合格也是影响样品检测结果是否准确的重要因素之一。第二部分上海市临床实验室梅毒血清学检测质量的评估目的了解上海市临床实验室梅毒血清学检测的整体质量,并对影响检测的因素进行干预,以提高上海市梅毒血清学检测的整体水平。方法2006通过发放梅毒质控样品,了解整体情况。2006到2007年间对上海市临床实验室进行干预,比较干预前后血清学检测的情况,评价干预的效果。结果上海市筛查试验3年的实验室合格率分别为73%、83.1%、85.2%,确诊试验为93.5%、95.4%、99.1%。筛查试验中,一级医院经过第一次干预后合格率均有所提高x2=5.517 p=0.019,二级医院经第二次干预后合格率有所提高,x2=5.411 p=0.020；第一次干预后医院的总体合格率有提高x2=0.958 p=0.010。确诊实验检测情况中,经过两次干预医院合格率无明显变化,p=0.065,p=0.550。3年评估显示,确诊试验的医院合格率均高于筛查试验p=0.000。从质控样品分析,在阴性样品通过第一次干预合格率有所提高p=0.000,低滴度样品在第二次干预后出现合格率提高p=0.000。结论上海市临床实验室梅毒检测质量总体情况尚可,梅毒的确诊试验的检测质量要高于梅毒的筛查试验。目前梅毒的筛查试验检测仍存在问题,特别是对于滴度的判断。对梅毒影响因素的干预能在一定程度上提高梅毒血清学的检测质量。
[Abstract]:Syphilis is a chronic disease caused by Treponema pallidum, which is mainly transmitted through sexual contact. In recent years, the increasing incidence of syphilis has become a serious social problem.
The diagnosis of syphilis mainly depends on the history, clinical symptoms and laboratory tests. Laboratory examination is an important indicator of syphilis diagnosis. The reliability of the results is directly affected by the diagnosis of syphilis, the treatment and the judgment of the curative effect are related to the life and health of the patients. Therefore, it is very important to improve the accuracy of the test results.
Serological tests are the main means for the diagnosis of syphilis. One is a non syphilis spirals test represented by rapid plasma test (RPR) or toluidine red unheated sera test (TRUST), usually called screening test, and a type of Treponema pallidum specificity test, represented by the Treponema pallidum gelatin agglutination test (TPPA), is called the diagnosis test.
At present, there is no analysis or report on the serological detection of syphilis in Shanghai. In this study, the clinical laboratory of syphilis detection in Shanghai was evaluated, the quality of syphilis detection in Shanghai was understood, the causes of the quality were found and the clinical laboratory was intervened to improve the syphilis sera in Shanghai. Study the quality of the test.
Part one
Analysis of Syphilis Serological Screening test in 59 hospitals of three grade and Central District in Shanghai
Objective to understand the screening test of Syphilis Serological Screening test in clinical laboratories of 59 three grade and district central hospitals in Shanghai, and to analyze the factors affecting the quality of serological screening test for syphilis. Methods in October 2004, a field investigation was carried out on the laboratory of 59 central hospitals in Shanghai, Shanghai, and the quality control samples of syphilis were detected. The results were analyzed to find the quality factors affecting the screening test of syphilis. The total qualified rate of the 59 hospitals was 89.8%, only 40 (67.8%) were qualified for the screening of syphilis, 48 (98%) of the reagents were qualified and the personnel were all conformed to the standard. The screening test for the high titer specimens, the screening results of different reagents (titers) There is a difference of F=4.498, p=0.038. qualified instrument can improve the accuracy of sample detection, x2=7.11 p=0.03. conclusion the total situation of syphilis screening test in 59 Shanghai three grade and District Central Hospital is good. The high titer specimen may get different results when using different reagents. One of the important factors of accuracy.
The second part
Evaluation of Syphilis Serological detection quality in Shanghai clinical laboratory
Objective to understand the overall quality of the serological examination of syphilis in Shanghai clinical laboratory and to intervene the factors affecting the detection in order to improve the overall level of Syphilis Serological Detection in Shanghai. Method 2006 through the distribution of the quality control samples of syphilis in Shanghai, the overall situation.2006 was intervened in the clinical laboratory in Shanghai and the intervention was compared. After 3 years of Shanghai screening test, the qualified rate of the laboratory was 73%, 83.1%, 85.2%, and the confirmed test was 93.5%, 95.4%. The first grade hospital had improved the qualified rate of x2 =5.517 p=0.019 after the first dry prognosis, and the two grade hospital was qualified after second times of dry prognosis. There were some improvement, x2=5.411 p=0.020; the overall qualified rate of the first hospital prognosis was higher than that of the x2=0.958 p=0.010. diagnosis test, and there was no obvious change in the qualified rate of the two intervention hospitals. The p=0.065, p=0.550.3 year evaluation showed that the qualified rate of the confirmed test was higher than the screening test p=0.000. from the quality control sample analysis. The sex sample was improved by the first intervention rate of p=0.000, the low titer samples increased p=0.000. after the second intervention. Conclusion the overall situation of the quality of syphilis detection in Shanghai clinical laboratory was still available. The quality of the diagnosis test of syphilis was higher than that of the screening test of syphilis. In particular, the intervention of factors affecting syphilis can improve the quality of syphilis serology.
【学位授予单位】：复旦大学
【学位级别】：硕士
【学位授予年份】：2010
【分类号】：R759.1

【参考文献】