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首页> 外文OA文献 >Proficiency Program for Real-Time PCR Diagnosis of Bordetella pertussis Infections in French Hospital Laboratories and at the French National Reference Center for Whooping Cough and other Bordetelloses▿ †
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Proficiency Program for Real-Time PCR Diagnosis of Bordetella pertussis Infections in French Hospital Laboratories and at the French National Reference Center for Whooping Cough and other Bordetelloses▿ †

机译：法国医院实验室和法国百日咳百日咳和其他百日咳杆菌参考中心的实时PCR诊断百日咳博德特氏菌感染的能力计划†

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With the support of a ministerial program for innovative and expensive technologies, dedicated to the economic evaluation of laboratory diagnosis of pertussis by real-time PCR, external quality assessment for real-time IS481 PCR was carried out. Coordinated by the National Centre of Reference of Pertussis and other Bordetelloses (NCR), this study aimed to harmonize and to assess the performances of eight participating microbiology hospital laboratories throughout the French territory. Between January 2006 and February 2007, 10 proficiency panels were sent by the NCR (ascending proficiency program), representing a total of 49 samples and including eight panels to analyze and evaluate the global sensitivity and specificity of real-time PCR, one to assess the limit of detection, and one to evaluate nucleic acid extraction methods. As part of the descending proficiency program, extracted DNA from clinical samples was sent by the eight participating laboratories in different panels and analyzed by the NCR. In the ascending proficiency analysis, the sensitivity and specificity of the real-time PCR methods were 92.2% and 94.3%, respectively. The limit of detection of the different methods ranged between 0.1 and 1 fg/μl (0.2 to 2 CFU/μl). The nucleic acid extraction methods showed similar performances. During the descending proficiency analysis, performed with 126 samples, the result of the NCR for 15 samples (11.9%) was discordant with the result obtained by the source laboratory. Despite several initial differences, harmonization was easy and performances were homogeneous. However, the risk of false-positive results remains quite high, and we strongly recommend establishment of uniform quality control procedures performed regularly.
机译：在一项部长级创新和昂贵技术计划的支持下，致力于通过实时PCR对百日咳的实验室诊断进行经济评估，从而对实时IS481 PCR进行了外部质量评估。该研究由百日咳和其他Bordetelloses国家参考中心（NCR）协调，旨在协调和评估整个法国境内八个参与的微生物医院实验室的性能。在2006年1月至2007年2月之间，NCR（提升能力计划）发送了10个能力验证小组，代表49个样本，其中包括8个小组来分析和评估实时PCR的整体敏感性和特异性，其中一个用于评估实时PCR的整体敏感性和特异性。检测限和一种评估核酸提取方法的方法。作为递减能力计划的一部分，从临床样品中提取的DNA由八个参与实验室的不同小组发送，并由NCR分析。在提升能力分析中，实时荧光定量PCR方法的灵敏度和特异性分别为92.2％和94.3％。不同方法的检测极限范围为0.1至1 fg /μl（0.2至2 CFU /μl）。核酸提取方法表现出相似的性能。在对126个样品进行的下降能力分析中，15个样品（11.9％）的NCR结果与来源实验室获得的结果不一致。尽管存在一些最初的差异，但是协调很容易，并且性能是一致的。但是，假阳性结果的风险仍然很高，我们强烈建议建立定期执行的统一质量控制程序。

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