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[乙型和丙型肝炎病毒核酸检测的NEQAS国际外部质量评估计划结果分析]

[Analysis of the results of NEQAS international external quality assessment programme for hepatitis B and C virus nucleic acid tests].

作者信息

Sayan Murat, Willke Ayşe, Meriç Meliha, Etiler Nilay

机构信息

Kocaeli Universitesi Tip Fakültesi Hastanesi, Merkez Laboratuvari, PCR Unitesi, Kocaeli.

出版信息

Mikrobiyol Bul. 2009 Jan;43(1):103-14.

Abstract

External quality assessment (EQA) has been playing an increasingly important role in the implementation of nucleic acid amplification techniques (PCR) for clinical diagnosis. In this study, the results of HBV-DNA quantification and HCV-RNA detection tests evaluated by United Kingdom National External Quality Assessment Scheme for Microbiology (NEQAS) were analysed and the performance of our laboratory was evaluated. Between April 2006-January 2008, in four different distribution panels including 16 freeze-dried serum and six plasma specimens for HBV-DNA and HCV-RNA testing, respectively, were received. Viral nucleic acids were extracted by magnetic particle technology (NucliSENS-easyMAG, bioMérieux, Boxtel, Holland). HBV-DNA and HCV-RNA tests were performed by Fluorion HBV quantitative v2.0 and Fluorion HCV quantitative v2.1 (lontek AS, Istanbul, Turkey) kits in real-time PCR (iCycler IQ v3.0a - BioRad Laboratories, Hercules, CA, USA) platform. The performance scores of all the quantification tests of HBV-DNA were 2 (completely correct result) and a strong correlation (r= 0.987) between the quantitative HBV data and the target values was found by linear regression analysis. The NEQAS scores of HCV-RNA testing, except for a false negative result (since the viral load in this specimen was very low--79 IU/ml--it was not scored by NEQAS), were 2 in all specimens. The evaluation of the data revealed 100% detection in HBV-DNA and 83.3% detection in HCV-RNA. In conclusion, the results of this study showed high accuracy of HBV quantification in the samples of HBV infected patients under antiviral therapy. However, the analytical sensitivity of HCV-RNA quantitative kit should be improved for the purpose of reliable HCV-RNA results. External quality control panels are important tools for monitoring the quality of diagnostic laboratory tests. Therefore, PCR laboratories should always have EQA in routine procedures.

摘要

外部质量评估(EQA)在临床诊断中核酸扩增技术(PCR)的应用中发挥着越来越重要的作用。在本研究中,分析了由英国国家微生物学外部质量评估计划(NEQAS)评估的HBV-DNA定量和HCV-RNA检测试验结果,并评估了我们实验室的性能。在2006年4月至2008年1月期间,分别收到了四个不同的分发小组的样本,其中包括16份用于HBV-DNA检测的冻干血清样本和6份用于HCV-RNA检测的血浆样本。采用磁珠技术(NucliSENS-easyMAG,生物梅里埃公司,荷兰博克斯泰尔)提取病毒核酸。在实时PCR(iCycler IQ v3.0a - 伯乐生命医学产品公司,美国加利福尼亚州赫拉克勒斯)平台上,使用Fluorion HBV定量v2.0和Fluorion HCV定量v2.1(土耳其伊斯坦布尔的Lontek AS公司)试剂盒进行HBV-DNA和HCV-RNA检测。所有HBV-DNA定量检测的性能得分均为2(结果完全正确),通过线性回归分析发现定量HBV数据与目标值之间存在强相关性(r = 0.987)。除了一个假阴性结果(由于该样本中的病毒载量非常低 - 79 IU/ml - NEQAS未对其进行评分)外,所有样本的HCV-RNA检测的NEQAS得分均为2。数据评估显示,HBV-DNA检测率为100%,HCV-RNA检测率为83.3%。总之,本研究结果表明,在接受抗病毒治疗的HBV感染患者样本中,HBV定量具有很高的准确性。然而,为了获得可靠的HCV-RNA结果,应提高HCV-RNA定量试剂盒的分析灵敏度。外部质量控制样本是监测诊断实验室检测质量的重要工具。因此,PCR实验室在常规程序中应始终进行EQA。

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