中国临床实验室丙型肝炎病毒RNA检测的室间质量评价

External quality assessment on detection of hepatitis C virus RNA in clinical laboratories of China.

作者信息

Wang Lu-nan, Zhang Rui, Shen Zi-yu, Chen Wen-xiang, Li Jin-ming

机构信息

National Center for Clinical Laboratory, Beijing Hospital, Beijing, China.

出版信息

Chin Med J (Engl). 2008 Jun 5;121(11):1032-6.

PMID:18706255

Abstract

BACKGROUND

As with many studies carried out in European countries, a quality assurance program has been established by the National Center for Clinical Laboratories in China (NCCL). The results showed that the external quality assessment significantly improves laboratory performance for quantitative evaluation of hepatitis C virus (HCV) RNA.

METHODS

Serum panels were delivered twice annually to the clinical laboratories which performed HCV RNA detection in China. Each panel made up of 5 coded samples. All laboratories were requested to carry out the detection within the required time period and report on testing results which contained qualitative and/or quantitative test findings, reagents used and relevant information about apparatus. All the positive samples were calibrated against the first International Standard for HCV RNA in a collaborative study and the range of comparison target value (TG) designated as +/- 0.5 log.

RESULTS

The numbers of laboratories reporting on qualitative testing results for the first and second time external quality assessment were 168 and 167 in the year of 2003 and increased to 209 and 233 in 2007; the numbers of laboratories reporting on quantitative testing results were 134 and 147 in 2003 and rose to 340 and 339 in 2007. Deviation between the mean value for quantitative results at home in 2003 and the target value was above 0.5 log, which was comparatively high. By 2007, the target value was close to the national average except for the low concentrated specimens (10(3) IU/ml). The percentage of results within the range of GM +/- 0.5 log(10) varied from 8.2% to 93.5%. Some laboratories had some difficulties in the exact quantification of the lowest (3.00 log IU/ml) as well as of the highest viral levels (6.37 log IU/ml) values, very near to the limits of the dynamic range of the assays.

CONCLUSIONS

The comparison of these results with the previous study confirms that a regular participation in external quality assessment (EQA) assures the achievement of a high proficiency level in the diagnosis of HCV infection. During the 5-year external quality assessment, sensitivity and accuracy of detection in most of the clinical laboratories have been evidently improved and the quality of kits has also been substantially improved.

摘要

背景

与许多在欧洲国家开展的研究一样，中国国家临床检验中心（NCCL）已建立了一项质量保证计划。结果表明，外部质量评估显著提高了丙型肝炎病毒（HCV）RNA定量评估的实验室性能。

方法

血清样本每年两次发放给中国进行HCV RNA检测的临床实验室。每个样本组由5个编码样本组成。要求所有实验室在规定时间内进行检测，并报告检测结果，包括定性和/或定量检测结果、使用的试剂以及仪器的相关信息。在一项协作研究中，所有阳性样本均根据首个HCV RNA国际标准进行校准，比较目标值（TG）范围设定为±0.5 log。

结果

2003年首次和第二次外部质量评估报告定性检测结果的实验室数量分别为168家和167家，2007年增至209家和233家；2003年报告定量检测结果的实验室数量为134家和147家，2007年增至340家和339家。2003年国内定量结果的平均值与目标值之间的偏差高于0.5 log，相对较高。到2007年，除低浓度样本（10³ IU/ml）外，目标值接近全国平均水平。GM±0.5 log₁₀范围内的结果百分比在8.2%至93.5%之间。一些实验室在对最低（3.00 log IU/ml）以及最高病毒水平（6.37 log IU/ml）值进行精确定量时存在一些困难，这些值非常接近检测方法动态范围的极限。