Impact of external quality assessment on antinuclear antibody detection performance
Impact of external quality assessment on antinuclear antibody detection performance
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DOI：
10.1191/0961203305lu2069oa
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发表时间：
2005-02
期刊：
影响因子：
2.6
通讯作者：
Bach-Nga Pham;S. Albarède;A. Guyard;E. Burg;Pascale Maisonneuve
中科院分区：
文献类型：
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作者：
Bach-Nga Pham;S. Albarède;A. Guyard;E. Burg;Pascale Maisonneuve
我们的目的是评估法国临床实验室使用间接免疫荧光法(IIF)检测抗核抗体(ANA)的表现。自1998年以来，法国保健品安全机构每年组织一次关于ANA检测的国家外部质量评估(EQA)。606至687个实验室和6个在进行自身免疫测试方面经验丰富的大学参考实验室参加了为期6年的连续调查。每个实验室都必须对方法学程序作出答复，并给出编码的答复。观察到IIF方法学程序的可变性。向有关实验室指出，使用不适当的显微镜放大倍数来读取载片或非常规的血清稀释截止值。在ANA检测方面，当样品中含有ANA时，实验室的良好响应率为92.7%至99.5%。在同一样本上获得的ANA滴度的广泛分散每年都会被重复观察到。对特定荧光模式的错误解释被注意到。在ANA阴性标本中，好转率为94.3%。综上所述，ANA检测在常规实践中还远未达到标准化。然而，如果在连续几年的调查中进行EQA，可能会对ANA的检测性能产生影响，因为它为参与的实验室提供建议，以限制与方法学程序有关的实验室间差异。
Our objective was to evaluate performance of the clinical laboratories for the detection of antinuclear antibodies (ANA) by using indirect immunofluorescence method (IIF), in France. A national external quality assessment (EQA) on ANA detection was organized by the French health products safety agency once a year since 1998. Between 606 to 687 laboratories together with six university reference laboratories experienced in performing tests in autoimmunity participated in the six-year consecutive survey. Each laboratory had to answer to methodological procedures and give coded responses. Variability in IIF methodological procedure was observed. Use of inappropriate microscope magnifications for reading slides or nonconventional cutoff dilution of serum were pointed out to concerned laboratories. Concerning ANA measurement, the rate of good responses ranged from 92.7% to 99.5% of the laboratories when the samples contained ANA. A wide dispersion of ANA titers obtained on a same sample was repeatly observed every year. Misinterpretation of particular fluorescence pattern was noticed. On ANA negative sample, the rate of good responses was 94.3%. In conclusion, ANA detection in routine practice is far from being standardized. However, EQA may have an impact on ANA detection performance when it is conducted on several consecutive year surveys, by providing advice for participating laboratories to limit inter laboratory variations related to methodological procedures.