【摘要】 目的：使用3种评价方式，对细菌内毒素动态浊度法能力验证检测结果进行评价，以探讨更科学、能深入区分实验室检测能力的方式。方法：首先收集1轮设计有重复策略的细菌内毒素动态浊度法能力验证结果，然后在对数结果状态下采用稳健算法A和稳健算法S分别获得指定值和能力评定标准差等统计量，再用质量限度标准（50%～200%）、Z值和均值-极差图3种评价方式，对实验室的检测能力进行评价。结果：40家实验室的检测结果，经统计分析后，在对数（log10）状态下，获得稳健算法A的指定值X为4.074和稳健算法S能力评定标准差σ_PT为0.042。实验室的能力，（1）按照质量限度标准方式评价，40家实验室的检测结果在指定值X的50%～200%，均被评价为满意。（2）按照Z值方式评价：a.当对实验室内结果按照对数均值进行Z值评价时，有36家实验室被评价为满意；有4家实验室被评价为可疑；未见不满意实验室。b.当对实验室内结果按照每个对数值进行Z值评价时，有31家实验室被评价为满意；有6家实验室被评价为可疑；有3家实验室被评价为不满意。（3）按照均值-极差图方式评价时，有25家实验室被评价为满意；有8家实验室被评价为可疑；有7家实验室被评价为不满意。结论：尽管国际上通常采用质量限度标准方式对参与实验室能力（细菌内毒素能力验证）作最终满意与否的评价，但均值-极差图方式在这3种评价方式中，能更好地区分出参与实验室的能力，并能直观显示出偏离指定值的距离和离散大小。更多还原

【Abstract】 Objective:To explore a more accurate and profound approach to distinguish the testing capabilities of laboratories by using three evaluation methods to evaluate the results of proficiency testing for the kinetic turbidimetric method of bacterial endotoxins. Methods:First, the results were collected from a round of proficiency testing program designed with repeated strategy of the kinetic turbidimetric method of bacterial endotoxins. Then, the assigned value and the proficiency testing standard deviation were calculated by using the robust algorithm A and robust algorithm S respectively under the logarithmic scale, and subsequently, three evaluation methods were utilized to assess the testing capabilities of the laboratories which were the quality acceptance criterion（ranging from 50% to 200%）, the Z-scores, and the plots of ranges against averages. Results:After statistical processing of the test data under the logarithmic（log10） scale from forty laboratories, the assigned value X was 4.074 which obtained by using the robust algorithm A, and the proficiency testing standard deviation(σ_PT) was 0.042 by using the robust algorithm S. The lab capability,（1） When accessed by using the quality acceptance criterion method, the test results of all forty laboratories fell within the range of 50%-200% of the assigned value X, and thus were all categorized as satisfactory;（2） When accessed by using the Z-scores method: a. Thirty-six laboratories were rated as satisfactory, four as questionable, and none as unsatisfactory when using the mean of the intra-laboratory logarithmic results to calculate the Z-scores. b. Thirty-one laboratories were rated as satisfactory, six as questionable, and three as unsatisfactory when using each logarithmic result of the intra-laboratory to calculate the Z-scores;（3） When accessed by using the plots of ranges against averages method, twenty-five laboratories were rated as satisfactory, eight as questionable, and seven as unsatisfactory. Conclusion:Although the international community generally adopts the quality acceptance criterion method to make a final evaluation of whether the participating laboratories’ capabilities（bacterial endotoxin proficiency testing） are satisfactory or not, it could be better distinguished the capability of the participating laboratories and could be more intuitively showed the bias from the assigned value and the degree of dispersion of each participating laboratory by the plots of ranges against averages method among these three evaluation methods.更多还原