Abstract：
OBJECTIVE: To assess the usefulness of the EP31-A-IR guideline published by the Clinical and Laboratory Standards Institute (CLSI) to perform the periodic verification of results\' comparability between several analyzers.
METHODS: Twenty-four biochemistry parameters that could be measured in different analyzers were included: albumin, alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, calcium, chloride, C-reactive protein, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, phosphate, potassium, sodium, total bilirubin, total cholesterol, total protein, triglycerides, urea and uric acid. In accordance with the EP31-A-IR guideline: (1) Patient samples were selected considering the concentration or activity of interest. (2) Acceptance criteria were established specifically for each concentration or activity level. A quality specification based on biological variation or on state of the art was selected, considering the analytical performance of the available technology. (3) Maximum allowable differences (MAD) between analyzers were calculated. (4) Measurements were performed as stated in appendix B of the guideline. (5) Maximum differences between analyzers were calculated. Results were considered comparable when the maximum difference was less than or equal to the MAD.
RESULTS: For the 24 parameters evaluated, any difference between analyzers exceeded the MAD.
CONCLUSIONS: The EP31-A-IR guideline proved to be useful for periodic verification of results\' comparability. However, it must be considered that, to be practicable, it may require to adjust the acceptance criteria in accordance to the analytical performance of the available technology; as well as the number of analytical measurements conforming to the laboratory resources.
METHODS: Twenty-four biochemistry parameters that could be measured in different analyzers were included: albumin, alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, calcium, chloride, C-reactive protein, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, phosphate, potassium, sodium, total bilirubin, total cholesterol, total protein, triglycerides, urea and uric acid. In accordance with the EP31-A-IR guideline: (1) Patient samples were selected considering the concentration or activity of interest. (2) Acceptance criteria were established specifically for each concentration or activity level. A quality specification based on biological variation or on state of the art was selected, considering the analytical performance of the available technology. (3) Maximum allowable differences (MAD) between analyzers were calculated. (4) Measurements were performed as stated in appendix B of the guideline. (5) Maximum differences between analyzers were calculated. Results were considered comparable when the maximum difference was less than or equal to the MAD.
RESULTS: For the 24 parameters evaluated, any difference between analyzers exceeded the MAD.
CONCLUSIONS: The EP31-A-IR guideline proved to be useful for periodic verification of results\' comparability. However, it must be considered that, to be practicable, it may require to adjust the acceptance criteria in accordance to the analytical performance of the available technology; as well as the number of analytical measurements conforming to the laboratory resources.
摘要：
目的：评估临床和实验室标准协会（CLSI）发布的EP31-A-IR指南对几种分析仪之间的结果可比性进行定期验证的有效性。
方法：包括可以在不同分析仪中测量的二十四个生物化学参数：白蛋白，碱性磷酸酶,丙氨酸氨基转移酶，淀粉酶，天冬氨酸转氨酶,钙，氯化物,C反应蛋白,肌酸激酶，肌酐,直接胆红素,γ-谷氨酰转移酶,葡萄糖，乳酸脱氢酶,镁，磷酸盐,钾，钠,总胆红素,总胆固醇,总蛋白质，甘油三酯，尿素和尿酸。根据EP31-A-IR指南:(1)考虑目标浓度或活性选择患者样品。(2)具体为每个浓度或活性水平建立验收标准。选择了基于生物变异或最新技术的质量标准，考虑到可用技术的分析性能。(3)计算分析仪之间的最大允许差异(MAD)。(4)按照指南附录B的规定进行测量。(5)计算分析仪之间的最大差异。当最大差异小于或等于MAD时，认为结果具有可比性。
结果：对于评估的24个参数，分析仪之间的任何差异都超过了MAD。
结论：EP31-A-IR指南被证明可用于定期验证结果的可比性。然而,必须考虑到，切实可行，它可能需要根据可用技术的分析性能调整验收标准；以及符合实验室资源的分析测量数量。
方法：包括可以在不同分析仪中测量的二十四个生物化学参数：白蛋白，碱性磷酸酶,丙氨酸氨基转移酶，淀粉酶，天冬氨酸转氨酶,钙，氯化物,C反应蛋白,肌酸激酶，肌酐,直接胆红素,γ-谷氨酰转移酶,葡萄糖，乳酸脱氢酶,镁，磷酸盐,钾，钠,总胆红素,总胆固醇,总蛋白质，甘油三酯，尿素和尿酸。根据EP31-A-IR指南:(1)考虑目标浓度或活性选择患者样品。(2)具体为每个浓度或活性水平建立验收标准。选择了基于生物变异或最新技术的质量标准，考虑到可用技术的分析性能。(3)计算分析仪之间的最大允许差异(MAD)。(4)按照指南附录B的规定进行测量。(5)计算分析仪之间的最大差异。当最大差异小于或等于MAD时，认为结果具有可比性。
结果：对于评估的24个参数，分析仪之间的任何差异都超过了MAD。
结论：EP31-A-IR指南被证明可用于定期验证结果的可比性。然而,必须考虑到，切实可行，它可能需要根据可用技术的分析性能调整验收标准；以及符合实验室资源的分析测量数量。
