Variability in the Upper Limit of Normal for Serum Alanine Aminotransferase Levels: A Statewide Study
Variability in the Upper Limit of Normal for Serum Alanine Aminotransferase Levels: A Statewide Study
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DOI：
10.1002/hep.23200
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发表时间：
2009-12-01
期刊：
影响因子：
13.5
通讯作者：
Chalasani, Naga
中科院分区：
文献类型：
--
作者：
Dutta, Anand;Saha, Chandan;Chalasani, Naga
我们进行了一项研究，以表征印第安纳州不同实验室（实验室）间丙氨酸氨基转移酶（ALT）正常值上限（ULN）的变异性，并了解导致此类变异性的因素。将调查问卷邮寄给印第安纳州所有符合条件的实验室（n = 108），回复率为62%。该调查询问了ALT ULN、所用化学分析仪的类型、五个美国病理学家学会（CAP）样本结果以及用于建立参考区间的方法。男性和女性的ALT ULN存在广泛变异性。85%的实验室使用的化学分析仪属于这四个品牌之一。对于所有5个CAP样本，不同分析仪测量的ALT值存在统计学显著差异（P < 0.0001），但这些差异无临床意义。大多数实验室使用制造商的建议来确定其ALT ULN，而不是内部健康志愿者测试（仅17%）。当对健康志愿者进行测试时，测试过程在测试个体的数量、测试频率和选择参考人群的标准方面是随机的。在控制化学分析仪类型后，ALT ULN值与其建立方法之间无显著相关性。结论：不同实验室间ALT ULN的广泛变异性更可能是由于不同化学分析仪的可变参考区间。通过（1）每个实验室仅遵循制造商的建议和（2）不同分析仪的制造商遵循一致和严格的方法建立参考范围，可以最大限度地减少ALT ULN的变异性。或者，应进行研究以确定ALT基于结果的参考区间。（《肝脏学》2009;50：1957-1962）
We conducted a study to characterize the variability in the upper limit of normal (ULN) for alanine aminotransferase (ALT) across different laboratories (labs) in Indiana and to understand factors leading to such variability. A survey was mailed to all eligible labs (n = 108) in Indiana, and the response rate was 62%. The survey queried for ALT ULN, the type of chemical analyzer used, five College of American Pathologists (CAP) sample results, and methods used to establish the reference interval. There was a wide variability in the ALT ULN for both men and women. Eighty-five percent of labs used chemical analyzers belonging to one of the four brands. For all five CAP samples, there was a statistically significant difference in ALT values measured by different analyzers (P < 0.0001), but these differences were not clinically significant. The majority of labs used the manufacturers' recommendations for establishing their ALT ULN rather than in-house healthy volunteer testing (only 17%). When healthy volunteers were tested, the process for testing was haphazard in terms of the number of individuals tested, frequency of testing, and criteria for choosing the reference population. After controlling for chemical analyzer type, there was no significant relationship between ALT ULN values and the method used for its establishment. Conclusion: Wide variability in ALT ULN across different labs is more likely due to variable reference intervals of different chemical analyzers. It may be possible to minimize variability in ALT ULN by (1) each lab solely following the manufacturers' recommendations and (2) manufacturers of different analyzers following consistent and rigorous methodology in establishing the reference range. Alternatively, studies should be undertaken to identify outcome-based reference intervals for ALT. (HEPATOLOGY 2009;50:1957-1962.)