通过直接和间接方法确定临床生物化学测试的参考间隔:一个多中心研究
Clinical laboratory
|January 14, 2025
概括
这项研究确定了健康成年人14项临床生物化学试验的参考间隔. 在九项测试中观察到性别特异性差异,影响了建立这些重要的健康基准方法的选择.
科学领域:
- 临床生物化学 临床生物化学
- 实验室医学 实验室医学
- 参考区间的确定 参考区间的确定
背景情况:
- 建立准确的参考间隔 (RI) 对于诊断18-65岁成年人的健康状况至关重要.
- 这项研究比较了直接和间接方法来确定14项临床生物化学试验的RI.
- 与制造商的RIs进行了性别特定的比较.
研究的目的:
- 确定健康成年人 (18-65岁) 14项临床生物化学试验的参考间隔.
- 通过直接和间接方法得出的RI相互比较,以及制造商的RI.
- 分析这些参考区间中的性别特异性差异.
主要方法:
- 根据CLSI C24-A3指南,从302名健康受试者收集了血液样本.
- 使用实验室分析系统进行了14项临床化学试验.
- 数据分析采用MedCalc,SPSS20 (直接方法) 和Bellview 1.2.6 (间接方法) 基于Bhattacharya程序.
主要成果:
- 在九项测试中发现了基于性别的统计学上显著的差异 (p <0.05):性酸酶,乳酸脱酶,高密度胆固醇,低密度胆固醇,尿素,尿酸,甘油三,总胆固醇和无机酸.
- 方法与制造商的RI之间的兼容性因测试和性别而异.
- 高密度胆固醇,低密度胆固醇, (Ca) 和 (Mg) 的间接RI与制造商的RI对齐,适用于两性.
结论:
- 直接方法是建立参考间隔的主要方法.
- 间接方法为一般人群中的氨基酶 (AMLY) 和尿酸 (UA) 测试提供了可行的替代方案.
- 特定测试RI (ALP,LDH,ALB) 显示与女性制造商RI的兼容性,强调了性别特定考虑的重要性.
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