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基于中国的技术现状,确定精液分析的允许总误差
Yan Zheng1,2, Lin Yu1,2, Yingbi Wu1,2
1Department of Andrology/Human Sperm Bank, West China Second University Hospital, Sichuan University, Chengdu, China.
Clinical chemistry and laboratory medicine
|January 8, 2026
概括
本研究建立了基于证据的可允许总误差 (TEa) 对中国的关键精液分析参数. 这些发现为生殖医学实验室提供了实用的,可实现的质量保证标准.
科学领域:
- 生殖医学 生殖医学
- 临床化学 临床化学
- 实验室的质量保证工作.
背景情况:
- 精液分析对于评估男性生育能力至关重要.
- 为了获得可靠的结果,需要标准化分析性能规范 (APS).
- 现有的基准标准可能不完全反映中国实验室的能力.
研究的目的:
- 建立基于证据的分析性能规范 (APS),特别是允许的总误差 (TEa),用于中国的五个基本精液分析参数.
- 将这些规格与现有的国际基准标准进行比较.
- 评估提议的TEa值的可实现性和临床相关性.
主要方法:
- 利用来自中国315个实验室 (2023-2025) 的国家外部质量评估 (EQA) 数据.
- 计算TEa使用基于结果偏离分配值的最先进模型.
- 根据已建立的TEa标准评估了实验室通过率.
主要成果:
- 已确定的TEa值是精子度 (34.3%),渐进性运动 (26.9%或13.5%),总运动 (26.3%或10.5%),形态 (67.7%) 和活力 (24.6%或7.9%).
- 实验室通过率约为80%,表明实际可行性.
- 导出的TEa值与现有标准一致或比现有标准更精细.
结论:
- 本研究介绍了在中国进行精液分析的第一个大规模,基于证据的TEa.
- 对运动和活力的分层TEa提高了诊断准确度.
- 拟议的规范为生殖医学的质量保证提供了实用和临床相关的基础.
相关概念视频
01:15Systematic Error: Methodological and Sampling Errors
In the case of systematic errors, the sources can be identified, and the errors can be subsequently minimized by addressing these sources. According to the source, systematic errors can be divided into sampling, instrumental, methodological, and personal errors.
Sampling errors originate from improper sampling methods or the wrong sample population. These errors can be minimized by refining the sampling strategy. Defective instruments or faulty calibrations are the sources of instrumental...
Sampling errors originate from improper sampling methods or the wrong sample population. These errors can be minimized by refining the sampling strategy. Defective instruments or faulty calibrations are the sources of instrumental...
01:15Data Validation
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
Key parameters for method validation include:
01:16Contaminants and Errors
Effective sample preparation is crucial for accurate and reliable laboratory analysis. During this process, two significant sources of error can arise: concentration bias from improper sample splitting and contamination caused by methods used to reduce particle size, such as grinding or homogenization. Identifying and minimizing these potential errors is crucial to ensuring the validity of the analysis.
Another key consideration is determining the appropriate number of samples required to...
Another key consideration is determining the appropriate number of samples required to...