Laboratory Medicine
CLSI EP31-A-IR 指南
CLSI EP31-A-IR GuidelineA guideline for verifying patient result comparability across multiple hematology analyzers by establishing acceptance criteria based on biological variation and calculating the maximum allowable difference (MAD) / 一种用于验证多台血液分析仪间患者结果可比性的指南，通过基于生物学变异建立接受标准并计算最大允许差异（MAD）来实现。
- Knowledge type
- 工艺技术
- First proposed or discovered
- 2015
- Proposer
- Clinical and Laboratory Standards Institute
- Creator
- 农场主
- Last updated
- 2026-11-13 19:07:10
Sub-knowledge points
Approximate target concentration estimationSelection of native patient samplesAcceptance criteria establishment based on biological variationLongitudinal stability monitoring
Higher-order knowledge points
ISO 15189 accreditationPatient safetyClinical interpretation consistency
Main parameters and performance indicators
Maximum Allowable Difference (MAD): The calculated limit for acceptable instrument variation.Biological Variation (BV): The basis for establishing acceptance criteria.Concentration Levels: Three levels used to estimate target concentrations from internal quality control data.
Open problems
No unresolved problem recorded yet
Related literature
ranked by community starsVerification of Patient Result Comparability Among Nine Hematology Analyzers Using the CLSI EP31 ‐A‐ IR Guideline: A Four‐Year ExperienceOpen source
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Creation and modification trail
1 recordsRecord title: CLSI EP31-A-IR Guideline.
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