⚖️ Accuracy Beyond Doubt: Ensuring Consistent Results Across Nine Hematology Analyzers
In modern laboratory diagnostics, large medical centers often use several redundant instruments. This is necessary to ensure an uninterrupted workflow: if one instrument is busy or undergoing maintenance, the blood sample is sent to another. But how can one guarantee that a patient’s result will be identical, regardless of which of the nine analyzers performed the test? 🧪
A group of specialists conducted a large-scale four-year study, implementing the international CLSI EP31-A-IR protocol for verifying result comparability. 📊
🔍 The Essence of the Scientific Work Over four years (2022–2025), scientists evaluated the performance of nine expert-class hematology systems. The study covered 17 key parameters, including: Complete blood count parameters; Differential leukocyte count; Monocyte distribution width (MDW) (an early sepsis detection marker); Reticulocyte count.
🔬 Methodology and Approach Native patient samples were used for evaluation, including biomaterial from individuals with oncohematological diseases and suspected septic conditions. This selection allowed for testing instrument performance in critical clinical ranges. 📈
Biological variability criteria were used as the “gold standard” for establishing acceptable deviation limits. This is the most stringent approach, accounting for natural fluctuations in human body parameters. Researchers calculated the maximum permissible difference and compared it with the actually observed differences between instruments.
✅ Key Findings
- Complete Identity: Throughout the entire monitoring period, the maximum observed difference between all nine analyzers did not exceed the established tolerances for any of the 17 parameters.
- Absence of “Drift”: Over four years of operation, no progressive analytical deviation was detected. This confirms the high stability of modern detection technologies. 🛡️
- Clinical Significance: The implementation of the EP31-A-IR model assures the clinician that changes in patient parameters reflect real changes in their condition, not technical errors of different instruments.
This work confirms that the use of standardized verification protocols is the foundation of patient safety and a necessary condition for compliance with international quality standards ISO 15189. 🏛️
Source for citation: Tejedor-Ganduxé X, Marqués-García F, Martínez-Bravo C, Aparicio-Calvente I, Jiménez-Añon L, Leis-Sestayo A, Rodríguez-Domínguez J, Martínez-Iribarren A, Morales-Indiano C. Verification of Patient Result Comparability Among Nine Hematology Analyzers Using the CLSI EP31-A-IR Guideline: A Four-Year Experience. 2026.
