When hemolysis changes interpretation: decision-level shifts and reportability failures in routine coagulation testing
SCANDINAVIAN JOURNAL OF CLINICAL & LABORATORY INVESTIGATION, cilt.86, sa.5, ss.489-504, 2026 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 86 Sayı: 5
- Basım Tarihi: 2026
- Doi Numarası: 10.1080/00365513.2026.2699751
- Dergi Adı: SCANDINAVIAN JOURNAL OF CLINICAL & LABORATORY INVESTIGATION
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, CINAHL, EMBASE, MEDLINE, Academic Search Ultimate (EBSCO), Biomedical Reference Collection: Corporate Edition (EBSCO)
- Sayfa Sayıları: ss.489-504
- Anahtar Kelimeler: bias, blood coagulation tests, clinical decision-making, fibrin fibrinogen degradation products, fibrinogen, Hemolysis, interference, partial thromboplastin time, prothrombin time
- Eskişehir Osmangazi Üniversitesi Adresli: Evet
Özet
Hemolysis is common in coagulation testing, yet generic acceptance or rejection rules may not reflect analyte-, decision-level, and reportability-specific effects. We assessed graded hemolysis across clinical decision strata on the Sysmex CS-5100. Residual citrated plasma was pooled into five decision strata for PT/INR, aPTT, Clauss fibrinogen, and D-dimer (>= 20 specimens/pool), spiked with standardized hemolysate to final hemolysis levels of 0-5% (0, 0.5, 1, 2, 3, 4, 5%), and measured in five replicates. Hemolysis severity was characterized using CS-5100 sample-check HI/flags, XN-1000 cell-free hemoglobin, and Roche cobas c702 hemolysis index. Percent bias versus the matched non-hemolyzed baseline was evaluated against EFLM-derived desirable bias specifications and RCV-based allowable change limits. Hemolysis effects were analyte- and decision-level dependent. PT/INR showed overall limited effects, although selected confidence intervals crossed desirable bias limits; all PT results remained within RCV-based limits. aPTT showed a biphasic, stratum-dependent pattern, with prolongation in lower strata and shortening in prolonged strata. Fibrinogen showed positive bias, but progressive loss of reportability, with earlier 'No coagulation' in low-fibrinogen strata, was more clinically relevant. D-dimer showed modest, consistent negative bias, mainly exceeding desirable bias in the lowest stratum; no above-cutoff pool shifted below the 0.50 mg/L FEU deep vein thrombosis cutoff. Across all assays, reportable results remained within RCV-based limits. Hemolysis management should integrate analyte- and decision-level effects, numeric reportability, instrument-derived HI/flags, and clinical context rather than rely on a universal rejection rule.