Method Comparison of PT, INR, and aPTT Results Obtained Using Two Coagulation Analyzers in Routine Laboratory Practice.

Background/

Objectives

Prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) are routinely used coagulation assays, and analyzer-reagent differences may affect result comparability. This study evaluated analytical comparability between the Sysmex CS-2500 System using Siemens reagents and the Tokra Medical NOVAE II for PT, INR, and aPTT.

Methods

Residual routine citrated plasma specimens were measured on both systems. The CS-2500 was designated as the comparator system. Passing-Bablok regression and Bland-Altman analysis were used as the primary method-comparison approaches; Pearson and Spearman correlations and exploratory categorical agreement were secondary analyses.

Results

Fifty paired measurements were analyzed for PT and INR and 54 for aPTT. For all three parameters, the 95% confidence interval (CI) for the Passing-Bablok intercept included 0 and the 95% CI for the slope included 1, providing no statistically supported evidence of constant or proportional bias by regression. Mean paired differences (NOVAE II minus CS-2500) were +1.27 s for PT, +0.023 for INR, and +2.32 s for aPTT. The 95% limits of agreement were -0.15 to +2.69 s for PT, -0.112 to +0.159 for INR, and -1.70 to +6.33 s for aPTT. Categorical agreement was influenced by analyzer-specific reference intervals and by the low prevalence of abnormal results.

Conclusions

The two analyzer-reagent systems showed positive analytical associations, but the magnitude and dispersion of paired differences varied by assay. Because no clinical equivalence margins were prespecified and markedly pathological or therapeutic-range samples were sparsely represented, these findings support analytical comparison and local verification but do not establish clinical interchangeability.