Analytical Performance and Comparability of Three New Coagulation Analyzers

Area of Science:

• Clinical Chemistry
• Laboratory Medicine
• Diagnostic Technology

Background:

• Evaluating analytical performance is crucial before adopting new coagulation analyzers in clinical laboratories.
• This study assessed three new analyzers: STA-R Max3, CN-6000, and Cobas t511.
• Key coagulation parameters evaluated include prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, and D-dimer.

Purpose of the Study:

• To evaluate the analytical performance of three new coagulation analyzers.
• To compare their performance for PT, aPTT, fibrinogen, and D-dimer.
• To assess their correlation with a currently used analyzer (STA-R Compact).

Main Methods:

• Analyzed 427 plasma samples (fresh and frozen/thawed).
• Evaluated precision, carryover, linearity, auto-dilution, and reference ranges per CLSI guidelines.
• Compared results with STA-R Compact and among the new analyzers, including samples with hemolysis, icterus, and lipemia (H/I/L).

Main Results:

• All analyzers demonstrated excellent performance within manufacturer targets for precision, carryover, linearity, auto-dilution, and reference range.
• Good correlation (Pearson's r: 0.84–1.00) was observed for PT, aPTT, and fibrinogen with STA-R Compact, but D-dimer showed weaker correlation.
• Weaker correlations and higher bias were noted for aPTT and D-dimer with total samples, and for all parameters with normal vs. abnormal samples. Differences were more pronounced with H/I/L samples.

Conclusions:

• The three new coagulation analyzers exhibit excellent analytical performance.
• Good correlations were found, but significant variability exists for aPTT and D-dimer results.
• Variability is likely due to differing reference and reportable ranges across analyzers.