engleski

The validation of Instrumentation laboratory ACL TOP 300 and ACL TOP 500 coagulation analyzers

Introduction: Novel Instrumentation Laboratory (Bedford, USA) ACL-TOP 300 and 500 coagulation analyzers were simultaneously validated in order to assess their routine work applicability. Materials and Methods: Original HemosIL reagents: PT (RecombiPlasTin 2G), APTT (SynthASil), fibrinogen (Fibrinogen-C), AT (Liquid Antithrombin) and D-dimer (D-Dimer HS 500) together with Normal and Low Control Assayed (PT, APTT, fibrinogen, AT) and Low and High Control (D-dimer) were used. Precision study results (within-run: 10 measurements ; between-run: 10 days, 2 measurements) and trueness were estimated according to Westgard criteria. Method comparison (Passing-Bablock analysis, n=30 for each analyte, wide range of concentrations) with referent methods was performed using Innovin (PT), Actin FS (APTT), Berichrom Antithrombin III (A) (AT), Multifibren U (fibrinogen) on BCS XP (Siemens Healthcare Diagnostics, Germany) and Vidas D-Dimer Exclusion II (miniVIDAS, bioMérieux, France). Results: Higher within-run precision coefficients of variation (CVs) were found for low fibrinogen (6.6%) and AT (6.1%) concentrations on ACL-TOP 300, and for AT (6.8%) on ACL-TOP 500. Between-run precision study on ACL-TOP 300 revealed slightly higher CVs for low PT (2.9%) and normal AT concentration (3.4%), and especially for low AT concentration (7.8%). Elevated biases were found for normal fibrinogen concentrations on both analyzers (8.2 and 7.6, respectively) and for low AT concentration on ACL-TOP 300 (13.1%). Method comparison criteria were fulfilled only for: APTT on ACL-TOP 300 (intercept -9.52, 95% CI -24.35, 0.44 ; slope 1.22, 95% CI 0.9, 1.68 ; r=0.775) and D-dimer on ACL-TOP 300 (intercept 0.05, 95% CI -0.04, 0.08 ; slope 0.87, 95% CI 0.78, 1.05 ; r=0.956). Comparison of results obtained on ACL-TOP analyzers was excellent for all analysis (r>0.970, P<0.0001). Conclusion: ACL-TOP 500 was found to be superior to ACL-TOP 300 for all analysis. As precision and trueness results indicate important disagreements for low AT concentration on ACL-TOP 300, we find it less applicable for routine work than ACL-TOP 500.

precision, trueness, Passing-Bablock estimation, instrument validation

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