Analytical Performance Evaluation of Siemens Sysmex CS-2500 and Sekisui CP-3000.

BACKGROUND: Automatic coagulation analyzers have been used in the last 50 years and have been developed considerably. Newly developed tests and methods cannot be conducted in routine laboratories without evaluating their performance. Therefore, their performance must be evaluated and approved before being used routinely. The aim of this study is to evaluate the analytical performance of Sysmex Coagulation System-2500 (CS-2500) and Sekisui CP-3000 automatic coagulation analyzer (CP-3000). METHODS: For APTT, PT, and D-dimer tests, reference range verification study, a method comparison study was performed in both analyzers in accordance with CLSI protocols, and precision and accuracy were evaluated using internal and external quality control samples. In the evaluation of precision and accuracy, CV% and bias% values were calculated. Bland-Altman, Passing-Bablok regression analysis, and correlation coefficient were used in the comparison study. RESULTS: The CV% values calculated for APTT and PT in both analyzers were found to be below the CLSI recommendation of 5%. D-dimer test results meet the quality criteria recommended by CLSI. Accuracy for both analyzers was within the acceptable limits. The reference ranges recommended by the manufacturer have been veryfied. Regression equations for APTT, PT, and D-dimer are y = -3.313 + 1.188x, y = -0.0399 + 1.048x, and y = 0.155 + 0.655x, respectively, and r values were 0.904, 0.978, and 0.974, respectively. CONCLUSIONS: CS-2500 and CP-3000 analyzers are suitable for laboratory use for routine coagulation. Since the CP-3000 device is newly used in our country, it needs to be supported by more comparison studies.

Analytical performance evaluation of Sysmex CS-2500 and Stago STA Compact.

: The Sysmex Coagulation System-2500 (CS-2500) is a fully automated coagulation analyzer that uses the optical reaction method. In this study, we aimed to evaluate performance characteristics of the CS-2500 in two coagulation tests [prothrombin time (PT) and activated partial thromboplastin time (aPTT)] at our hospital laboratory. PT and aPTT measurements were performed using the CS-2500 and STA-Compact Diagnostica Stago coagulometers (STA-Compact). Then, precision, accuracy, reference range verification, and method comparison statistics were performed. In the precision study, which was performed with normal and pathologic controls for the PT-international normalized ratio (INR) and aPTT tests, all coefficient of variation% were found less than 3.5%. In the comparison study, the Passing-Bablok regression analysis demonstrated the good agreement between each analyzer for PT-INR (y = -0.081 + 1.07x and r = 0.962) and for aPTT (y = 5.498 + 0.86x and r = 0.944). Both analyzers exhibited less than 9.9% bias in the accuracy study. The reference range verification analyses revealed that the manufacturer ranges were acceptable. The verification studies of the CS-2500 coagulation system were acceptable; however, in the comparison studies, there were small differences between STA-Compact. Overall, we propose that these differences could be eliminated in future standardization studies performed to use the same reference ranges for all systems.