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.