Analytical performance evaluation of Siemens Sysmex CS–2500 and Abbott CP–3000 devices

Aim: Hemostasis tests are requested by clinicians for many purposes such as screening, diagnosis, and drug monitoring. Automatic coagulation devices have been used in the last 50 years and have been seriously developed. The diversity of the methods, kits and devices used, and being influenced by many preanalytical factors made standardization difficult in these tests. One of the most basic methods for standardization is method comparison. In this study, it was aimed to evaluate analytical performances of CS–2500 and CP–3000 devices and to compare methods. Material and Method: Reference interval verification study, precision, trueness evaluation and method comparison study were performed for APTT, PT and D–dimer tests. IQC were used for precision assessment, EQC samples were used for trueness assessment. Samples from 220 patients were used for reference interval validation and method comparison study. In evaluating precision and trueness, % CV and % bias values were calculated. In the comparison study, Blant – Altman, Passing – Bablok regression analysis and correlation coefficient were used. All studies were carried out in accordance with CLSI protocols. Results: The calculated% CV values for APTT and PT in both devices were below 5%, which is the CLSI recommendation. D–dimer reagents meet the quality criteria recommended by CLSI. Trueness is within acceptable limits on both devices. The reference ranges suggested by the manufacturer are verified. Regression equations for APTT, PT and D–dimer were found as y = –3,313 + 1,188, y = –0,0399+ 1,048 x, y = 0,155 + 0,655 x, and r values were 0,904, 0,978, 0,974, respectively. Conclusion: CS–2500 and CP–3000 devices measure with sufficient trueness and precision. In the method comparison study, there are measurement differences as different reagents are used between the devices, but they are generally acceptable. Both devices are suitable for use in laboratories for routine coagulation. It is important to standardize the results for coagulation tests. Since the CP–3000 device has recently been used in our country, it must be supported by comparison studies.