engleski

Analytical Validation of Atellica COAG 360 System

Background : Replacement of instrumentation and/or reagents in a coagulation laboratory requires validation of a new system. Aims : The aim was to perform the analytical validation of Atellica COAG 360 (Siemens Healthineers, Germany) for prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), fibrinogen, antithrombin (AT), anti- Xa activity, protein C (PC) activity and lupus anticoagulant screening test (LA1). Methods : Validation was performed according to the CLSI EP15- A2 protocol. Within- run and between- run precision were assessed in the normal and pathological range for five consecutive days in triplicate using: Control plasma N, Control plasma P, Dade Ci- Trol 2, Heparin LMW Control 1/Control 2, and LA Control 1/Control 2. Accuracy was calculated from between- run precision data. Measurement uncertainty (MU) was estimated by 10 replicate measurements of Standard Human Plasma. Method comparison with the routinely used analyzer BCS XP (Siemens Healthineers, Germany) included analysis of routine plasma samples covering a wide analytical range. Results : The highest within- run and between- run CVs were 1.7% and 1.4% (PT), 1.3% and 1.1% (INR), 0.5% and 0.5% (aPTT), 1.4% and 2.1% (fibrinogen), 2.0% and 2.6% (AT), 1.6% and 2.6% (anti- Xa), 2.1% and 1.7% (PC), 1.5% and 2.5% (LA1), and all met the Westgard and/ or manufacturer´s acceptance criteria, where applicable. The highest bias and MU were obtained for PT, - 11.3% and 19.9%, respectively. Spearman´s rank correlation coefficients were ≥0.97, except for PC (0.89). Passing- Bablok regression analysis showed constant and proportional difference for aPTT [y=- 4.43(- 5.18 to - 3.64)+1.0(0.99- 1.01) x], fibrinogen [y=- 0.52(- 0.75 to - 0.32)+1.16(1.10- 1.22)x] and INR [y=0.03(0.01- 0.05)+0.95(0.93- 0.97)x], constant difference for PT [y=0.02(0.02- 0.03)+1.0(0.99- 1.01)x] and proportional difference for AT [y=0.31(- 6.76 to 5.32)+0.92(0.86- 0.99)x]. Conclusions : Minor discrepancies to the previously used system were observed. Overall, Atellica Coag 360 showed satisfactory analytical performance and can be implemented into routine practice.

haemostasis, global coagulation tests, validation study, Atellica COAG360

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