Coagulation Analyzers Evaluated and Compared in Coagulation Laboratory

Diagnosis of bleeding disorders in a specialized coagulation laboratory involves the correct diagnosis of hemophilia A, B, and C, von Willebrand disease, factor XIII (FXIII), factor XII (FXII), factor II (FII), factor V (FV), factor VII (FVII), and factor X (FX) deficiency.

Coagulation Analyzer Blood clotting tests are the tests used for diagnostics of the hemostasis system. Coagulometer is the medical laboratory analyzer used for testing of the hemostasis system. Modern coagulometers realize different methods of activation and observation of development of blood clots in blood or in blood plasma.

Laboratorians specializing in Coagulation at the Skåne University Hospital (Malmö, Sweden) obtained 50 in-house normal pooled platelet poor plasma from 13 male (26%) and 37 female (74%) donors (aged 22–70) with informed consent. Blood samples (3.2% sodium citrate, 109 mmol/L) were collected and centrifuged for 20 minutes at 2,000 g at room temperature. Plasma supernatants were frozen and stored at −70 °C until analysis.

The scientists evaluated the analytical performance of the Atellica COAG 360 analyzer (Siemens Healthineers, Erlangen, Germany) in a specialized coagulation laboratory with focus on specific coagulation parameters involved in the diagnosis of bleeding disorders. Verification included assessment of precision, reference interval, and method comparison according to local guidelines. For FVIII (Chromogenix, Gothenburg, Sweden) and FIX (Rossix, Mölndal, Sweden), extended verifications were performed with additional assessment of linearity, detection limit, and comparability to Siemens’ BCS-XP System.

The investigators reported that the precision of the Atellica COAG 360 analyzer either improved or was similar when compared to expected target values from a BCS-XP. In general, the total coefficient of variation (CV) reached the assigned target values, below 5.0% for normal levels and below 10.0% for abnormal levels except for 10.1% at 0.05 IU/mL FVIII OSA and 5.6% at 0.9 IU/mL FXIII. The locally established reference range agreed well being equal to or greater than 80% of measured values within manufacturer's assigned ranges, for most of the methods. The lower limit of quantification was calculated to below 0.01 IU/mL for FVIII chromogenic (Chromogenix) and FIX chromogenic (Rossix), both with acceptable linearity. Bland–Altman analyses revealed generally good agreement between Atellica COAG 360 and BCS-XP in the determination of coagulation parameters, and differences between the two instruments did not result in any diagnostic change.

The authors concluded that the results of the evaluation show that the Atellica COAG 360 analyzer performs as expected to target values and equivalent to BCS-XP for the diagnosis of bleeding disorders in a specialized coagulation laboratory providing service to a hemophilia treatment center (HTC). The study was published on February 11, 2022 in the Journal of Clinical Laboratory Analysis.

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