Evaluation of the Analytical Properties of the Diagon CoagXL Coagulation Analyzer

Koç, Hacer; Yıldız, Zeynep; Hürmeydan, Özlem; Madenci, Özlem Çakır; Yücel, Nihal; Orçun, Asuman

doi:10.7754/clin.lab.2018.181029

Cited by 2 publications

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“…Inter-assay precision for PT assay was not within 5% CV although the total precision was within the criteria for acceptance. This result was similar to a previous study that was performed using Diagon Coag XL for PT assay [7]. However, the correlation coefficient was strongly positive for the PT test.…”

Section: Discussionsupporting

confidence: 91%

“…The slope of the regression line for aPTT demonstrated approximately 20% negative bias of Diagon Coag XL compared with Cobas t 511, being more prominent at high aPTT levels. This result was inconsistent with a previous study comparing aPTT results on Diagon Coag XL with another coagulation analyzer [7]. We think that the inconsistency between the Diagon Coag XL and Cobas t 511 for aPTT may be due to the Cobas measurement.…”

Section: Discussioncontrasting

confidence: 77%

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A comparison study of characteristics of the diagon coag xl coagulation analyzer

Güven¹

2022

Int J Med Biochem

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T he coagulation analyzer and its tests play an important role in clinical laboratories. Coagulation tests are used quite commonly for the diagnosis of coagulopathies, the management of surgical processes, and the monitoring of anticoagulant medication [1][2][3]. The most recommended tests to evaluate coagulation are prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, and D-dimer. It is important that the new analyzers installed in the laboratory are evaluated for precision and compared with the existing analyzers. Therefore, the aim of this study was to evaluate the performance characteristics of PT, aPTT, fibrinogen, and Ddimer tests measured using the Diagon Coag XL (Diagon Ltd., Budapest, Hungary) coagulation analyzer. Objectives:We compared prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, and Ddimer test results measured using the Diagon Coag XL coagulation analyzer with Cobas t 511 analyzer.Methods: Imprecision studies were performed for the PT, aPTT, fibrinogen, and D-dimer tests used by the Diagon Coag XL analyzer. For the comparison study, we used the leftover citrated plasma from patient samples after routine analysis with Cobas t 511. All of the results were analyzed using the correlation coefficient and Passing-Bablok regression analysis.Results: Total coefficient of variation obtained for all tests were within the criteria for acceptance. The method comparison study showed a good correlation between the results obtained on Diagon Coag XL and Cobas t 511 analyzers, except for aPTT test. The correlation coefficients obtained were 0.98 for PT, INR, and D-dimer, 0.95 for fibrinogen, and 0.80 for aPTT. Conclusion:For PT, aPTT, fibrinogen, and D-dimer tests, Diagon Coag XL analyzer is suitable for monitoring the coagulation system, and it can be used in clinical laboratories. However, the precision values of tests stated by the manufacturer must be verified.

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Section: Discussionsupporting

confidence: 91%

Section: Discussioncontrasting

confidence: 77%

A comparison study of characteristics of the diagon coag xl coagulation analyzer

Güven¹

2022

Int J Med Biochem

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

Yis

Buğdaycı

Pehlivan

et al. 2020

Blood Coagulation &Amp; Fibrinolysis

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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.

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Evaluation of the Analytical Properties of the Diagon CoagXL Coagulation Analyzer

Cited by 2 publications

References 0 publications

A comparison study of characteristics of the diagon coag xl coagulation analyzer

A comparison study of characteristics of the diagon coag xl coagulation analyzer

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

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