Performance evaluation of coaguchek pro II in comparison with coaguchek XS plus and sta‐r Max using a sta‐neoplastine CI plus

Abstract

Introduction We evaluated the analytical performance of CoaguChek Pro II (Roche Diagnostics GmbH, Mannheim, Germany), a new point‐of‐care device measuring the international normalized ratio (INR) values, in comparison with CoaguChek XS Plus (Roche Diagnostics GmbH) and STA‐R Max using STA‐Neoplastine CI Plus (Diagnostica Stago SAS, Asnières‐sur‐Seine, France). Methods The precision of Pro II was analyzed, according to the Clinical and Laboratory Standards Institute guidelines (CLSI POCT14‐A2 and EP15‐A3). In 105 clinical samples, the Pro II INR values were compared with those of XS Plus and STA‐R Max using STA‐Neoplastine CI Plus (CLSI EP09‐A3 and EP35). We also compared the Pro II INR values between capillary blood (CB) and venous blood (VB; CLSI EP35). Results The precision of Pro II was acceptable (within‐run and between‐run CV%: 2.71% and 3.28% at normal level; 1.52% and 4.47% at abnormal level, respectively). The Pro II INR values showed very high correlation and almost perfect agreement with those of XS Plus and STA‐R Max using STA‐Neoplastine CI Plus (r = .97 and κ = .94; r = .95 and κ = .91). The mean difference between Pro II and STA‐R Max using STA‐Neoplastine CI Plus increased as INR values increased, with 60% of samples showing differences >0.5 in the supratherapeutic range. The Pro II INR values showed very high correlation between CB and VB (r = .98). Conclusion Pro II INR values are accurate and reliable using both CB and VB; however, they should be confirmed by laboratory analyzers in the supratherapeutic range.

Reliability of International Normalized Ratio Results in the CoaguChek Pro II System in a Clinical Setting

“…This pattern was expected as the thromboplastin used in the CoaguChek test strip is recombinant, and its behavior with respect to tissue thromboplastins shows greater sensitivity to the reduction of vitamin K-dependent factors, mainly Factor VII, producing progressively longer results compared with tissue thromboplastins. [17][18][19] To examine this relationship further, the patients were stratified into 3 groups according to their INR. The correlation between the CoaguChek Pro II system and the cobas t 411 analyzer was strong in all 3 groups (sub-anticoagulated, anticoagulated, and over-anticoagulated), implying that the CoaguChek Pro II system can recognize whether patients are or are not within the therapeutic range.…”

“…This pattern was expected as the thromboplastin used in the CoaguChek test strip is recombinant, and its behavior with respect to tissue thromboplastins shows greater sensitivity to the reduction of vitamin K-dependent factors, mainly Factor VII, producing progressively longer results compared with tissue thromboplastins. 17 – 19 …”

Standardization of Coagulation Factor V Reference Intervals, Prothrombin Time, and Activated Partial Thromboplastin Time in Mice for Use in Factor V Deficiency Pathological Models

“…Moreover, a coagulometer routinely used in clinical practice was employed, together with human diagnostic reagents. Although reagents used for coagulometric diagnosis of human samples may be applied to mouse models ( 26 , 27 ), they have limitations in terms of the sample amounts that may be analyzed ( 18 , 28 ).…”

“…The PT and APTT values measured were also high, although these tend to be lineage- and sex-dependent ( 19 ). When obtaining such values, calibration curves must be created for each species, as must also be done when studying humans ( 27 ). In the case of the very short PTs or APTTs found in some species, which are typically correlated with high clotting rates, a correction must be applied in the dilutions, as suggested by some authors ( 14 , 19 ).…”

Analytical Performances of the Novel i-STAT Alinity Point-of-Care Analyzer

“…The following supporting information can be downloaded at: https:// www.mdpi.com/article/10.3390/diagnostics13020297/s1: Table S1: Review of the existing literature on the analytical performances of various Point-of-Care (POC) analyzers [2,4,7,12,21,22,[27][28][29][30][31][32][33][34][35][36][37][38].…”