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. 2022 Dec 28;13(1):85.
doi: 10.3390/diagnostics13010085.

Evaluation of the Analytical Performances of the Biolabo SOLEA 100 Optical Coagulometer and Comparison with the Stago STA-R MAX Analyser in the Determination of PT, APTT, and Fibrinogen

Pierangelo Bellio  1 , Simonetta De Angelis  1 , Alessandra Piccirilli  1 , Giulio Di Michele  2 , Remo Barnabei  2 , Gianfranco Amicosante  1 , Mariagrazia Perilli  1 , Giuseppe Celenza  1
Affiliations

Evaluation of the Analytical Performances of the Biolabo SOLEA 100 Optical Coagulometer and Comparison with the Stago STA-R MAX Analyser in the Determination of PT, APTT, and Fibrinogen

Pierangelo Bellio et al. Diagnostics (Basel). .

Abstract

Introduction: The Biolabo Solea 100 is a fully automated coagulation analyser using an optical system to detect coagulation designed to meet the needs of small- and medium-sized laboratories. This study aimed to evaluate the analytical performance in terms of bias, precision, and interference of the Biolabo Solea 100 coagulometer under routine laboratory conditions. In addition, a comparison was made with Stago STA-R MAX.

Materials and methods: Imprecision and bias were evaluated for activated partial thromboplastin time (APTT), fibrinogen (FIB), and prothrombin time (PT) at the medical decision levels. The results of 200, 181, and 206 plasma samples for APTT, FIB, and PT, respectively, were compared with those obtained by Stago STA-R MAX. In addition, the interference level of bilirubin, haemoglobin, triglycerides, and fractionated heparin was evaluated.

Results: Repeatability, intermediate imprecision, bias, and total error are overall below the defined limits of acceptability. Of interest is the high degree of agreement between Solea 100 and STA-R MAX with respect to PT (s), which fits perfectly with the theoretical line of identity (y = 0 + 1.00x). No interferences were found within the limits stated by the manufacturer, with some exceptions for APTT with heparin and APTT and PT for higher bilirubin concentrations.

Conclusions: In conclusion, the performance of the Solea 100 optical analyser is satisfactory and adequate for the determination of routine coagulation tests. Moreover, they are perfectly comparable to mechanical systems, such as STA-R MAX and other upper-level analysers, even considering the low interference levels under routine conditions.

Keywords: analytical techniques and equipment; haematology and coagulation; mechanical clot detection; optical clot detection; validation/evaluation.

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Conflict of interest statement

The author Giuseppe Celenza received a grant from Biolabo S.A.S. for research activities not related to the subject of this study. The other authors have no conflict of interest to disclose.

Figures

Figure 1
Figure 1
PassingBablok regression analysis for (A) activated partial thromboplastin time (APTT), 200 samples; (B) fibrinogen (FIB), 181 samples; and (C) prothrombin time (PT), 206 samples to evaluate the correlation between STA-R MAX (x-axis) and Solea 100 (y-axis). The solid line represents the regression line, the dotted line the theoretical identity line, and the dashed lines the 95% confidence interval.
Figure 2
Figure 2
BlandAltman difference plots for (A) activated partial thromboplastin time (APTT), 200 samples; (B) fibrinogen (FIB), 181 samples; and (C) prothrombin time (PT), 206 samples to evaluate the correlation between STA-R MAX and Solea 100. The solid line represents the mean percentage difference, the dotted line the theoretical identity line, the dashed lines the 95% confidence interval, the dot-dashed line the regression line, the solid orange line the 95% CI of the regression line, and the grey band the 95% confidence interval on the mean percentage difference value.
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