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
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...
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| Format: | Article |
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MDPI AG
2022-12-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/13/1/85 |
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| author | Pierangelo Bellio Simonetta De Angelis Alessandra Piccirilli Giulio Di Michele Remo Barnabei Gianfranco Amicosante Mariagrazia Perilli Giuseppe Celenza |
| author_facet | Pierangelo Bellio Simonetta De Angelis Alessandra Piccirilli Giulio Di Michele Remo Barnabei Gianfranco Amicosante Mariagrazia Perilli Giuseppe Celenza |
| author_sort | Pierangelo Bellio |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T10:05:09Z |
| format | Article |
| id | doaj.art-a2744aff61c6450da4487c2a4796b0f3 |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-11T10:05:09Z |
| publishDate | 2022-12-01 |
| publisher | MDPI AG |
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| series | Diagnostics |
| spelling | doaj.art-a2744aff61c6450da4487c2a4796b0f32023-11-16T15:08:37ZengMDPI AGDiagnostics2075-44182022-12-011318510.3390/diagnostics13010085Evaluation 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 FibrinogenPierangelo Bellio0Simonetta De Angelis1Alessandra Piccirilli2Giulio Di Michele3Remo Barnabei4Gianfranco Amicosante5Mariagrazia Perilli6Giuseppe Celenza7Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, 67100 L’Aquila, ItalyDepartment of Biotechnological and Applied Clinical Sciences, University of L’Aquila, 67100 L’Aquila, ItalyDepartment of Biotechnological and Applied Clinical Sciences, University of L’Aquila, 67100 L’Aquila, ItalyClinical Laboratory, Regional Hospital “San Salvatore”, 67100 L’Aquila, ItalyClinical Laboratory, Regional Hospital “San Salvatore”, 67100 L’Aquila, ItalyDepartment of Biotechnological and Applied Clinical Sciences, University of L’Aquila, 67100 L’Aquila, ItalyDepartment of Biotechnological and Applied Clinical Sciences, University of L’Aquila, 67100 L’Aquila, ItalyDepartment of Biotechnological and Applied Clinical Sciences, University of L’Aquila, 67100 L’Aquila, ItalyIntroduction. 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.https://www.mdpi.com/2075-4418/13/1/85analytical techniques and equipmenthaematology and coagulationmechanical clot detectionoptical clot detectionvalidation/evaluation |
| spellingShingle | Pierangelo Bellio Simonetta De Angelis Alessandra Piccirilli Giulio Di Michele Remo Barnabei Gianfranco Amicosante Mariagrazia Perilli Giuseppe Celenza 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 Diagnostics analytical techniques and equipment haematology and coagulation mechanical clot detection optical clot detection validation/evaluation |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | analytical techniques and equipment haematology and coagulation mechanical clot detection optical clot detection validation/evaluation |
| url | https://www.mdpi.com/2075-4418/13/1/85 |
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