Evaluation of the Innovance D-DIMER analytical performance
Background: Widespread use of D-dimer in recent years has led to the development of a number of new fully automated quantitative D-dimer assays. Methods: We evaluated the analytical performance of the particle-enhanced immunoturbidimetric assay Innovance D-DIMER (Siemens Medical Solutions) on the Be...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Coen Herak, Desiree [verfasserIn] Milos, Marija [verfasserIn] Zadro, Renata [verfasserIn] |
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| Format: |
E-Artikel |
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| Erschienen: |
Walter de Gruyter ; 2009 |
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| Schlagwörter: |
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| Umfang: |
7 |
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| Reproduktion: |
Walter de Gruyter Online Zeitschriften |
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| Übergeordnetes Werk: |
Enthalten in: Clinical chemistry and laboratory medicine - Berlin [u.a.] : De Gruyter, 1998, 47(2009), 8 vom: 24. Juni, Seite 945-951 |
| Übergeordnetes Werk: |
volume:47 ; year:2009 ; number:8 ; day:24 ; month:06 ; pages:945-951 ; extent:7 |
| Links: |
|---|
| DOI / URN: |
10.1515/CCLM.2009.219 |
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NLEJ246727624 |
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| 520 | |a Background: Widespread use of D-dimer in recent years has led to the development of a number of new fully automated quantitative D-dimer assays. Methods: We evaluated the analytical performance of the particle-enhanced immunoturbidimetric assay Innovance D-DIMER (Siemens Medical Solutions) on the Behring Coagulation System (BCS) analyzer. Results: Within-run coefficients of variation (CVs) for samples with low, borderline, slightly, and extremely increased D-dimer concentrations were 2.1%–5.5%, whereas between-run CVs for control samples with low and extremely increased D-dimer were 5.5%–8.4%. The assay exhibited good linearity in the working range between 0.17 mg/L and 5.45 mg/L fibrinogen equivalent units (FEU), with the lower limit of detection of 0.099 mg/L FEU. The upper reference value determined in 40 plasma samples from healthy volunteers was 0.495 mg/L FEU. The results obtained in 457 fresh plasma samples were compared with results obtained with VIDAS D-Dimer Exclusion. Passing and Bablok regression analysis demonstrated highly significant correlation (y=1.370x–0.108, r=0.952, p<0.001). Bland and Altman difference plots demonstrated slightly higher results obtained with Innovance D-DIMER that was more pronounced with increasing values. Very good agreement between both assays was observed (κ=0.860; 95% confidence interval (CI), 0.811–0.908). Conclusions: This study demonstrates that Innovance D-DIMER fulfills all analytical requirements for daily routine use. Clin Chem Lab Med 2009;47:945–51. | ||
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10.1515/CCLM.2009.219 doi artikel_Grundlieferung.pp (DE-627)NLEJ246727624 DE-627 ger DE-627 rakwb Coen Herak, Desiree verfasserin aut Evaluation of the Innovance D-DIMER analytical performance Walter de Gruyter 2009 7 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Widespread use of D-dimer in recent years has led to the development of a number of new fully automated quantitative D-dimer assays. Methods: We evaluated the analytical performance of the particle-enhanced immunoturbidimetric assay Innovance D-DIMER (Siemens Medical Solutions) on the Behring Coagulation System (BCS) analyzer. Results: Within-run coefficients of variation (CVs) for samples with low, borderline, slightly, and extremely increased D-dimer concentrations were 2.1%–5.5%, whereas between-run CVs for control samples with low and extremely increased D-dimer were 5.5%–8.4%. The assay exhibited good linearity in the working range between 0.17 mg/L and 5.45 mg/L fibrinogen equivalent units (FEU), with the lower limit of detection of 0.099 mg/L FEU. The upper reference value determined in 40 plasma samples from healthy volunteers was 0.495 mg/L FEU. The results obtained in 457 fresh plasma samples were compared with results obtained with VIDAS D-Dimer Exclusion. Passing and Bablok regression analysis demonstrated highly significant correlation (y=1.370x–0.108, r=0.952, p<0.001). Bland and Altman difference plots demonstrated slightly higher results obtained with Innovance D-DIMER that was more pronounced with increasing values. Very good agreement between both assays was observed (κ=0.860; 95% confidence interval (CI), 0.811–0.908). Conclusions: This study demonstrates that Innovance D-DIMER fulfills all analytical requirements for daily routine use. Clin Chem Lab Med 2009;47:945–51. Walter de Gruyter Online Zeitschriften coagulation D-dimer evaluation particle-enhanced immunoturbidimetric assay Milos, Marija verfasserin aut Zadro, Renata verfasserin aut Enthalten in Clinical chemistry and laboratory medicine Berlin [u.a.] : De Gruyter, 1998 47(2009), 8 vom: 24. Juni, Seite 945-951 (DE-627)NLEJ248235222 (DE-600)1492732-9 1437-4331 nnns volume:47 year:2009 number:8 day:24 month:06 pages:945-951 extent:7 https://doi.org/10.1515/CCLM.2009.219 Deutschlandweit zugänglich GBV_USEFLAG_U ZDB-1-DGR GBV_NL_ARTICLE AR 47 2009 8 24 06 945-951 7 |
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10.1515/CCLM.2009.219 doi artikel_Grundlieferung.pp (DE-627)NLEJ246727624 DE-627 ger DE-627 rakwb Coen Herak, Desiree verfasserin aut Evaluation of the Innovance D-DIMER analytical performance Walter de Gruyter 2009 7 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Widespread use of D-dimer in recent years has led to the development of a number of new fully automated quantitative D-dimer assays. Methods: We evaluated the analytical performance of the particle-enhanced immunoturbidimetric assay Innovance D-DIMER (Siemens Medical Solutions) on the Behring Coagulation System (BCS) analyzer. Results: Within-run coefficients of variation (CVs) for samples with low, borderline, slightly, and extremely increased D-dimer concentrations were 2.1%–5.5%, whereas between-run CVs for control samples with low and extremely increased D-dimer were 5.5%–8.4%. The assay exhibited good linearity in the working range between 0.17 mg/L and 5.45 mg/L fibrinogen equivalent units (FEU), with the lower limit of detection of 0.099 mg/L FEU. The upper reference value determined in 40 plasma samples from healthy volunteers was 0.495 mg/L FEU. The results obtained in 457 fresh plasma samples were compared with results obtained with VIDAS D-Dimer Exclusion. Passing and Bablok regression analysis demonstrated highly significant correlation (y=1.370x–0.108, r=0.952, p<0.001). Bland and Altman difference plots demonstrated slightly higher results obtained with Innovance D-DIMER that was more pronounced with increasing values. Very good agreement between both assays was observed (κ=0.860; 95% confidence interval (CI), 0.811–0.908). Conclusions: This study demonstrates that Innovance D-DIMER fulfills all analytical requirements for daily routine use. Clin Chem Lab Med 2009;47:945–51. Walter de Gruyter Online Zeitschriften coagulation D-dimer evaluation particle-enhanced immunoturbidimetric assay Milos, Marija verfasserin aut Zadro, Renata verfasserin aut Enthalten in Clinical chemistry and laboratory medicine Berlin [u.a.] : De Gruyter, 1998 47(2009), 8 vom: 24. Juni, Seite 945-951 (DE-627)NLEJ248235222 (DE-600)1492732-9 1437-4331 nnns volume:47 year:2009 number:8 day:24 month:06 pages:945-951 extent:7 https://doi.org/10.1515/CCLM.2009.219 Deutschlandweit zugänglich GBV_USEFLAG_U ZDB-1-DGR GBV_NL_ARTICLE AR 47 2009 8 24 06 945-951 7 |
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10.1515/CCLM.2009.219 doi artikel_Grundlieferung.pp (DE-627)NLEJ246727624 DE-627 ger DE-627 rakwb Coen Herak, Desiree verfasserin aut Evaluation of the Innovance D-DIMER analytical performance Walter de Gruyter 2009 7 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Widespread use of D-dimer in recent years has led to the development of a number of new fully automated quantitative D-dimer assays. Methods: We evaluated the analytical performance of the particle-enhanced immunoturbidimetric assay Innovance D-DIMER (Siemens Medical Solutions) on the Behring Coagulation System (BCS) analyzer. Results: Within-run coefficients of variation (CVs) for samples with low, borderline, slightly, and extremely increased D-dimer concentrations were 2.1%–5.5%, whereas between-run CVs for control samples with low and extremely increased D-dimer were 5.5%–8.4%. The assay exhibited good linearity in the working range between 0.17 mg/L and 5.45 mg/L fibrinogen equivalent units (FEU), with the lower limit of detection of 0.099 mg/L FEU. The upper reference value determined in 40 plasma samples from healthy volunteers was 0.495 mg/L FEU. The results obtained in 457 fresh plasma samples were compared with results obtained with VIDAS D-Dimer Exclusion. Passing and Bablok regression analysis demonstrated highly significant correlation (y=1.370x–0.108, r=0.952, p<0.001). Bland and Altman difference plots demonstrated slightly higher results obtained with Innovance D-DIMER that was more pronounced with increasing values. Very good agreement between both assays was observed (κ=0.860; 95% confidence interval (CI), 0.811–0.908). Conclusions: This study demonstrates that Innovance D-DIMER fulfills all analytical requirements for daily routine use. Clin Chem Lab Med 2009;47:945–51. Walter de Gruyter Online Zeitschriften coagulation D-dimer evaluation particle-enhanced immunoturbidimetric assay Milos, Marija verfasserin aut Zadro, Renata verfasserin aut Enthalten in Clinical chemistry and laboratory medicine Berlin [u.a.] : De Gruyter, 1998 47(2009), 8 vom: 24. Juni, Seite 945-951 (DE-627)NLEJ248235222 (DE-600)1492732-9 1437-4331 nnns volume:47 year:2009 number:8 day:24 month:06 pages:945-951 extent:7 https://doi.org/10.1515/CCLM.2009.219 Deutschlandweit zugänglich GBV_USEFLAG_U ZDB-1-DGR GBV_NL_ARTICLE AR 47 2009 8 24 06 945-951 7 |
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10.1515/CCLM.2009.219 doi artikel_Grundlieferung.pp (DE-627)NLEJ246727624 DE-627 ger DE-627 rakwb Coen Herak, Desiree verfasserin aut Evaluation of the Innovance D-DIMER analytical performance Walter de Gruyter 2009 7 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Widespread use of D-dimer in recent years has led to the development of a number of new fully automated quantitative D-dimer assays. Methods: We evaluated the analytical performance of the particle-enhanced immunoturbidimetric assay Innovance D-DIMER (Siemens Medical Solutions) on the Behring Coagulation System (BCS) analyzer. Results: Within-run coefficients of variation (CVs) for samples with low, borderline, slightly, and extremely increased D-dimer concentrations were 2.1%–5.5%, whereas between-run CVs for control samples with low and extremely increased D-dimer were 5.5%–8.4%. The assay exhibited good linearity in the working range between 0.17 mg/L and 5.45 mg/L fibrinogen equivalent units (FEU), with the lower limit of detection of 0.099 mg/L FEU. The upper reference value determined in 40 plasma samples from healthy volunteers was 0.495 mg/L FEU. The results obtained in 457 fresh plasma samples were compared with results obtained with VIDAS D-Dimer Exclusion. Passing and Bablok regression analysis demonstrated highly significant correlation (y=1.370x–0.108, r=0.952, p<0.001). Bland and Altman difference plots demonstrated slightly higher results obtained with Innovance D-DIMER that was more pronounced with increasing values. Very good agreement between both assays was observed (κ=0.860; 95% confidence interval (CI), 0.811–0.908). Conclusions: This study demonstrates that Innovance D-DIMER fulfills all analytical requirements for daily routine use. Clin Chem Lab Med 2009;47:945–51. Walter de Gruyter Online Zeitschriften coagulation D-dimer evaluation particle-enhanced immunoturbidimetric assay Milos, Marija verfasserin aut Zadro, Renata verfasserin aut Enthalten in Clinical chemistry and laboratory medicine Berlin [u.a.] : De Gruyter, 1998 47(2009), 8 vom: 24. Juni, Seite 945-951 (DE-627)NLEJ248235222 (DE-600)1492732-9 1437-4331 nnns volume:47 year:2009 number:8 day:24 month:06 pages:945-951 extent:7 https://doi.org/10.1515/CCLM.2009.219 Deutschlandweit zugänglich GBV_USEFLAG_U ZDB-1-DGR GBV_NL_ARTICLE AR 47 2009 8 24 06 945-951 7 |
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Evaluation of the Innovance D-DIMER analytical performance |
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Background: Widespread use of D-dimer in recent years has led to the development of a number of new fully automated quantitative D-dimer assays. Methods: We evaluated the analytical performance of the particle-enhanced immunoturbidimetric assay Innovance D-DIMER (Siemens Medical Solutions) on the Behring Coagulation System (BCS) analyzer. Results: Within-run coefficients of variation (CVs) for samples with low, borderline, slightly, and extremely increased D-dimer concentrations were 2.1%–5.5%, whereas between-run CVs for control samples with low and extremely increased D-dimer were 5.5%–8.4%. The assay exhibited good linearity in the working range between 0.17 mg/L and 5.45 mg/L fibrinogen equivalent units (FEU), with the lower limit of detection of 0.099 mg/L FEU. The upper reference value determined in 40 plasma samples from healthy volunteers was 0.495 mg/L FEU. The results obtained in 457 fresh plasma samples were compared with results obtained with VIDAS D-Dimer Exclusion. Passing and Bablok regression analysis demonstrated highly significant correlation (y=1.370x–0.108, r=0.952, p<0.001). Bland and Altman difference plots demonstrated slightly higher results obtained with Innovance D-DIMER that was more pronounced with increasing values. Very good agreement between both assays was observed (κ=0.860; 95% confidence interval (CI), 0.811–0.908). Conclusions: This study demonstrates that Innovance D-DIMER fulfills all analytical requirements for daily routine use. Clin Chem Lab Med 2009;47:945–51. |
| abstractGer |
Background: Widespread use of D-dimer in recent years has led to the development of a number of new fully automated quantitative D-dimer assays. Methods: We evaluated the analytical performance of the particle-enhanced immunoturbidimetric assay Innovance D-DIMER (Siemens Medical Solutions) on the Behring Coagulation System (BCS) analyzer. Results: Within-run coefficients of variation (CVs) for samples with low, borderline, slightly, and extremely increased D-dimer concentrations were 2.1%–5.5%, whereas between-run CVs for control samples with low and extremely increased D-dimer were 5.5%–8.4%. The assay exhibited good linearity in the working range between 0.17 mg/L and 5.45 mg/L fibrinogen equivalent units (FEU), with the lower limit of detection of 0.099 mg/L FEU. The upper reference value determined in 40 plasma samples from healthy volunteers was 0.495 mg/L FEU. The results obtained in 457 fresh plasma samples were compared with results obtained with VIDAS D-Dimer Exclusion. Passing and Bablok regression analysis demonstrated highly significant correlation (y=1.370x–0.108, r=0.952, p<0.001). Bland and Altman difference plots demonstrated slightly higher results obtained with Innovance D-DIMER that was more pronounced with increasing values. Very good agreement between both assays was observed (κ=0.860; 95% confidence interval (CI), 0.811–0.908). Conclusions: This study demonstrates that Innovance D-DIMER fulfills all analytical requirements for daily routine use. Clin Chem Lab Med 2009;47:945–51. |
| abstract_unstemmed |
Background: Widespread use of D-dimer in recent years has led to the development of a number of new fully automated quantitative D-dimer assays. Methods: We evaluated the analytical performance of the particle-enhanced immunoturbidimetric assay Innovance D-DIMER (Siemens Medical Solutions) on the Behring Coagulation System (BCS) analyzer. Results: Within-run coefficients of variation (CVs) for samples with low, borderline, slightly, and extremely increased D-dimer concentrations were 2.1%–5.5%, whereas between-run CVs for control samples with low and extremely increased D-dimer were 5.5%–8.4%. The assay exhibited good linearity in the working range between 0.17 mg/L and 5.45 mg/L fibrinogen equivalent units (FEU), with the lower limit of detection of 0.099 mg/L FEU. The upper reference value determined in 40 plasma samples from healthy volunteers was 0.495 mg/L FEU. The results obtained in 457 fresh plasma samples were compared with results obtained with VIDAS D-Dimer Exclusion. Passing and Bablok regression analysis demonstrated highly significant correlation (y=1.370x–0.108, r=0.952, p<0.001). Bland and Altman difference plots demonstrated slightly higher results obtained with Innovance D-DIMER that was more pronounced with increasing values. Very good agreement between both assays was observed (κ=0.860; 95% confidence interval (CI), 0.811–0.908). Conclusions: This study demonstrates that Innovance D-DIMER fulfills all analytical requirements for daily routine use. Clin Chem Lab Med 2009;47:945–51. |
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| title_short |
Evaluation of the Innovance D-DIMER analytical performance |
| url |
https://doi.org/10.1515/CCLM.2009.219 |
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| author2 |
Milos, Marija Zadro, Renata |
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Milos, Marija Zadro, Renata |
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| doi_str |
10.1515/CCLM.2009.219 |
| up_date |
2024-07-06T09:12:12.641Z |
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