Title
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Validation of the Sysmex CS5100 coagulation analyzer and comparison to the Stago STA-R analyzer for routine coagulation parameters
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Author
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Abstract
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IntroductionThe CS5100 analyzer (Sysmex) was validated for the determination of routine coagulation parameters. This fully automated coagulation analyzer uses multiple wavelength technology to perform coagulation (e.g., activated partial thromboplastin time - APTT, prothrombin time - PT, fibrinogen - FBG), chromogenic (e.g., antithrombin - AT) and immunological (e.g., D-dimers - DDi) assays. MethodsA comparison with the currently used STA-R Evolution (Stago) was performed. Validation and verification of reference values of the CS5100 was performed in accordance to CLSI guidelines (H57-A, H47-A2, and C28-A3). ResultsAs a different detection system and reagents were used, significant differences were observed (e.g. APTT). The within-day and between-day imprecision, accuracy and total error were all acceptable. The reference values defined by the manufacturer could be used except for APTT. In our settings, the therapeutic anti-Xa range of 0.3-0.7IU/mL corresponded to an APTT range of 60-100s (Dade actin FS reagent). The APTT reagent showed factor sensitivities between 46 and 72% for FVIII, IX, XI and XII while the PT reagent showed sensitivities between 34 and 52% for FII, FV, FXII, and FX. ConclusionIn conclusion, the CS5100 instrument is suitable for the determination of the APTT, PT, FBG, DDi and AT in routine analysis. |
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Language
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English
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Source (journal)
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International Journal of Laboratory Hematology. - -
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Publication
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2015
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ISSN
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1751-5521
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DOI
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10.1111/IJLH.12295
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Volume/pages
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37
:3
(2015)
, p. 372-381
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ISI
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000354024700011
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Pubmed ID
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25233923
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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