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Validation protocol of analytical hemostasis systems: measurement of anti-Xa activity of low-molecular-weight heparins by L Houbouyan; B Boutière; G Contant; M D Dautzenberg; P Fievet; G Potron; A Vassault; Y Gourmelin is a Medicine article available to read on EtoBox.
What is Validation protocol of analytical hemostasis systems: measurement of anti-Xa activity of low-molecular-weight heparins about?
## Abstract A standard validation protocol adapted to the chromogenic assay of anti-Xa activity of low-molecular-weight heparins was used in a multicenter study to assess its suitability for comparing and evaluating analytical hemostasis systems. The protocol included: familiarization with the system (repeatability); assessment of limits of linearity, detection limits, and cross-contamination; and validation (reproducibility and accuracy of measurements of treated patients' plasmas). We calibrated the systems with the same range of lyophilized plasmas daily and evaluated repeatability and reproducibility by using a single batch of lyophilized plasmas at three anti-Xa activities. The two automated systems tested [SB 300 (Gilford) and ACL (IL)] and the two semiautomated systems [ST 888 (D. Stago) and Chromotimer (Behring)] gave similar mean values. Dispersion of results was lower with the automated systems than with the semiautomated ones, especially at low anti-Xa activities, a tendency that also was observed for reproducibility. Because each analytical system gave linear results for activities as great as 1000 IU/L, suitable sample dilution is advisable for higher anti-Xa activitie
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- Author
- L Houbouyan; B Boutière; G Contant; M D Dautzenberg; P Fievet; G Potron; A Vassault; Y Gourmelin
- Publisher
- American Association for Clinical Chemistry; American Association for Clinical Chemistry, Inc.; Oxford University Press (OUP); American Association for Clinical Chemistry (AACC); Test accounts (ISSN 0009-9147)
- Published
- 1996
- Language
- EN
- Field
- Medicine (Health Sciences)