Key result
Automated hemostasis systems improve measurement accuracy and reduce dispersion compared with semiautomated systems.
Why the study?
A standard validation protocol adapted to the chromogenic assay of anti-Xa activity of low-molecular-weight heparins was needed to assess suitability for comparing analytical hemostasis systems.
Do automated analytical hemostasis systems improve the repeatability, reproducibility, and accuracy of anti-Xa activity measurements compared to semiautomated systems?
Do automated analytical hemostasis systems improve the repeatability, reproducibility, and accuracy of anti-Xa activity measurements compared to semiautomated systems?
A standard validation protocol demonstrates that automated hemostasis systems provide greater accuracy and lower dispersion of results than semiautomated systems for measuring anti-Xa activity.
Answers are grounded in this paper and cite their sources.
Validates multicenter anti-Xa assay protocol for LMWH; leaves open whether monitoring improves clinical outcomes.
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 activities. Accuracy was greater in the automated systems. We conclude that this protocol is feasible and is applicable to validation of other analytical hemostasis instruments, in particular the latest generation of fully automated instruments.
No takes yet. Share an insight, caveat, or question.
Houbouyan et al. (1996) studied Patients treated with low-molecular-weight heparins. Automated analytical hemostasis systems (SB 300 and ACL) vs. Semiautomated systems (ST 888 and Chromotimer) was evaluated on Repeatability, reproducibility, and accuracy of anti-Xa activity measurements. Automated analytical hemostasis systems demonstrated lower dispersion and greater accuracy than semiautomated systems, with all systems giving linear results for activities up to 1000 IU/L.
Synapse has enriched 10 related papers. Consider them for comparative context: