Analytical validation of the iSED automated analyzer for ... | 合法醫療器材資訊網

由ILapić著作·2020—Introduction:iSEDisanalternateautomatedanalyzerforerythrocytesedimentationrate(ESR)basedonphotometricrheologytechnologythat ...

Introduction: iSED is an alternate automated analyzer for erythrocyte sedimentation rate (ESR) based on photometric rheology technology that estimates ESR by measuring rouleaux formation. The aim was to evaluate the analytical performance of the iSED analyzer and compare the results with the Westergren method and another alternate ESR analyzer, TEST1.

Methods: Validation was performed at two study sites according to the recommendations by the International Council for Standardization in Haematology and included determination of intrarun precision and inter-run precision, bias, carryover, and method comparison, which was further assessed for samples with normal and low hematocrit, as well as per low, middle, and upper third of the analytical range.

Results: Intrarun coefficients of variation (CVs) with commercial controls were 4.0% and 1.8%, while inter-run CVs 7.5% and 0.7%, for the...