Abstract
Objectives:
Manual Westergren method is routinely used for ESR measurement; however, it has many limiting factors which include inherent and technical factors. Alternate/modified Westergren methods have been devised to overcome the limitations of the manual Westergren method. These new methods must be properly evaluated before introducing in clinical laboratories.
Material and Methods:
A total of 350 randomly collected Ethylene Diamine Tetraacetic Acid (EDTA) samples from hospitalized and ambulatory patients were assayed parallelly in the recently launched Hematology Analyzer Celltac α+ (MEK 1305) and manual Westergren method. Results of these assays were subjected to statistical analysis using a coefficient of correlation, Passing-Bablok regression, and the Bland-Altman statistical methods and the results of the present study were also compared with 16 selected similar studies published in the past 22 years. Intrarun precision using patient samples and inter-run precision using manufacturer’s controls (MEK-3DN and MEK-3DL) were also determined.
Results:
The present study revealed a Pearson correlation of 0.9058, mean bias of −6.43, and limits of agreements 17.5–−30.4, between Celltac α+ (MEK 1305) and the reference Westergren method. Intrarun precision using patient samples yielded a coefficient of variation ranging from 0% to 14% and inter-run precision using commercial controls yielded a CV of 9.32% for abnormal (MEK-3DL) control and 13.6% for normal level control (MEK-3DN).
Conclusion:
With good correlation between Celltac α+ (MEK 1305) and the reference Westergren method, acceptable bias, and limits of agreements, automated Celltac α+ (MEK 1305) with its additional advantages is a valid substitute for the reference ESR method in clinical laboratories.