Evaluation of Automated Differential Cell Counting Devices. Volume 1. Review of Literature and Labeling

摘要

In this study, the contractor attempted to provide some insight into the complex and important question 'Are automated differential cell classifiers 'safe and effective' by studying the instruments which have recently become available for automated differentiation. The approach has been to identify the performance claims made for each instrument, and to investigate the available scientific data which relate to these claims. This report covers characteristics and performance claims for four LDC systems available in 1980: the Abbott ADC-500; Coulter diff3; Geometric Data Hematrak models 240, 300, 360, and 480; and the Technicon Hemalog D/90. The contractor has attempted to summarize fairly and specified functions and performance definitions, providing side-by-side listings where possible, but avoiding inappropriate comparisons or ascriptions of correctness in areas of legitimate scientific disagreement.