A multicenter evaluation of the Iris iQ200 automated urine microscopy analyzer Body Fluids Module and comparison with hemacytometer cell counts

Manual hemacytometer cell counting of body fluids is labor-intensive and requires skilled testing personnel. We performed a multicenter evaluation of the Iris iQ200 automated microscopy analyzer Body Fluids Module (Iris Diagnostics, Chatsworth, CA) and compared 350 iQ200 body fluid cell counts with manual hemacytometer cell counts. Within-run imprecision, expressed as coefficient of variation (CV), ranged from 2.6% to 5.9% for RBC counts between 875 and 475 x 10(6)/L and from 4.2% to 6.5% for nucleated cell counts between 820 and 590 x 106/L. The lower limits of detection, based on a CV of 20% or less, were 30 and 35 x 10(6)/L for RBCs and nucleated cells, respectively. There was very good agreement between automated iQ200 and manual body fluid cell counts based on slopes and r(2) values. The iQ200 has satisfactory performance for enumerating RBCs and nucleated cells in most body fluids, with the exception of cerebrospinal fluid specimens that contain low cell numbers.