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 10(6)/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 r2 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.

Analytic performance of the iQ200 automated urine microscopy analyzer and comparison with manual counts using Fuchs-Rosenthal cell chambers.

Automated instruments that can examine urine for cells and particles have reduced the need for labor-intensive manual microscopy. We evaluated the performance of the Iris iQ200 Automated Urine Microscopy Analyzer (Iris Diagnostics, Chatsworth, CA) and compared results with manual cell and particle counts using Fuchs-Rosenthal counting chambers. Within-run imprecision (coefficient of variation) of the iQ200 for urine samples ranged from 3.0% to 45% for RBC counts between 1,029 and 3 x 10(6) cells/L, 3.4% to 40% for WBC counts between 1,006 and 4 x 10(6) cells/L, and 8.9% to 35% for epithelial cell counts between 93 and 4 x 10(6) cells/L. Between-run imprecision was 3.3% at 1,017 x 10(6) cells/L and 19.2% at 28 x 10(6) cells/L. There was good agreement between the iQ200 and manual cell counts (r > or = 0.94); however; the iQ200 produced lower results based on slopes of 0.92 (RBC count), 0.81 (WBC count), and 0.94 (epithelial cell counts). The iQ200 has satisfactory performance and correlates well with manual cell counts. Most urine samples containing RBCs, WBCs, and epithelial cells can be reported without review of captured images.