RT Journal Article
T1 Automated urinalysis combining physicochemical analysis, on-board centrifugation, and digital imaging in one system: A multicenter performance evaluation of the cobas 6500 urine work area.
A1 Cobbaert, Christa M
A1 Arslan, Figen
A1 Caballé Martín, Imma
A1 Serra, Antoni Alsius
A1 Picó-Plana, Ester
A1 Sánchez-Margalet, Víctor
A1 Carmona-Fernández, Antonio
A1 Burden, John
A1 Ziegler, André
A1 Bechel, Walter
K1 Automated biology—high-throughput screening
K1 Clinical automation
K1 Laboratory management—workflow
AB We evaluated the analytical performance of the fully automated cobas® 6500 urine work area and its automated components-cobas u 601 and cobas u 701. The study was conducted at three European centers using un-centrifuged surplus routine urine samples; all measurements were performed within 2 h of sample collection. Precision, sample carry-over, and method comparisons were evaluated per Clinical and Laboratory Standards Institute guidelines. Method comparisons: cobas u 601 versus Urisys 2400 and cobas u 411 urine test strips; and cobas u 701 versus KOVA® visual microscopy and iQ200 analyzer. Operability and functionality were assessed using questionnaires. Precision of the entire cobas 6500 system was within predefined acceptance limits and no significant carry-over was observed. Erythrocytes, leukocytes, nitrites, and protein were in good agreement (≥93%) with cobas u 411 reflectometry. High correlation was shown between the cobas u 701 analyzer and KOVA visual microscopy for red blood cells (RBC; slope, 0.89; Pearson's r, 0.95) and white blood cells (WBC; slope, 0.96; Pearson's r, 0.96), demonstrating equivalence of test results. The 97.5% percentile reference values on the cobas u 701 analyzer were 5.3 cells/μL (RBC) and 6.2 cells/μL (WBC). The cobas 6500 system showed good sensitivity for small bacteria (>1 μm) and pathological casts, and the user interface, maintenance wizards, and system design were highly rated by operators. The fully automated workflow, high precision, and high throughput of the cobas 6500 system have the potential to facilitate standardization of urine screening.
SN 2352-5517
YR 2019
FD 2019-09-19
LK https://hdl.handle.net/10668/24530
UL https://hdl.handle.net/10668/24530
LA en
DS RISalud
RD Apr 20, 2025