Optimizing the u411 automated urinalysis instrument for veterinary use

Abstract

Background The Cobas u411 Analyzer (Roche Diagnostics) is an automated, reflectance photometry‐based urinalysis instrument designed for use with Roche's CHEMSTRIP 10UA technology and human urine samples. Objective We aimed to optimize and validate the Cobas u411 Analyzer for use in canine and feline urinalysis. Methods Patient urine samples presenting to the Clinical Pathology Laboratory at the Colorado State University Veterinary Teaching Hospital were analyzed with the Cobas u411 and by manual readings in parallel. Initially, 223 canine and 83 feline urine samples were run using the u411 factory settings. Following comparisons with manual results, and evaluation for directional bias, adjustments to the reflectance values were made in the instrument's programming. An additional 183 canine and 95 feline samples were run using the adjusted settings. Total urine protein concentrations were measured in 48 samples and used to generate receiver operating characteristic curves for the protein test pad. Results Following adjustments in reflectance programming, concordance between u411 and manual results was increased by 17.7% for protein, 11.7% for ketones, and 4.5% for bilirubin. Concordances for pH, glucose, and blood were not substantially changed. Discordance for all analytes was ≤3%. Canine and feline samples had similar levels of discordance, though marginal concordance was higher in dogs for ketones, bilirubin, and blood. Conclusions Adjustments to the reflectance programming of the Cobas u411 Analyzer improved concordance with manual results for canine and feline samples. This instrument has the potential to greatly increase both efficiency and consistency of urinalysis procedures in higher throughput veterinary diagnostic laboratories.

Analytical performance evaluation of two automated urine chemistry analysers using two levels of commercially available quality control material

“…Limited quality evaluation of automated urinalysis instrumentation is available in the veterinary medical literature with variable results (Bauer et al 2008, Defontis et al 2013, Ferreira et al 2018, Hernandez et al 2019. Notably, the Cobas u411 Analyser with Roche's CHEMSTRIP 10UA urine strips, designed for use with human urine samples, was recently validated for canine and feline samples (Evans et al 2020). The Cobas u411 required reflectance programming when analysing dog and cat samples, but did have excellent concordance with manual methods after this optimization.…”

“…The Cobas u411 required reflectance programming when analysing dog and cat samples, but did have excellent concordance with manual methods after this optimization. The instrument was found to have the potential to increase efficiency and consistency of urinalyses in high throughput veterinary diagnostic laboratories (Evans et al 2020). No independent investigators have evaluated the semiquantitative in-clinic automated analysers using quality goals, and instrument distributors provide only minimal analytical performance claims (LePage et al 2006, Lem & Rosenfeld 2018.…”

“…Notably, the Cobas u411 Analyser with Roche's CHEMSTRIP 10UA urine strips, designed for use with human urine samples, was recently validated for canine and feline samples (Evans et al . 2020). The Cobas u411 required reflectance programming when analysing dog and cat samples, but did have excellent concordance with manual methods after this optimization.…”

“…The instrument was found to have the potential to increase efficiency and consistency of urinalyses in high throughput veterinary diagnostic laboratories (Evans et al . 2020). No independent investigators have evaluated the semiquantitative in‐clinic automated analysers using quality goals, and instrument distributors provide only minimal analytical performance claims (LePage et al .…”