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.
Automated biology—high-throughput screening
Clinical automation
Laboratory management—workflow
Journal
Practical laboratory medicine
ISSN: 2352-5517
Titre abrégé: Pract Lab Med
Pays: Netherlands
ID NLM: 101690848
Informations de publication
Date de publication:
Nov 2019
Nov 2019
Historique:
received:
21
12
2018
revised:
12
09
2019
accepted:
17
09
2019
entrez:
26
10
2019
pubmed:
28
10
2019
medline:
28
10
2019
Statut:
epublish
Résumé
We evaluated the analytical performance of the fully automated cobas 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 The fully automated workflow, high precision, and high throughput of the cobas 6500 system have the potential to facilitate standardization of urine screening.
Sections du résumé
BACKGROUND
BACKGROUND
We evaluated the analytical performance of the fully automated cobas
DESIGN AND METHODS
METHODS
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.
RESULTS
RESULTS
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
CONCLUSIONS
CONCLUSIONS
The fully automated workflow, high precision, and high throughput of the cobas 6500 system have the potential to facilitate standardization of urine screening.
Identifiants
pubmed: 31649991
doi: 10.1016/j.plabm.2019.e00139
pii: S2352-5517(18)30150-1
pii: e00139
pmc: PMC6804654
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e00139Informations de copyright
© 2019 The Authors.
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