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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.

ABSTRACT: Background: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. Design and 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: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. Conclusions:The fully automated workflow, high precision, and high throughput of the cobas 6500 system have the potential to facilitate standardization of urine screening.

SUBMITTER: Cobbaert CM

PROVIDER: S-EPMC6804654 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundCurrent evidence does not recommend screening urine culture and curing asymptomatic bacteriuria (ASB) before joint arthroplasty. The bacteriuria count on pre-operative urinalysis is a more common clinical parameter. We aimed to investigate whether the bacteriuria count on preoperative urinalysis can increase postoperative wound complications in primary total hip arthroplasty (THA).MethodsWe conducted a retrospective study that included patients who underwent primary THA in our institution from 2012 to 2018. We obtained preoperative urinalysis results before THA during the same hospitalization and identified patients with abnormal urinalysis. Receiver operating characteristic (ROC) curves were first generated to evaluate the predicted value of leukocyte esterase (LE), nitrite, bacteriuria, and pyuria in the urinalysis for superficial wound infection. Then, all included patients were divided into two groups according to the preoperative urinalysis: a bacteriuria-positive group and a bacteriuria-negative group. The primary outcome was the superficial wound infection rate within 3 months postoperatively, and the secondary outcomes included wound leakage, prosthetic joint infection (PJI), pulmonary infection, urinary tract infection (UTI), readmission rate within 3 months postoperatively, and length of stay (LOS) during hospitalization. We utilized univariable analyses to compare the outcomes between the two groups. A multivariable logistic regression model was generated to explore the potential association between bacteriuria and the risk of superficial wound infection, wound leakage, and readmission rate controlling for baseline values.ResultsA total of 963 patients were included in the study. One hundred sixty patients had abnormal urinalysis. The AUCs for LE, nitrite, bacteriuria, and pyuria were 0.507 (95% confidence interval (CI), 0.315 to 0.698), 0.551 (0.347 to 0.756), 0.675 (0.467 to 0.882), and 0.529 (0.331 to 0.728), respectively. Bacteriuria was diagnostically superior to LE, nitrite, and pyuria. Among the 963 patients, 95 had a positive bacteriuria on preoperative urinalysis, and only 9 (9.5%) had a positive urine culture. Compared with the bacteriuria-negative group, the bacteriuria-positive group had a higher superficial wound infection rate (4.2% vs. 0.6%, P = 0.008), higher wound leakage rate (11.6% vs. 4.5%, P = 0.007), higher readmission rate (5.3% vs. 1.3%, P = 0.015) within 3 months postoperatively and longer LOS (6.19 ± 2.89 days vs. 5.58 ± 2.14 days, P = 0.011). After adjustment, the bacteriuria-positive group had a significantly increased risk of superficial wound infection (OR = 7.587, 95%CI: 2.002 to 28.755, P = 0.003), wound leakage (OR = 3.044, 95%CI: 1.461 to 6.342, P = 0.003), and readmission (OR = 4.410, 95%CI: 1.485 to 13.097, P = 0.008).ConclusionPreoperative bacteriuria positivity on urinalysis significantly increased the risk of postoperative wound complications, readmission, and LOS in primary THA regardless of the result of the urine culture. Urinalysis is a fast and cost-acceptable test whose advantages have been underestimated.Level of evidenceLevel III, observational study.

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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.

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