Multicentre evaluation of the Boehringer Mannheim/Hitachi 917 analysis system

The new selective access analysis system BM/Hitachi 917 was evaluated in an international multicentre study, mainly according to the ECCLS protocol for the evaluation of analysers in clinical chemistry. Forty-three different analytes, covering 56 different methods enzymes, substrates, electrolytes, specific proteins, drugs and urine applications were tested in seven European clinical chemistry laboratories. Additionally, the practicability of the BM/ Hitachi 917 was tested according to a standardized questionnaire. Within-run CVs (median of 3 days) for enzymes, substrates and electrolytes were <2% except for creatine-kinase MB isoform and lipase at low concentration. For proteins, drugs and urine analytes the within-run CVs were < 4% except for digoxin and albumin in urine. Between-day median CVs were generally < 3% for enzymes, substrates and electrolytes, and < 6% for proteins, drugs and urine analytes, except for lipase, creatine kinase and MB isoform, D-dimer, glycosylated haemoglobin, rheumatoid factors, digoxin, digitoxin, theophylline and albumin in urine in some materials. Linearity was found according to the test specifications or better and there were no relevant effects seen in drift and carry-over testing. The interference results clearly show that also for the BM/Hitachi 917 interference exists sometimes, as could be expected because of the chemistries applied. It is a situation that can be found in equivalent analysers as well. The accuracy is acceptable regarding a 95–105% recovery in standard reference material, with the exception of the creatinine Jaffé method. Most of the 160 method comparisons showed acceptable agreement according to our criteria: enzymes, substrates, urine analytes deviation of slope ± 5%, electrolytes ± 3%, and proteins and drugs ± 10%. The assessment of practicability for 14 groups of attributes resulted in a grading of one–three scores better for the BM/Hitachi 917 than the present laboratory situation. In conclusion, the results of the study showed good analytical performance and confirmed the usefulness of the system as a consolidated workstation in medium-sized to large clinical chemistry laboratories

Role of Penile Doppler US in the Preoperative Assessment of Penile Squamous Cell Carcinoma Patients: Results From a Large Prospective Multicenter European Study

Objective To determine the role of penile Doppler ultrasound (PDU) compared with magnetic resonance imaging (MRI) in preoperative diagnostic evaluation of patients with penile squamous cell carcinoma. Materials and Methods A prospective analysis on patients presenting with clinical diagnosis of penile squamous cell carcinoma from 6 different European hospitals between 2012 and 2014 was carried out. Each patient who had planned an organ sparing approach underwent an MRI and PDU both with an artificial erection with prostaglandin E 1. Age, evidence of MRI or PDU corpora cavernosa infiltration, frozen section examination report, definitive pathological report, and surgical approach used per patient were recorded. Accuracy, precision, negative predictive value, sensitivity, and specificity were calculated. Outcomes were statistically evaluated. Results Two hundred patients were enrolled in the study. The mean age of the patients was 67.35\u2009\ub1\u200915.45 (range 51-82). All of the patients were treated surgically. Of the 200 patients, 135 (67.5%) underwent a corpora sparing approach, whereas 65 had a partial penectomy because of the frozen section outcome. About corpora cavernosa infiltration, the definitive outcome confirmed the frozen section examination. PDU vs MRI accuracy was 96.5% vs 90.5%; precision was 92.6% vs 96%; sensitivity was 96.9% vs 73.8%, specificity was 96.2% vs 98.5%. Despite sensitivity (P\u2009<.05) no statistical evidence was found between ultrasound and MRI. Conclusion PDU has a statistical similar outcome on detecting infiltration of corpora cavernosa and could be used as a less expensive tool to drive surgical strategy in patient with a diagnosis of penile squamous cell carcinoma

Diuron-induced rat urinary bladder carcinogenesis: Mode of action and human relevance evaluations using the International Programme on Chemical Safety framework

Diuron, a high volume substituted urea herbicide, induced high incidences of urinary bladder carcinomas and low incidences of kidney pelvis papillomas and carcinomas in rats exposed to high doses (2500 ppm) in a 2-year bioassay. Diuron is registered for both occupational and residential uses and is used worldwide for more than 30 different crops. The proposed rat urothelial mode of action (MOA) for this herbicide consists of metabolic activation to metabolites that are excreted and concentrated in the urine, leading to cytotoxicity, urothelial cell necrosis and exfoliation, regenerative hyperplasia, and eventually tumors. We show evidence for this MOA for diuron using the International Programme on Chemical Safety (IPCS) conceptual framework for evaluating an MOA for chemical carcinogens, and the United States Environmental Protection Agency (USEPA) and IPCS framework for assessing human relevance.Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES

Multicentre evaluation of the Boehringer Mannheim/Hitachi 917 analysis system

The new selective access analysis system BM/Hitachi 917 was evaluated in an international multicentre study, mainly according to the ECCLS protocol for the evaluation of analysers in clinical chemistry. Forty-three different analytes, covering 56 different methods-enzymes, substrates, electrolytes, specific proteins, drugs and urine applications-were tested in seven European clinical chemistry laboratories. Additionally, the practicability of the BMI Hitachi 917 was tested according to a standardized questionnaire. Within-run CVs (median of 3 days) for enzymes, substrates and electrolytes were <2% except for creatine-kinase MB isoform and lipase at low concentration. For proteins, drugs and urine analytes the within-run CVs were <4% except for digoxin and albumin in urine. Between-day median CV's were generally <3% for enzymes, substrates and electrolytes, and <6% for proteins, drugs and urine analytes except for lipase, creatine kinase and IMB isoform, D-dimer, glycosylated haemoglobin, rheumatoid factors, digoxin, digitoxin, theophylline and albumin in urine in some materials. Linearity was found according to the test specifications or better and there were no relevant effects seen in drift and carryover. testing. The interference results clearly show that also for the BM/Hitachi 917 interference exists sometimes, as could be expected because of the chemistries applied. It is a situation that can be Sound in equivalent analysers as well. The accuracy is acceptable, regarding a 95-105% recovery in standard reference material, with the exception of the creatinine Jaffe' method. Most of the 160 method comparisons showed acceptable agreement according to our criteria: enzymes substrates, urine analytes deviation of slope +/-5%, electrolytes +/-3%; and proteins and drugs +/-10%. The assessment of practicability for 14 groups of attributes resulted in a grading of one-three scores better for the BM/Hitachi 917 than the present laboratory situation. In conclusion, the results of the study showed good analytical performance and confirmed the usefulness of the system as a consolidated workstation in medium-sized to large clinical chemistry laboratories