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Urisys 2400

Manufactured by Roche
Sourced in Germany

The Urisys 2400 is an automated urine analyzer designed for in-vitro diagnostic use. It performs quantitative and semi-quantitative analysis of various urine parameters, including pH, protein, glucose, and more. The Urisys 2400 is capable of processing multiple samples and providing accurate, reliable results to support clinical decision-making.

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6 protocols using urisys 2400

1

Automated Urine Analysis: Comparing Methods

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The cobas u 411 and Urisys 2400 analyzers (Roche Diagnostics GmbH, Mannheim, Germany) are urine test strip analyzers that use reflectance photometry. Urisys 2400 test strip cassettes were used with the Urisys 2400 analyzer and Combur [10 (link)] Test® M test strips were used with the cobas u 411 analyzer.
Visual microscopy using KOVA® chamber technology (Cat. No. 3518345001, Kova International Inc., Garden Grove, CA), a standardized methodology according to European urinalysis guidelines [14 (link)], was used as a harmonized comparison method across the three evaluation centers. Two KOVA slides of each sample were prepared and counted using bright field microscopy, each by two experienced operators, to reduce counting error; the mean value was then calculated. Further details on the KOVA procedure are provided in Supplementary Material S2.
The iQ200 analyzer (Iris Diagnostics, Chatsworth, CA) is a second-generation automated microscopy analyzer that captures images from planar flow of urine particles. A neural network (Auto-Particle Recognition™) is used to classify and quantify particles in the sample; 500 photographs are taken from each urine sample and compared with standard images.
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2

Anthropometric Measures and Biomarkers

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Body weight and height were measured to the nearest 0.1 kg and 0.1 cm, respectively, while participants wore light indoor clothing without shoes. BMI was calculated by dividing weight in kilograms by height in meters squared (kg/m2). BMI < 18.5 kg/m2 was defined as underweight, BMI between ≥ 18.5 kg/m2 and < 25.0 kg/m2 as normal weight, and BMI ≥ 25.0 kg/m2 as overweight or obese.[16 (link)]Blood samples were collected after at least an 8-hour fast, and random spot urine samples were obtained from participants. The samples were properly processed, immediately refrigerated, and transported in cold storage to the central laboratory within 24 hours. Serum creatinine and blood urea nitrogen were measured using the Hitachi Automatic Analyzer 7600-210 (Hitachi High-Tech Corp., Tokyo, Japan). Urine dipstick analysis was conducted using the Urisys 2400 automated urine analyzer (Roche Diagnostics GmbH, Mannheim, Germany), and proteinuria was considered as trace or greater.
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3

Urine Analysis Workflow Validation

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Urine dipstick measurements were performed with Urisys 2400 (Roche Diagnostics GmbH, Mannheim, Germany) using Combur10Test strips. This analyzer uses the following measurement methods: reflectance photometry (wave lengths 470 nm, 555 nm, 620 nm; refractometry (density), turbidimetry (cloudiness)). Urine particle analysis was performed with UF-1000i™ (Sysmex, Norderstedt, Germany) as quantitative and semi-quantitative analysis. This instrument uses the following measurement methods: fluorescence flow cytometry with diode laser and hydrodynamic focusing and conductometry. The reference ranges were as recommended by the respective manufacturers.
Measurements were done within 90 min, 120 min and 240 min from sample collection. The measurement time point of 90 min was chosen since it represents a feasible preanalytical time period in our daily routine.
Prior to each measurement, the urine was mixed automatically as well as manually. First, urine dipstick analysis was performed for the following parameters: specific weight, pH, leucocytes, erythrocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin. Next, automated urine particle analysis was performed for the following parameters: conductivity, white blood cell count (WBC), red blood cell count (RBC), epithelial cells (EC), bacteria (bac) and casts. For each measurement, 4 mL of urine were used.
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4

Urine pH Measurement and Classification

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Urine samples were collected in the morning after fasting overnight. UpH was measured using a Urisys 2400 analyzer (Roche, Mannheim, Germany). The measured values were categorized into 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. Based on previous studies, the samples were classified as <5.5 and ≥5.5 [18 (link),19 (link)].
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5

Urinary Bisphenol Levels and Birth Outcomes

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Urinary bisphenol concentrations below the LOD were assigned to LOD/√2 [21 (link)], and all the urinary bisphenol concentrations were log10-transformed for normality assumption. The urinary bisphenols were corrected for specific gravity (SG) and measured using a urine analyzer (Urisys 2400, Roche, Mannheim, Germany) to adjust the urinary dilution [22 (link)]. The SG-correction formula was as follows: SG-corrected concentration (μg/L)=Bisphenol concentration×(SGp1)(SGi1)
where SGp is the study population median SG (1.018) and SGi is the individual SG.
We used Student’s t-test to assess the differences in the birth weight and gestational age according to the maternal and infant characteristics. We selected potential confounders, known as influential factors, for bisphenol exposure and birth outcomes from previous studies with a directed acyclic graph (Figure S1). All the multivariable-adjusted models included the following confounders: maternal age (<30 or ≥30 years), educational level (2) [23 ] before pregnancy, parity (nulliparous or multiparous), infant sex (male or female), and gestational age (weeks).
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6

Comprehensive Health Assessment Protocol

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Trained medical staff conducted physical examinations following standard protocols. Body weight and height were measured to the nearest 0.1 kg and 0.1 cm, respectively, with subjects wearing light indoor clothing without shoes. Blood pressure was measured twice on the right arm at five-minute intervals using a mercury sphygmomanometer (Baumanometer; Baum, Copiague, NY, USA) and was charted as a mean value. After participants fasted overnight, blood samples were collected from the antecubital vein. The levels of fasting plasma glucose, cholesterol, alanine aminotransferase (ALT), and creatinine were measured enzymatically using a Hitachi Automatic Analyzer 7600 (Hitachi, Tokyo, Japan). White blood cell (WBC) counts were assessed using laser flow cytometry methods by XE-2100 (Sysmex, Kobe, Japan). Serum ferritin levels were measured by immunoradiometric assay using a 1470 WIZARD gamma-counter (PerkinElmer, Kurku, Finland). Dipstick urinalyses were conducted with an Urisys 2400 (Roche, Mannheim, Germany).
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