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multiCare-in Glucose Strips Page Description Quantitative test for whole blood glucose. For self-monitoring. SAMPLE: Capillary blood. Minimum volume: 0.5 mcL. HEMATOCRIT RANGE: 30-55% MEASUREMENT RANGE: 10-600 mg/dL (0.6-33.3 mmol/L) SENSITIVITY: minimum measurable value: 10 mg/dl PERFORMANCE CHARACTERISTICS REPEATABILITY ASSESSMENT The multiCare-in glucose strips showed good performance. Based on the results, the CV is: - for glucose concentrations < 100 mg/dl, from 2.4% to 4.3% - for glucose concentrations ~ 100 mg/dl, 2.0% to 2.8% REPRODUCIBILITY ASSESSMENT (INTERMEDIATE PRECISION) The multiCare-in glucose strips demonstrated good performance across all ranges. Three batches were evaluated, the CVs obtained are presented below: Lot 1: CV between 2.53% and 4.72% Lot 2: CV between 2.66% and 4.29% Lot. 3: CV between 3.03% and 4.29% 1. PRECISION Comparison between the multiCare-in blood glucose monitoring system and the reference method, using capillary whole blood samples collected simultaneously from 100 subjects. 1.1 Acceptability criteria Minimum acceptable requirements for accuracy according to ISO 15197:2015. - 95% of individual blood glucose results should fall within ± 15 mg/dl (0.83 mmol/l) for glucose concentrations < 100 mg/dl (5.55 mmol/l). - 95% of individual blood glucose results should fall within ± 15% for glucose concentrations ≥ 100 mg/dl (5.55 mmol/l) 1.2 Results System accuracy results for glucose concentrations < 100 mg/dl (5.55 mmol/l) within ± 5 mg/dl (0.28 mmol/L) within ± 10 mg/dl (0.56 mmol/L) within ± 15 mg/dl (0.83 mmol/L) 80/150 (53.3%) 125/150 (86.6%) 145/150 (96.6%) System accuracy results for glucose concentrations ≥ 100 mg/dL (5.55 mmol/L) within ± 5% within ± 10% within ± 15% 274/450 (60.8%) 411/450 (91.3%) 445/450 (98.8%) System accuracy results for glucose concentrations between 28 mg/dL (1.5 mmol/L) and 580 mg/dL (32.2 mmol/L) within ± 15 mg/dl (0.83 mmol/l) or within ± 15% = 590/600 (98.3%) READING TIME: 5 seconds TAPE USAGE TEMPERATURE: 10-40°C components Glucose oxidase: 21 mcg; Mediator (hexaammineruthenium chloride): 139 mcg; Buffer solution 5.7 mcg; Stabilizer: 86 mcg. warnings To be used with the instrument. Conservation Store at temperatures between 4° and 30°C. EXPIRY AFTER OPENING: 90 days EXPIRY: 24 months Format Contains: strips; 1 leaflet; 1 data chip. Pack of 25 strips Code 3830230
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Vânzător: Liki24.co.uk
Brand: N/a
