Description
Quantitative blood glucose test. For self-control.
CHAPTER: capillary blood. Minimum volume: 0.5 mcL.
EMATOCRITE INTERVAL: 30-55%
INTERVIEW MISURA: 10-600 mg/dL (0.6-33.3 mmol/L)
SENSIBILITY: minimum measurable value: 10 mg/dl
CHARACTERISTICS
EVALUATION OF REPETIBILITY
The multiCare-in glucose strips showed good performance.
Based on the results, the CV is:
- for glucose concentrations - for glucose concentrations~ 100 mg/dL, 2.0% to 2.8%
EVALUATION OF REPRODUCBILITY (INTERMEDIA)
MultiCare-in glucose strips have shown good performance in all ranges.
Three batches were evaluated, following the CVs obtained:
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
Comparison of the multiCare-in blood glucose monitoring system with the reference method using whole capillary blood samples taken simultaneously by 100 subjects.
1.1 Acceptability criteria
Acceptable minimum requirements for accuracy according to ISO 15197:2015.
- 95% of individual glycemia results must be within ± 15 mg/dL (0.83 mmoi/L) for glucose concentrations - 95% of individual glycemia results must be within ± 15% for glucose concentrations ≥ 100 mg/dL (5.55 mmol/L)
1.2 Results
System accuracy results for glucose concentrations

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%) TEMPO OF LETTURE: 5 seconds
STRISCE USE TEMPERATURE: 10-40°C

Components
Glucose Oxidase: 21 mcg; Mediator (Hexaammineruthenium chloride): 139 mcg; Buffer5,7 mcg; Stabilizer: 86 mcg.

Warnings
To be used with the instrument.

Conservation
Store at temperature between 4th and 30°C.
Expiry date after opening: 90 days
SCADENCE: 24 months

Format
Contains: strips; 1 leaflet; 1 data chip.
Pack of 25 strips

Cod. 3830230