OKRA 06, Руководство пользователя

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OKRA OKRA
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OKRA Pro test strip results can be used with hematocrit levels in the range of 20% to
65%. If the hematocrit range is out of the range(20%~65%), then the test results may
be lower or higher than the actual value.
- Interferences: Acetaminophen, uric acid, ascorbic acid (vitamin C), and other
reducing substances
(when occurring in normal blood or normal therapeutic concentrations) do not
significantly affect results. However, abnormally high concentrations in blood may
cause inaccurately high results. Samples containing Bilirubin up to 30.0 mg/dL,
Ascorbic acid up to 3.0 mg/dL & Ibuprofen up to 37.5 mg/dL do not significantly
affect results.
- Lipemic samples; Cholesterol up to 500 mg/dL or triglyceride up to 3000 mg/dL do
not significantly affect the results. Values beyond these levels should be interpreted
with caution.
- Do not use during or soon after xylose absorption testing. Xylose in the blood will
cause interference.
- Icodextrin does not interfere with OKRA Pro strips.
Please note the following interferences that may affect test results:
The performance of the test strips has been evaluated in clinical trials. Measurement
Range: The measurement range of the OKRA Pro glucose monitoring system is 20 to
600 mg/dL.
Accuracy: The accuracy results obtained with the OKRA Pro glucose monitoring
system were compared to glucose results obtained with the YSI 2300 Auto analyzer,
a laboratory instrument. Glucose levels were measured on 100 fresh capillary
specimens at three different clinical centers.
System accuracy results for Glucose concentration <75 mg/dL
System accuracy results for Glucose concentration <75 mg/dL
Performance Characteristics
Within ±5 mg/dL Within ±10 mg/dL Within ±15 mg/dL
35/51 (68.6%) 48/51 (94.1%) 51/51 (100.0%)
Within ±5% Within ±10% Within ±15% Within ±20%
148/249 (59.4%) 222/249 (89.2%) 248/249 (99.6%) 249/249 (100.0%)