OKRA 06 - Interferences Affecting Test Results; Performance Characteristics

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
signicantly aect 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 signicantly
aect results.
- Lipemic samples; Cholesterol up to 500 mg/dL or triglyceride up to 3000 mg/dL do
not signicantly aect 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 aect 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 dierent 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%)