• 14 •
• 15 •
LipidPro
TM
Test Strip Information
LIMITATIONS OF SYSTEM (for Glucose test):
The LipidPro
TM
Glucose Test Strips provide accurate results when the following
constraints are observed:
• Do not use neonate samples.
• Inaccurate results may occur when in shock, hypotensive, hyperglycemic, or
hyperosmolar state, with or without ketosis.
• Glucose test strips used above altitudes of 10,000 feet will have an effect on
test results.
Please note the following interferences that may affect test results:
• Extremes in hematocrit may affect test results. Hematocrit levels less than 20
% may cause falsely high reading. Hematocrit levels greater than 60 % may
cause falsely low readings.
• Interferences: Acetaminophen, Uric and, 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 may cause inaccurately high results.
• Lipemic samples; Cholesterol up to 500 mg/dL or triglyceride up to 3000mg/dl
do not significantly affect the results. Values beyond these levels should be
interpreted with caution.
• Blood samples that contain a high concentration of dissolved oxygen may
lower the test result.
• EDTA containing tube is recommended as an anticoagulant tube.
Performance Characteristics:
The performance of the glucose test strips has been evaluated in laboratory and
in clinical tests (Please refer to strip instructions for use for more details).
Measurement Range: The measurement range of the LipidPro
TM
Glucose
Testing is 10 to 600 mg/dL (0.6-33.3mmol/L).
Accuracy:
The accuracy results obtained with the LipidPro
TM
lipid profile and glucose
measuring system were compared to glucose results obtained with the Hitachi
meter 747, a laboratory instrument. Glucose levels were measured on 160
patients at three different clinical centers.
System accuracy results for glucose concentration <75 mg/dL (4.2 mmol/L)
System accuracy results for glucose concentration ≥ 75 mg/dL(4.2 mmol/L)
Precision:
Precision Results for venous blood samples.
Within ± 5mg/dL
(within ± 0.28 mmol/L)
20/28(71%)
Within ± 10mg/dL
(within ± 0.56 mmol/L)
26/28 (93%)
Within ± 15mg/dL
(within ± 0.83 mmol/L)
28/28 (100 %)
Within ± 5mg/dL
76/132(58%)
Within ± 10mg/dL
111/132(84%)
Within ± 15mg/dL
128/132 (97%)
Within ± 20mg/dL
132/132(100%)
Mean (mg/dL)
CV (%)
40
3.7
81
2.7
135
3.1
233
3.3
350
1.8
Precision Results for control solutions.
Mean (mg/dL)
CV (%)
47
3.3
106
3.1
307
3.1
