• 15 •
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
• 12 •
• 13 •
LipidPro
TM
Test Strip Information
1-1. Total Cholesterol
LIMITATIONS OF SYSTEM (for lipid profile test):
Lipid Profile Test Strips provide accurate results when the following constraints are
observed:
• Do not use neonate samples
Please note the following interferences that may affect the results:
• Extremes in hematocrit may affect test results. Hematocrit levels less than 30 % may
cause falsely high reading and hematocrit levels greater than 55 % may cause
falsely low reading.
• Interferences: Acetaminophen, uric acid, ascorbic acid (vitamin C), and other
reducing substances (when occurring in normal blood or normal therapeutic concen-
trations) do not significantly affect results. However, abnormally high concentrations
in blood may cause inaccurately high results.
• Only EDTA and Heparin containing tubes are recommended as an anticoagulant
tube.
• Total cholesterol may be decreased by dopamine and gentisic acid.
• HDL-cholesterol may be decreased by dopamine.
• Triglyceride may be decreased by dopamine and Methyldopa.
Performance Characteristics:
The performance of the lipid profile test strips has been evaluated in laboratory and in
clinical tests (Please refer to strip instructions for use for more details).
Testing Range: The test range of LipidPro
TM
is 100 ~ 400 mg/dL (2.59-10.36mmol/L)
for total cholesterol, 25~80mg/dL (0.65-2.08mmol/L) for HDL-cholesterol and
70~600 mg/dL (0.80-6.86mmol/L) for Triglyceride.
Accuracy
Sample Type
Capillary
Regression line
Y=0.9871x+2.2856
slope
0.9871
y-interceptor
2.2856
R
2
0.9842
Regression line
Y=0.9732x+1.4038
slope
0.9732
y-interceptor
1.4038
R
2
0.9656
Regression line
Y=0.9975x+1.3080
slope
0.9975
y-interceptor
1.3080
R
2
0.9816
2-1. Total cholesterol
Mean Conc (mg/dL)
SD (mg/dL)
CV (%)
178.6
8.4
4.7
271.5
10.4
3.8
2-2. HDL-cholesterol
Mean Conc (mg/dL)
SD (mg/dL)
CV (%)
49.8
3.0
5.9
25.2
1.6
6.3
2-3. Triglyceride
Mean Conc (mg/dL)
SD (mg/dL)
CV (%)
120.8
5.3
4.4
267.4
10.2
3.8
2-1. Total cholesterol
Mean Conc (mg/dL)
SD (mg/dL)
CV (%)
150.3
2.2
1.5
250.6
3.6
1.4
2-2. HDL-cholesterol
Mean Conc (mg/dL)
SD (mg/dL)
CV (%)
60.1
2.1
3.5
30.0
1.4
4.7
2-3. Triglyceride
Mean Conc (mg/dL)
SD (mg/dL)
CV (%)
120.5
2.9
2.4
250.5
2.8
1.4
1-2. HDL-Cholesterol
Sample Type
Capillary
1-3. Triglyceride
Sample Type
Capillary
Regression line
Y=0.9257x+8.4998
slope
0.9257
y-interceptor
8.4998
R
2
0.8815
1-4. LDL-Cholesterol
Precision
- Precision Results for Human Serum samples tested for 20 days.
- Precision Results for Control Solutions.
Sample Type
Capillary
