User's Manual

• 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 Glucose Auto 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
System accuracy results for glucose concentration ≥ 75 mg/dL
Alternate site :
Alternate site glucose test results obtained from alternative sites were comparend to the
glucose results obtained with the Hitachi Glucose Auto meter 747(reperence method), a
laboratory instrument. Glucose levels were measured at three different clinical centers.
Test results of DORSAL HAND were compared to the reference method.
System accuracy results for glucose concentration<75mg/dL
Within ± 5mg/dL
24/27 (93%)
Within ± 10mg/dL
27/27 (100%)
Within ± 15mg/dL
27/27 (100%)
Within ± 5mg/dL
4/5 (80%)
Within ± 10mg/dL
5/5 (100%)
Within ± 15mg/dL
5/5 (100%)
Within ± 5mg/dL
84/133 (63%)
Within ± 10mg/dL
119/133 (89%)
Within ± 15mg/dL
129/133 (97%)
Within ± 20mg/dL
133/133 (100%)
System accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5mg/dL
84/133 (63%)
Within ± 10mg/dL
119/133 (89%)
Within ± 15mg/dL
129/133 (97%)
Within ± 20mg/dL
133/133 (100%)
Test results of VENTRAL HAND were compared to the reference method.
System accuracy results for glucose concentration<75mg/dL
Within ± 5mg/dL
4/5 (60%)
Within ± 10mg/dL
5/5 (100%)
Within ± 15mg/dL
5/5 (100%)
System accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5mg/dL
111/145 (77%)
Within ± 10mg/dL
143/145 (99%)
Within ± 15mg/dL
145/145 (100%)
Within ± 20mg/dL
145/145 (100%)
• 12 • • 13 •
LipiPro
TM
Test Strip Information
Total Cholesterol
*NOTE: Please read individual Package of LipidPro
TM
test strip for complete detail information.
LIMITATIONS OF SYSTEM (for Lipid profile test):
Lipid Profile Test Strips provide accurate when the following constraints are observed :
• Do not use neonate samples
1) Physicians - Please note the following interferences that may affect the results:
- For is with capillary whole blood.
- Extremes in hematocrit may affect test results. Hemartocrit levels less than 30% may
cause falsely high reading and hematocrit level greater than 55% may cause falsely low
reading.
- Interference: 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.
- Use LIpidPro system
TM
at the frequency your doctor recommends testing for total
cholesterol, HDL-cholesterol, and triglyceride.
Performance Characteristics:
The performance or the Lipid Profile test strips has been evaluated in laboratory and in
clinical tests(Please refer to strip instructions for use in for more details). Testing Range: The
test range of Lipid Pro™ is 100 ~ 400mg/dL for Total Cholesterol, 25~80mg/dL for HDL-
Cholesterol and 70 ~ 600mg/dL for Triglyceride.
1) Accurracy
The accuracy lipid profile results obtained with the LipidPro™‚ test system were compared to
results obtained with Reference device. Lipid profile levels were measured on 1200 capillary
whole blood specimens at three different centers.
Precision
- The precision Total Cholesterol, HDL-cholesterol and Triglyceride test results were
measured with Three level venous whole blood samples for 20 days.
- The precision Total cholesterol, HDL-cholesterol and Triglyceride test results were
measured with two control solutions for 20 days.
Sample Type
Capillary
slope
1.0013
y-interceptor
2.2025
R
2
0.9933
Total Cholesterol
Mean Conc. (mg/dL)
SD (mg/dL)
CV (%)
120.0
1.9
1.6
231.8
3.2
1.4
349.7
4.0
1.1
Triglyceride
Mean Conc. (mg/dL)
SD (mg/dL)
CV (%)
130.0
1.9
1.4
357.2
5.0
1.4
530.1
6.1
1.2
Total Cholesterol
Mean Conc. (mg/dL)
SD (mg/dL)
CV (%)
150.3
2.2
1.5
250.6
3.6
1.4
HDL-Cholesterol
Mean Conc. (mg/dL)
SD (mg/dL)
CV (%)
59.9
1.3
2.1
29.9
0.8
2.7
Triglucerode
Mean Conc. (mg/dL)
SD (mg/dL)
CV (%)
120.5
2.9
2.4
250.5
2.8
1.1
HDL-Cholesterol
Lipid Profile
Mean Conc. (mg/dL)
SD (mg/dL)
CV (%)
30.9
0.8
2.5
51.9
1.1
2.1
73.0
1.6
2.2
HDL-Cholesterol
Sample Type
Capillary
slope
0.9935
y-interceptor
-1.2036
R
2
0.9938
Triglyceride
Sample Type
Capillary
slope
1.0169
y-interceptor
-0.2810
R
2
0.9938
Mean
SD
CV
TC
118.9
2.1
1.8
TG
128.5
2.2
1.7
Level 1 Level 2 Level 3
HDL
31.5
0.7
2.3
TC
236.0
3.4
1.4
TG
357.6
4.3
1.2
HDL
50.2
1.1
2.2
TC
348.0
5.
1.4
TG
529.0
6.0
1.1
HDL
71.2
1.5
2.1