47
46
-
BGMS is not intended for serum or plasma test.
- Inaccurate test results may be obtained at high altitude more than about 3048 meters (10,000 feet)
above sea level.
- Severe dehydration and excessive water loss may cause inaccurately low results.
-
BGMS has not been validated for use on neonates.
- The glucose test may be interfered under abnormal concentration of
Uric acid >
( >
)
TM
Rightest
GM550
TM
Rightest
GM550
16 mg/dL
0.96 mmol/L
Accuracy
Limitations
NOTE
-
Suggest not to use this meter close to source of strong electromagnetic radiation, to avoid
interference with proper operation.
-
Suggest to keep meter free of dust, water or any liquid.
Traceability calibration:
We use YSI 2300 STAT Plus™ Analyzer as the measurement reference. The YSI 2300 STAT Plus™
Analyzer was calibrated by YSI 2747 Standard solution and can be traced to NIST Standard
Reference Material 917c, D-Glucose (Dextrose).
Type sample calibration:
The type sample used for calibration is blood.
The accuracy of the test study of the
Blood Glucose Meter was demonstrated by
comparing whole blood (plasma equivalent) glucose values on the
Rightest™
meter with plasma
glucose values on a lab instrument.
A total of 114 patients were enrolled. Each patient collected and tested their own blood samples
(from the fingertip,
) using the
Rightest™
. Another blood sample was
collected within 5 minutes and got the plasma.
Rightest™
Rightest™
Rightest™
palm and forearm
System
Analyze the plasma by the lab instrument - Olympus
AU640. Ninety-seven percent of
meter values were within ± 20% of the Olympus values
at glucose concentrations
≧
75 mg/dL and within ±15 mg/dL at glucose concentrations
<
75 mg/dL.
The results and differences between the two methods,
System and Olympus AU640 (as
the reference method) are proved in the tables below.
Difference range in values
between the Olympus value
and the
Rightest™
meter
value
Within ± 5 mg
/
dL
Within ± 10 mg
/
dL
Within ± 15 mg
/
dL
The percent ( and number ) of samples for which the difference between the
Rightest™
meter value and the Olympus value were within the difference range
shown in the side row.
Table 1: represents samples for glucose results lower than 75 mg/dL.
Fingertip
78.9% (15/19)
100% (19/19)
100% (19/19)
Palm
78.9% (15/19)
94.7% (18/19)
100% (19/19)
Forearm
42.1% (8/19)
78.9% (15/19)
94.7% (18/19)