101-3GS55
1
-
080
EN
Accuracy
The accuracy of the
Blood Glucose Monitoring System was tested by comparing
RIGHTEST ALPHA
fingertip whole blood (plasma equivalent) glucose values measured by the
Blood
RIGHTEST ALPHA
Glucose Meter with plasma glucose values obtained from a YSI 2300 reference instrument.
The YSI 2300 was calibrated with NIST (SRM) 917c reference.
The results and variations between the two methods,
Blood Glucose Monitoring
RIGHTEST ALPHA
System and YSI 2300 (as the reference method) are shown in the tables below.
Additional Information for Healthcare Professionals
(ii) Control solution:
P-01
300
47.3 (2.6)
1.5 (0.08)
3.2%
P-02
300
105.6 (5.9)
2.0 (0.11)
1.9%
P-03
300
139.5 (7.7)
2.8 (0.15)
2.0%
(i) Venous whole blood sample:
Glucose levels
(1) Total test numbers (n)
(2) Mean mg/dL (mmol/L)
(3) SD mg/dL (mmol/L)
(4) CV (%)
Glucose levels
(1) Total test numbers (n)
(2) Mean mg/dL (mmol/L)
(3) SD mg/dL (mmol/L)
(4) CV (%)
(2)
Detection Principle
The glucose oxidase and potassium ferricyanide in the strip react with the glucose in the sample to
produce an electrical current which is proportional to the amount of glucose in the sample. The meter
measures the current and converts it to the corresponding glucose concentration.
Performance Characteristics
Precision
The precision was evaluated by including (i) venous whole blood samples - the blood samples were
collected over a span of time so as not to exceed one day per meter and reagent lot combination and
(ii) 3 control solutions of different glucose concentrations (across a period of 10 days with 10 meters and
3 batches of strips).
P-04
300
234.9 (13.0)
4.3 (0.24)
1.8%
P-05
300
374.0 (20.8)
5.5 (0.31)
1.5%
CS-L
300
46.7 (2.6)
1.2 (0.06)
2.5%
CS-N
300
98.7 (5.5)
2.0 (0.11)
2.0%
CS-H
300
289.9 (16.1)
4.1 (0.23)
1.4%
Storage and Handling
- Store the strips in the original capped vial at temperatures between 4°C to 30°C (39°F to 86°F) and 10
to 90% relative humidity. Do not freeze.
- Replace the vial cap immediately and close tightly after taking test strip out from the vial. Do not leave
the cap of vial opened. If the strip is exposed to the air too long, it will absorb the moisture and cause
wrong test result.
- Every time when you open a new vial of test strips, please write the opening date on the label. Use test
strips within 3 months after opened or until the expiration date printed on the label (whichever comes first).
Measurement Range
The measurement range of the RIGHTEST System is 10 to 600 mg/dL or 0.6 to 33.3 mmol/L.
Quality Control Section
Please refer to the Quality Control section of the User's Manual.
Troubleshooting and Customer Service
For more information on error messages and trouble shooting, please refer to the Error Messages and
Trouble Shooting section of the RIGHTEST
User's Manual.
If you have any questions or in case of problems with the RIGHTEST
products, please contact local
Bionime distributor or email to info@bionime.com .
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.
- Severe dehydration and excessive water loss may cause inaccurately low results.
- RIGHTEST Blood Glucose Monitoring System has not been validated for use on neonates. DO NOT
use it test for neonates.
- Do not perform the blood glucose test at temperatures below 10°C (50°F) or above 40°C (104°F), below
10% or above 90% relative humidity. The suggested temperature range for the control solution test is
15 - 40°C (59 - 104°F).
Difference range in values
between the YSI value and
the
RIGHTEST ALPHA BGMS
The percent (and number) of samples was the difference between the
RIGHTEST ALPHA BGMS
and the YSI value within the following intervals.
Difference range in values
between the YSI value and the
RIGHTEST ALPHA BGMS
Within ± 5%
Within ± 10%
Within ± 15%
The percent (and number) of samples was the difference between the
RIGHTEST ALPHA BGMS
and the YSI value within the following intervals.
*Acceptance criteria in ISO15197 : 2013 are that 95% of all differences in glucose values should be
within
±
15 mg/dL (0.83 mmol/L) at glucose concentrations < 100 mg/dL (5.55 mmol/L), and within
± 15% at glucose concentrations
≧
100 mg/dL (5.55 mmol/L).
Note:
For glucose concentrations < 100 mg/dL (5.55 mmol/L), difference values are expressed in
mg/dL (mmol/L), and for glucose concentrations
≧
100 mg/dL (5.55 mmol/L), difference values are
compared in percentage.
Lay User Evaluation
A total of 108 users were enrolled. Each user tested their fingertip blood samples with 3 lots of strip
ALPHA and ALPHA meter. Then the professional collected blood samples were centrifuged immediately
after collection to obtain plasma. Analyze the plasma by the lab instrument (YSI 2300 analyzer). 100% of
the ALPHA BGMS values were within ± 15% of YSI values at glucose concentrations
≧
100 mg/dL (5.55
mmol/L) and within ± 15 mg/dL (0.83 mmol/L) at glucose concentrations < 100 mg/dL (5.55 mmol/L).
Hematocrit (Hct)
Hematocrit (Hct) should be between 30 - 57%. If you do not know your hematocrit, ask your healthcare
professional.
Interferences
26 substances were tested in low and high glucose concentrations using the blood glucose measuring
device. Only 3 substances may interfere with glucose measurement:
Ascorbic acid
≧
6 mg/dL (0.34 mmol/L)
Glutathione reduced
≧
70 mg/dL (2.28 mmol/L)
Uric Acid
≧
16 mg/dL (0.95 mmol/L)
Other 23 substances within specified concentration may not interfere with glucose measurement:
Acetaminophen
≦
20 mg/dL (1.32 mmol/L) Dopamine
≦
2.5 mg/dL (0.13 mmol/L)
EDTA
≦
0.1 mg/dL (0.003 mmol/L); Gentisic Acid
≦
7.5 mg/dL (0.49 mmol/L); Heparin
≦
18.75 U/mL;
Ibuprofen
≦
50 mg/dL (2.42 mmol/L); L-Dopa
≦
3 mg/dL (0.15 mmol/L); Methyldopa
≦
1.5 mg/dL
(0.06 mmol/L); Pralidoxime Iodide
≦
4 mg/dL (0.15 mmol/L); Salicylic Acid
≦
60 mg/dL (4.34 mmol/L);
Tetracycline
≦
1.5 mg/dL (0.03 mmol/L); Tolazamide
≦
15 mg/dL (0.48 mmol/L); Tolbutamide
≦
64 mg/dL (2.37 mmol/L); Bilirubin
≦
50 mg/dL (0.86 mmol/L); Cholesterol
≦
700 mg/dL (18.10 mmol/L);
Creatinine
≦
10 mg/dL (0.67 mmol/L); Hemoglobin
≦
6000 mg/dL (0.94 mmol/L); Triglycerides
≦
3000 mg/dL (99.22 mmol/L); Maltose
≦
200 mg/dL (5.55 mmol/L); Xylose
≦
40 mg/dL (2.66 mmol/L);
Galactose
≦
200 mg/dL (11.10 mmol/L); Lactose
≦
50 mg/dL (1.46 mmol/L); Icodextrin
≦
500 mg/dL
(30.84 mmol/L).
Reagents
Each Blood Glucose Test Strip contains the following reagents: Glucose Oxidase (GOD) 18.8%
Potassium Ferricyanide 37.7%
Non-reactive Ingredients 43.5%
References
1) Diabetes Information - American Association for Clinical Chemistry(AACC)
〔
Electronic Version
〕
Retrieved Jan. 26, 2021 from www.labtestsonline.org/understanding/analytes/glucose/test.html
2)
In vitro
Diagnostics in Diabetes: Meeting the Challenge. Clinical Chemistry 45:9, 1596-1601 (1999).
Fingertip
72.5% (287/396)
95.5% (378/396)
100.0% (396/396)
Palm
71.2% (282/396)
95.7% (379/396)
100.0% (396/396)
Forearm
65.9% (261/396)
88.6% (351/396)
98.7% (391/396)
Fingertip
87.5% (210/240)
100.0% (240/240)
100.0% (240/240)
Palm
77.1% (185/240)
95.4% (229/240)
99.6% (239/240)
Forearm
62.9% (151/240)
96.3% (231/240)
100.0% (240/240)
Within ± 5 mg
/
dL (0.28 mmol/L)
Within ± 10 mg
/
dL (0.56 mmol/L)
Within ± 15 mg
/
dL (0.83 mmol/L)
Table 3: Represents samples for glucose results
≧
100 mg/dL (5.55 mmol/L).
Table 2: Represents samples for glucose results < 100 mg/dL (5.55 mmol/L).
Table 1: Accuracy basic information
Test range in mg/dL (mmol/L)
Within ± 15 mg/dL (0.83 mmol/L) or within ± 15%
Fingertip
29 - 466 (1.61 - 25.89)
636/636 (100%)
Palm
29 - 461 (1.61 - 25.61)
635/636 (99.8%)
Forearm
32 - 463 (1.78 - 25.72)
631/636 (99.2%)
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 4 23692388
Fax: +886 4 22617586
Email: info@bionime.com http://www.bionime.com
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Prinsessegracht 20
2514 AP The Hague
The Netherlands
Email: EmergoVigilance@ul.com
Storage tempe rature limitation
Humidity limitation
For
in vitro
diagnostic use
Manufacturer
LOT
Lot number
For single use only
EU Representive
Biological risks
CE-mark (with No. of notified body)
Consult the instruction for use
Expiry date
Importer
Rev. Date:2021-06
