Additional Information for Healthcare Professionals
Lay User Evaluation
A total of 100 users were enrolled. Each user tested their fingertip blood samples with strip GS280 and
meter GM280. 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 BGMS values
were within±15% of YSI values at glucose concentrations 100 mg/dl (5.55mmol/L) and within±15 mg/dL
(0.83 mmol/L) at glucose concentration <100 mg/dL (5.55 mmol/L).
Hematocrit
Hematocrit should be between 30%-57%. If you do not know your hematocrit, ask your healthcare
professional.
Lay User Evaluation
A total of 135 users were enrolled. Each user tested their fingertip blood samples with strip GS280 and
meter GM280B. 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
BGMS values were within±15% of YSI values at glucose concentrations 100 mg/dl (5.55mmol/L) and
within±15 mg/dL (0.83 mmol/L) at glucose concentration <100 mg/dL (5.55 mmol/L).
Interferences
26 toxic amount tested substances: (acetaminophen, ascorbic acid, bilirubin, cholesterol, creatinine,
dopamine, EDTA, galactose, gentisic acid, glutathione, haemoglobin, heparin, ibuprofen, icodextrin,
L-DOPA, maltose, Methyl-DOPA, pralidoxime iodide, salicylate, tolbutamide, tolazamide,
triglycerides, uric acid, xylose, triglycerides, lactose)in two blood sample concentrations.
Substance and possible level may interfere the glucose measurement:
Ascorbic acid ≧ 6 mg/dL (0.34 mmol/L)
Uric Acid ≧ 16 mg/dL (0.95 mmol/L)
Glutathione reduced ≧ 70 mg/dL (2.28 mmol/L)
Reagents
Each Blood Glucose Test Strip contains the following reagents:
1.Potassium Ferricyanide 37.7 %
2.Glucose Oxidase (GOD) 18.8 %
3.Non-reactive Ingredients 43.5 %
References
1) Diabetes Information - American Association for Clinical Chemistry (AACC)〔Electronic Version〕
Retrieved Mar 02, 2018 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).
(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
As representative, Data of Precision were generated with RIGHTEST Blood Glucose Meter GM280B, data
of Accuracy and Lay User Evaluation were generated with RIGHTEST Blood Glucose Meter GM280.
Precision
The precision was evaluated including (i) venous whole blood sample-the blood sample are collected
over a span of time not to exceed one day per meter and reagent lot combination. (ii) 3 levels glucose
control solution in period of 10 days, by 10 meters and 3 batch of strip.
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
relative humidity below 90%. 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.
- When you open a new vial of test strips please write the opening date on the label. Use test strips
within 3 months after first opening 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 your local
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.
Difference range in values
between the YSI 2300
value and the RIGHTEST
meter value
Within± 5 mg/dL (0.28 mmol/L)
Within±10 mg/dL (0.56 mmol/L)
Within±15 mg/dL (0.83 mmol/L)
The percent ( and number ) of samples of alternative site were
the difference between the RIGHTEST and the YSI value
within the range shown in the side row.
Bias range in values
between the YSI 2300
value and the RIGHTEST
meter value
Within ± 5%
Within ± 10%
Within ± 15%
The percent ( and number ) of samples of alternative site were
the bias between the RIGHTEST and the YSI value within the
range shown in the side row.
Table 2: represents samples for glucose concentrations ≧ 100 mg/dL (5.55 mmol/L).
Table 1: represents samples for glucose concentrations < 100 mg/dL (5.55 mmol/L).
* Acceptance criteria in ISO 15197 : 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 value are compared in
percentage.
(ii) Control solution:
P-01
300
43.6(2.4)
1.3 (0.07)
2.9 %
P-02
300
102.7(5.7)
2.2 (0.12)
2.1 %
P-03
300
134.5(7.5)
2.9(0.16)
2.2 %
(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 (%)
P-04
300
229.1(12.7)
4.2(0.23)
1.8 %
P-05
300
328.9(18.3)
4.9(0.27)
1.5 %
CS-L
300
44.8(2.5)
1.3(0.07)
2.9 %
CS-N
300
101.9(5.7)
2.2(0.12)
2.2 %
CS-H
300
274.5(15.2)
5.0(0.28)
1.8 %
Palm
253/426 (59.4 %)
405/426 (95.1 %)
425/426 (99.8 %)
Palm
128/198 (64.6 %)
192/198 (97.0 %)
198/198 (100 %)
Fingertip
133/198 (67.2 %)
193/198 (97.5 %)
198/198 (100 %)
Forearm
106/198 (53.5 %)
182/198 (91.9 %)
198/198 (100 %)
Fingertip
279/426 (65.5 %)
412/426 (96.7 %)
426/426 (100 %)
Forearm
247/426 (58.0 %)
413/426 (96.9 %)
425/426 (99.8 %)
Accuracy
The accuracy of the Blood Glucose Monitoring System GM280 was tested by comparing fingertip whole
blood (plasma equivalent) glucose values measured by the Blood Glucose Meter GM280 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 System GM280 and YSI
2300 (as the reference method) are shown in the tables below.
- RIGHTEST Blood Glucose Test Strips are designed for use with capillary whole blood samples.
Do not use serum or plasma samples.
- Incorrect test results may be obtained at high altitude more than about 3,048 meters (10,000 feet) above
sea level.
- Severe dehydration and excessive water loss may cause inaccurately low results.
- RIGHTEST Blood Glucose Monitoring System has not been validated for use on neonates.
Therefore, it should not be used 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 Control Solution Test should be conducted between 15 - 40 °C (59 - 104 °F).
Store between tempe rature 4°C and 30°C ( 39°F and 86 °F)
For in vitro diagnostic use Manufacturer
LOT
IVD
Lot number
For single use only EC Representive
Biological risks
CE-mark (with No. of notified body)
Consult the instruction for use
Expiry date
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 4 2369 2388 Fax:+886 4 2261 7586
Bionime GmbH
Tramstrasse 16
9442 Berneck
Switzerland
101-3GS280-020
EN
Rev. Date:2018-09
