Storage and Handling
- Store the strips in the original capped vial at temperatures between 4°C - 30°C (39°F - 86°F) and relative humidity
below 90%. Do not freeze.
- Replace vial cap immediately and close lid tightly after removing a test strip. If the strip is exposed to the air too
long, it will absorb the moisture and cause inaccurate test results.
- When you open a new vial of test strips please write the opening date on the label. Use test strips within 12 months
after first opening or until the expiration date printed on the label (whichever comes first).
Quality Control
Please refer to the Quality Control section of the RIGHTEST GT200 Blood Glucose Monitoring System User’s Manual.
Troubleshooting and Customer Service
For more information on error messages and troubleshooting, please refer to the Error Messages and
Troubleshooting section of the RIGHTEST GT200 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 [email protected] .
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.
Additional Information for Healthcare Professionals
(2)
Detection Principle
The glucose Dehydrogenase 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
Measurement Range
The measurement range of the
is 10 to 600 mg/dL
.
RIGHTEST GT200 Blood Glucose Monitoring System
(0.6 to 33.3 mmol/L)
Precision
The precision was evaluated with (i) venous whole blood sample (ii) 5 different glucose concentrations in 10 days by 10
meters.
P-01
P-02
P-03
P-04
P-05
300
42.2 (2.3)
1.1 (0.06)
2.6%
300
98.2 (5.5)
1.8 (0.10)
1.9%
300
131.6 (7.3)
2.8 (0.16)
2.1%
300
233.5 (13.0)
4.5 (0.25)
1.9%
300
352.6 (19.6)
5.8 (0.32)
1.6%
CS-L
CS-N
CS-H
300
57.5 (3.2)
1.8 (0.10)
3.1%
300
108.4 (6.0)
2.5 (0.14)
2.3%
300
272.3 (15.1)
6.3 (0.35)
2.3%
Accuracy
The accuracy of RIGHTEST GT200 Blood Glucose Monitoring System was tested by comparing fingertip whole blood
(plasma equivalent) glucose values measured by RIGHTEST GT200 with plasma glucose values obtained from a YSI 2300
(Calibrated with NIST 917c) reference instrument.
The result is shown in the tables below.
*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 values are compared inpercentage.
Lay User Evaluation
A total of 104 users were enrolled. Each user tested their fingertip blood samples with RIGHTEST GT200 test strip and
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 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 concentration < 100
mg/dL (5.55 mmol/L).
Hematocrit(Hct)
Hematocrit(Hct) should be between 20%-70% when blood glucose
≤
200 mg/dL (11.1 mmol/L), Hct 20%-60% when blood
glucose > 200 mg/dL (11.1 mmol/L). If you do not know your hematocrit , ask your healthcare professional.
Interferences
26 toxic amount tested substances (Acetaminophen, Ascorbic acid, Dopamine, EDTA, Gentisic acid, Heparin, Ibuprofen,
L-dopa, Methyldopa, Pralidoxime iodide, Salicylic Acid, Tetracycline, Tolazamide, Tolbutamide, Bilirubin, Cholesterol,
Creatinine, Glutathione, Haemoglobin, Triglycerides, Uric acid, Maltose, Xylose, Galactose, Lactose, Icodextrin) in two
blood sample concentrations.
Substance and possible level may interfere the glucose measurement:
Ascorbic acid
≧
5 mg/dL (0.28 mmo/L)
Uric acid
≧
20 mg/dL (1.19 mmol/L)
Xylose
≧
20 mg/dL (1.33 mmol/L)
Reagents
Each Blood Glucose Test Strip contains the following reagents:
1. FAD-Glucose dehydrogenase 12.4 %
2. Potassium Ferricyanide
49.6 %
3. Non-reactive Ingredients
38.0 %
References
1) Diabetes Information - American Association for Clinical Chemistry (AACC)
〔
Electronic Version
〕
Retrieved Mar. 02,
2018 form www.labtestsonline.org/understanding/analytes/glucose/test.html
2) In Vitro Diagnostics in Diabetes: Meeting the Challenge. Clinical Chemistry 45:9, 1596-1601 (1999).
(1) Total test numbers
(2) Mean mg/dL (mmol/L)
(3) SD mg/dL (mmol/L)
(4) CV
(1) Total test numbers
(2) Mean mg/dL (mmol/L)
(3) SD mg/dL (mmol/L)
(4) CV
(i) Venous whole blood sample:
(ii) Control solution:
Glucose levels
Glucose levels
Bionime GmbH
Tramstrasse 16
9442 Berneck
Switzerland
E-mail: [email protected]
BIONIME CORPORATION
No. 100, Sec.2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 800-241-688
http: //www.bionime.com
E-mail: [email protected]
0197
101-3GS750-
XXX
EN
Rev. Date:2019-04
Store between tempe rature 4
and 30
( 39 and 86 )
°
C
°
C
°
F
°
F
For
in vitro
diagnostic use
Manufacturer
LOT
IVD
Lot number
Expiry date
EC Representive
Do not reuse
CE-mark (with No. of notified body)
Biological risks
Consult the instruction for use
Capillary samples collected
from different testing sites
Fingertip
Palm
Forearm
The percent (and number) of samples for which the difference between the RIGHTEST
GT200 Blood Glucose Monitoring Meter value (Alternate site) and the YSI 2300 value
were within the following intervals.
Within ± 5%
318/420 (75.7%)
300/420 (71.4%)
296/420 (70.5%)
Within ± 10%
411/420 (97.9%)
412/420 (98.1%)
395/420 (94.0%)
Within ± 15%
420/420(100.0%)
420/420(100.0%)
420/420(100.0%)
Table 3: represents samples for glucose concentrations
≧
100 mg/dL (5.55 mmol/L).
Table 1: Accuracy basic information
Test range in mg/dL (mmol/L)
Within ±15mg/dL
(0.83 mmol/L) or within ±15 %
25-599 (1.39-33.28)
624/624 (100.0%)
26-599 (1.44-33.28)
624/624 (100.0%)
24-599 (1.33-33.28)
624/624 (100.0%)
Fingertip
Palm
Forearm
Capillary samples
collected from different
testing sites
Fingertip
Palm
Forearm
The percent (and number) of samples for which the variation between the RIGHTEST
GT200 Blood Glucose Meter value (Alternate site) and the YSI 2300 value were within the
following intervals.
Within ± 5 mg/dL (0.28 mmol/L)
150/204 (73.5%)
145/204 (71.1%)
140/204 (68.6%)
Within ± 10 mg/dL (0.56 mmol/L)
201/204 (98.5%)
200/204 (98.0%)
192/204 (94.1%)
Within ± 15 mg/dL (0.83 mmol/L)
204/204 (100.0%)
204/204 (100.0%)
204/204 (100.0%)
Table 2: represents samples for glucose concentrations< 100 mg/dL (5.55 mmol/L).