Οg-Care Glucose Test Strips
Glucose test strips for OG Care Glucose meter in package of 50 pieces.
IMPORTANT: Read these instructions for use and the User’s manual supplied with your meter before you monitor your blood glucose. Failure to follow instructions will cause incorrect results.Suitable for self-testing Product name OGCare Blood Glucose Test Strip
Contents of the pack
OGCare Reactive strips in the capped vial and instruction for use.
Intended Use
Test strips are to be used with OGCare Blood Glucose Meter, to monitor glucose concentration of capillary blood.
Application Scope
Test strips are for in-vitro diagnostic use and for self-testing, result should only be used for monitoring, not as diagnostic tools.
Testing Principles
The test strip measures glucose concentration in blood sample by measuring current produced by glucose oxidase solidified on test strip.
The System is plasma-calibrated to allow easy comparison of results with laboratory methods, in the line with the recommendations of the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC).
This method is traceable to an NIST standard. If you have previously used whole-blood referenced test strips, your meter has been showing results that reflect blood glucose concentrations in whole blood. Blood glucose results from test strips that are plasma-referenced are approximately 11% higher than those obtained with whole-blood referenced test strips.
Major Components
Each Test strip contains:
Glucose oxidase (A.Niger) ..................................... 2.5unit
Redox mediator ..................................... 32.3ug
Buffer & Non-reactant ..................................... 50.5ug
Storage Condition
Test strips should be stored in the original strip vial and be located where is cool and dry at 4~30°C (39.2~86℉), and must not be frozen.
Expiration Date
Discard any remaining test strips 3 months after first opening the vial. Expiration date is printed on the packing box and the strip vial.
Test Sample References
Fresh whole blood from capillary vessel.
Test Procedure
Step 1. Prepare for testing supplies, the OGCare meter and OGCare test strips, lancing device and sterile lancets.
Step 2. Open strip vial, take one test strip and quickly close vial.
Step 3. Make sure that three black line is upward inserted straightly into the test strip slot of the meter and the test strip slit of the strip is outward.
Step 4. Once test strip is inserted, the meter turns on automatically. If the code on the meter is not same as the one printed on the strip vial, please contact to Customer Service. When blood symbol is flashing, you can begin the test.
Step 5. Perfrom the finger pricking by lancing device with a sterile lancet inserted (both are is inside the meter kit) .
Step 6. Gently press the finger to obtain a blood drop (0.5μL)
Step 7. Approach the finger with the blood drop to the part of the strip that is outside the meter. The blood will be aspirated from the strip and the meter will emit an acoustic signal.
Step 8. The result will be displayed after 5 seconds.
Step 9. Remove the used test strip by ejector and meter turns off automatically.
Only one measurement should be carried out for each fingerpricking.
Carefully follow the instructions contained in the user manual.
All components of the pack have to be disposed properly, avoiding contaminations.
Quality Control by control solutions
Generally, quality check by Control Solution should be performed in following situation.
When you feel that the meter and strip are not functioning properly.
When you feel the result is abnormal.
When you open and begin using a new strip vial.
Perform the checking process with control solution provided for the OGCare meter. If results are in the range printed on the vial, it declares that the operation is correct.
If results are out of range, please re-test. If the abnormal result is still displaying, please contact Customer Service.
How to convert the measurement unit
1mmol/L result is same as approximately result of 18mg/dL.(Example: 5.5mmol/L ≒ 99mg/dL )
Blood glucose measuring units are pre-set. You cannot change the measuring unit. Please consult to your healthcare professional, if you have any question about the measuring unit.
Non-Diabetics Reference Value
Normal blood glucose reference value for non-diabetics are as follow:
Before eating: 70 ~ 110mg/dL (3.9 ~ 6.1mmol/L)
2 hours after meal: Less than 140mg/dL (7.8mmol/L)
In case results are out of reference range, please contact your healthcare professional and follow his advice
Specification
Testing Range : 20 ~ 600mg/dL (1.1 ~ 33.3mmol/L)
Sample Volume : 0.5 ㎕
Operating Temperature : (10~40℃) 50 ~ 104℉
Operating Humidity : 10 ~ 90%RH
Permissible Hematocrit Range : 20 ~ 60%
Limitations
Hematocrit is the percentage of red blood cells in the blood. Exceeding proper hematocrit level may cause falsely low readings. If you do not know your hematocrit level, consult your health care professional.
This test strip is not designed for use with arterial, venous, serum or plasma samples.
Testing under out of the specification range may cause inaccurate results.
The OGCare test strip may be used at altitude up to 10,000 feet.
Performance Characteristics
Accuracy :
Compare with OGCare series system and YSI2300 Biochemical Analyzer for venous blood samples from 108 subjects at the same time, the following result was obtained
No. of samples: 216
Regression Equation:
y = 1.011x - 0.0902 (mmol/L)
y = 1.011x - 1.6247 (mg/dL)
r(corr.coef.) = 0.977
Storage and Handling
This product is only for in-vitro diagnostic use only.
Before using please check the expiration date on the strip vial.
This products should be used with the OGCare Blood Glucose Meter.
Do not touch with wet or uncleaned hands.
Do not touch test strip slit.
When inserting test strip into the meter, please do not force too much.
The results of this product should not be used for diabetic treatment or medications without doctor's consulting.
It is important to discard the used test strip and lancets carefully. Used test strips and lancets may be considered biohazardous waste in your area. Be sure to follow your local regulation for proper disposal.
Use test strips immediately after retrieving from the vial and to keep the test strip vial tightly closed at all times.
WARNING: Keep the test strip vial away from children; the test strips may be a choking hazard.
Healthcare Professionals Information
Fresh capillary blood may be collected into test tubes containing heparin if the blood is used within 10 minitues. Do not use any other anticoagulants or preservatives.
Interferences: Acetaminophen, salicylates, uric acid, ascorbic acid(vitamin C) and other interferent substances in normal blood or normal therapeutic concentrations, do not significantly affect results however, abnormally high concentrations in blood may cause inaccurate results.
Patients undergoing oxygen therapy may yield falsely low results.
Test results may be falsely low if the patient is severely dehydrated, in shock or in a hyperosmolar state(with or without ketosis). Critically ill patients should not be tested using blood glucose meters.
Lipemic samples:
Cholesterol levels up to 500mg/dL do not significanltly affect the results.
Grossly lipemic patient samples have not been tested and are not recommended for testing with the OGCare System.
