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Understanding your test results
How do I read the result? Results are obtained by comparing the test zone to the colour chart on the label. Use natural light (e.g.
stand near a window) when colour matching for best results. When matching colours always ask the question: is the test zone
lighter or darker than the colour standard it is being compared to. After deciding move to the next colour standard and repeat until
you find the closest match. If the test zone colours lie between two values on the label then calculate the average value, e.g. (7 +
9) / 2 = 8. If the colour does not lie exactly between colour blocks you may approximate the value using your judgement. The test
zone will remain stable for 10 minutes. The test may be compared to the label at any time during this period.
Expected results – Blood glucose levels normally vary from time to time depending on food intake, medication dosages, health,
stress or exercise. Consult your physician or healthcare professional for the target glucose value appropriate for you. Normal
glucose values for an adult without diabetes (related to plasma):
• Fasting: 4.1 - 5.9 mmol/l or 74 - 106 mg/dl
Source: Stedman's Medical Dictionary, 28 Edition, 2006: App 104.
Warning – Low or high blood glucose readings may indicate a potentially serious medical condition. If you have readings
above or below your prescribed range of blood glucose values, repeat the test. If your results continue to fall outside your
prescribed range, you should contact your healthcare professional and follow their advice. If you have readings that are not
consistent with your symptoms, you should contact your healthcare professional immediately.
Problem solving – Unexpected results. Common errors that may result in invalid results include;
Contamination – Do not handle the test pads as moisture, oil and dirt from fingers will damage them. Dirty fingers carry traces of
glucose from food and will also distort the result. Therefore, it is essential to carry out the entire process with cleanliness.
Expiry date – Check your strips are in date.
Incorrect timing – Leaving blood on too long will cause a falsely high result. Wiping blood off too early will cause a falsely low result.
Inadequate blood – Too little blood will give an incorrect result. A drop sufficient to cover the pads to all corners is required (5µl).
Moisture damage – The reagent pads are extremely absorbent. If the cap is accidentally left off for even a short period of time
the test strips will be damaged by moisture.
If you still experience unusual results that are not in agreement with your symptoms then there may be a problem with your test
strips (see quality checks).
Record your blood glucose levels – Keeping a daily record of results allows you to see how well you are controlling your blood glucose levels.
Precautions and limitations
Protect the test strips from sunlight and moisture by replacing the cap immediately after use. For in vitro diagnostic use.
Use the test strips only between 18 and 35˚C (64 and 95˚F). Use only fresh capillary whole blood from a finger stick.
Do not use venous blood, plasma or serum. The test strips are for single use only. Incorrect timing – leaving the blood on too long
will cause a falsely high result, and wiping the blood off too early will cause a falsely low result. Hematocrit values above 55% can
reduce glucose values by as much as 15%. Hematocrit values below 35% can increase glucose values by as much as 10%. Do
not touch the test area as it contains chemicals. Wash hands after accidental contact. Do not use test strips if they have expired.
Dispose of used test strips in an appropriate container for contaminated waste.
Quality checks – The test strips can be checked against the "0 Unused" colour block to see they are in good condition.
If any sign of blue is visible, the strip should not be used.
Performance characteristics
Measurement range – The measurement range is 20-800 mg/dl (1.1-44.4 mmol/l ).A test result lighter than the 1 mmol/l colour standard
is less than 1.1 mmol/l (20 mg/dl). A test result darker than the 44.4 mmol/l colour standard is greater than 44.4 mmol/l (800 mg/dl).
Calibration and comparing to lab – The results obtained using Glucoflex-R are equivalent to those obtained using plasma.
Results may be compared directly to lab results. The calibration is traceable to a method of higher metrological order.
Accuracy – In a study involving 120 patients attending a diabetes clinic, results obtained using Glucoflex-R gave a correlation
coefficient of 0.99, indicating good agreement with the laboratory method.
Precision – The within-lot precision of Glucoflex-R Strips was determined for three lots of strips at four different glucose levels.
CV's for all lots were <5%.
How does the test work? The test zone consists of two test pads containing sensitive chemicals. When blood is applied to the
test zone, a chemical reaction takes place, causing colour to develop in direct proportion to the amount of glucose in the blood. The
test uses the Glucose Oxidase/Peroxidase reaction.
Chemical composition – Each test strip contains:
Green field: TMB 18.0 µg, APAC 0.59 µg, Glucose Oxidase 2.4 U, Peroxidase 4.6 U
Blue field: TMB 17.2 µg, Glucose Oxidase 2.4 U, Peroxidase 4.6 U
Key to symbols: On the box, label and instructions for use you may encounter the following symbols:
2
Do not
Temperature
+30°C
+85°F
reuse
limitation
+2°C
+35°F
Use by (unopened
or opened test strip
container)
Distributed in the UK by Ambe Medical Group
Ambe House, Commerce Way, Edenbridge, TN8 6ED
Tel: +44-(0)1732-760900 / Email: info@ambemedical.com
Distributed in the Philippines by L. Meyerf Pharma Inc.
2F Solar Century Tower, 100 Tordesillas St., Salcedo Village, Makati City
Telefax: +63-2-817 71 32 / Email: info@lmeyerf.com
Ref: GFXI.V9-ENG-MAY14 - Date issued: 2014-05 , version 9
Batch
code
Authorised Representative in
EC REP
the European Community
Catalogue
Caution
number
In vitro diagnostic
medical device
Manufacturer
Consult instructions
for use
This product fulfils the requirements
0123
of European Directive 98/79/EC on
in vitro diagnostic medical devices
National Diagnostic Products
7-9 Merriwa Street, Gordon
Sydney NSW 2072 Australia
Email: info@betachek.com
National Diagnostic Products
EC REP
503 Cambridge Heath Road
Bethnal Green, E29BU, UK
Email: eu@ndp.com.au
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