R
Pro
Quick test for the detection of gluten in food and on
surfaces.
Ed.3 - February 2012
KT-5288 (5 units)
KT-5660 (25 units)
R
Pro
Quick test for the detection of gluten in food and on surfaces
Contents
1. Intended purpose .......................................................................... 2
2. Introduction .................................................................................. 2
3. Storage and disposal ..................................................................... 2
4. Supplied materials ......................................................................... 2
5. Useful but not supplied materials ................................................... 2
6. Precautions ................................................................................... 2
7. Preparation and sample analysis .................................................... 3
7.1. Food Analysis .................................................................. 3
7.1. Surface Analysis .............................................................. 5
8. Results .......................................................................................... 5
9. Quality control .............................................................................. 6
10. Specificity ................................................................................... 6
11. Features ...................................................................................... 6
11.1. Food ............................................................................. 6
11.2. Surface .......................................................................... 6
12. References .................................................................................. 6
Appendix 1 ................................................................................... 7
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1. Intended purpose
R
Pro
Pro is a rapid and user-friendly test for the detection of gluten in food and drinks which is harmful
for celiac disease sufferers.
2. Introduction
Celiac disease is a disorder which damages the small intestine causing the atrophy of the intestinal villi and intervenes
with the absorption of nutrients such as proteins, lipids, carbohydrates, mineral salts and vitamins. This disease is
caused by an inappropriate response of the immune system to gluten (a mix of proteins found in cereals) from
wheat, barley, rye, and to a lesser extent, from oat [ref.1].
Nowadays, the only treatment for celiac disease sufferers is a lifelong gluten-free diet, which is not always straight
forward because gluten, in addition of being present in many types of food, can also be present in food additives
and preservatives.
According to the Codex Alimentarius Commission, food can be considered as "gluten-free" if the amount of gluten
does not exceed 20 parts per million (ppm*).
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Pro gives you the option to test food at a threshold of 40 ppm, 20 ppm (limit recommended by
the Codex Alimentarius), 10 ppm or 5 ppm (maximal sensitivity of the test).
* Miligrams of gluten per kilo of food.
3. Storage Conditions
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Pro must be stored at a temperature ranging from 2ºC-25ºC. GlutenTox Pro sticks must be kept
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in their tube until needed.
All components of the kit are fully disposable in ordinary trash.
WARNING: The product should not be opened until its time of use. Always keep the tubes containing the test sticks
closed as tightly as possible. Once the seal is broken, keep the tube with the tests at room temperature. To avoid
water condensation, do not refrigerate the tubes after opening. Do not freeze.
4. Supplied materials
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Pro 5 units (KT-5288)
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- GlutenTox Pro stick (x5) in a tube.
- Plastic pipette (x10).
- Disposable plastic spoons (x5).
- Extraction bottle with yellow cap (x5).
- Dilution bottle with blue cap (x5).
- Instructions leaflet.
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Pro 25 units (KT-5660)
- GlutenTox Pro stick (x25) in a tube.
- Plastic pipette (x50).
- Disposable plastic spoons (x25).
- Extraction bottle with yellow cap (x25).
- Dilution bottle with blue cap (x25).
- Instructions leaflet.
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5. Useful but not supplied materials
- Watch (a stopwatch is preferable).
- Scale.
- Non-powdered disposable gloves.
- Mortar or any other utensil to grind the sample.
- Alcohol (ethanol).
6. Precautions
- Only for foodstuff analysis, except for food containing chocolate. (Visit our updated FAQ on our website
www.glutentoxhome.com for special products).
- To avoid contaminations that interfere with the analysis, the use of non-powdered disposable gloves is recommended.
If you do not have disposable gloves, wash your hands thoroughly before the test.
- Once the GlutenToxR Pro stick has been taken out from the tube, it must be used as soon as possible under strict
clean conditions. Close the tube afterwards.
- Do not use any material from the kit after the expiry date.
- Do not drink any solution (liquid) from the kit (the extraction solution contains alcohol [ethanol]).
- Keep out of reach of children.
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7. Preparation and sample analysis
7.1. Food Analysis
¡IMPORTANT NOTE!
- Before using the kit, use soap and water to clean any utensils and areas with which the
sample will enter in contact, and rinse well. After cleaning, it is highly recommended to wipe
utensils and surfaces with a clean cloth dampened with alcohol, to thoroughly prevent crosscontamination. Materials included in the kit are ready to use and do not require cleaning.
1. Grind the sample as much as possible using a mortar and/or a domestic meat grinder/mincer
which must be perfectly clean. If the food sample is too hard, chop it with a knife or small hammer
prior to grinding.
2. Open one extraction bottle with yellow cap.
Use the provided spoon with leveled amounts of sample following the table or if you have an
appropriate scale* weight 1 gram of sample. If the sample is liquid, use one leveled spoon or
take 1 milliliter of the liquid.
Examples
Kind of food
Flours, Fine powders
Spoonful
Maize flour, rice flour,
powdered milk, spices, etc.
Fine crumbs
Bread, cookies, cakes, snacks,
etc.
Liquids
Milk, condensed milk, yogurt,
soup, gravy, etc.
3. Add the content of the spoon, the gram or the milliliter to the extraction bottle with yellow cap.
4. Close the bottle, shake vigorously for at least 2 minutes and let it settle for about 5 minutes so
that the solids fall on the bottom of the tube. The settling time will depend on the type of sample.
(1)
5. Open one dilution bottle with blue cap.
Using the disposable plastic pipette, take some liquid from the extraction
bottle with yellow cap and add the drop according to your required threshold
(1)
to the dilution bottle with blue cap. Mix softly for at least 15 seconds.
Drops Limit
8 drops 5 ppm
4 drops 10 ppm
2 drops 20 ppm
1 drops 40 ppm
6. Open the dilution bottle with blue cap, and place inverted cap on a clean surface. Use a new,
disposable plastic pipette to place 5-6 drops from the dilution bottle into the blue cap. Place the
cotton wool side of the stick in contact with the liquid present in the blue cap until all the liquid
is absorbed. Let is stand in the blue cap.
7. Wait maximum 10 minutes to see the final result (if there is a high concentration of
gluten, the result may appear in less than 1-2 minutes). Note that after 10 minutes the results
are not completely reliable.
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* Following the table
Drops Limit
8 drops 5 ppm
4 drops 10 ppm
2 drops 20 ppm
1 drops 40 ppm
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Maximum
10 minutes
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7.2. Surface Analysis
1. Rub the cotton wool side of the stick against a surface of at least 16 cm2 or in a line of 40 cm
(see appendix 1).
2. Open a dilution bottle with blue cap, and place inverted cap on a clean surface. Use a new,
disposable plastic pipette to place 5-6 drops from the dilution bottle into the blue cap.
3. Put the cotton wool side of the stick in contact with the liquid present in the blue cap until all
the liquid is absorbed. Let it stand in the blue cap.
4. Wait precisely 10 minutes to see the final result. If the result is negative, the potential
contamination of the surface is less than 0.01 ppm per Kg of food for an analyzed working
surface of at least 900 cm2 (<30 cm x 30 cm).
16 cm2
4 cm
4 cm
16 cm2
40 cm
Maximum
10 minutes
8. Results
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Pro is adjusted taking into account international norms of Codex Alimentarius:
Negative Result: a single BLUE line (control line) appears in the central part of the stick
(C).
Positive Result: in addition to the control line (Blue), a PINK line (result line) appears in
the result zone (T).
NOTE: The intensity of the pink line in the results zone will vary depending on the gliadin
concentration present in the sample.
Invalid Result: if the Blue control line does not appear, the test is considered as invalid,
even if a PINK line appears. An invalid result may be due to: an insufficient quantity of sample,
a mistake done while following the steps of the manual, or the deterioration of the reagents.
In case of an invalid result, it is necessary to repeat the test, and if the problem persists,
contact your supplier.
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9. Quality control
The internal control is included in the test. The blue line that appears on the stick is the internal control of the
test which checks that the sample volume is sufficient and that the followed procedure is adequate.
10. Specificity
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Pro can detect the presence of the 33-mer fraction of gluten from
wheat, rye, barley, and oat,
which can be harmful for celiacs. However, when the samples contain rice, corn and soy no positive signal is observed,
as these ingredients are safe for celiac disease sufferers.
If a type of food is composed of several different structures, take a sample of each part to ensure that the final
sample is homogeneous. If you don’t do so and gluten was distributed unevenly in such type of food, the result
could be negative even if it contains more than the threshold of gluten set up by the user (5 ppm, 10 ppm, 20 ppm
or 40 ppm).
11. Features
11.1. Food
The detection limit of the test is 5 ppm.
11.2. Surface
The result obtained with the test indicates the presence or absence of gluten on the analyzed surface; it
cannot be extrapolated into any value of gluten in ppm.
If by analyzing a surface of 16 cm2 a minimum of 10 ng/cm2 are detected, it can be "estimated" that for
a analyzed working surface of 1.000 cm2 (40 cm x 25 cm), working with a food mass of 1 Kg, the final
product will have less than 0,01 ppm (0,01 mg gluten/Kg of food). This quantity is about 2000 times less
than the quantity recommended by the European norms and Codex Alimentarius established at 20 ppm
(20 mg gluten/Kg of food). This means that the method has a large safety margin and that its use provides
guarantee to clients, celiac associations and food safety inspectors.
12. Referencia
1. Shan L., et al.; "Structural basis for gluten intolerance in celiac sprue"; Science; 2002; 297: 2275-2279.
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Appendix 1
Minimal surface to analyze.
16 cm2
16 cm2
40 cm
For more information,
please visit our website
or contact us:
Biomedal S.L.
www.glutentoxhome.com
[email protected]
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