Gluten Sensitivity TestA simple and reliable way to find out if you have coeliac disease

PLEASE DO NOT OPEN OR TOUCH ANY OF THE COMPONENTS UNTIL INSTRUCTED TO DO SO

Make sure that you have read and understood the instructions before starting.

The SELFCheck® Gluten Sensitivity Test is a rapid, simple and reliable home test for the detection of antibodies in your blood that are associated with coeliac disease.

We recommend that you sit at a table in a room with good lighting when performing the test.

Principle of the test

Coeliac disease is a serious, lifelong gastrointestinal disorder that can cause a wide spectrum of clinical symptoms. The symptoms can differ from person to person but often these include diarrhoea, bloating, wind, weight loss, malnutrition and skin disorders. The cause is a permanent intolerance to gluten, a complex mixture of storage proteins found in wheat, barley and rye. Once diagnosed, it is necessary to follow a strict gluten free diet.

The SELFCheck® Gluten Sensitivity Test detects Immunogloblin A tissue transglutaminase antibodies (IgA tTG) in a blood drop. The presence of these antibodies in your blood are a reliable sign that you have coeliac disease. If you get a positive result with this test you should speak with your GP who may refer you to a consultant gastroenterologist. Do not start a gluten free diet until your diagnosis is confirmed by your doctor.

If you have coeliac disease and you start a gluten free diet, the level of your IgA tTG antibodies will decrease and may become undetectable after a few weeks. So, if you have been on a strict gluten free diet for longer than a few weeks then you must follow a normal, gluten containing diet for at least six weeks before taking any test for coeliac disease. Blood tests that detect IgA tTG antibodies can also be used to monitor your compliance with a gluten free diet.

The test only requires one drop of blood from your finger tip and you will get a result after just 5 minutes.

Contents

• 1 instruction leaflet – which you are reading!• 1 foil pouch containing the test cassette and a plastic pipette• 1 sterile finger pricker• 1 plastic tube containing a thin glass tube• 1 plastic tube containing a solution to dilute your blood drop• 1 alcohol swab• 1 plaster

You will also require a watch or clock and a clean tissue.

Obtaining a blood sample

Most people find obtaining the blood drop easy and practically painless.

Firstly, make sure all the test components are at room temperature, but do not open them until instructed to do so.

Wash your hands with soap and warm water, rinse with clean warm water and dry thoroughly. Warming your hands makes it easier to collect the blood drop.

1. Remove the thin, blue protective cap from the finger pricker by twisting and pulling straight off

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2. Gently massage your finger towards your finger tip, clean with the alcohol swab and wait until completely dry (your ring or middle finger is best)

3. Whilst pressing the open end of the finger pricker firmly against the soft pad of your finger tip, press the blue button to activate the needle

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4. Carefully remove the thin glass capillary tube from the plastic tube

5. Gently squeeze a drop of blood from your finger tip

6. Keeping the glass capillary tube horizontal, gently touch the blood drop with one end of the tube – hold the capillary tube against the blood drop until it is completely full

7. Put the blood filled capillary tube into the tube containing the solution to dilute the blood, screw the cap back on and shake the tube several times to mix the blood with the solution. You can now clean your finger and apply the plaster.

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Performing the test

1. Let the solution settle to the bottom of the tube for a couple of minutes. Now, open the foil pouch containing your test cassette and pipette and place on a flat surface

2. Suck up some of the diluted sample with the plastic pipette. Holding the pipette vertically place 3 drops into the well marked ‘S’ on the test cassette

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3. Do not touch or move the cassette for 5 minutes, then read your result. Do not read your test more than 10 minutes after adding your sample

Reading your results

If you can see two pink lines, one in the control section ‘C’ and another in the test section ‘T’ then this is a positive result. You should record a positive result even if the line in the test section ‘T’ is very faint.

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Positive result

If you can only see a pink line in the control section ‘C’ then you have a negative result.

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Negative result

If after 10 minutes there is no line in the ‘C’ section then your result is invalid. It is highly unlikely that you will get an invalid result, the reason could be either you have not followed the procedure correctly or the test cassette is damaged. Please contact us for help.

What your results mean

A positive result means that IgA tTG antibodies have been detected in your blood. It is highly likely that you have coeliac disease. Please discuss your result with your doctor before changing your diet. If you would like a letter for your doctor explaining the test that you have used please contact us.

A negative result means that no IgA tTG antibodies have been detected in your blood. It is unlikely that you have coeliac disease. However, you may also get a negative result if you are IgA deficient. You should speak to your doctor if your symptoms continue.

Sensitivity and specificity

The sensitivity and specificity of the SELFCheck® Gluten Sensitivity Test was studied with 390 clinical samples and the results compared with biopsy proven diagnosis.

The self test showed 97.4% sensitivity and 96.9% specificity with a cut-off of 5U/ml.

Storage

The test kit should be stored at room temperature (10 to 27oC) and can be used until the expiry date printed on the packaging.

Warnings and limitations

• Failure to follow the instructions could provide a misleading result

• A final diagnosis should be made by your doctor• Do not start a gluten free diet before speaking to your doctor• Dispose of the used test and components with your usual

household waste. For hygiene reasons the components are not recyclable

• Do not use the test after the expiry date• Do not use the test cassette if the foil pouch is broken• Do not use any components if they are broken• You should use the test cassette within 20 minutes of removing it

from its foil pouch• The solution to dilute your blood contains 0.09% w/v sodium

azide. Avoid contact with your skin and do not swallow.• Do not swap components from one kit with another• This test is very reliable and is not affected by alcohol or

painkillers. The test may give a false negative result in a few

medical cases such as IgA deficiency. You should speak with your doctor if your result is different to what you had expected

• Keep all components out of reach of children

References

1. Raivio T, Kaukinen K, Nemes E, Laurila K, Collin P, Kovács JB, Mäki M, Korponay-Szabó IR. Self transglutaminase-based rapid coeliac disease antibody detection by a lateral flow method. Aliment Pharmacol Ther. 2006 Jul 1;24(1):147-154.

2. Korponay-Szabó IR, Raivio T, Laurila K, Opre J, Király R, Kovács JB, Kaukinen K, Fésüs L, Mäki M. Coeliac disease case finding and diet monitoring by point-of-care testing. Aliment Pharmacol Ther. 2005 Oct 15;22(8):729-737.

3. Nemec G, Ventura A, Stefano M, Di Leo G, Baldas V, Tommasini A, Ferrara F, Taddio A, Città A, Sblattero D, Marzari R, Not T. Looking for celiac disease: diagnostic accuracy of two rapid commercial assays. Am J Gastroenterol. 2006 Jul;101(7):1597-1600.

4. Vijay Kumar, Immunoglobulin deficiency and celiac disease, CLI, 2004, Vol 28, no.3: 10-11.

5. Mäki M, Mustalahti K, Kokkonen J, Kulmala P, Haapalahti M, Karttunen T, Ilonen J, Laurila K, Dahlbom I, Hansson T, Höpfl P, Knip M. Prevalence of Celiac disease among children in Finland. N Engl J Med. 2003 Jun 19;348(25):2517-2524.

Further information

UK Helpline 0845 094 1861 Monday to Friday 9am to 5pm.

Online help www.1sthealthproducts.co.uk

LOT Lot number

Use by date

2 Single use product

Read instructions before use

Store between 10 and 27oC

IVD In Vitro Diagnostic Medical Device

Contains 1 test

Manufacturer

Manufacturer of Gluten Sensitivity Test 0483 Besurence GmbH, Hietzinger Hauptstraße 46, 1130 Vienna, Austria.

Manufacturer of Sterile Lancet 0344 HTL-STREFA S.A., Adamówek 7, STERIL R 95-035 Ozorków, Poland

Manufacturer of plaster 0124 BSN medical GmbH,

D-22771, Hamburg, Germany

Manufacturer of Alcohol Swab Heinz Herenz GmbH, Rudarffweg 10-12, D-21031, Hamburg, Germany

SELFCheck® is a registered trademark of 1st Health Products Ltd used under licence by the manufacturer Besurence GmbH.

Revision date: September 2018

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