Patient Information

 
The T.R.U.E. TEST® system consists of 3 pieces of surgical tape/plaster (panels) containing 29 allergens or allergen mixes. That are well-known causes of contact dermatitis.
 
The test is developed to determine whether or not you are allergic to any of the substances included on the test panel.
 
The concentration of each allergen has been established so that it is high enough to evoke a reaction even in weakly sensitized patíents - yet low enough to minimize the risk of irritant reactions.
mg/cm2 mg/patch
Panel 1 1. Nickel sulphate 0.20 0.16
2. Wool alcohols 1.0 0.81
3. Neomycin sulphate 0.23 0.19
4. Potassium dichromate 0.0023 0.019
5. Caine mix 0.63 0.51
6.. Fragrance mix 0.43 .0.35
7. Colohony 0.85 0.69
8. Epoxy resin 0.050 0.041
9. Quinoline mix 0,19 0,154
10. Balsam of Peru 0,80 0,65
11. Ethylenediamine dihyrocloride 0,050 0,041
12. Cobalt chloride 0,020 0,016
Panel 2 13. P-tert Butylphenol formaldehyderesin 0,050 0,041
14. Paraben mix 1,0 0,80
15. Carba mix 0,25 0,20
16. Black rubber mix 0,075 0,060
17. Cl+Me-Isothiazolinone (Kathon CG) 0,0040 0,0032
18. Quaternium-15 0,10 0,081
19. Mercaptobenzothiazole 0,075 0,061
20. P-Phenylenediamine 0,090 0,073
21. Formaldehyde 0,18 0,15
22. Mercapto mix 0,075 0,060
23. Thimerosal 0,0080 0,0065
24. Thiuram mix 0,025 0,020
Panel 3 25. Diazolidinyl urea (Germall II) 0,55 0,45
26. Imidazolidinyl urea (Germal 115) 0,60 0,49
27. Budesonide 0,0010 0,00081
28. Tixocortol Pivalate 0,0030 0,0024
29. Hydrocortisone-17-butyrate 0,020 0,016

What is T.R.U.E. TEST®?

T.R.U.E. TEST® (Thin-layer Rapid Use Epicutaneous Test) is a ready-to-use patch test system for diagnosis of allergic contact dermatitis. Allergic contact dermatitis is an inflammatory reaction that occurs when substances to which you are allergic come in contact with your skin. These substances can be found in many different ingredients: for example, in your perfume or aftershave, an antibiotic ointment or cream, even rubber boots.

 

Manufacturer

 
MEKOS Laboratories ApS
Herredsvejen 2
3400 Hillerød Denmark
 

Local Distributors

 
T.R.U.E. TEST® can be purchased thruogh a local distributor in your country. Click here for a listing of our world-wide distributors.
 

Are there any special instructions that I must follow while using T.R.U.E. TEST® ?

T.R.U.E. TEST® can be used all year. Moisture around the test area must be avoided. Therefore, when bathing or showering, you must be careful not to get the test panel or surrounding area wet. If the test panel does become wet, it may loosen and the test must be repeated. For the same reason, any activity such as sunbathing or exercising, which may cause you to sweat, should be avoided while wearing the panels.

What other precautions or warnings should I be aware of before using T.R.U.E. TEST®?

The substance on the test panel seldom lead to sensitization. A test reaction that appears later than 10 days after application of the test may be a sign of contact sensitization. Excited skin syndrome (angry back) is a state of hyperreactivity induced by dermatitis on other parts of the body or by a strong positive skin test reaction. Therefore, test results should be evaluated carefully in patients with multiple, positive, concomitant patch test results. To determine which reactions are false positive, retesting at a later date may be necessary.

The doctor should avoid applying the test on skin with acne, scars, dermatitis or any other condition that may interfere with test results.
 
If a severe patch test reaction develops, the patient may be treated with a topical corticosteroid or, in rare cases, with a systemic corticosteroid.
 

Avoidance

T.R.U.E. TEST® is not recommended for women who are pregnant or breastfeeding.

T.R.U.E. TEST® is not recommended for use in children.
 
Precautions should be taken if you are using T.R.U.E. TEST® together with other medicaments and other forms of interaction Since steroids may supress a positive test reaction, use of topical steroids on the patch test site or oral steroids (equivalent to 10 mg prednisolone) should be discontinued for at least two weeks prior to testing.
 

How does the doctor use T.R.U.E. TEST®?

 
Peel open the package and remove T.R.U.E. TEST® Panel
Remove the protective plastic covering the test surface of the panel
Position the test panel on the patient's back
Mark the location of the panel by using a medical skin marker to fill in the two notches
 
 
An identification template is provided with each package of T.R.U.E. TEST®. Notice the difference between page 1, 2 and 3 on the template corresponding to panels 1, 2 and 3.
 
The patient must wear T.R.U.E. TEST® for a minimum of 48 hours without removing it and being careful not to get the test area wet (water, sweat). Following this period, the test panels can be removed either by the physician or the patient.
 

When will the results be read?

The reaction should be read 1/2 a hour after removal of the test panels and again 1 to 2 days after removal, when the allergic reactions are fully developed and mild irritant reactions have faded.

Allergens neomycin sulphate and p-phenylenediamine, sometimes cause reactions, which might not appear for 4 to 5 days after test panels have been removed. Patients should be instructed to inform their doctor of any late reactions and if appropriate, an office visit should be scheduled to verify a late reaction.
 

What is the doctor looking for?

The doctor will carefully examine the test area for signs of an allergic reaction. This reaction usually consists of a rash with swelling, redness and tiny blisters. Redness alone, however, does not necessarily mean that it is an allergic reaction.

 
If you are allergic, the doctor will provide information on where in the everyday surroundings you are likely to come in contact with the offending substances. The doctor will also tell how best to avoid these substances and often suggest alternatives to the items that should be avoided.
 

Information to the doctor

An identification template is provided with each package of T.R.U.E. TEST® for quick identification of any allergen, which causes a reaction. To assure correct positioning, marks on the skin should correlate with the notches on the template. Notice the difference between pages 1, 2 and 3 on the template corresponding to panels 1, 2 and 3.

The interpretation method recommended by the International Contact Dermatitis Research Group is:
 
? doubtful reaction; faint macular erythema only
 
+ weak (nonvesicular) positive reaction; erythema, infiltration, possible papules
 
++ strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles
 
+++ extreme reaction
 
- negative reaction IR irritant reaction of different types NT not tested
 

Additional Information

Patients showing a negative reaction may still be sensitized to another substance not included in the test panels. Furthermore, false-negative results may occur. It may be necessary to retest or test with complementary substances.

A positive reaction should meet the criteria for an allergic reaction (papular or vesicular erythema and infiltration).
 
Pustules, as well as patchy follicular or homogeneous erythema without infiltration, are usually signs of irritation and do not indicate allergy.
 
When evaluating a positive test reaction, remember to determine whether the response is a true positive reaction or a non-specific irritant reaction.
 

Overdose

Not relevant to the T.R.U.E. TEST® patch testing system.

What are the possible undesirable effects of T.R.U.E. TEST®?

A flare-up of your dermatitis if the test is used during an active phase of your condition. A positive test reaction usually disappears within 1 to 2 weeks. On rare occasions, test reactions may persist for a month, leaving an area of transient hypo pigmentation. Irritation caused by the surgical tape adhesive may occur, but usually disappears rapidly.

How should T.R.U.E. TEST® be stored?

By refrigerating and storage at 2-8 °Celsius, the shelf life is 2 years. Expire date as stated on the package must not be exceeded.