Patient information leaflet/pack insert

The TRUE Test® system consists of 3 pieces of surgical tape/plaster (panels) containing 35 allergens or allergen mixes - all 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 reactioneven in weakly sensitised patíents - yet low enough to minimise the risk of irritant reaction.
      mg/cm2 mg/patch
Panel 1 1. Nickel sulphate 0,20 0,16
  2. Wool alcohols 1,00 0,81
  3. Neomycin sulphate 0,60 0,49
  4. Potassium dichromate 0,054 0,044
  5. Caine mix 0,63 0,51
  6.. Fragrance mix 0,43 0,35
  7. Colohony 1,20 0,97
  8. Paraben mix 1,00 0,81
  9. Blank patch    
  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 formaldehyde resin 0,045 0,036
  14. Epoxy resin 0,050 0,041
  15. Carba mix 0,25 0,20
  16. Black rubber mix 0,075 0,061
  17. Cl+Me-Isothiazolinon (Kathon CG) 0,0040 0,0032
  18. Quaternium-15 0,100 0,081
  19. Methyldibromo Glutaronitrile 0,0050 0,0041
  20. P-Phenylenediamine 0,080
0,065
  21. Formaldehyde 0,18 0,15
  22. Mercapto mix 0,075 0,061
  23. Thiomersal 0,070 0,057
  24. Thiuram mix 0,027 0,022
Panel 3 25. Diazolidinyl urea (Germall II) 0,55 0,45
  26. Quinoline mix 0,19 0,15
  27. Tixocortol Pivalate 0,0030 0,0024
  28. Gold sodiumthiosulphate 0,075 0,061
  29. Imidazolidinyl urea (Germal 115) 0,60 0,49
  30. Budesonide 0,0010 0,00081
  31. Hydrocortisone-17-butyrate 0,020 0,016
  32. Mercaptobenzothiazole 0,075 0,061
  33. Bacitracin 0,60 0,49
  34. Parthenolide 0,0030
0,0024 
  35. Disperse blue 125 0,050
0,041
  36. 2-Bromo-2-Nitropropane-1,3 diol 0,25
0,20

What is TRUE Test® ?

TRUE 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 could be an ingredient in your perfume or aftershave, an antibiotic ointment or cream, rubber boots etc.
 

Manufacturer

SmartPractice Denmark ApS (former MEKOS Laboratories ApS)
Herredsvejen 2
3400 Hillerød Denmark
 

Distributor

 

Are there any special instructions that I must follow while using TRUE Test® ?

TRUE 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.
 

What other precautions or warnings should I be aware of before using TRUE Test® ?

The substance on the test panel seldom lead to sensitisation. A test reaction that appears later than 10 days after application of the test may be a sign of contact sensitisation. 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.
 

Pregnancy and lactation

TRUE Test® is not recommended to be applied to the skin of pregnant or breastfeeding women. Children: TRUE Test® is not recommended for use in children. Precautions by use together with other medicaments and other forms of interaction Since steroids may supress a positive test reaction, use of topical steroids on the 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 TRUE Test®? 

 
Peel open the package and remove TRUE Test® Panel
Remove the protective plastic covering the test surface of the panel
Position the test on the patient's back
With a medical marking pen indicate the location of the two notches
 
 
An identification template is provided with each package of TRUE Test®. Notice the difference between page 1 and 2 on the template corresponding to panel 1 and 2.
 
The patient must wear TRUE 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 is removed either by the physician or the patient.
 

When should the results be read ?

The reaction should be read 1/2 a hour after removal of the test and again 1-2 days after removal, when the allergic reactions are fully developed and mild irritant reactions have faded.
 
Neomycin sulphate and p-phenylenediamine, however sometimes cause reactions, which may not appear until 4-5 days after the application. Patients should be instructed to report this. If appropriate, an additional office visit will 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 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 TRUE 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 page 1 and 2 on the template corresponding to panel 1 and 2.
 
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
 

Note

Patients showing a negative reaction may still be sensitised to another substance not included in this test panel. Furthermore, false-negative results may occur. Retesting or testing with complementary substances may be indicated.
 
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.
 
What is important in evaluation a positive test response is not the number of plusses assigned to the test response, but determining whether the response is a truly positive reaction (caused by allergy) or a non-specific irritant reaction.
 

Overdose

Not relevant
 

What are the possible undesirable effects of TRUE 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 1-2 weeks. On rare occasions, test reactions may persist for a month, leaving an area of transient hypopigmentation. Irritation caused by the surgical tape adhesive may occur, but usually disappears rapidly.
 

How should TRUE Test® be stored ?

Storage at 2-8 °C. Expiry date is stated on the package must not be exceeded.

Who we are

SmartPractice Denmark is located in Hillerød, 35 km north of Copenhagen in beautiful surroundings near the Frederiksborg Castle.
 
SmartPractice Denmark | VAT number: 89669510 | Herredsvejen 2, 3400 Hillerød  | Phone: +45 4820 7100