TRUE TEST

1. Open the package and remove the test panel. 2. Remove the protective plastic from the test surface of the panel. Be careful not to touch the test substances. 3. Position the test on the patient's upper back - the outer part of the upper arm can eventually be used.

Smooth gently outward toward the edges, making sure each allergen makes firm contact with the skin. The first 2 panels should be placed on each side of the dorsal spine, at a few cm from the midline. The third panel should be placed next to one of the other panels.

4. Indicate on the skin the location of the two notches on each panel with a medical marking pen. 4). The patient should wear True Test 36 for 48 hours without removing it and being careful not to get the test area wet (water, sweat).

Following this period, the test is removed. The reaction should be read 1/2 an 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. Some of the allergens (neomycin sulphate, p-phenylenediamine, wool alcohols, caine mix, gold sodium thiosulfate, parthenolide, disperse blue 106, bacitracin, imidazolidinyl urea, diazolidinyl urea, budesonide, hydrocortisone- 17-butyrate and tixocortol-21-pivalate) 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 with a late reading at day 5-7 will verify a late reaction. Reading of the test should be done by the doctor. e. gold sodium thiosulphate). An identification template is provided with each package of True Test 36 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: - Negative reaction ?

Doubtful reaction; faint macular erythema, none or insignificant infiltration + Weak (nonvesicular) positive reaction; erythema, weak infiltration, possible papules ++ Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles +++ Extreme positive reaction: intense erythema, infiltrate, coalescing vesicles 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.

The following adverse reactions have been reported from clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

System organ classes Frequency Undesirable effect Very common (≥1/10) long-lasting reaction, burning sensation Common ( 1/100 to <1/10) transient hypopigmentation/hyperpigmentation, erythema Skin and subcutaneous tissue disorders Uncommon ( 1/1,000 to <1/100) flare-up of dermatitis General disorders and administration site conditions Very common (≥1/10) irritation caused by the surgical tape Immune system Rare ( 1/10,000 to <1/1,000) Sensitisation disorders Not known Anaphylactic hypersensitivity* reactions*, *From postmarketing data In extremely rare cases and only in relation to certain substances, anaphylactic reactions (systemic reaction, possibly with a life-threatening drop of blood pressure) have occurred.

The allergy departments are for other reasons prepared to treat such incidences. Anaphylactic type reactions in relation to application of True Test 36 are not documented Irritation caused by the surgical tape adhesive disappears rapidly.

A positive test reaction usually disappears within 1-2 weeks. Long-term reactions are positive reactions, which persist for weeks or months. Positive test reaction may leave an area of transient hypopigmentation/hyperpigmentation at application site.

A flare-up of dermatitis may be observed when testing during an active phase of dermatitis. Sensitisation. 4 (special warnings and special precautions for use). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Sensitisation to a substance on the test panel only seldom occurs. 8). 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 use of True Test 36 in patients with a known history of anaphylactoid reactions should be carefully evaluated before application. Excessive sweating and sun exposure of the test site is to be avoided.

Sun tan may decrease patch test reactivity and cause false negative tests. 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.

In rare case treatment with systemic corticosteroid may be necessary. Butylated hydroxyanisole (BHA) (E320) and Butylated hydroxytoluene (BHT) (E312) are present as antioxidants in allergen patch no. 7 Colophony (panel 1). g. contact dermatitis), so a false positive reaction for Colophony may occur.

Severe or generalized active dermatitis. Testing should be postponed until the acute course has passed. 1)