Thin Layer Rapid Use Epicutaneous Test
The Thin-layer Rapid Use Epicutaneous (T.R.U.E.) Test is a standardized, ready-to-use patch test system. It consists of panels containing multiple patches preloaded with specific allergens or allergen mixes. When applied to the skin, the moisture from the skin reconstitutes the dried allergens in the gel vehicle, allowing them to penetrate the epidermis and trigger a localized allergic reaction if hypersensitivity is present.
Dosage by Body Weight
The test panels are applied to healthy skin of the upper back by a healthcare professional. The panels must remain in place for 48 hours, during which the patient must avoid washing or sweating excessively in that area. The panels are removed after 48 hours, and an initial reading is performed. A second delayed reading is conducted at 72 to 96 hours (and sometimes up to 7 days) to detect late-occurring reactions.
- Body Weight
- Below 5 kg
- Dose
- Not recommended
- Frequency
- Not applicable
- Tracking Notes
- Safety and efficacy have not been established in infants.
- Body Weight
- 5-7 kg
- Dose
- Not recommended
- Frequency
- Not applicable
- Tracking Notes
- Safety and efficacy have not been established in this age/weight group.
- Body Weight
- 8-10 kg
- Dose
- Not routine
- Frequency
- Not applicable
- Tracking Notes
- Rarely indicated. Diagnostic testing must be directed by a pediatric allergist or dermatologist.
- Body Weight
- 11-15 kg
- Dose
- Not routine
- Frequency
- Single application if prescribed
- Tracking Notes
- Approved for children 6 years of age and older. If used off-label in younger/smaller children, panel size may need modification due to limited skin area on the back.
- Body Weight
- 16-20 kg
- Dose
- 1 application of selected test panels
- Frequency
- Once per diagnostic evaluation
- Tracking Notes
- Approved for pediatric patients aged 6 years and older. Ensure sufficient healthy skin space on the back to accommodate the test panels.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Not recommended | Not applicable | Safety and efficacy have not been established in infants. |
| 5-7 kg | Not recommended | Not applicable | Safety and efficacy have not been established in this age/weight group. |
| 8-10 kg | Not routine | Not applicable | Rarely indicated. Diagnostic testing must be directed by a pediatric allergist or dermatologist. |
| 11-15 kg | Not routine | Single application if prescribed | Approved for children 6 years of age and older. If used off-label in younger/smaller children, panel size may need modification due to limited skin area on the back. |
| 16-20 kg | 1 application of selected test panels | Once per diagnostic evaluation | Approved for pediatric patients aged 6 years and older. Ensure sufficient healthy skin space on the back to accommodate the test panels. |
Formulation
Purpose
Used as an aid in the diagnosis of allergic contact dermatitis in patients 6 years of age and older by identifying specific allergens causing contact allergy.
Generic Name
Allergen patch test systemScheduled Drug
No. This medicine is generally not treated as a scheduled/prescription-only drug in common consumer references, but local rules may vary.