T.R.U.E. Test
T.R.U.E. Test (Thin-layer Rapid Use Epicutaneous Test) is a ready-to-use allergen patch test system containing allergen-infused polyester patches. When applied to the skin, it helps identify specific substances that trigger allergic contact dermatitis by producing a localized, controlled reaction.
Dosage by Body Weight
Applied to healthy skin of the back by a healthcare professional. The panels must remain in place for 48 hours, during which the patient must avoid moisture and excessive sweating. The patch is removed at 48 hours, and interpretations of the skin reaction are made at 48 hours and again at 72 to 96 hours after application.
- Body Weight
- Below 5 kg
- Dose
- Contraindicated
- Frequency
- Not applicable
- Tracking Notes
- Safety and efficacy not established in infants.
- Body Weight
- 5-7 kg
- Dose
- Contraindicated
- Frequency
- Not applicable
- Tracking Notes
- Safety and efficacy not established in toddlers.
- Body Weight
- 8-10 kg
- Dose
- Contraindicated
- Frequency
- Not applicable
- Tracking Notes
- Safety and efficacy not established.
- Body Weight
- 11-15 kg
- Dose
- Not routine
- Frequency
- Single diagnostic application
- Tracking Notes
- Only indicated for patients 6 years of age and older. Diagnostic testing does not use weight-based dosing.
- Body Weight
- 16-20 kg
- Dose
- One system (Panels 1.3, 2.3, and 3.3)
- Frequency
- Single diagnostic application
- Tracking Notes
- Applicable only if the pediatric patient is 6 years or older. Dosing is a single application of the patch panels, not calculated by weight.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | Contraindicated | Not applicable | Safety and efficacy not established in infants. |
| 5-7 kg | Contraindicated | Not applicable | Safety and efficacy not established in toddlers. |
| 8-10 kg | Contraindicated | Not applicable | Safety and efficacy not established. |
| 11-15 kg | Not routine | Single diagnostic application | Only indicated for patients 6 years of age and older. Diagnostic testing does not use weight-based dosing. |
| 16-20 kg | One system (Panels 1.3, 2.3, and 3.3) | Single diagnostic application | Applicable only if the pediatric patient is 6 years or older. Dosing is a single application of the patch panels, not calculated by weight. |
Formulation
Purpose
A diagnostic patch test indicated for use as an aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older.
Generic Name
Allergen patch testScheduled Drug
Yes. This medicine should be supplied or used only according to applicable prescription and regulatory requirements.