Mycobacterial antigen for delayed-type hypersensitivity testing Pregnancy: Pregnancy Category C (US). Tuberculin skin testing is considered valid and safe throughout pregnancy; give to a pregnant woman only if clearly needed. Animal reproduction studies not conducted.

Tuberculin purified protein derivative

Tuberculin purified protein derivative is a diagnostic preparation of mycobacterial antigens used intradermally in the Mantoux test to assess cell-mediated immunity to tuberculosis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 0.1 mL intradermally (equivalent to 5 tuberculin units)

Route: Intradermal injection (volar aspect of the forearm, Mantoux test)

Frequency: Single test dose; read the result 48 to 72 hours later (palpable induration only, measured transversely in mm)

US labelling (Aplisol). The 0.1 mL dose is equivalent to the 5 TU dose used for standard intradermal Mantoux testing. Administer with a tuberculin syringe and short (1/4-1/2") 27-gauge needle; a pale bleb 6-10 mm should form. If injected subcutaneously or if a significant part leaks, repeat immediately at another site at least 5 cm away. Same 0.1 mL dose applies to paediatric patients; interpretation thresholds differ by risk group (e.g. positive at induration >=5 mm in children exposed to active TB, >=10 mm in children under 4 years at increased risk, >=15 mm with minimal risk). Verify against current guidelines.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Known hypersensitivity or allergy to Aplisol or any of its components
Persons who have previously experienced a severe reaction (e.g. vesiculation, ulceration or necrosis)

Side effects

Strongly positive reactions with vesiculation, ulceration or necrosis at the test site (in highly sensitive individuals)
Scarring at the test site
Local hypersensitivity reactions: erythema, pruritus, edema, urticaria, rash
Immediate erythematous reactions at the injection site
Systemic allergic reactions including anaphylaxis/anaphylactoid reactions (generally within 24 hours)

Interactions

Corticosteroids or immunosuppressive agents: reactivity to the test may be depressed or suppressed (may persist 5-6 weeks after discontinuation)
Live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, varicella): may temporarily depress reactivity - test before or simultaneously (separate site) with the vaccine, or postpone testing 4-6 weeks

Clinical monograph

How it works

Intradermal antigen elicits a delayed-type hypersensitivity response in sensitised individuals, producing a measurable area of skin induration after a defined interval.

Prescribing in practice

It must be given strictly intradermally and the result read as induration at the specified time, as incorrect technique or timing invalidates interpretation.
Results require clinical interpretation, since prior BCG vaccination, some infections, and immunosuppression can cause false-positive or false-negative reactions.
A positive test indicates immune sensitisation and does not by itself distinguish latent infection from active tuberculosis disease.

Monitoring

Ensure the reaction is read by trained staff at the correct interval, measuring induration rather than erythema, and interpret alongside the clinical picture.

Counselling the patient

You must return at the specified time to have the test site measured.
A raised firm area, not redness alone, is what is measured.
The result will be interpreted together with your history and other tests.

Evidence & guidelines

The Mantoux tuberculin test is the standard intradermal method for assessing tuberculosis infection in UK NICE and Health Security Agency guidance.

Reference: UKHSA Green Book Ch.32; NICE NG33; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways