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Tuberculin Tests

Pronunciation

(too BER kyoo lin tests)

Index Terms

  • Mantoux
  • PPD
  • TB Skin Test
  • TST
  • Tuberculin Purified Protein Derivative
  • Tuberculin Skin Test

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intradermal:

Aplisol: 5 units/0.1 mL (1 mL, 5 mL) [latex free; contains phenol, polysorbate 80]

Tubersol: 5 units/0.1 mL (1 mL, 5 mL) [contains phenol]

Brand Names: U.S.

  • Aplisol
  • Tubersol

Pharmacologic Category

  • Diagnostic Agent

Pharmacology

Tuberculosis results in individuals becoming sensitized to certain antigenic components of the M. tuberculosis organism. Culture extracts called tuberculins are contained in tuberculin skin test preparations. Upon intracutaneous injection of these culture extracts, a classic delayed (cellular) hypersensitivity reaction occurs. This reaction is characteristic of a delayed course (peak occurs >24 hours after injection, induration of the skin secondary to cell infiltration, and occasional vesiculation and necrosis). Delayed hypersensitivity reactions to tuberculin may indicate infection with a variety of nontuberculosis mycobacteria, or vaccination with the live attenuated mycobacterial strain of M. bovis vaccine, BCG, in addition to previous natural infection with M. tuberculosis.

Onset of Action

Delayed hypersensitivity reactions: 5-6 hours; Peak effect: 48-72 hours

Duration of Action

Reactions subside over a few days

Use: Labeled Indications

Skin test in diagnosis of tuberculosis

Contraindications

Hypersensitivity to tuberculin purified protein derivative (PPD) or any component of the formulation; previous severe reaction to tuberculin PPD skin test (TST)

Dosing: Adult

Diagnosis of tuberculosis, cell-mediated immunodeficiencies: Intradermal: 0.1 mL

TST interpretation: Criteria for positive TST read at 48-72 hours (see Note below for healthcare workers):

Induration ≥5 mm: Persons with HIV infection (or risk factors for HIV infection, but unknown status), recent close contact to person with known active TB, persons with chest x-ray consistent with healed TB, persons who are immunosuppressed

Induration ≥10 mm: Persons with clinical conditions which increase risk of TB infection, recent immigrants, IV drug users, residents and employees of high-risk settings, children <4 years of age

Induration ≥15 mm: Persons who do not meet any of the above criteria (no risk factors for TB)

Note: A two-step test is recommended when testing will be performed at regular intervals (eg, for healthcare workers). If the first test is negative, a second TST should be administered 1-3 weeks after the first test was read.

TST interpretation (CDC guidelines) in a healthcare setting:

Baseline test: ≥10 mm is positive (either first or second step)

Serial testing without known exposure: Increase of ≥10 mm is positive

Known exposure:

≥5 mm is positive in patients with baseline of 0 mm

≥10 mm is positive in patients with negative baseline or previous screening result of ≥0 mm

Read test at 48-72 hours following placement. Test results with 0 mm induration or measured induration less than the defined cutoff point are considered to signify absence of infection with M. tuberculosis. Test results should be documented in millimeters even if classified as negative. Erythema and redness of skin are not indicative of a positive test result.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Refer to adult dosing.

Administration

For intradermal administration only. Administer to upper third of forearm (palm up) ≥2 inches from elbow, wrist, or other injection site. If neither arm can be used, may administer to back of shoulder. Administer using inch 1/4 to1/2 inch 27-gauge needle or finer tuberculin syringe. Should form wheal (6-10 mm in diameter) as liquid is injected which will remain ~10 minutes. Avoid pressure or bandage at injection site. Document date and time of injection, person placing TST, location of injection site, and lot number of solution.

Storage

Aplisol®, Tubersol®: Store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Opened vials should be discarded after 30 days.

Drug Interactions

Vaccines (Live): May diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4-6 weeks following the administration of the vaccine. Consider therapy modification

Test Interactions

False-positive reactions may occur with BCG vaccination or previous mycobacteria (nonTB) infection (previous BCG vaccination is not a contraindication to testing). False-negative reactions may occur with impaired cell mediated immunity.

Adverse Reactions

Suspected adverse reactions should be reported to the Food and Drug Administration (FDA) MedWatch Program at 1-800-332-1088

Frequency not defined:

Dermatologic: Rash

Local: Injection site reactions: Bleeding, bruising, discomfort, erythematous reaction, hematoma, necrosis, pain, pruritus, redness, scarring, ulceration, vesiculation

Miscellaneous: Anaphylaxis

Warnings/Precautions

Disease-related concerns:

• Burns: Do not administer to persons with extensive burns.

• Eczema: Do not administer to persons with eczema.

• Tuberculosis: Do not administer to persons with documented tuberculosis or a clear history of treatment for tuberculosis.

• Viral infections: Skin testing may be deferred with major viral infections.

Special populations:

• Pediatric: Very young children (<6 weeks of age) may also have an absent or delayed response.

Other warnings/precautions:

• Administration: For intradermal administration only; do not administer IV, IM, or SubQ. Epinephrine (1 mg/mL) should be available to treat possible allergic reactions.

• Appropriate use: Patients with a previous severe reaction to TST (vesiculation, ulceration, necrosis) at the injection site should not receive tuberculin PPD again.

• Conditions decreasing response: Tuberculous or other bacterial infections, viral infection, live virus vaccination, malignancy, immunosuppressive agents, and conditions which impair immune response may cause a decreased response to test.

• Vaccinations: Skin testing may be deferred with live-virus vaccination within 1 month.

Monitoring Parameters

Monitor for immediate hypersensitivity reactions for ~15 minutes following injection.

Pregnancy Risk Factor

C

Pregnancy Considerations

Reproduction studies have not been conducted. Pregnancy is not a contraindication to testing.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber severe dizziness or passing out (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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