Medically reviewed by Drugs.com. Last updated on Jun 12, 2020.
(too BER kyoo lin tests)
- TB Skin Test
- Tuberculin Purified Protein Derivative
- Tuberculin Skin Test
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
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, polysorbate 80]
Brand Names: U.S.
- Diagnostic Agent
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
Tuberculosis skin test: An aid in the diagnosis of tuberculosis (TB) infection.
Hypersensitivity to tuberculin purified protein derivative (PPD) or any component of the formulation; previous severe reaction to tuberculin PPD skin test (TST); documented active TB or clear history of treatment for TB infection or disease; extensive burns or eczema.
Note: Dosing below is based on US/Canadian products which contain the PPD-S formulation; in regions outside of North America other products may be used, including the RT 23 formulation, and standard doses may differ between products as the units are not equivalent (Yang 2012).
Tuberculin skin test: Intradermal: 5 units (0.1 mL)
TST interpretation: Criteria for positive TST read at 48 to 72 hours (see Note below for health care workers; CDC 2000):
Induration ≥5 mm: Patients with HIV infection (or risk factors for HIV infection, but unknown status), recent close contact to person with known active TB, patients with chest x-ray consistent with prior TB, patients with organ transplants and other immunosuppressed patients (receiving the equivalent of prednisone ≥15 mg/day for ≥1 month
Induration ≥10 mm: Patients with clinical conditions that increase risk of TB infection, recent immigrants (ie, ≤5 years) from high-prevalence countries, IV drug users, residents and employees of high-risk congregate settings, mycobacteriology laboratory workers, children <4 years of age, or infants, children, and adolescents exposed to adults at high risk
Induration ≥15 mm: Patients 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 health care workers). If the first test is negative, a second TST should be administered 1 to 3 weeks after the first test was read.
TST interpretation (CDC guidelines) in a health care setting (CDC 2005):
Baseline test: ≥10 mm is positive (either first or second step); 0 to 9 mm is negative
Serial testing without known exposure: Increase of ≥10 mm is positive
≥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
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
Tuberculin skin test: Intradermal: Infants ≥6 months, Children, and Adolescents: Refer to adult dosing.
For intradermal administration only; do not administer IV, IM, or SubQ. 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 (CDC 2005). Avoid skin that is red or swollen; avoid visible veins. Administer using 1/4- to 1/2-inch 27-gauge needle or finer tuberculin syringe (CDC 2005). Should form wheal (6 to 10 mm in diameter) as liquid is injected which will remain ~10 minutes. Avoid pressure or bandage at injection site. Should wheal fail to form, repeat the test immediately at another site, at least 2 inches from the first site and circle the second injection site as an indication that this is the site to be read. Document date and time of injection, person placing TST, location of injection site, and lot number of solution. Read test at 48 to 72 hours following placement. 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.
Store 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.
Vaccines (Live): May diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, do administer a scheduled PPD skin test for at least 4-6 weeks following administration of the vaccine. Simultaneous administration of a parenteral live vaccine and PPD skin test is acceptable. Consider therapy modification
False-positive reactions may occur with BCG vaccination or previous mycobacteria (non-TB) infection (previous BCG vaccination is not a contraindication to testing; however, an interferon gamma release assay is preferred [CDC 2010]). False-negative reactions may occur with any condition that impairs or attenuates cell-mediated immunity, including aging.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined:
Cardiovascular: Presyncope, syncope
Dermatologic: Erythematous rash, localized erythema, localized vesiculation, rash at injection site, skin rash, skin ulceration at injection site, urticaria at injection site
Hypersensitivity: Anaphylactoid reaction, anaphylaxis, angioedema, hypersensitivity reaction
Local: Injection site reactions, discomfort at injection site, hematoma at injection site, injection site scarring, local pruritus, localized edema, local tissue necrosis, pain at injection site
Respiratory: Dyspnea, stridor
• Viral infections: Skin testing may be deferred with major viral infections.
• Pediatric: Infants <6 months of age may have an absent or delayed response.
• 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, fungal infections, viral infection, live virus vaccination, malignancy, corticosteroids or immunosuppressive agents, chronic renal failure, severe protein depletion, afibrinogenemia, and other conditions that impair immune response may cause a decreased response to test.
Monitor for immediate hypersensitivity reactions for ~15 minutes following injection.
Tuberculin skin tests are valid and acceptable for use during pregnancy. Active tuberculosis infection is associated with adverse fetal outcomes, including intrauterine growth restriction, low birth weight, preterm birth, and perinatal death (Esmail 2018; Miele 2020), as well as adverse maternal outcomes, including increased risks for anemia and cesarean delivery. Placental transmission may rarely occur with active maternal disease (Miele 2020). An evaluation of tuberculosis risk factors and tuberculosis testing is recommended as part of antenatal care when indicated (Miele 2020).
What is this drug used for?
• It is used during a TB (tuberculosis) test.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Severe dizziness
• Passing out
• Injection site burning, discoloration, pain, skin breakdown, or swelling
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
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