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Tuberculin skin test: Drug information

Tuberculin skin test: Drug information
(For additional information see "Tuberculin skin test: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Aplisol;
  • Tubersol
Brand Names: Canada
  • Tubersol
Pharmacologic Category
  • Diagnostic Agent
Dosing: Adult

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

Tuberculin skin test: Intradermal: 5 units (0.1 mL)

TST interpretation: Criteria for positive TST read at 48 to 72 hours (CDC 2020):

Induration ≥5 mm: Patients with HIV infection (or risk factors for HIV infection, but unknown status), recent close contact to person with known tuberculosis (TB) disease (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 or those taking TNF-α antagonists).

Induration ≥10 mm: Patients with clinical conditions that increase risk of TB infection, people born in countries where TB disease is common, IV drug users, residents and employees of high-risk congregate settings, mycobacteriology laboratory workers, people <90% of ideal body weight, children <5 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)

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

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

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Tuberculin skin test

Tuberculin skin test: Intradermal: Infants ≥6 months, Children, and Adolescents: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

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

Miscellaneous: Fever

Contraindications

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.

Warnings/Precautions

Disease-related concerns:

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

Special populations:

• Pediatric: Infants <6 months of age may 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, 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.

• False positive reaction: A false positive reaction may occur in patients with nontuberculosis mycobacteria infection and patients previously vaccinated with bacilli Calmette-Guerin.

Dosage Forms: US

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, polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution (Aplisol Intradermal)

5 unit/0.1 mL (per mL): $106.60

Solution (Tubersol Intradermal)

5 unit/0.1 mL (per mL): $115.57

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Solution, Intradermal:

Tubersol: 5 units (1 mL, 5 mL) [contains phenol, polysorbate 80]

Administration: Adult

Intradermal: 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.

Administration: Pediatric

Intradermal: 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 product manufacturer and lot number of solution (CDC 2005). 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.

Use: Labeled Indications

Tuberculosis skin test: An aid in the diagnosis of tuberculosis (TB) infection.

Medication Safety Issues
Sound-alike/look-alike issues:

Aplisol may be confused with Anusol

PPD (purified protein derivative tuberculin test) may be confused with IPV (inactivated poliovirus vaccine).

PPD (purified protein derivative tuberculin test) may be confused with IIV (inactivated influenza vaccine).

PPD (purified protein derivative tuberculin test) may be confused with PCV (pneumococcal conjugate vaccine, PCV13 is the correct abbreviation).

Administration issues:

Tuberculin products may be confused with tetanus toxoid products, poliovirus vaccine (inactivated), and influenza virus vaccine. Medication errors have occurred when tuberculin skin tests (PPD) have been inadvertently administered instead of tetanus toxoid products and influenza virus vaccine. These products are refrigerated and often stored in close proximity to each other.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Vaccines (Live): May diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: Consider therapy modification

Pregnancy Considerations

Tuberculin skin tests are valid and acceptable for use during pregnancy. Tuberculosis (TB) disease (active TB) 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 TB risk factors and TB testing is recommended as part of antenatal care when indicated (Miele 2020).

Breastfeeding Considerations

It is not known if tuberculin purified protein derivative (PPD) is present in breast milk.

The manufacturer recommends that caution be exercised when administering tuberculin tests to breastfeeding women.

Monitoring Parameters

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

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Delayed hypersensitivity reactions: 5-6 hours

Peak effect: 48-72 hours

Duration: Reactions subside over a few days

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (QA) Qatar: Tubersol
  1. Aplisol (tuberculin purified protein derivative, diluted) [prescribing information]. Spring Valley, NY: Par Pharmaceutical Companies; August 2014.
  2. Centers for Disease Control and Prevention; American Thoracic Society. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR Recomm Rep. 2000;49(RR-6):1-51. [PubMed 10881762]
  3. Centers for Disease Control and Prevention (CDC). Updated guidelines for using Interferon Gamma Release Assays to detect Mycobacterium tuberculosis infection - United States. 2010. MMWR Recomm Rep. 2010;59(RR-5):1-25. [PubMed 20577159]
  4. Centers for Disease Control and Prevention (CDC). Tuberculin skin testing fact sheet. https://www.cdc.gov/tb/publications/factsheets/testing/skintesting.pdf. Published September 2020.
  5. Esmail A, Sabur NF, Okpechi I, Dheda K. Management of drug-resistant tuberculosis in special sub-populations including those with HIV co-infection, pregnancy, diabetes, organ-specific dysfunction, and in the critically ill. J Thorac Dis. 2018;10(5):3102-3118. doi:10.21037/jtd.2018.05.11 [PubMed 29997980]
  6. Jensen, PA, Lamber LA, Iademarco MF, Ridzon R; Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR Recomm Rep. 2005;30;54(RR-17):1-141. [PubMed 16382216]
  7. Miele K, Bamrah Morris S, Tepper NK. Tuberculosis in pregnancy. Obstet Gynecol. 2020;135(6):1444-1453. doi:10.1097/AOG.0000000000003890 [PubMed 32459437]
  8. Tubersol (tuberculin purified protein derivative) [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; October 2021.
  9. Yang H, Kruh-Garcia NA, Dobos KM. Purified protein derivatives of tuberculin--past, present, and future. FEMS Immunol Med Microbiol. 2012;66(3):273-280. doi: 10.1111/j.1574-695X.2012.01002.x. [PubMed 22762692]
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