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Aplisol (Tuberculin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Tuberculin PPD is recommended by the American Lung Association as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test recommended employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD. 7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose recommended as clinically established and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections. 4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3

DOSAGE AND ADMINISTRATION

Aplisol vials should be inspected visually for both particulate matter and discoloration prior to administration and discarded if either is seen. Vials in use for more than 30 days should be discarded.

STANDARD METHOD (MANTOUX TEST)

The Mantoux test is performed by intradermally injecting with a syringe and needle exactly 0.1mL of Aplisol. The result is read 48 to 72 hours later and induration only is considered in interpreting the test. Induration is a hard, raised area with clearly defined margins at and around the injection site. Erythema may develop at the injection site but has no diagnostic value. The standard test is performed as follows:

  1. The site of the test is usually the flexor or dorsal surface of the forearm about 4" below the elbow. Other skin sites may be used, but the flexor surface of the forearm is preferred. The use of a skin area free of lesions and away from any veins is recommended. 7
  2. The skin at the injection site is cleansed with 70% alcohol and allowed to dry.
  3. The test material is administered with a tuberculin syringe (0.5 or 1.0mL) fitted with a short (1/2") 26 or 27 gauge needle.
  4. A separate, sterile, single-use disposable syringe and needle should be used for each individual patient.
  5. The diaphragm of the vial-stopper should be wiped with 70% alcohol.
  6. The needle is inserted through the stopper diaphragm of the inverted vial. Exactly 0.1mL is filled into the syringe with care being taken to exclude air bubbles and to maintain the lumen of the needle filled.
  7. The point of the needle is inserted into the most superficial layers of the skin with the needle bevel pointed upward. As the Tuberculin solution is injected, a pale bleb 6 to 10mm in size (1/3") will rise over the point of the needle. This is quickly absorbed and no dressing is required.

In the event the injection is delivered subcutaneously (i.e., no bleb will form), or if a significant part of the dose leaks from the injection site, the test should be repeated immediately at another site at least 5 cm (2") removed.

The Mantoux test is the standard of comparison for all other tuberculin tests.

INTERPRETATION OF TUBERCULIN REACTION

Readings of Mantoux reactions should be made during the period from 48 to 72 hours after the injection. Induration only should be considered in interpreting the test. The diameter of induration should be measured transversely to the long axis of the forearm and recorded in millimeters. Erythema has no diagnostic value and should be disregarded. The presence and size of necrosis and edema if present should be recorded although not used in the interpretation of the test. In the absence of induration, an area of erythema greater than 10 mm is diameter may indicate the injection was made too deeply and retesting is indicated.

REACTIONS SHOULD BE INTERPRETED AS FOLLOWS:

Positive-- A positive reaction to the tuberculin skin test may not be seen until 2-10 weeks after the infection. 7 Based in current guidelines, 3, 12 interpretation of positive reactions (depending on the age, immune status or risk factors of the persons tested) is:

1.An induration of >5 mm is classified as positive in the following:

  • Persons who have had recent close contact with persons who have active TB;
  • Persons who have human immunodeficiency virus (HIV) infection or risk factors for HIV infection but unknown HIV status;
  • Persons who have fibrotic chest radiographs consistent with healed TB.

2.An induration of >10 mm is classified as positive in all persons who do not meet any of the above criteria, but who belong to one or more of the following groups at high risk for TB:

  • Injecting-drug users known to be HIV seronegative;
  • Persons who have other medical conditions that have been reported to increase the risk for progressing from latent TB infection to active TB. These medical conditions include diabetes mellitus, conditions requiring prolonged high-dose corticosteroid therapy and other immunosuppressive therapy (including bone marrow and organ transplantation), chronic renal failure, some hematologic disorders (e.g., leukemias and lymphomas), other specific malignancies (e.g., carcinoma of the head or neck), weight loss of >10% below ideal body weight, silicosis, gastrectomy, jejunileal bypass;
  • Residents and employees of high-risk congregate settings; prisons and jails, nursing homes and other long-term facilities for the elderly, health-care facilities (including some residential mental health facilities), and homeless shelters;
  • Foreign-born persons recently arrived (i.e., within the last 5 years) from countries having a high prevalence or incidence of TB;
  • Some medically underserved, low-income populations, including migrant farm workers and homeless persons;
  • High-risk racial or ethnic minority populations, as defined locally;
  • Children <4 years of age or infants, children and adolescents exposed to adults in high-risk categories.

3.An induration of > 15mm is classified as positive in persons who do not meet any of the above criteria.

Negative-- Induration of less than 5 mm. This indicates a lack of hypersensitivity to tuberculoprotein and tuberculous infection is highly unlikely.

Booster Effect-- Infection of an individual with tubercle bacilli or other mycobacteria or BCG vaccination results in a delayed hypersensitivity response to tuberculin which is demonstrated by the skin test. The delayed hypersensitivity response may gradually wane over a period of years. If a person receives a tuberculin test at this time, a significant reaction may not be detected. However, the stimulus of the test may boost or increase the size of the reaction to a second test, sometimes causing an apparent conversion or development of sensitivity. This booster effect can be seen on a second test done one week after the initial stimulating test and can persist for a year, and perhaps longer. When routine periodic tuberculin testing of adults is done, initially two-stage testing should be considered to minimize the likelihood of interpreting a boosted reaction as a conversion. 13, 14

It should be noted that reactivity to tuberculin may be depressed or suppressed for as long as 5-6 weeks by viral infections, live virus vaccines (i.e., measles, smallpox, polio, rubella and mumps), or after discontinuation of therapy with corticosteroids or immunosuppressive agents. Malnutrition may also have a similar effect. When of diagnostic importance, a negative test should be accepted as proof that hypersensitivity is absent only after normal reactivity to non-specific irritants has been demonstrated. A primary injection of tuberculin may possibly have a boosting effect on subsequent tuberculin reactions. A pediatric patient who is known to have been exposed to a person with tuberculosis must not be adjudged free of infection until that patient has a negative tuberculin reaction at least ten weeks after contact with tuberculous person has ceased. 15 Annual testing is generally recommended for pediatric patients in high risk populations, such as persons from countries with a high prevalence of tuberculosis and low-income groups. 16

A positive tuberculin reaction does not necessarily signify the presence of active disease. Further diagnostic procedures (e.g., chest radiograph, sputum smear and/or culture examination) should be carried out before a diagnosis of tuberculosis is made. A small percentage of responders may not have been infected with M. tuberculosis but by some other mycobacterium. The negative tuberculin skin test should never be used to exclude the possibility of active tuberculosis among persons for whom the diagnosis is being considered (symptoms compatible with tuberculosis).

HOW SUPPLIED

Tuberculin PPD-Aplisol bioequivalent to 5US units (TU) PPD-S per test dose (0.1mL) is available in the following presentations:

NDC 64029-4525-1 (Bio. 1525)

1 mL (10 tests) - rubber-diaphragm-capped vial

NDC 64029-4525-2 (Bio. 1607)

5 mL (50 tests) - rubber-diaphragm-capped vial

This product is ready for use without further dilution.

STORAGE

DO NOT FREEZE

This product should be stored at 2°-8°C (36°-46°F) and protected from light.

Vials in use more than 30 days should be discarded due to possible oxidation and degradation which may affect potency.

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