Tuberculin Purified Protein Derivative, Diluted [Stabilized Solution].
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 TU dose of tuberculin PPD. 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. 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.
The Aplisol 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.
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 ed 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 ed 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.
Consult Your Physician.
The predictive value of the tuberculin skin test depends on the prevalence of infection with M. tuberculosis and the relative prevalence of cross-reactions with nontuberculous mycobacteria. A separate, sterile, single-use disposable syringe and needle should be used for each individual patient to prevent possible transmission of serum hepatitis virus and other infectious agents from one person to another. Special care should be taken to ensure that the product is injected intradermally and not into a blood vessel. Before administration of Aplisol, a review of the patient's history with respect to possible immediate-type hypersensitivity to the product, determination of previous use of Aplisol and the presence of any contraindication to the test should be made. As with any biological product, epinephrine should be immediately available in case an anaphylactoid or acute hypersensitivity reaction occurs. Failure to store and handle Aplisol as recommended may result in a loss of potency and inaccurate test results. Reactivity to the test may be depressed or suppressed for as long as 5-6 weeks in individuals following immunization with certain live viral vaccines, viral infections or discontinuation of corticosteroids or immunosuppressive agents.
If overdose is suspected, contact your local poison control center or emergency room immediately.
The above information is intended to supplement, not substitute for, the expertise and judgment of your physician,pharmacist,or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your
healthcare professional before taking the product.
In patients who are receiving corticosteroids or immunosuppressive agents, reactivity to the test may be depressed or suppressed. This reduced reactivity may be present for as long as 5-6 weeks after discontinuation of therapy. The reactivity to PPD may be temporarily depressed by certain live virus vaccines. Therefore, if a tuberculin test is to be performed, it should be administered either before or simultaneously with the use of oral polio and/or injection of measles, mumps and rubella vaccines in combined form or as separate antigens, or testing should be postponed for 4-6 weeks.