False positive or false negative tuberculin skin test reactions may occur in some individuals. See Interpretation of the Test. False positive tuberculin reaction tests occur in individuals who have been infected with other mycobacteria, including vaccination with BCG.
Many factors have been reported to cause a decreased ability to respond to the tuberculin test in the presence of tuberculous infection. The health-care provider should inform the patient of the need to return for the reading of the test.
Self-reading of the test has been shown to be inaccurate and unreliable. The health-care provider should give the patient a permanent personal record. In addition, it is essential that the health professional record the testing history in the permanent medical record of each patient.
This permanent office record should contain the name of the product, date given, dose, manufacturer and lot number, as well as the test result in millimeters of induration including 0 mm, if appropriate. Reporting results only as negative or positive is not satisfactory. Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents. When tuberculin screening is required at the same time as a measles-containing vaccine or other parenteral live attenuated virus vaccine, simultaneous administration of TUBERSOL and the vaccine at separate sites is the preferred option.
There is no age contraindication to tuberculin skin testing of infants. Clinical studies of TUBERSOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Injection site erythema or injection site rash without induration occurring within 12 hours of testing. These reactions do not indicate TB infection. Injection site hemorrhage and injection site hematoma up to three days after the administration of the test.
Injection site vesicles, injection site ulcer or injection site necrosis in highly sensitive persons. Presyncope, syncope including syncope associated with tonic-clonic movements and other seizure-like activity sometimes resulting in transient loss of consciousness with injury.
Five 5 tuberculin units TU per test dose of 0. Do not inject intravenously, intramuscularly, or subcutaneously. If subcutaneous injection occurs, the test cannot be interpreted. If these conditions exist, do not administer the product. In the event of an improperly performed injection ie, no bleb formed , 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.
Inform the patient of the need to return for the reading of the test by a trained health professional. Self-reading may be inaccurate and is strongly discouraged. Skin test sensitivity is indicated by induration only; redness should not be measured. Measure the diameter of induration transversely to the long axis of the forearm and record the measurement in millimetres including 0 mm.
Also record presence and size if present of necrosis and edema, although these are not used in the interpretation of the test. Persons showing positive tuberculin reactions should be considered positive by current public health guidelines and referred for further medical evaluation. The significance of induration measurements in diagnosing latent TB infection must be considered in terms of the patient's history and the risk of developing active TB disease as indicated in Table 1.
Persons with the following clinical conditions that place them at high risk: silicosis, diabetes mellitus, chronic renal failure, some hematologic disorders e. Children younger than 4 yrs of age or infants, children, and adolescents exposed to adults at high-risk. The possibility should be considered that the skin test sensitivity may also be due to a previous contact with atypical mycobacteria or previous BCG vaccination.
An individual who does not show a positive reaction to 5 TU on the first test, but is suspected of being TB positive, may be retested with 5 TU. See Booster Effect and Two-Step Testing Any individual who does not show a positive reaction to an initial injection of 5 TU, or a second test with 5 TU may be considered as tuberculin negative.
False positive tuberculin reactions can occur in individuals who have been infected with other mycobacteria, including vaccination with BCG. Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test.
In those who are elderly or those who are being tested for the first time, reactions may develop slowly and may not peak until after 72 hours. Since tuberculin sensitivity may take up to 8 weeks to develop following exposure to M. Impaired or attenuated cell mediated immunity CMI can potentially cause a false negative tuberculin reaction.
These reactions do not indicate TB infection. Injection site hemorrhage and injection site hematoma up to three days after the administration of the test.
Injection site vesicles, injection site ulcer or injection site necrosis in highly sensitive persons. Injection site scar as a result of strongly positive reactions.
Respiratory, thoracic, and mediastinal disorders Stridor, dyspnea. Skin and subcutaneous tissue disorders Rash, generalized rash. Nervous system disorders Presyncope, syncope including syncope associated with tonic-clonic movements and other seizure-like activity sometimes resulting in transient loss of consciousness with injury. Use a separate syringe and needle for each injection. Avoid areas on the skin that are red or swollen.
Avoid visible veins. Clean the skin site with a suitable germicide and allow the site to dry prior to injection of the antigen. Administer the test dose 0. Wipe the stopper of the vial with a suitable germicide and allow to dry before needle insertion. Then insert the needle gently through the stopper and draw 0. Avoid injection of excess air with removal of each dose so as not to over pressurize the vial and possibly cause seepage at the puncture site.
Insert the point of the needle into the most superficial layers of the skin with the needle bevel pointing upward and administer the dose by slow intradermal injection. This bleb will disperse within minutes. Do not dress the site. A drop of blood may appear at the administration site following injection. Blot the site lightly to remove the blood but avoid squeezing out the injected tuberculin test fluid.
Negative Reactions An individual who does not show a positive reaction to 5 TU on the first test, but is suspected of being TB positive, may be retested with 5 TU.
False Positive Reactions False positive tuberculin reactions can occur in individuals who have been infected with other mycobacteria, including vaccination with BCG.
False Negative Reactions Not all infected persons will have a delayed hypersensitivity reaction to a tuberculin test. Booster Effect and Two-Step Testing If tuberculin testing will be conducted at regular intervals, for instance among healthcare workers or prison workers, two-step testing should be performed as a baseline to avoid interpreting a booster effect as a tuberculin conversion.
NDC No. Preparation, purification, and stability of tuberculin. Appl Microbiol ; Preparation and characterization of a large batch of tuberculin purified protein derivative PPD-CT Ann Scalvo. Adsorption of tuberculin PPD to glass and plastic surfaces. WHO ; Disparity of potency between stabilized and nonstabilized dilute tuberculin solutions.
Am Rev Respir Dis ; Stability of dilute solutions of tuberculin purified protein derivative. Tubercle ; Interpretation of repeated tuberculin tests. Targeted tuberculin testing and treatment of latent tuberculosis infection. Immediate hypersensitivity reactions after use of tuberculin skin testing. Clin Infect Dis ;e The timing of tuberculin tests in relation to immunization with live viral vaccines. Reporting results only as negative or positive is not satisfactory.
Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents. When tuberculin screening is required at the same time as a measles-containing vaccine or other parenteral live attenuated virus vaccine, simultaneous administration of TUBERSOL and the vaccine at separate sites is the preferred option.
There is no contraindication to tuberculin skin testing of infants. Clinical studies of TUBERSOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
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