Tuberculin

TUBERCULIN, OLD, TINE TEST® Wyeth-Ayerst Diagnostic Test

Indications And Clinical Uses:

For detection of tuberculin sensitive individuals, as a determinant for additional testing (i.e., chest x-rays), and in epidemiological surveys to identify those areas having high levels of infection. Also useful in mass tuberculosis screening programs.

In clinical studies covering various geographical areas and all age groups, with a total of 30 588 test subjects, there were 911 (4%) false positive reactors among 26 236 subjects who were Mantoux negative, and 342 (8%) false negative reactors among 4 352 subjects who were Mantoux positive.

The frequency of repeated tuberculin tests depends on risk of exposure of the individual and on the prevalence of tuberculosis in the population group. The repeated testing of uninfected individuals does not sensitize to tuberculin. Among individuals with waning sensitivity to homologous or heterologous mycobacterial antigens, however, the stimulus of a tuberculin test may boost or increase the size of the reaction to a second test, even causing an apparent development of sensitivity in some cases.

Contra-Indications:

There are no known contraindications for use of Tuberculin, Old, TINE TEST. See Precautions for information regarding special care to be exercised for safe and effective use.

Warnings in Clinical States:

There are no known serious adverse reactions or potential safety hazards associated with the use of Tuberculin, Old, TINE TEST. However, as with the use of any biological product, the possibility of anaphylactic reaction should be considered. See Precautions for information regarding special care to be exercised for safe and effective use.

Precautions:

Individuals with active tuberculosis. Although activation of quiescent lesions is rare, if a patient has a history of vesiculation and necrosis with a previous tuberculin test by any method, testing should be avoided.:

This product contains some acacia as stabilizer and should be used with caution in patients with known allergy to this component. In these instances, remedial measures for anaphylactoid reactions, including epinephrine injection (1:1 000), must be available for immediate use.

Reactivity to the test may be suppressed in patients who are receiving corticosteroids or immunosuppressive agents, or those who have been recently vaccinated with live virus vaccines such as measles, mumps, rubella and polio, etc.

Further diagnostic procedures must be considered with a positive reaction such as chest x-ray, microbiologic examinations of sputa and other specimens, and confirmation of the positive reaction (except vesiculation reactions) using the Mantoux method. In general, the Tine Test does not need to be repeated. Antituberculous chemotherapy should not be instituted solely on the basis of a single positive Tine Test.

When vesiculation occurs, the reaction is to be interpreted as strongly positive and a repeat Mantoux not attempted. Similar or more severe vesiculation with or without necrosis is likely to occur.

Pregnancy: Safe use during pregnancy is unknown and therefore should not be given to a pregnant woman unless clearly needed.

During pregnancy, known positive reactors may demonstrate a negative response to a Tuberculin Tine Test.

Never reuse Tuberculin, Old, Tine Test unit.

Adverse Reactions:

Vesiculation (positive reaction), ulceration, or necrosis may occur at the test site in highly sensitive persons. Localized pain, pruritus, and discomfort may be relieved by cold packs or by topical glucocorticoid ointment or cream. Transient bleeding may be observed at a puncture site and is of no significance.DosageDosage

Dosage And Administration:

Standardized by clinical evaluation in humans the test is equivalent to, or more potent than 5 T.U.* of standard old tuberculin administered intradermally in the Mantoux test. However, all multiple puncture type devices must be regarded as screening tools and other appropriate diagnostic procedures such as the Mantoux test should be utilized for retesting reactors.

*U.S. (International) tuberculin units.

The volar surface of the upper one third of the forearm, over a muscle belly, is the preferred site. Hairy areas and areas without adequate subcutaneous tissue, e.g., concavities over a tendon or bone should be avoided.

Alcohol, acetone, ether, or soap and water may be used to cleanse the skin. The area must be clean and thoroughly dry before application.

Expose the 4 coated tines by removing the protective cap while holding the plastic handle. Grasp the patient’s forearm firmly, since the sharp momentary sting may cause the patient to jerk his or her arm, resulting in scratching. Stretch the skin of the forearm tightly and apply the disc with the other hand. Sufficient pressure should be exerted so that the 4 puncture sites, and circular depression of the skin from the plastic base are visible. Hold at least 1 second. Release tension grip on forearm. Withdraw tine unit and discard. Local care of the skin is not necessary.

Reading and Interpretation: Read at 48 to 72 hours. Vesiculation or the extent of induration are the determining factors; erythema without induration is of no significance. Readings should be made in good light with the forearm slightly flexed. The size of the induration in millimeters should be determined by inspection, measuring, and palpation with gentle finger stroking. The site is easily identified because of the distinct 4 point pattern. The diameter of the largest single reaction around one of the puncture sites should be measured. With pronounced reactions, the areas of induration around the puncture sites may coalesce.

If vesiculation and induration of 2 mm or greater occurs, the test should be interpreted as positive. If induration is less than 2 mm the test reaction is negative. Unless the person is a contact of a patient with tuberculosis, or there is clinical evidence suggestive of the disease, there is no need for retesting.

Availability And Storage:

Each multiple puncture, disposable, intradermal test consists of a stainless steel disc attached to a plastic handle. Projecting from the disk are 4 triangular shaped prongs (tines) which are 2 mm long and approximately 4 mm apart. The tines have been mechanically dipped in a solution of old tuberculin, containing 7% acacia (gum arabic) and 8.5% lactose as stabilizers, and then dried. The entire unit has been sterilized by irradiation. No preservative has been added. Boxes of 25 individual tests. Tartrazine-free. Store unrefrigerated below 30°C.

TUBERCULIN, OLD, TINE TEST® Wyeth-Ayerst Diagnostic Test

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