The Tuberculin, Old, TINE TEST is a sterile, simple, multiple-puncture, disposable intradermal test device for the detection of tuberculin reactivity. These convenient devices are especially useful in mass tuberculosis screening programs.
Each test unit consists of a stainless steel disc attached to a white plastic handle. Projecting from the disc are four triangular-shaped prongs (tines) which are 2 mm long and approximately 4 mm apart. The tines have been mechanically dipped into 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 Cobalt 60 irradiation. No preservative has been added. The unit is disposable and there is no need for syringes, needles, and other equipment necessary for the standard intradermal tests.
Tuberculin, Old, TINE TEST units have been standardized by clinical evaluation in human subjects to give reactions equivalent to or more potent than 5 TU (US tuberculin units) 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 individuals with positive reactions.
Tuberculin deposited in the skin of tuberculin reactive individuals reacts with sensitized lymphocytes to effect the release of mediators of cellular hypersensitivity. Some of these mediators (eg, skin reactive factor) induce an inflammatory response in the skin causing the induration and erythema characteristic of a "positive" reaction. 1,2
Tuberculin, Old, TINE TEST is indicated to detect tuberculin-sensitive individuals. Tuberculin, Old, TINE TEST units are also useful in programs to determine priorities for additional testing (eg, chest X-rays) and in epidemiological surveys to identify those areas having high levels of infection.
In clinical studies covering various geographical areas of the US 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. 1
Tuberculin testing should be done with caution in individuals with active tuberculosis (see PRECAUTIONS ).
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.
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.
Tuberculin testing should be done with caution in individuals with active tuberculosis. Although activation of quiescent lesions is rare, if a patient has a history of occurrence of vesiculation and necrosis with a previous tuberculin test by any method, tuberculin testing should be avoided.
Although clinical allergy to acacia is very rare, 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 (1:1000), 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 recently been immunized with live virus vaccines such as measles, mumps, rubella, polio. If tuberculin skin testing is indicated it should be done preceding, or at the time of such immunization, and read 48 to 72 hours later. If the test is not administered in the time suggested, an interval of 4 to 6 weeks should be allowed between tuberculin skin testing and immunization with live virus vaccines to prevent suppression of tuberculin reactivity. 3
With a positive reaction further diagnostic procedures must be considered. These may include X-ray of the chest, microbiological examinations of sputa and other specimens, and confirmation of the positive TINE TEST 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 test by the Mantoux method must not be attempted. Similar or more severe vesiculation with or without necrosis is likely to occur.
Pregnancy Category C. Animal reproduction studies have not been conducted with Tuberculin, Old, TINE TEST. It is also not known whether Tuberculin, Old, TINE TEST can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Tuberculin, Old, TINE TEST should be given to a pregnant woman only if clearly needed. During pregnancy, known positive reactors may demonstrate a negative response to a Tuberculin, Old, TINE TEST.
Tuberculin, Old, TINE TEST units must never be reused. The units should be discarded into an impenetrable sharps container without recapping.
Vesiculation (positive reaction), ulceration, or necrosis may occur at the test site in highly sensitive persons. Pain, pruritus, and discomfort at the test site 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.
Tuberculin, Old, TINE TEST units have been standardized by clinical evaluation in human subjects to give reactions equivalent to or more potent than 5 TU (US tuberculin units) 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.
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, eg, 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 of the Tuberculin, Old, TINE TEST.
Expose the four coated tines by removing the protective cap while holding the plastic handle. Grasp the patient' 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. Hold at least one second. Release tension grip on forearm. Withdraw tine unit.
After administration of the test, local care of the skin is not necessary.
Tuberculin, Old, TINE TEST units must never be reused. The units should be discarded into an impenetrable sharps container without recapping.
Reading Reactions. Tests should be 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. Identification of the application site is usually easy because of the distinct four-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.
Induration less than 2 mm. With a negative reaction there is no need for retesting unless the person is a contact of a patient with tuberculosis or there is clinical evidence suggestive of the disease. 1
Induration indicator cards illustrating typical reactions are enclosed.
Tuberculin, Old, TINE TEST is supplied as follows:
NDC 0005-2722-25 25 individual tests
NDC 0005-2722-28 100 individual tests
NDC 0005-2722-34 250 individual tests
STORE AT CONTROLLED ROOM TEMPERATURE 15°C to 30°C (59°F to 86°F).
DO NOT REFRIGERATE.
Manufactured by:
LEDERLE LABORATORIES
Division American Cyanamid Company
Pearl River, NY 10965
US Gov't. License No. 17
Marketed by:
WYETH-LEDERLE VACCINES
Wyeth-Ayerst Laboratories
Philadelphia, PA 19101
CI 4560-1 Issued October 24, 1995
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