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CLINICAL PHARMACOLOGY The tuberculin skin test is based on the fact that mycobacterial infection produces delayed hypersensitivity to certain products of the organisms contained in culture extracts called tuberculins. The intracutaneous injection of tuberculin in sensitized individuals results in an area of induration, with or without surrounding erythema, which varies in size and intensity according to the dose of tuberculin and the sensitivity of the individual. This cell-mediated or delayed hypersensitivity reaction is characterized by its delayed course, reaching a peak at 48 to 72 hours, and by induration, due largely to cellular infiltration at the site of the antigen injection in sensitized persons called "reactors". Occasionally vesiculation and necrosis may occur. Not all reactors are infected with M. tuberculosis; infection with other species of mycobacteria may cause cross-reactions. The larger the reaction with a given antigenic dose, the greater is the probability that the reaction is specific for that antigen.

DESCRIPTION The Tuberculin, Old, Mono-Vacc ® Test (O.T.) is a sterile, multiple puncture intradermal test for the detection of tuberculin sensitivity. It provides a convenient and reliable method for determining tuberculin sensitivity of individuals in tuberculosis screening programs or for office or clinical use. The Mono-Vacc ® Test (O.T.) unit consists of a sterile, disposable, multiple-puncture plastic scarifier with liquid old tuberculin on the points. No preservative has been added. A plastic cap provides an airtight seal over the points assuring sterility of the points and tuberculin until the unit is used. Tuberculin color variation may occur between different lots without alteration of potency or stability. The preloaded test unit is disposable.

INDICATIONS The Mono-Vacc ®Test (O.T.) is indicated for the detection of tuberculin sensitivity in high risk children: including American Indian and Alaskan native children, children living in neighborhoods where the case rate is higher than the national average; children from, or whose parents have immigrated from Asia, Africa, the Middle East, Latin America, or the Caribbean; and children in households with one or more cases of tuberculosis. 1 Annual testing of low-risk groups (from areas of low prevalence) is not indicated. 1,2 In low-risk groups, a reasonable alternative to no routine testing is to perform skin tests at three stages of childhood and adolescence which coincide with routine health appraisals or immunizations: (1) at 12 to 15 months of age (before or at the time of administration of measles-mumps-rubella (MMR), before school entry (4 to 6 years of age), and (2) in adolescence (at 14 to 16 years of age). The tuberculin skin test is always indicated for individuals with known contact with a person with tuberculous disease; if the test is negative, it should be repeated 8 to 10 weeks after separation from the contact. 1 The following groups also are recommended to be screened for tuberculosis and tuberculous infection: 3 1. Persons infected with the human immunodeficiency virus (HIV). 3 2. Persons with medical risk factors known to increase the risk of disease if infection has occurred. 3 3. Alcoholics and intravenous drug users. 3 4. Residents of long-term-care facilities, correctional institutions, mental institutions, nursing homes/facilities, and other long-term residential facilities. 3 Since this test is a screening procedure, positive Mono-Vacc ®Test (O.T.) reactions should be confirmed by a 5 TU Tuberculin, PPD Mantoux Test (intradermal) and possibly other diagnostic test procedures. The need for repeat skin testing should be determined by the likelihood of exposure to infectious tuberculosis. All tuberculin-negative individuals in high-risk groups should be retested if exposure to an infectious case occurs. In some institutional and group-living environments (e. g., hospitals, prisons, nursing homes, shelters for the homeless), the risk of exposure is probably high enough to justify repeat testing at 6 to 24-month intervals. 3 Repeated testing of the uninfected individual does not sensitize to tuberculin. 3 DOSAGE AND ADMINISTRATION The activity per test is comparable to or greater than 5 tuberculin units (5 TU) administrated by the Mantoux method. Discard the Mono-Vacc® Test (O.T.) after use. DO NOT REUSE. Directions for Application of Mono-Vacc® Test (O.T.): 1. Cleanse volar surface of mid-forearm with alcohol, ether, or acetone and allow to dry. 2. Grasp test unit as you would a syringe with your thumb on top and the stem between your first two fingers. 3. While twisting the cap, carefully pull it away from the points. 4. With skin taut, press the loaded points firmly into the cleansed site. With proper pressure of the punctures, an imprint of the base and liquid tuberculin are visible. Reading the Reaction The test should be read 48 to 96 hours following administration. Local erythema may or may not be observed with a positive reaction. Erythema should be disregarded. The sole criterion for a positive reaction is palpable induration. The presence of palpable induration (even 1 to 2 mm) indicates a positive reaction. A negative reaction is indicated by complete absence of induration. As with all screening procedures, positive Mono-Vacc ®Test (O.T.) reactions should be confirmed by a standard Mantoux (PPD, 5 TU) Test and possibly other diagnostic test procedures such as chest x-ray and microbiological examination of sputa and other specimens. A significant reaction to the tuberculin skin test indicates the presence of infection but does not signify disease. The test is only a diagnostic aid in the evaluation of an individual patient. Descriptive literature illustrating typical reactions is available on request. Advantages of Mono-Vacc® Test (O.T.): 1. The Mono-Vacc® Test (O.T.) employs liquid tuberculin for instantaneous administration, eliminating two variables associated with dried tuberculin † the length of time tines are held in the skin, and the moisture content of the skin. 2. The uniform presence of liquid tuberculin on each Mono-Vacc ®Test (O.T.) is visually assured by the user. 3. The Mono-Vacc ®Test (O.T.) has consistently shown a high level of sensitivity when compared to intradermal PPD 5 TU. 4-10 The risk of false negative results from the Mono-Vacc ®Test (O.T.) is not statistically significant. 4,5,8,9 In contrast, reported false negative results from multiple puncture tests containing tuberculin dried on the tines has ranged from a low to significant incidence. 5,10-12 4. The Tuberculin, Mono-Vacc® Test (O.T.) produces a well defined single, usually circular reaction that is easy to read. 4,6-9 A multiple puncture test utilizing tuberculin dried on the tines may produce one, two, three or four separate reactions of varying size, or two or more reactions may coalesce. 5. The Mono-Vacc ®Test (O.T.) utilizes old tuberculin because concentrated old tuberculin is considered very stable under ordinary conditions of storage. 10 There are no reliable data supporting greater specificity of purified protein derivative (PPD) over old tuberculin (O.T.). 6. The Mono-Vacc®Test (O.T.) rarely produces bleeding upon administration and is well accepted by patients. HOW SUPPLIED Tamperproof. Box of 25 tests. STORAGE Store at 15° to 30° C (59° to 86° F). REFERENCES 1. Report of the Committee of Infectious Diseases (Red Book), pp 429- 447, American Academy of Pediatrics (1988). 2. Recommendations of the Advisory Committee for Elimination of Tuberculosis. Screening for tuberculosis and tuberculous infection in high- risk populations. MMWR 39: Vol 39, No. RR- 8 (1990). 3. Diagnostic Standards and Classification of Tuberculosis and other Mycobacterial Diseases, Amer. Rev. Resp. Dis., Sept 1990, pp 726- 735. 4. Kravitz H, Burg F, Lawson R: Skin testing with liquid oil tuberculin with a multiple puncture technique. Pediatrics42: 465- 470 (1968). 5. Donaldson JC, Elliott RC: A study of copositivity of three multipuncture techniques with intradermal PPD tuberculin. Amer Rev Respir Dis118: 843- 846 (1978). 6. Stocker JA: Comparison of multiple puncture tuberculin test with purified protein derivative. Amer Rev Respir Dis96: 1067- 1068 (1967). 7. Grabau AA: Comparison of tuberculin testing between MONO- VACC and Mantoux. Dis Chest55: 411- 414 (1969). 8. Rouhe S, Tupper G, Yahiku P, and West RO: Comparison of Mantoux and Mono- Vacc tests. Med Digest20: 25- 33 (1974). 9. Byrd RB, Gracey DR, Campbell, Jr., DC, and Knies AA: The Mono- Vacc tuberculin skin test. Dis Chest 56: 447- 449 (1969). 10. Federal Register42: 52674- 52723 (1977). 11.Herzog D: Multiple- puncture tuberculin testing: Reason for variable response to tine test. Tubercle62: 249- 256 (1981). 12. Lunn JA, Johnson AJ: Comparison of the tine and Mantoux Tuberculin Tests. Brit Med J1: 1451- 1453 (1978).

PATIENT INFORMATION See WARNINGS, PRECAUTIONS and CONTRAINDICATIONS.

OVERDOSE No information provided. CONTRAINDICATIONS There are no known contraindications to the use of the Mono-Vacc ® Test (O.T.) when used as indicated.

WARNINGS Although anaphylactic reactions have not been reported with the Mono-Vacc®Test (O.T.), this remote possibility should be considered. PRECAUTIONS General Epinephrine Injection (1:1000) should be available in the rare event an anaphylactic or acute hypersensitivity reaction occurs. Do not apply the Mono-Vacc® Test (O.T.) to acneiform skin, hairy areas or where there is inadequate subcutaneous tissue. Although repeated testing of uninfected individuals does not sensitize to tuberculin, it may have a "booster" effect in persons with low levels of sensitivity to homologous or heterologous mycobacterial antigens. Testing should be done with caution in persons with active tuberculosis, however, activation of quiescent lesions is rare. Drug Interactions The administration of adrenal corticosteroids or immunosuppressive drugs may decrease the intensity of or prevent a tuberculin reaction. Tuberculin sensitivity may decrease or disappear temporarily as a result of febrile illness; measles and other exanthemas; live virus vaccination; sarcoidosis and miliary or pulmonary tuberculosis. Pregnancy Reproductive Studies — Category C: Animal reproduction studies have not been conducted with Tuberculin, Old Mono-Vacc ®Test (O.T.). It is also not known whether Tuberculin, Old can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Tuberculin, Old should be given to a pregnant woman only if clearly needed.