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Standardization and Evaluation of the Clinical Usefulness of Mycobacterial Skin Test Antigens

CDC, assisted by selected physicians and health departments throughout the United States, recently completed a study to determine biologically equipotent doses for skin test antigens prepared from several species of nontuberculous mycobacteria (NTM). This standardization study was planned as a first step in evaluating the clinical and epidemiologic usefulness of the NTM antigens. In the past, these antigens were formulated on a protein-weight basis equivalent to intermediate strength (5 TU) tuberculin-purified protein derivative (PPD) (0.1 ug/dose) and contained no stabilizer to reduce losses from adsorption to the container.

To standardize the individual NTM antigen, consenting patients with compatible signs and symptoms and bacteriologically confirmed NTM disease received four skin tests of differing strengths of the antigen prepared from the homologous species of Mycobacterium and stabilized by Tween-80R. The skin tests were administered and measured by one experienced nurse, and the amount of induration was measured at 48 hours. Dose-response curves for each antigen were used to estimate the concentration bioequivalent to 5 TU of PPD-S (international standard tuberculin), i.e., the dose expected to produce a mean reaction of 16.0 mm induration, which is the mean reaction to 5 TU of PPD-S observed among a series of tuberculosis cases. From these data, standardized doses of PPD-B (M. avium complex), PPD-Y (M. kansasii), PPD-G (M. scrofulaceum), and PPD-platy (M. marinum) have now been prepared (Table 1). Reported by J Shinnick, Bucks County Health Dept, Pennsylvania; LB Reichman, MD, UMDNJ, New Jersey Medical School, Newark; E Wolinsky, MD, Cleveland Metropolitan General Hospital, Cleveland, Ohio; P Smith, MD, SUNY Health Science Center at Brooklyn, R Dattwyler, MD, SUNY Health Science Center at Stoneybrook, New York; J Landis, MD, Bay State Medical Center, Springfield, Massachusetts; R Ratard, MD, New Orleans, Louisiana; DP Schlueter, MD, Medical College of Wisconsin, Milwaukee; RJ Wallace, Jr, MD, University of Texas Health Science Center, Tyler, C Ahn, MD, Dallas; CR Horsburgh, Jr, MD, University of Colorado Health Science Center, Denver; M Marks, MD, University of Oklahoma Health Science Center, Oklahoma City; R Hayes, MD, New Mexico Health Svcs Div, Santa Fe; Respiratory Disease Br, Div of Bacterial Diseases, Center for Infectious Diseases, Div of Tuberculosis Control, Center for Prevention Svcs, CDC.

Editorial Note

Editorial Note: A battery of standardized skin test antigens, including tuberculin and those prepared from NTM, has several potential uses: distinguishing mycobacterial from nonmycobacterial diseases; distinguishing M. tuberculosis from NTM infections and diseases; and distinguishing among specific NTM infections. This diagnostic potential could not be adequately assessed using the nonstandardized and nonstabilized preparations.

CDC is now beginning two studies to determine the clinical usefulness of the standardized NTM antigens. Adults with suspected mycobacterial pulmonary disease and children with chronic cervical lymphadenitis will be offered a battery of four standardized skin test antigens: PPD-B, PPD-Y, PPD-G, and PPD-tuberculin. The test results will be compared to the mycobacterial species subsequently isolated from the patients to determine the operational characteristics of these tests, e.g., sensitivity, specificity, and predictive value. Physicians interested in participating in these studies should contact CDC's Tuberculosis Clinical Research Branch at (404) 329-2530.

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