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Comparable Specificity of 2 Commercial Tuberculin Reagents in Persons at Low Risk for Tuberculous Infection
Margarita E. Villarino, MD, MPH;
William Burman, MD;
Yong-Chen Wang, PhD;
Linda Lundergan, MD, MPH;
Antonino Catanzaro, MD;
Naomi Bock, MD, MS;
Crystal Jones, MD;
Charles Nolan, MD
JAMA. 1999;281:169-171.
Context One or both commercial tuberculin skin test reagents (Aplisol and Tubersol) may have a high rate of false-positive reactions.
Objective To compare the reaction size and specificity of skin testing with Aplisol, Tubersol, and the standard purified protein derivative (PPD-S1).
Design Double-blind trial, conducted between May 14, 1997, and October 28, 1997, in which each individual received 4 tuberculin skin reagents at sites assigned at random.
Setting Health departments and universities in 6 US cities.
Participants A total of 1555 persons at low risk of latent tuberculosis infection.
Intervention Simultaneous skin tests with Aplisol, Tubersol, PPD-S1, and either a second PPD-S1 or PPD-S2 (a proposed new standard).
Main Outcome Measure Reaction size at each injection site measured by 2 investigators blinded to type of reagent.
Results Aplisol produced slightly larger reactions than Tubersol, but this difference did not significantly change skin test interpretation. The mean ± SD reaction sizes were 3.4 ± 4.2 mm with Aplisol, 2.1 ± 3.2 mm with Tubersol, and 2.5 ± 3.6 mm with PPD-S1. Assuming that all participants were uninfected and using a 10-mm cutoff, the specificities of the tests were high: Aplisol, 98.2%; Tubersol, 99.2%; and PPD-S1, 98.9%. Significant variability was not detected in interobserver, host, and lot-to-lot reagent comparisons.
Conclusion Using a cutoff of at least 10 mm, testing with 3 different PPD reagents resulted in similar numbers of uninfected persons being correctly classified.
Author Affiliations: Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, Ga (Drs Villarino and Wang); Department of Public Health, Denver, Colo (Dr Burman); Department of Campus Health Services, the University of Arizona, Tucson (Dr Lundergan); Division of Pulmonary and Critical Care Medicine, the University of California, San Diego (Dr Catanzaro); Division of Infectious Diseases, Emory University, Atlanta (Dr Bock); the Marion County Health Department, Marion County, Indianapolis, Ind (Dr Jones); the Seattle-King County Health Department, Seattle, Wash (Dr Nolan).
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