Nationwide Shortage of Tuberculin Skin Test Antigens

CDC Recommendations for Patient Care and Public Health Practice

Morbidity and Mortality Weekly Report. 2019;68(24):552-553. 

In This Article

Abstract and Introduction

Introduction

CDC is expecting a 3–10 month nationwide shortage of Aplisol, a product of Par Pharmaceuticals, and one of two purified-protein derivative (PPD) tuberculin antigens licensed by the Food and Drug Administration (FDA) for use in performing tuberculin skin tests. This time frame is the manufacturer's current estimate and is subject to change. The manufacturer notified CDC that they anticipate an interruption of supply of Aplisol 5 mL (50 multidose vials) beginning in June 2019, followed by an interruption of the supply of Aplisol 1 mL (10 multidose vials) in November 2019. The expected shortage of Aplisol 1 mL could occur before November 2019 if demand increases before then. Information on the status of this supply interruption will be updated at FDA's Center for Biologics Evaluation and Research–Regulated Products: Current Shortages website (https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages). This report includes CDC recommendations for mitigating a reduction in tuberculosis (TB) testing capability resulting from the anticipated Aplisol shortage.[1]

Two types of immunological methods (tuberculin skin tests [TSTs] and interferon-gamma release assay [IGRA] blood tests) are used for detecting Mycobacterium tuberculosis infection. TSTs and IGRAs are used for the diagnosis of latent TB infection and can aid in the diagnosis of TB disease, but additional evaluation and testing is necessary to distinguish between latent TB infection and TB disease to determine the appropriate treatment.[2] When findings such as chest radiography and mycobacterial cultures are sufficient for confirming or excluding a TB diagnosis, the results from a TST or an IGRA blood test might not be needed.[2] However, most TB cases in the United States are diagnosed through a combination of findings, including results from one of these tests. When TB disease is strongly suspected, specific treatment should be initiated, regardless of results from TST or an IGRA blood test.[3,4]

Two FDA-approved PPD tuberculin antigen products are available in the United States for use in performing TSTs: Tubersol (Sanofi-Pasteur) and Aplisol. In controlled studies, the concordance between the two products is high.[5]

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