The Centers for Disease Control and Prevention (CDC) is expecting a three- to 10-month nationwide shortage of Aplisol, one of two purified-protein derivative (PPD) tuberculin antigens licensed by the Food and Drug Administration (FDA) for use in performing tuberculin skin tests (TSTs).
Two types of immunological methods are used for detecting Mycobacterium tuberculosis infection: TSTs and interferon-gamma release assay (IGRA) blood tests. Aplisol is one of two FDA-approved PPD tuberculin antigens available in the United States for TSTs.
The manufacturer of Aplisol notified CDC that it anticipates a supply interruption of multidose 5 mL vials (50 tests) beginning this month, followed by a supply interruption of multidose 1 mL vials (10 tests) in November.
CDC recommends three general approaches to prevent a decrease in TB testing capability because of the expected shortage, including:
- substituting IGRA blood tests for TSTs;
- substituting Tubersol, the other FDA-approved PPD tuberculin antigen, for Aplisol for skin testing; and
- prioritizing allocation of TSTs, including testing only for persons who are at high-risk of TB, in consultation with state and local public health authorities.
To monitor the status of this supply interruption, visit FDA’s Center for Biologics Evaluation and Research-Regulated Products: Current Shortages.