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Clinical Advisory

Clinical Advisory Nationwide Shortage of Tuberculin Skin Test Antigens

Date: 08/15/2019
Organization: Bureau of Infectious Disease and Laboratory Sciences
Referenced Sources: Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice

The Massachusetts Department of Public Health (DPH) has been made aware of a current national shortage, and anticipated supply interruption, of APLISOL®, one of two purified-protein derivative (PPD) tuberculin products licensed by the U.S. Food and Drug Administration (FDA) for detecting TB infection. The APLISOL® shortage was announced by the Centers for Disease Control and Prevention (CDC).

Limited availability of TUBERSOL®, the other FDA-licensed PPD tuberculin product, has also been reported. 

In an attempt to help providers and public health programs that currently use APLISOL® manage this situation, CDC has issued an advisory that suggests several operational strategies.  CDC notes that switching products or methods might make serial changes in test results difficult to interpret: the apparent conversions of results from negative to positive or reversions from positive to negative could be caused by inherent inter-product or inter-method discordance.

Consistent with the CDC guidance, DPH recommends:

  1. Substitute interferon gamma release assay (IGRA) blood tests for tuberculin skin tests (TST). (Note that TST is the preferred test for children under 2 years of age.)
  2. Substitute TUBERSOL® for APLISOL® for skin testing.
  3. Prioritize skin testing to focus testing on persons at risk for TB infection and/or progression to disease by using a TB Risk Assessment. For persons with TB symptoms or abnormal chest X-ray consistent with active TB disease, evaluate for active TB disease.
  4. Defer routine skin testing of persons in settings with low risk for exposure until APLISOL® availability is restored.*

*Note: Routine annual testing is no longer recommended for most health care personnel. See (Tuberculosis screening, testing, and treatment of U.S. health-care personnel; MMWR 2019;68:439–443) for more information.  

Contact the DPH TB Program at 617-983-6970 for additional assistance.

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