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Association for Professionals in Infection Control and Epidemiology
NEW: CDC Health Alert Network (HAN): CDC Info Service: Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice – April 12 (CDC)
TUBERSOL®, a product of Sanofi Pasteur Limited, is in shortage nationwide until at least the end of May 2013. TUBERSOL® is one of two purified-protein derivative (PPD) tuberculin products that are licensed by the United States Food and Drug Administration (FDA). The manufacturer notified CDC that 50-dose vials of TUBERSOL® are unavailable and that the supplies of 10-dose vials will be limited. This notice advises public health officials, clinicians, and workers in occupational health and infection control about how to adapt to the shortage.
CDC recommends any of three general approaches for addressing the shortages of tuberculin skin test antigens:
1. Substitute IGRA blood tests for TSTs. The costs associated with using the blood tests can be greater than the cost of TSTs. The blood tests require phlebotomy, preparation of blood specimens, and specific laboratory services for analysis. Thus, these tests are not available in all practice settings. Clinicians who use the IGRA blood tests should be aware that the criteria for test interpretation are different than the criteria for interpreting TSTs (1).
2. Allocate TSTs to priority indications, such as TB contact investigations, as determined by public health authorities. This might require deferment of testing some persons. CDC does not recommend testing persons who are not at risk of TB (4).
3. Substitute APLISOL® for TUBERSOL® for skin testing. In cross-sectional studies, the two products give similar results for most patients. Shortages of APLISOL® are expected to become more widespread, thus limiting the feasibility of this approach.
Some surveillance programs for TB infection control rely on routine serial TSTs. 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 (1,5). In settings with a low likelihood of TB exposure, the deferment of routine serial testing should be considered in consultation with public health and occupational health authorities.
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