Tuberculin Skin Test Antigen Shortage
DEAR VALUED CUSTOMER,
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.1 As a result, there has been increased demand for the other skin testing product Tubersol® and obtaining this has been becoming increasingly difficult.
In anticipation of depleting supplies of PPD antigen, FOH is taking the following actions:
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Canvasing all potential sources of PPD antigen and placing orders for product as soon as available. Currently FOH is in queue for orders, but it is unknown if and when these orders will be fulfilled |
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Taking inventory of our current supplies: assuming normal usage, if no additional product can be obtained, we anticipate only a one month supply of PPD antigen left
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Providing recommendations to customer agencies for interim measures until the supply has been replenished. These recommendations are based upon risk of TB infection. |
While there are alternative tests available to detect TB infection, the interferon-gamma release assay [IGRA] blood tests (QuantiFERON-TB Gold®; T-Spot.TB®), they are significantly more expensive and involve a blood draw. Therefore routine testing for TB in lower risk situations may not be practical for many agencies. FOH therefore recommends the following risk-based strategy:
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Prioritize allocation of TB skin tests with the current limited supply. CDC recommends testing only for persons in groups at high risk for TB infection:
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persons who are recent contacts exposed to persons with TB disease2
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persons at significant risk of exposure with compromised immune systems, including those with health conditions or taking medications that might alter immunity |
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Test those individuals who are required to present proof that they do not have current TB infection – e.g. facility inspections, travel requirements |
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Once PPD antigen supplies have been depleted, substitute the skin test with the IGRA blood test following the above criteria until supplies are replenished. (Note: This service may need to be included or added to the agency Statement of Work.) |
If you are a current FOH customer, please contact your FOH Business Representative and let them know how you wish to proceed given your anticipated need per the CDC guidelines.
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