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CDC: Shortage of tuberculin skin test antigens expected :

June 6, 2019

An antigen used in tuberculin skin tests is expected to be in short supply for up to 10 months, according to analert from the Centers for Disease Control and Prevention (CDC).

Aplisol, a product of Par Pharmaceuticals, is one of two purified-protein derivative (PPD) tuberculin antigens licensed in the U.S. A shortage of Aplisol 5 mL may begin this month followed by a shortage of Aplisol 1 mL by November. The shortages are expected to last three to 10 months.

Tuberculin skin tests are used to diagnose latent Mycobacterium tuberculosis infection and aid in diagnosing tuberculosis disease.

During the shortage, the CDC recommends several options for testing. Clinicians can perform the skin tests with Tubersol, the other licensed PPD tuberculin antigen. They also can use interferon-gamma release assay blood tests, keeping in mind test interpretation will be different than for the skin tests.

Allocation of skin tests should be prioritized in consultation with state and local public health authorities. This may mean testing only people who are at high risk such as those recently exposed to people with tuberculosis disease, those born in or frequently traveling to countries where tuberculosis disease is common, those living in large group settings like homeless shelters or correctional facilities, those with weak immune systems and high-risk children.

Officials also noted changing tests may change a person’s results even though his or her infection status hasn’t changed.

“Clinicians should assess test results based on the person’s likelihood of infection and risk of progression to TB disease, if infected,” officials wrote in the alert.

The Food and Drug Administration will update the status of the supply at

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