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News From the Centers for Disease Control and Prevention
August 13, 2019

Tuberculin Antigen Shortage

JAMA. 2019;322(6):496. doi:10.1001/jama.2019.10855

The CDC recently warned clinicians of a potential 3- to 10- month shortage of Aplisol (tuberculin PPD), 1 of 2 tuberculin antigens approved by the US Food and Drug Administration for tuberculosis skin tests.

Par Pharmaceuticals, which manufactures the test, notified the CDC that they expect an interruption in the supply of 5-mL vials starting in June 2019 and 1-mL vials starting in November 2019 or sooner, according to the agency. Updated information about the supply of the drug will be posted on the FDA’s website.

To mitigate the effects of the shortage, the CDC recommends that physicians substitute interferon gamma release assay blood tests for tuberculosis skin tests to detect Mycobacterium tuberculosis infection or use the other FDA-approved tuberculin antigen Tubersol for tuberculosis skin testing. However, they caution that switching between tests or antigens during serial testing may lead to false conversions from negative to positive or vice versa, which “might be attributable to inherent interproduct or intermethod discordance rather than change in M tuberculosis infection status.”

The CDC also recommends consulting with local public health authorities to prioritize which patients should receive tuberculosis skin tests. According to the agency, testing should be reserved for high-risk groups including those recently exposed to an infected individual, those born in or who frequently travel to countries where the disease is common, those living in large group settings like homeless shelters or correctional facilities, and people with compromised immune systems. Children younger than 5 years with any of those risk factors are particularly vulnerable, the authors note.

“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,” the authors wrote. “Annual TB testing of health care personnel is not recommended unless there is a known exposure or ongoing transmission.”