A nationwide shortage of a product used for tuberculosis (TB) screenings is forcing the Allegheny County Health Department to limit the skin test to only those at high-risk for contracting the disease.
The U.S. Centers for Disease Control (CDC) confirmed that there is a shortage of Tubersol across the country. The company that manufactures the product, Sanofi Pasteur Limited, did not immediately return requests for comment.
Guillermo Cole, Health Department spokesman, said the low supply is in fact a manufacturing problem, but he couldn't say if the issue was supply of the Tubersol or demand for tuberculosis screenings.
Cole stressed that even though routine screenings for tuberculosis, such as those needed for school or work, will be put on hold, the small supply of Tubersol the county does have will be used for those who are at a higher risk.
"That would include contacts of known cases, patients undergoing chemotherapy, or radiation therapy," Cole said. "If they're HIV positive, a recent arrival from a foreign country with a high incidence of TB, these are all higher priority screenings, and they will continue."
When people have a positive skin test, they need further evaluation, and Cole said having a positive skin test does not mean someone has tuberculosis.
"It tells you, really, only whether someone has ever been exposed to the bacterium that causes TB," Cole said. "It is not a test for active tuberculosis."
Of the skin tests for tuberculosis in the county last year, only 3% were positive for exposure. Among those 3%, Cole said very few had active tuberculosis. The Allegheny County Health Department recorded 17 diagnosed cases last year.
Cole said he hopes the shortage doesn't last more than a couple of weeks, but if it does, the Health Department could consider another brand. The CDC said the other brand of TB skin screening solution approved by the FDA is Apilsol, which is manufactured by JHP Pharmaceuticals.
"We do have a preference for the Tubersol, that is a tried and true product, one that we've been using for quite some time," Cole said. "It's reliable and there are no problems with that solution in terms of yielding false negatives or false positives."
Cole said for those who do need a routine screening, other health care providers may be able to help. However, the nation-wide shortage could cause delays and shortages of Apilsol as well.