TB Advisory: Nationwide Shortage of Tuberculin
The CDC received the following statement from Sanofi-Pasteur yesterday regarding a supply interruption for Tubersol®. Current demand on the 10 test presentation size has placed the company in a position where it perceives that it will temporarily need to allocate the test.
TUBERSOL is manufactured in 2 presentation sizes: 10 tests per presentation and 50 tests per presentation. TUBERSOL Diagnostic Antigen in the 50-test presentation is experiencing a supply interruption until late-spring 2013 due to a temporary delay in production. As a result, increased demand has limited the availability of TUBERSOL Diagnostic Antigen in the 10-test presentation. To allow us to continue to supply the market with product, we are placing allocations on customer orders which will go into effect immediately. Allocations will be based on a percentage of historical usage for customers who order an average of 10 doses or more per month, and these allocations are expected to be in effect until late-March. A follow-up communication will be sent in late-March when we expect to lift these allocations. –Sanofi-Pasteur
Indiana State Department of Health’s TB Program recommends the following measures until the shortage is resolved.
Recommendations for Responding to Tuberculin Shortages
· If available and appropriate, screen for LTBI with an Interferon Gamma Release Assay (IGRA) (T-SPOT®.TB and QuantiFERON® Gold in-tube) instead of a tuberculin skin test (TST).
· Prioritize TSTs if necessary. High priority groups include:
o Contacts to a person with pulmonary or laryngeal TB
o Persons who are immunoccompromised
o Evaluation of persons with symptoms suggestive of TB disease
· If necessary, defer annual screening of employees, residents, and/or inmates as part of an infection control plan until sufficient tuberculin becomes available.
Aplisol®, an alternative formulation of tuberculin, is an acceptable alternative to Tubersol® for tuberculin skin testing. It is recommended that programs that do serial testing use the same preparation of tuberculin year to year to avoid reported issues with false-positive tests associated with switching preparations. Aplisol® is a good choice for persons requiring one-time screening or for testing performed as part of a contact investigation (i.e. initial and 8-week testing) as long as Aplisol® is used for both tests. Be advised that due to anticipated increased demand, it is not clear that an adequate supply of Aplisol® will be available to meet all future need.
Questions and concerns about this advisory may be addressed to Sarah Burkholder, RN, MPH, Director of the TB/Refugee Health Division at 317-233-7545 or email@example.com.