Shortage of TB Skin Test Antigens

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CONTRA COSTA
P U B LI C HE AL TH
WILLIAM B. WALKER, M.D.
HEALTH SERVICES DIRECTOR
COMMUNICABLE
DISEASE PROGRAMS
597 CENTER AVENUE, SUITE 200-A
MARTINEZ, CALIFORNIA 94553
PH (925) 313-6740
FAX (925) 313-6465
WENDEL BRUNNER, M.D.
DIRECTOR OF PUBLIC HEALTH
HEALTH ADVISORY
AUGUST 30, 2013
SHORTAGE OF
TB
SKIN TEST ANTIGENS
SUMMARY:
There is currently a shortage of Tubersol and limited availability of Aplisol, the two purified protein
derivative (PPD) solutions used for TB skin tests (TST). Other tests for detecting TB infection such as
Interferon Gamma Release Assays (IGRA) (e.g. QuantiFERON and T-SPOT) continue to be available. If you
experience difficulty obtaining PPD solution, Contra Costa Public Health recommends testing only those
patients at high risk for TB exposure and for progression to active TB disease.
CURRENT SITUATION
Over the last few weeks, there have been reports from multiple states of difficulty obtaining both
Tubersol and Aplisol.
Shortages are expected to continue until sometime in the fall.
BACKGROUND:
In April 2013, the US Centers for Disease Control (CDC) issued a notification regarding shortages of
Tubersol and Aplisol. It was expected that the shortages would be over by June when normal Tubersol
production was expected to resume. However, over the last few weeks, there have been reports from
multiple states of difficulty obtaining both Tubersol and Aplisol. Production of Tubersol continues to be
delayed: the 50-test preparation may not be available and the 10-test preparation may only be available
in limited quantities. This has led to an increase in demand for Aplisol resulting in a shortage of both
PPD solutions.
RECOMMENDATIONS FOR HEALTH CARE PROVIDERS
Existing supplies of PPD antigens should be prioritized for persons at increased risk of TB. Specific
recommendations include:
1. Persons who have had a BCG vaccination should not have a TST; if at increased risk of TB, they
should be tested with an IGRA.
2. If possible, programs and providers using TSTs should continue to use the same brand of PPD
antigen, as discrepancies have been reported between results of testing from different antigens;
the significance of such discrepancies has not been determined. If only one PPD antigen is
available, it is acceptable either to switch from the other brand or to an IGRA.
∎ Contra Costa Behavioral Health Services ∎ Contra Costa Emergency Medical Services ∎ Contra Costa Environmental Health ∎
∎ Contra Costa Hazardous Materials ∎ Contra Costa Health Plan ∎ Contra Costa Public Health ∎ Contra Costa Regional Medical Center and Health Centers ∎
Contra Costa Public Health Provider Health Advisory
Shortage of TB Skin Test Antigens – August 30, 2013
Page 2 of 2
3. Contacts to an infectious case of TB are the highest priority for TB testing; with the exceptions
noted above, TB contacts may be tested with an IGRA or a TST; if neither PPD antigen is available,
an IGRA should be used regardless of age. Children under 5 years of age with a positive test
should be reported to Contra Costa Public Health on a Confidential Morbidity Report form
(http://cchealth.org/cd/pdf/cmr_110b.pdf).
4. Persons at increased risk of TB disease are the next highest priority for TB testing; in most cases,
an IGRA may be used instead of a TST.
5. Occupational testing for TB may be performed with either an IGRA or a TST. However, problems
may arise when switching from one method to the other due to discrepant results. Occupational
TB testing utilizing TSTs should be deferred at this time until supplies are once again readily
available. Such programs may choose to convert to IGRA testing. Programs already utilizing
IGRAs may continue testing without interruption.
6. TB testing of low risk patients is not recommended, due to the relative likelihood of false positive
results.
ADDITIONAL QUESTIONS:
The Contra Costa Public Health, Communicable Disease Programs can be reached 8AM-5PM M-F at:
925-313-6740 (phone) or 925-313-6465 (fax).
More information may be found at www.cchealth.org or www.cdc.gov
∎ Contra Costa Behavioral Health Services ∎ Contra Costa Emergency Medical Services ∎ Contra Costa Environmental Health ∎
∎ Contra Costa Hazardous Materials ∎ Contra Costa Health Plan ∎ Contra Costa Public Health ∎ Contra Costa Regional Medical Center and Health Centers ∎
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