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HEALTH TB Test Shortage?
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  1. #1
    Join Date
    Jul 2005
    Happy on the mountain

    TB Test Shortage?

    Someone we know who was getting ready for the new school year had to have a TB test. Her doctor couldn't do it - says there's a shortage of the skin test whatever.

    So I went looking, and guess what? The shortage was announced in APRIL... and it's still not fixed?


    This is an official


    Distributed via the CDC Health Alert Network
    April 12, 2013, 11:00 a.m. EDT

    Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice

    TUBERSOL®, a product of Sanofi Pasteur Limited, is in shortage nationwide until at least the end of May 2013. TUBERSOL® is one of two purified-protein derivative (PPD) tuberculin products that are licensed by the United States Food and Drug Administration (FDA). The manufacturer notified CDC that 50-dose vials of TUBERSOL® are unavailable and that the supplies of 10-dose vials will be limited. This notice advises public health officials, clinicians, and workers in occupational health and infection control about how to adapt to the shortage.

    JHP Pharmaceuticals, LLC, the manufacturer of APLISOL®, the other PPD tuberculin product that is licensed by FDA, has notified FDA that the product is on allocation and is available in restricted quantity. Acute local shortages of APLISOL® are being reported to CDC by healthcare providers who switch from TUBERSOL® to APLISOL®.

    Two kinds of immunological methods are used for detecting Mycobacterium tuberculosis infection: tuberculin skin tests (TSTs) and interferon-γ release assay (IGRA) blood tests. The indications for using these tests are the same for the two methods, although one or the other method is preferred for certain populations (1), and this could play a factor in setting priorities when one of the methods is unavailable. Together, these tests are the only means for detecting latent M. tuberculosis infection, and they contribute to diagnosing tuberculosis (TB) disease. When findings such as chest radiography and mycobacterial cultures are sufficient for confirming or excluding the TB diagnosis, the results from a TST or an IGRA blood test might not be needed (2). However, most TB cases in the United States are diagnosed with a set of findings including results from one of these tests. When TB disease is strongly suspected, specific treatment should be started regardless of results from tuberculin skin test or an IGRA blood test (1,3).

    In controlled studies, the concordance between TST results from TUBERSOL® and APLISOL® is high. The concordance between results from a TST and an IGRA blood test or between results from the two commercial IGRA blood tests is lower (1).

    CDC recommends any of three general approaches for addressing the shortages of tuberculin skin test antigens:

    Substitute IGRA blood tests for TSTs. The costs associated with using the blood tests can be greater than the cost of TSTs. The blood tests require phlebotomy, preparation of blood specimens, and specific laboratory services for analysis. Thus, these tests are not available in all practice settings. Clinicians who use the IGRA blood tests should be aware that the criteria for test interpretation are different than the criteria for interpreting TSTs (1).

    Allocate TSTs to priority indications, such as TB contact investigations, as determined by public health authorities. This might require deferment of testing some persons. CDC does not recommend testing persons who are not at risk of TB (4).

    Substitute APLISOL® for TUBERSOL® for skin testing. In cross-sectional studies, the two products give similar results for most patients. Shortages of APLISOL® are expected to become more widespread, thus limiting the feasibility of this approach.
    Some surveillance programs for TB infection control rely on routine serial TSTs. Switching products or methods might make serial changes in test results difficult to interpret: the apparent conversions of results from negative to positive or reversions from positive to negative could be caused by inherent inter-product or inter-method discordance (1,5). 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.

    1. CDC. Updated guidelines for using interferon gamma release assays to detect Mycobacterium tuberculosis infection — United States, 2010. MMWR 2010;59 (RR-5).
    2. American Thoracic Society. Diagnostic standards and classification of tuberculosis in adults and children. Am J Respir Crit Care Med 2000;161:1376–95.
    3. CDC. Treatment of tuberculosis. MMWR 2003;52(RR-11).
    4. CDC. Targeted tuberculin testing and treatment of latent tuberculosis infection. MMWR 2000;49(RR-6).
    5. CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR 2005;54(RR-17)
    Be without fear in the face of your enemies. Stand brave and upright, that the Lord may love thee. Speak the truth always, even if it means your death. Protect the helpless and do no wrong.

  2. #2
    Join Date
    Sep 2010
    No problem here in Washington. Have known several individuals who have just had tests in the last few weeks.

  3. #3
    Join Date
    Jul 2005
    Happy on the mountain
    Only place to get it done here is at the local Health Dept. -
    Be without fear in the face of your enemies. Stand brave and upright, that the Lord may love thee. Speak the truth always, even if it means your death. Protect the helpless and do no wrong.

  4. #4
    Join Date
    May 2001
    In CLE again
    Quote Originally Posted by Dozdoats View Post
    Only place to get it done here is at the local Health Dept. -
    Not REALLY a surprise since, if you pop positive AND then pop pos on the chest xray your azz is THEIRS for up to 13 months if it goes well...OH and ABSOLUTELY NO BOOZE during that time....not so much because they don't want you drinking but YOU damn sure won't do it twice,,,,

    Look up antabuse reactions....
    I will sing your praise when you send the rain
    I will praise you still in these thirsty days
    I will worship you with all I am
    even if all I have are empty hands

    Mookie War Creed
    "I am the Sword of my Family and Shield of my Nation. If sent, I will crush everything you have built, burn all that you love, and kill every one of you."

  5. #5
    Join Date
    Sep 2006
    Where fog and sun meet.
    This is going to be a hassel for folks who have to have it to keep their jobs.
    Glad I got my done before April
    Good to go for three more years.

  6. #6
    Join Date
    Jul 2005
    Happy on the mountain
    Used to be no big deal to get done at your doc's office.

    Not now - and I didn't know it had been a shortage item till I went looking for info.
    Be without fear in the face of your enemies. Stand brave and upright, that the Lord may love thee. Speak the truth always, even if it means your death. Protect the helpless and do no wrong.

  7. #7
    Join Date
    Mar 2003
    St. Louis
    I have to get one for an internship I am doing with hispanic children this fall. My doctor said they don't give them anymore so I am going to my college who will give it to me.

  8. #8
    Join Date
    Oct 2002
    Prisons do annual tb testing on employees. Many prisons are simply doing the paperwork and writing on the paperwork that the tb shot is in short supply so they are only doing it if you answer questions to where you might have symptoms of tb.

    There are a lot of things having shortages right now.

    I kind of got to wondering the other day if perhaps things are going to get worse before they get better.
    working on unplugging.


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