Tuberculin Shortage

Updated November 1, 2013

The U.S. Centers for Disease Control and Prevention has notified state TB programs that Sanofi Pasteur has notified them that the supply of TUBERSOL® is improving and is expected to steadily improve for the remainder of 2013.

According to the manufacturer, existing Sanofi Pasteur customers can purchase directly from Sanofi Pasteur by visiting VaccineShoppe.com® or by calling 1-800-VACCINE (1-800-822-2463). In addition, limited quantities of TUBERSOL Diagnostic Antigen are available through the wholesaler/distributer channel. Customers who normally order through this channel should work with their preferred wholesaler/distributor to better understand TUBERSOL Diagnostic Antigen quantities that may be available to them. If you are a new customer or have inquiries regarding the availability of Tubersol Diagnostic Antigen, you should contact Sanofi Pasteur at 1-800-VACCINE (1-800-822-2463), or your wholesaler/distributor.

MDH’s Recommendations for the Use of Tuberculin During the Nationwide Shortage (see below) issued on April 17, 2013, remain in effect for facilities who cannot yet obtain their desired supply. MDH continues to encourage the use of interferon gamma release assays (IGRAs) for TB screening when feasible, particularly for foreign-born individuals who likely have received the BCG vaccine or individuals who may find it difficult to return to have a TB skin test read.

As tuberculin supplies improve, MDH recommends the following for institutions that are required by law to screen employees and/or residents, but have been deferring one or both steps of the two-step tuberculin skin test (TST) due to the shortage:

  • If neither TST was administered: administer one TST now, and if negative, administer the second TST one to three weeks after the first TST is read.
  • If one TST was administered: administer one TST now. This will complete the two-step TST requirement even though it is more than three weeks after the first TST was administered.
  • Resume serial testing as appropriate for your setting.

Recommendations for the Use of Tuberculin During the Nationwide Shortage

Posted April 17, 2013

On this page:
General Principles
Recommendations for Prioritizing Tuberculin Use in Specific Settings
References

Download PDF version formatted for print: Recommendations for the Use of Tuberculin During the Nationwide Shortage (PDF:37KB/2 pages)

There currently is a nationwide shortage of tuberculin used for tuberculosis skin testing (TST). The shortage involves both commercial products: TUBERSOL® (Sanofi Pasteur Limited), and APLISOL® (JHP Pharmaceuticals, LLC). The duration of the shortage is unknown but likely will be at least through May 2013. This notice advises Minnesota public health officials, clinicians, and workers in occupational health and infection control about how to adapt to the shortage. These recommendations are consistent with guidance from the Centers for Disease Control and Prevention (CDC) (1) and are in effect until the tuberculin shortage resolves.

General Principles:

During the shortage, the Minnesota Department of Health (MDH) recommends that providers, local health departments, correctional facilities, and health care settings:  

  1. Do NOT administer TSTs to persons who have no risk factors for TB or to persons with a documented previous history of a positive TST or TB disease.
  2. Substitute interferon gamma release assays (IGRAs) for TSTs when feasible. IGRAs can be used in most situations in which the TST is indicated and are preferred for people who have received BCG vaccine (2, 3). QuantiFERON®-TB Gold In-Tube and T-SPOT®.TB have FDA approval for TB testing. IGRAs may not be available in all practice settings. The MDH Public Health Laboratory does not perform IGRA testing. MDH does not maintain a list of IGRA providers; contact your local hospital laboratory or laboratory vendor.
  3. Temporarily defer TSTs for certain persons if tuberculin supply is low. The highest priorities for tuberculin use are:
    1. Evaluating persons with suspected active TB disease,
    2. TB contact investigations,
    3. Evaluating newly-arrived refugees and “Class B” immigrants and refugees; however, IGRAs are being widely used for refugee screening in Minnesota and are preferred for BCG-vaccinated persons, and
    4. Persons at high risk of progressing to active TB, if infected (e.g., HIV+, age <5).
  4. Continue to ensure that persons with symptoms of active TB disease receive immediate medical evaluation.
  5. Follow the recommendations in the table below for institutional/provider TB testing required by law. The TB Program has verified with the MDH Compliance Monitoring Division and the Minnesota Department of Corrections that these recommendations will be taken into account when inspecting and conducting complaint investigations of facilities and providers during this nationwide shortage.
  6. Tuberculin may become available from some suppliers or in some areas sooner than others. Facilities should continue to periodically check with their suppliers so that they can obtain tuberculin and resume testing as soon as possible. 

Recommendations for Prioritizing Tuberculin Use in Specific Settings

Setting

Group

Recommendations

Correctional Facilities

Offenders

At time of admission: Conduct TB symptom screen. Use IGRA if available. If IGRA not available administer one TST (county jails should postpone TST until day 11 or 12 of confinement).  If tuberculin supply is low, defer second step TST until shortage resolves. If not able to obtain any tuberculin, defer both TSTs until shortage resolves.

Annual re-testing: Conduct TB symptom screen. Use IGRA if available. If IGRA not available, defer annual TST until shortage resolves.

Testing offenders is a higher priority than testing employees. If necessary, use limited supplies for testing offenders and defer employee testing until shortage resolves.

Correctional Facilities

Employees

At time of hire: Conduct TB symptom screen. Use IGRA if available. If IGRA not available administer one TST and defer second step TST until tuberculin shortage resolves. If not able to obtain any tuberculin, defer both TSTs until shortage resolves.

Annual re-testing: Conduct TB symptom screen. Use IGRA if available. If IGRA not available defer annual TST until shortage resolves.

Testing offenders is a higher priority than testing employees. If necessary, use tuberculin for testing offenders and defer employee testing until shortage resolves.

Boarding Care/Nursing Homes

Residents

At time of admission: Conduct TB symptom screen. Use IGRA if available. If IGRA not available administer one TST and defer second step TST until shortage resolves. If not able to obtain any tuberculin, defer both TSTs until shortage resolves.

Health Care Settings

Employees

At time of hire: Conduct TB symptom screen. Use IGRA if available. If IGRA not available administer one TST and defer second step TST until shortage resolves. If not able to obtain any tuberculin, defer both TSTs until shortage resolves.

Annual re-testing: Conduct TB symptom screen. Use IGRA if available. If IGRA not available defer annual TST until tuberculin shortage resolves.

All Settings

Contact investigation

Continue to use TST or IGRA to evaluate close contacts of persons with infectious (i.e., pulmonary or laryngeal) TB disease. Consult MDH or local health department for guidance in identifying who should be included in contact testing.

Public Health

Class B & refugee health assessments

IGRA preferred. If not available, do one TST. Two-step TST testing is not indicated. Conduct TB symptom screen and other testing, as medically indicated.

 

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Questions should be directed to MDH at 651-201-5414.

References

  1. CDC. Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice. Health Alert Network message issued April 12, 2013. Attention: Non-MDH link
  2. CDC. Updated Guidelines for using interferon gamma release assays to detect Mycobacterium tuberculosis infection — United States, 2010. MMWR 2010;59 (RR-5). Attention: Non-MDH link
  3. CDC. Interferon-Gamma Release Assays (IGRAs) - Blood Tests for TB Infection (fact sheet). Attention: Non-MDH link


Updated Friday, 01-Nov-2013 10:23:32 CDT