Nationwide Shortage of Tuberulin Skin Test Antigens

The Centers for Disease Control and Prevention (CDC) is expecting a 3 to 10 month nationwide shortage of APLISOL®, a product of Par Pharmaceuticals. APLISOL® is one of two purified-protein derivative (PPD) tuberculin antigens that are licensed by the United States Food and Drug Administration (FDA) for use in performing tuberculin skin tests.

For the full June 12, 2019 Health Advisory: Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice.

The North Daktoa Department of Health June 17, 2019 Memo regarding state supplied PPD.   Restriction on the Release of PPD from NDDoH Supply

Use this tool to identify adults that may need testing for tuberculosis. Tuberculosis Risk Assessment Tool for Adults

Even during this shortage, it remains important to detect and treat tuberculosis.

Setting	Group	Recommendations
All Settings	All Groups	Do NOT Administer TSTs to persons with a documented previous history of positive TST, IGRA or TB Disease.
Correctional Facilities	Residents	At Time of Admission: • Conduct TB Symptom Screen. • Perform TB Screening Test using IGRA.  If IGRA not available, administer one TST.  • If one TST administered, defer second step TST until shortage resolves.  • If unable to obtain any PPD, defer both TSTs until shortage resolves. Annual Screening: Conduct TB Symptom Screen.  Perform TB Screening Test using IGRA.  If IGRA not available, defer annual TST in the absence of TB symptoms until shortage resolves. The testing of residents is a higher priority than testing employees.  • For residents under the US Marshal Service, a symptom screen alone is not acceptable; an IGRA or chest x-ray must be performed to screen for TB.
Boarding Care/Nursing Homes	Residents	At Time of Admission: • Conduct TB Symptom Screen. Perform TB Screening Test using IGRA.  If IGRA not available, administer one TST.  • If one TST administered, defer second step TST until shortage resolves.  • If unable to obtain any PPD, defer both TSTs until shortage resolves.
Health Care Settings	Employees	At Time of Hire:  • Conduct TB Symptom Screen. • Perform TB Screening Test using IGRA.  If IGRA not available, administer one TST.  • If one TST administered, defer second step TST until shortage resolves.  • If unable to obtain any PPD, defer both TSTs until shortage resolves.
All Settings	Contact Investigations	• Conduct TB Symptom Screen.  • Perform TB Screening Test using IGRA.  If IGRA not available, administer TST as otherwise indicated.  • Consult with NDDoH for guidance in identifying who should be included in contact testing.
Public Health	Class B and Refugee Health Assessments	• Conduct TB Symptom Screen.  • Perform TB Screening Test using IGRA.  If IGRA not available, administer one TST.  • Two-step testing is not indicated.  • Conduct other testing and screening as medically indicated.
Clinical Practice	Asymptomatic adults at increased risk for TB infection	USPSTF recommends all adults at increased risk for TB infection be screened for TB infection.  These groups include: persons born in or who are former residents of countries with increased prevalence of TB; persons who live in, or have lived in, high-risk congregate settings (e.g., homeless shelters and correctional facilities).  • Conduct TB symptom screen.  • Perform TB screening test using IGRA.  If IGRA not available, administer one TST.

For additional information, please contact the ND TB Prevention and Control program by calling 701.328.2378.