Health

Alert

NATIONWIDE SHORTAGE OF TUBERCULIN SKIN TEST ANTIGEN

The Division of Public Health (DPH) is issuing this health alert regarding an impending shortage

of APLISOL® (JHP Pharmaceuticals, LLC).

Summary

In June the Centers for Disease Control and Prevention (CDC) informed health care providers of an

impending shortage of APLISOL®, one of two brands of tuberculin purified protein derivative (PPD) used

in the U.S. for tuberculin skin tests (TST). According to the CDC, the shortage is expected to last three

to 10 months.

This notice alerts health care providers and facilities who test for tuberculosis (TB) and provides

guidance on how to manage the shortage.

Background

Two types of immunological methods (tuberculin skin tests (TSTs) and interferon-gamma release assay

[IGRA] blood tests) are used for detecting Mycobacterium tuberculosis infection. TSTs and IGRAs are used

for the diagnosis of latent TB infection (LTBI) and can aid in the diagnosis of TB disease, though additional

evaluation and testing is necessary to distinguish between LTBI and TB disease and to determine the appropriate

treatment.

Two FDA-approved PPD tuberculin antigen products are available in the U.S. for use in performing TSTs:

APLISOL® and TUBERSOL® (Sanofi Pasteur Limited).

“Although overall test concordance is high, switching between PPD skin test products or TSTs and IGRAs in

serial testing might result in apparent conversions from negative to positive or reversions from positive to

negative that might be attributable to inherent interproduct or intermethod discordance rather than change in

M. tuberculosis infection status. Clinicians should assess test results based on the person’s likelihood of

infection and risk for progression to TB disease, if infected¹,” according to the CDC.

As a result of this shortage, supplies of TUBERSOL® may also run out.

Recommendations

When the CDC announced the shortage, they also provided recommendations to providers on how to manage for the

duration. Chief among them were to prioritize the allocation of TSTs to conserve PPD stock and to substitute with

IGRAs to test for TB.

In Delaware, regulations for the following types of long-term care facilities specifically require the two-step

TST in order to satisfy testing requirements:

•   HIV homes
•   Group homes for persons with mental illness
•   Neighborhood homes for individuals with intellectual and/or developmental disabilities
•   Family care homes, and
•   Intensive behavioral support and educational residence

Recognizing this, for the duration of the APLISOL® shortage, the Division of Health Care Quality (DHCQ) will

not enforce the TST requirement and will allow use of the IGRA as an acceptable alternative for TB testing of new

employees and residents in these facilities. This does not suspend any testing requirements but allows for use of an

alternative testing method in the facilities listed above. All other facility-specific relevant regulations already

allow for the use of the IGRA.

At this time, Delaware is not authorizing deferment of testing.

DPH has been advised by the Centers for Medicare and Medicaid Services (CMS) that physicians may call their provider

advice line to see about negotiating reimbursement for the TB blood test on a case-by-case basis.

As of May 2019, per CDC recommendations, annual TB testing of health care personnel is not recommended unless there

is a known exposure, or evidence of ongoing transmission.

As a reminder, a chest X-ray is not an appropriate first line diagnostic tool for TB, and for adults, should only be

obtained if the individual has already tested positive with a TST or IGRA.

If you have any further questions or concerns, contact the Delaware Division of Public Health TB Program central office

at 302-744-1053 or email the TB Program manager, Crystal Vicidomini, MSN/MBA, RN (Crystal.Vicidomini@delaware.gov).

Additional Information

CDC

• Morbidity and Mortality Weekly Report (MMWR). Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice.https://www.cdc.gov/mmwr/volumes/68/wr/mm6824a4.htm
• CDC: Tools for Health Care Providershttps://www.cdc.gov/mmwr/volumes/68/wr/mm6824a4.htm
• CDC: Targeted Testinghttps://www.cdc.gov/tb/publications/ltbi/targetedtesting.htm

Delaware Code

• Delaware Administrative Code. 3201: Skilled and Intermediate Care Nursing Facilitieshttp://www.hpm.umn.edu/nhregsplus/NHRegs_by_State/Delaware/Deleware_AdminCode_3201.pdf
• Delaware Administrative Code. 3225: Assisted Living Facilitieshttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Health%20Care%20Quality/3225.shtml
• Delaware Administrative Code. 3230: Rest (Residential) Homehttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Health%20Care%20Quality/3230.shtml
• Delaware Administrative Code. 3301: Group Home Facilities for Persons with AIDShttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Health%20Care%20Quality/3301.shtml
• Delaware Administrative Code. 3305: Group Homes for Persons with Mental Illnesshttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Health%20Care%20Quality/3305.shtml
• Delaware Administrative Code. 3310: Neighborhood Homes for Individuals with Intellectual and/or Developmental Disabilitieshttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Health%20Care%20Quality/3310.shtml
• Delaware Administrative Code. 3315: Family Care Homeshttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Health%20Care%20Quality/3315.shtml
• Delaware Administrative Code. 3320: Intensive Behavioral Support and Educational Residencehttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Health%20Care%20Quality/3320.shtml
• Delaware Administrative Code. 3330: Dialysis Centershttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Health%20Care%20Quality/3330.shtml
• Delaware Administrative Code. 4402: Adult Day Care Facilitieshttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Public%20Health/Health%20Systems%20Protection%20(HSP)/4402.shtml
• Delaware Administrative Code. 4403: Free Standing Birthing Centershttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Health%20Care%20Quality/3330.shtml
• Delaware Administrative Code. 4405: Free Standing Surgical Centershttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Public%20Health/Health%20Systems%20Protection%20(HSP)/4405.shtml
• Delaware Administrative Code. 4406: Home Health Agencieshttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Public%20Health/Health%20Systems%20Protection%20(HSP)/4406.shtml
• Delaware Administrative Code. 4410: Skilled Home Health Agencieshttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Public%20Health/Health%20Systems%20Protection%20(HSP)/4410.shtml
• Delaware Administrative Code. 4469: Personal Assistance Services Agencieshttp://regulations.delaware.gov/AdminCode/title16/Department%20of%20Health%20and%20Social%20Services/Division%20of%20Public%20Health/Health%20Systems%20Protection%20(HSP)/4469.shtml
• Delaware TB Programhttps://www.dhss.delaware.gov/dph/dpc/tbelimination.html

¹Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice. MMWR Morb Mortal Wkly Rep 2019;68:552–553. DOI: http://dx.doi.org/10.15585/mmwr.mm6824a4

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