Reliable in the immunocompromised
Who are the immunocompromised?
Many diagnosed with an underlying condition don’t realize that they are immunocompromised.1 Those with compromised immune systems face a higher risk of contracting tuberculosis (TB) and a higher risk of latent tuberculosis infection (LTBI) becoming active. The Centers for Disease Control and Prevention (CDC) has published the following list of people at high-risk for developing active TB disease once infected with Mycobacterium tuberculosis (MTB):2,3
Persons living with diabetes
34,200,000 people live with diabetes4
Persons living with Crohn’s disease or other inflammatory bowel disease
3,000,000 people live with Crohn’s disease or other inflammatory bowel disease5
Persons living with rheumatoid arthritis
1,500,000 people live with rheumatoid arthritis6
Persons living with HIV/AIDS
1,200,000 people live with HIV/AIDS7
Persons living with chronic kidney disease
37,000,000 people live with chronic kidney disease8
- Persons who are receiving immunosuppressive therapy
- Persons who were recently infected with MTB (within the past 2 years)
- Persons with a history of untreated or inadequately treated active TB disease
- Persons living with leukemia, lymphoma or cancer of the head, neck or lung
- Persons who have had a gastrectomy or jejunoileal bypass
- Persons who weigh less than 90% of their ideal body weight
- Persons who smoke cigarettes or abuse drugs or alcohol
- Populations defined locally as having an increased incidence of active TB disease, possibly including medically underserved or low-income populations
Why are the immunocompromised at risk?
There are many reasons for the increased risk faced by those with compromised immune systems. These include:
- Risk of progression from LTBI to active TB can be much higher than in a healthy population9
- TB infection can increase the progression of comorbid conditions, such as HIV10
- Management of TB can be complicated by drug interactions and cumulative toxicities11
- Reduced T cell counts and functionality can make it difficult for some tests to detect an immune response to MTB infection12
The T-SPOT.TB test is the only IGRA without a warning in its package insert for screening immunocompromised individuals13,14
The reliability of the T-SPOT.TB test design, which includes washing and standardizing the number of cells in each patient specimen, is supported by clinical data obtained even in challenging patient populations. The cell enumeration technology in the proprietary T-SPOT.TB test therefore will allow clinicians to confidently screen and detect TB infection.13
Patient populations can vary, but your TB test results should not. The T-SPOT.TB test is accurate across patient populations. In fact, the T-SPOT.TB test is the only TB test without a warning against use in the immunocompromised in the package insert.
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Accurate across patient populations13
- Immunocompromised
- BCG-vaccinated
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Only TB test with sensitivity and specificity > 95%13
- Sensitivity: 95.6%
- Specificity: 97.1%
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FDA-approved borderline zone provides increased test resolution for results around the cut-off point15,16