The T-SPOT.TB test is reliable, even in challenging testing populations, such as immunosuppressed patients. The test is based on a simplified ELISPOT method and is the most accurate test available for the detection of MTB with a sensitivity of 98.8%2. Immunosuppressed individuals face a higher risk of contracting tuberculosis (TB) and a higher risk of latent tuberculosis infection (LTBI) becoming active.9
Various organisations, including the World Health Organization have identified the following groups of people as being at high-risk for developing active TB disease once infected with Mycobacterium tuberculosis (MTB)1:
People living with diabetes in the world
422,000,000 people living with diabetes 10
Cases of Crohn’s disease and inflammatory bowel disease globally
6,800,000 cases of Crohn’s disease and inflammatory bowel disease globally in 201711
Global population who are living with rheumatoid arthritis
1% of the global population are living with rheumatoid arthritis12
People worldwide living with HIV/AIDS
37,900,000 people currently living with HIV or AIDS13
Population worldwide who are affected by chronic kidney disease
10% of the population affected by chronic kidney disease14
Why are the immunosuppressed at risk?
There are many reasons for the increased risk faced by those with suppressed 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 HIV15
Management of TB can be complicated by drug interactions and cumulative toxicities1
Reduced T cell counts and functionality can make it difficult for some tests to detect an immune response to MTB infection16
The T-SPOT.TB test is the only IGRA available that is normalised for both cell number and culture conditions. The test standardises the number of cells and removes serum factors that could adversely affect the test result, making it the most sensitive and most specific test for TB infection2,3. You can quickly and reliably diagnose and treat TB infection in all patient groups, including the immunosuppressed4.
The T-SPOT.TB test is designed to maintain performance, even in the immunosuppressed2
The reliability of the T-SPOT.TB test design, which includes washing and standardising 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.2
Patient populations can vary, but your TB test results should not. The T-SPOT.TB test is accurate across patient populations.
Accurate across patient populations4
Only TB test with sensitivity and specificity > 98%2
High test accuracy around result cut-off due to regulatory approved borderline zone – helping to prevent inappropriate therapy2,5
Global tuberculosis report 2020. Geneva: World Health Organization; 2020. CC BY-NC-SA 3.0 IGO
Lewinsohn DM, Leonard MK, LoBue PA, et al. Official American ThoracicSociety/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Infect Dis. Published online December 8, 2016:ciw694. doi:10.1093/cid/ciw694
Wong SH, Gao Q, Tsoi KKF, et al. Effect of immunosuppressive therapy on interferon γ release assay for latent tuberculosis screening in patients with autoimmune diseases: a systematic review and meta-analysis. Thorax. 2016;71:64–72.
Mazurek GH, Jereb J, Vernon A, LoBue P, Goldberg S, Castro K, IGRA Expert Committee, Centers for Disease Control and Prevention (CDC). Updated guidelines for using Interferon Gamma Release Assays to detect Mycobacterium tuberculosis infection – United States, 2010. MMWR Recomm Rep. 2010; 59(RR-5:1-25.
WHO End TB Strategy. World Health Organization. Published September 8, 2015. Accessed November 12, 2020.
Wrighton-Smith P, Sneed L, Humphrey F, Tao X, Bernacki E. Screening health care workers with interferon-γ release assay versus tuberculin skin test: Impact on costs and adherence to testing (the SWITCH study). J Occupational & Environmental Med. 2012;54(7):806-815
GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. The Lancet Gastroenterology & Hepatology. 2020;5(1):17-30
Lai CC, Tan CK, et al. Diagnostic performance of whole-blood interferon-γ assay and enzyme-linked immunospot assay for active tuberculosis. J Microbiol Immunol Infect. 2011 Oct;44(5):406-7. doi: 10.1016/j.jmii.2011.07.002. Epub 2011 Sep 8.
Redelman-Sidi G, Sepkowitz KA. Interferon-gamma release assays in the diagnosis of latent tuberculosis infection among immunocompromised adults. Am J Respir Crit Care Med 2013; 188:422-431. 2012/12/25. DOI: 10.1164/rccm.201209-1621CI.
Exposure to TB. Centers for Disease Control and Prevention. CDC Exposure to TB. Published March 21, 2016. Accessed January 8, 2020.
TB Risk Factors. Centers for Disease Control and Prevention. CDC TB Risk Factors. Published March 18, 2016. Accessed January 8, 2020.
Huebner R, Schein M, Bass J. The tuberculin skin test. Clin Infect Dis. 1993;968-975.
Treatment for TB Disease. Centers for Disease Control and Prevention. CDC Treatment for TB Disease. Published April 5, 2016. Accessed January 8, 2020.
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