immunocompromised T-SPOT.TB test females

IGRA TB test for immunocompromised

No warning and limitations for screening immunocompromised individuals. 

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 World Health Organization (WHO) and 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

thumbnail preview
0

Persons living with diabetes

77,000,000 people live with diabetes5

thumbnail preview
0

Persons living with Crohn’s disease or other inflammatory bowel disease

Persons living with inflammatory bowel disease (IBD)6

thumbnail preview
0

Persons living with rheumatoid arthritis

1,500,000 people live with rheumatoid arthritis7

thumbnail preview
0

Persons living with HIV/AIDS

1,100,000 people live with HIV/AIDS8

thumbnail preview
0

Persons living with chronic kidney disease

37,000,000 people live with chronic kidney disease9

  • 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

The T-SPOT.TB is the only IGRA, or TB blood test, without a warning or limitation in their package insert for screening immunocompromised individuals10,11

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.14

Patient populations can vary, but your TB blood test results should not. The T-SPOT.TB test is accurate across all patient populations. In fact, the T-SPOT.TB test is the only TB blood test without a warning in their package insert against use the immunocompromised population.

  1. Accurate across patient populations14

    • Immunocompromised
    • BCG-vaccinated

  2. Highest sensitivity and specificity compared to other IGRAs

    • Sensitivity: 98.8%
    • Specificity: 100%

  3. US-FDA approved borderline zone provides increased test resolution for results around the cut-off point16,17

Learn more about the
T-SPOT.TB test

Contact Us

  1. Helwick C. Immunosuppression Surprisingly Prevalent in American Adults. Medscape. Immunosuppression Surprisingly Prevalent in American Adults. Published November 2, 2016. Accessed January 9, 2020.
  2. TB Risk Factors. Centers for Disease Control and Prevention. CDC TB Risk Factors. Published March 18, 2016. Accessed January 8, 2020.
  3. CDC – TB 101 – Groups at High Risk for Developing TB Disease – Web Courses – TB. Centers for Disease Control and Prevention. CDC Groups at High Risk for Developing TB Disease. Accessed January 9, 2020.
  4. Latent tuberculosis infection: updated and consolidated guidelines for programmatic management. Geneva: World Health Organization; 2018.
  5. World Health Organization. Diabetes Country Profiles.
  6. Alatab et al, 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. 2017 Oct; Volume 5, Issue 1, P17-30. DOI: https://doi.org/10.1016/S2468-1253(19)30333-4
  7. World Health Organization (WHO) Chronic Diseases and Health Promotion. Accessed January 14, 2021.
  8. UNAIDS. Fact Sheet—Global AIDS Update 2019. Published July 2019. Accessed January 2020.
  9. Cockwell P., Fisher L.A., et al. The global burden of chronic kidney disease. The Lancent. 2020 Feb; Volume 395, Issue 10225, P662-664. DOI: https://doi.org/10.1016/S0140-6736(19)32977-0.
  10. Oxford Immunotec. T-SPOT.TB Package Insert PI-TB-IVD-UK-V3. Abingdon, UK. September 2020.
  11. Qiagen. QuantiFERON-TB Gold Plus (QFT-Plus) ELISA Package Insert. 622120/622822, Version 1, Rev. 06. April 2019.
  12. Global tuberculosis report 2019. World Health Organization. WHO Global Tuberculosis Report 2019. Published January 7, 2020. Accessed January 9, 2020.
  13. 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.
  14. Oxford Immunotec. T-SPOT.TB Package Insert PI-TB-IVD-UK V3. Abingdon, UK. February 2019
  15. Qiagen. QuantiFERON-TB Gold Plus (QFT-Plus) ELISA Package Insert. 1095849 Rev. 06. November 2019.
  16. Rego K, Pereira K, MacDougall J, Cruikshank W. Utility of the T-SPOT®.TB test’s borderline category to increase test resolution for results around the cut-off point. Tuberculosis. 2018;108:178-185. doi:10.1016/j.tube.2017.12.005.
  17. 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.

QFT is a registered trademark of The Qiagen Group.