What is the T-SPOT.TB test?
Can I use the T-SPOT.TB test instead of the tuberculin skin test (TST)?
What are the limitations of the tuberculin skin test (TST)?
What are the advantages of the T-SPOT.TB test?
Are there any patients that should be excluded from diagnosis with the T-SPOT.TB test?
Where can I send blood specimens for the T-SPOT.TB test?
Is the T-SPOT.TB test affected by previous BCG vaccination?
How much blood do you need for the T-SPOT.TB test?
How will the T-SPOT.TB test results be reported?
What do I do with a Borderline or Invalid test result?
Is the T-SPOT.TB test covered by insurance?
What blood collection tubes do I use?
Can I use blood collection tubes that contain EDTA?
What is the sensitivity and specificity of the T-SPOT.TB test?
The T-SPOT.TB test is a blood test, also known as an Interferon Gamma Release Assay, or IGRA, for TB infection. The test was approved by the FDA in 2008. The T-SPOT.TB test is an in vitro diagnostic test that enumerates the response of effector T cells that have been senstitized to Mycobacterium tuberculosis. The
T-SPOT.TB test is an indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography and other medical and diagnostic evaluations.¹
Yes. The Centers for Disease Control and Prevention (CDC) state in their updated guidelines that IGRAs (e.g. the T-SPOT.TB test) can be used in all situations requiring TB testing.² The CDC states that IGRAs are preferred for BCG vaccinated individuals and for those persons who are unlikely to return for the reading of the test result.² In addition, the CDC states that the administrative and logistic difficulties associated with the skin test make the T-SPOT.TB test an attractive diagnostic aid for detecting TB.²
- Requires two visits
- Test results are affected by the BCG vaccine and immunosuppressive conditions
- Subjectivity due to inoculation technique and interpretation of results
- Accurate: The only TB test with sensitivity and specificity exceeding 95% in pivotal clinical trials¹
- Reliable: Even in challenging testing populations, including foreign-born and immunosuppressed persons¹
- Simple: Requires just one visit and one standard collection tube
No, the test can be used in screening of all at-risk groups.
Oxford Diagnostic Laboratories®, the only national TB testing service exclusively dedicated to performing the T-SPOT.TB test, has the ability to set up your facility through a simple process. Please contact Client Services at 1-877- 59 TBLAB to get started.
Unlike the TST, there is no association with BCG vaccination and T-SPOT.TB test results.¹ The test utilizies two M. tuberculosis specific antigens (ESAT-6 and CFP 10) that do not cross react with the BCG vaccine or most common non-tuberculosis mycobacteria (NTMs).
The guidelines for the volume of blood are:
- Adults and children 10 years old and over: 6mL
- Children 2 to 9 years old: 4mL
- Children up to 2 years old: 2mL
Note: For immunosuppressed individuals, collect 2 tubes.
The T-SPOT.TB test results will be reported as positive, negative, borderline, or invalid. Spot counts are also reported.
It is recommended that borderline and invalid results be retested with a new blood specimen as soon as the individual can return back for collection of the new specimen.
Yes, the T-SPOT.TB test is covered by most insurance. The test is covered by a unique CPT® code: 86481
EDTA affects the secretion of interferon gamma. Blood collection tubes that contain this anti-coagulant cannot be used.
¹T-SPOT.TB Package Insert
²CDC MMWR 2010;59 (No.RR-5): 1-25
CPT is a registered trademark of the American Medical Association
T-SPOT and Oxford Diagnostic Laboratories are registered trademarks of Oxford Immunotec Ltd.