Advanced Diagnostic Laboratories

Collect

Green top tube (sodium heparin)

Pediatric Collection

Minimum volume: 6 mL

Unacceptable Conditions

Frozen, clotted, hemolyzed, spun down, citrate anticoagulant (blue top)

Storage Transport Temp

Maintain and transport specimens at room temperature (18-22°C).
Ship specimens Priority Overnight via Fed Ex in container sufficiently insulated to avoid temperature extremes (<10°C and >37°C).

Stability

24 hours at room temperature (18-22°C).

Notes

Samples must arrive within 24 hours of draw and are accepted Monday through noon on Friday.

 

Performed

Mon-Thur

Methodology

Elispot

Turnaround Time

48 hours

Department

Immunology Lab - Functional Assay

Synonyms

t spot;IGRA;T-Spot (Tuberculosis Interferon Gamma Release Assay)

Study Offerings

RUO
CAP/CLIA

Related Tests

Quantiferon TB Test (QTB)

Reference Interval

Negative

Interpretation

The T-SPOT.TB test is based on the measurement of a cell mediated response to Mycobacterium tuberculosis-specific antigens (ESAT-6 and CFP-10). Peripheral blood mononuclear cells (PBMC) are separated from whole blood and incubated in plates coated with anti-interferon gamma (IFNg) antibodies with these antigens for 16-24 hours. Following incubation, IFNg-producing cells are detected using a second anti- IFNg antibody, an enzyme linked conjugate, and substrate. Controls include unstimulated cells (Nil control) and phytohemagglutinin stimulated cells (Mitogen control). A test is considered positive or borderline when IFNg- spot forming units (SFU) produced in response to either of the TB antigens is significantly greater than the Nil control (TB-Nil; positive = > 8 SFU, borderline = 5, 6 or 7 SFU), and the Mitogen control has a robust IFNg response. The T-Spot.TB result is invalid if the Nil control is high (>10 SFU) or the mitogen control is low (< 20 SFU). Although the test is reported qualitatively, IFNg SFU for the individual test conditions are also reported as recommended by the Centers for Disease Control and Prevention¹.

The T-Spot.TB detects infections due to M. tuberculosis complex (M. tuberculosis, M. bovis and M. africanum). BCG strains and nontuberculous mycobacteria with the exception of M. marinum, M. kansasii, M. szulgai and M. gordonae do not express ESAT-6 and CFP-10 proteins. Therefore, patients either vaccinated with BCG or infected with most nontuberculous mycobacterial strains should test negative.

T-Spot.TB results should always be interpreted in conjunction with clinical and other relevant laboratory findings.

¹ Guidelines for Using the QuantiFERON^®-TB Gold Test for Detecting Mycobacterium tuberculosis Infection, United States. Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report (MMWR). December 16, 2005 / 54(RR15);49-55

CPT Code

86481

New York Approved

FDA Approved or Cleared

FDA

Approved or Cleared