The QuantiFERON® TB Gold Plus (in Tube) assay is intended for use as an aid in diagnosis of TB infection.
This test uses a peptide cocktail of CD4+ and CD8+ T cell antigens to stimulate cells in whole blood. Detection of interferon-gamma is used to identify in vitro responses to these peptide antigens that are associated with Mycobacterium tuberculosis infection.
A negative result suggests that M. tuberculosis infection is unlikely. However, in patients with high suspicion of exposure, a negative test should be repeated on a new sample.
A positive result indicates an interferon-gamma response to M. tuberculosis antigens, suggesting infection with M. tuberculosis.
Positive results in patients at low-risk for tuberculosis should be interpreted with caution and repeat testing on a new sample is advised. If repeat testing is positive, treatment may be indicated. Consult Infectious Disease Services for further recommendations.
False positive results may occur in patients with prior infection with M. marinum, M. szulgai, or M. kansasii.
For an indeterminate result, the likelihood of determining infection with M. tuberculosis cannot be determined. If clinically indicated, repeat testing on a new sample is advised.
Diagnosing or excluding tuberculosis disease, and assessing the probability of LTBI, requires a combination of epidemiological, historical, medical, and diagnostic findings that should be considered when interpreting QFT-Plus results. See general guidance on the diagnosis and treatment of TB disease and LTBI https://www.cdc.gov/tb/publications/guidelines/default.htm.
*Special pre-approved events require direct draw into the four QFT-Plus blood collection tubes. Collect 1 mL of blood by venipuncture directly into each QFT-Plus blood collection tubes. The black mark on the side of each tube indicates the appropriate fill volume. Under-or-over filling of tubes outside this fill volume may lead to erroneous results.
If a "butterfly needle" is being used to collect blood, a "purge" tube should be used to ensure that the tubing is filled with blood prior to the QFT-Plus blood collection tubes being used.
Immediately after filling the tubes, shake them ten (10) times just firmly enough to make sure the entire inner surface of the tube is coated with blood. This will dissolve any antigens on the tube walls. Avoid over vigorous shaking as this may lead to gel disruption.
Following filling and shaking, the tubes must be transferred to an incubator within 16 hours of collection. Prior to incubation, maintain tubes at room temperature.