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Interferon gamma (IFN-γ) release assays, such as QuantiFERON®-TB Gold test (QFT-G) and QuantiFERON®-TB Gold In-Tube test (QFT-GIT) are designed to detect  M. tuberculosis  ( Mtb ) infection. Recognition of unusual IFN-γ measurements may help indicate inaccurate results.    Methods  We examined QFT-G and QFT-GIT results from subjects who had two or more tests completed. We classified unusual IFN-γ measurements as: 1) High Nil Concentration ( HNC ) when IFN-γ concentration in plasma from unstimulated blood exceeded 0.7 IU/mL; 2) Low Mitogen Response ( LMR ) when Mitogen Response was <0.5 IU/mL; 3) Very Low Mitogen Response ( VLMR ) when Mitogen Response was ≤−0.5 IU/mL; and 4) Very Low Antigen Response ( VLAR ) when the response to a Mtb antigen was ≤−0.35 IU/mL and ≤−0.5 times the IFN-γ concentration in plasma from unstimulated blood.    Results  Among 5,309 results from 1,728 subjects,  HNC  occurred in 234 (4.4%) tests for 162 subjects,  LMR  in 108 (2.0%) tests for 85 subjects,  VLMR  in 22 (0.4%) tests for 21 subjects, and  VLAR  in 41 (0.8%) tests for 39 subjects. QFT-GIT had fewer  HNC ,  VLMR , and  VLAR  (p = 0.042, 0.004, and 0.067 respectively); QFT-G had fewer  LMR  (p = 0.005). Twenty-four (51.6%) of 47 subjects with positive results and  HNC  were negative or indeterminate by all other tests. Thirteen (61.9%) of 21 subjects with positive results and  LMR  were negative or indeterminate by all other tests.    Conclusion  Unusual IFN-γ measurements including  HNC ,  LMR ,  VLMR , and  VLAR  were encountered in small numbers, and in most instances were not seen on simultaneously or subsequently performed tests. To avoid erroneous diagnosis of  Mtb  infection, IGRAs with unusual IFN-γ measurements should be repeated with another blood sample and interpreted with caution if they recur.

Unusual Interferon Gamma Measurements with QuantiFERON-TB Gold and QuantiFERON-TB Gold In-Tube Tests