Table 1. Interpretation Criteria used for QuantiFERON-TB Gold and QuantiFERON-TB Gold In-Tubea Tests.
Interpretation | [Nil]b | TB Responsec d | Mitogen Responsee |
Positive | Any | ≥0.35 IU/mL and ≥50% of [Nil] | Any |
Negative | ≤0.7 IU/mL | <0.35 IU/mL | ≥0.5 IU/mL |
Indeterminate | ≤0.7 IU/mL | <0.35 IU/mL | <0.5 IU/mL |
>0.7 IU/mL | <50% of Nilc | Any |
Interpretation criteria used for QFT-GIT differed from that approved by the FDA in Nov, 2008.
“[Nil]” is the IFN-γ concentration in plasma from unstimulated blood.
“TB Response” for the QuantiFERON-TB Gold test is the higher IFN-γ concentration in plasma from blood stimulated by a cocktail of peptides representing ESAT-6 or CFP10, minus [Nil].
“TB Response” for the QuantiFERON-TB Gold In-Tube test is the IFN-γ concentration in plasma from blood stimulated by a single cocktail of peptides representing ESAT-6, CFP10, and part of TB7.7 minus [Nil].
“Mitogen Response” is the IFN-γ concentration in plasma from mitogen stimulated blood minus [Nil].