Performance and variability of QuantiFERON Gold Plus assay associated with phlebotomy type

Background: QuantiFERON Gold Plus (Plus) assay has two approved methods for blood collection: direct in-tube (Plus direct) or the transfer of blood from a lithium heparin tube (Plus transfer). Currently, there is little data comparing the results of Plus and the QuantiFERON Gold In-Tube (Gold) based on blood collection. Methods: In 2017, high risk healthcare workers undergoing annual tuberculosis infection screening at Houston Methodist Hospital, a private hospital in the Texas Medical Center (Houston, TX, U.S.A.) were consented and enrolled in a study comparing the Gold-in-tube (Gold), Plus direct in-tube, and Plus transfer assays. Blood was drawn concurrently for all 3 assays. Results: Phlebotomy occurred on 300 consecutive, consented and enrolled participants in the study. The proportion of positive test results for the Gold, Plus direct and Plus transfer assays were 10% (29/300), 12% (35/299) and 17% (51/299), respectively. The agreement in the results of Gold versus Plus direct, Gold versus Plus transfer, and Plus direct versus Plus transfer was 91%, kappa (κ) = 0.56; 91%, κ = 0.59; and 85%, κ = 0.37, respectively. Conclusions: Among high risk healthcare workers in a low prevalence tuberculosis setting, the Gold Plus assay had a higher proportion of positive results than the Gold in-tube assay. The agreement between the Gold, Plus direct and Plus transfer assays was unexpectedly low for simultaneously obtained samples. Blood transfer using lithium heparin offers individual clinics and public health programs greater ability to customize protocols, but variability of results still exists.