Discordance between the QuantiFERON Gold In-Tube and QuantiFERON Gold Plus assays associated with country of birth TB incidence

Abstract

BackgroundThe new QuantiFERON Gold Plus (QFT+) assay is used for diagnosing tuberculosis (TB) infection and has 2 phlebotomy methods: direct (QFT + D) and single tube transfer (QFT + T). Little data is available on how the TB incidence in the country of birth (COB) of healthcare workers (HCWs) can impact the assay results. MethodsQuantiFERON Gold In-Tube (QFT-G), QFT + D and QFT + T assays were obtained from a single blood draw and compared for HCWs annually tested for TB infection. HCWs COB was ranked as: high (≥150 per 100,000), medium (20–149), and low TB incidence (<20 TB cases). ResultsIn 265 HCWs, QFT-G/+D/+T results from medium TB incidence COB (15.6%, 16.9% and 22.1%) were more likely to be positive than high (9.7%, 11.8% and 16.1%) or low incidence COB (6.3%, 8.4% and 10.5%). Agreement between assay results for high, medium and low TB incidence COB were: 95.7%, 83.1%, and 95.8% between QFT-G/QFT + D (p = 0.003), 91.4%, 88.3% and 95.8% between QFT-G/QFT + T (p = 0.187), and 91.4%, 76.6%, and 91.6% between QFT + D/QFT + T (p = 0.005). ConclusionLower agreement and a higher proportion of positivity were found in QFT-G/+D/+T results in individuals from medium TB incidence COB. QFT + may be more sensitive than QFT-G in HCWs from medium TB incidence COB.