Comparative Evaluation of Standard E TB-Feron ELISA and QuantiFERON-TB Gold Plus Assays in Patients with Tuberculosis and Healthcare Workers

Abstract

Recently, the American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention advised against performing the interferon-γ-release assay (IGRA) test for individuals with a low risk of TB, and also recommended retesting low-risk individuals with an initial positive IGRA result. However, to evaluate both sensitivity and specificity of available tests, we compared the performance of the Standard E TB-Feron (TBF) and QuantiFERON-TB Gold Plus (QFT-Plus) assays in healthcare workers (HCWs) and tuberculosis (TB) patients. We also retrospectively investigated diabetes mellitus (DM) comorbidity among the enrolled TB patients. We prospectively collected samples from 177 HCWs and 48 TB patients. The TBF and QFT-Plus tests were performed and analyzed according to the manufacturers’ instructions. We also defined IGRA results between 0.2 and 0.7 IU/mL as ‘borderline’. The agreement rate between TBF and QFT-Plus was 92.0% (207/225) with a Cohen’s kappa value of 0.77 (95% CI, 0.68–0.87). While the majority (26/31, 83.9%) of borderline TBF results were in HCWs, the majority (14/19, 73.7%) of borderline QFT-Plus results were in TB patients. Discordant results were found in 18 samples, with TBF-positive/QFT-Plus-negative or indeterminate results in 11 HCWs and seven TB patients. After resampling from 10 HCWs (seven borderline-positive and three positive results, all <1.0), six reverted to negative. The prevalence of DM comorbidity was very high (35.4%). In summary, TBF showed substantial agreement with the QFT-Plus assay but had a higher positivity rate in both HCWs and TB patients. The negative conversion rate was high (60%) among HCWs whose initial (TB Ag-nil) result was <1.0.