K Fukushima1, K Akagi2, A Kondo2, T Kubo3, N Sakamoto4, H Mukae4. 1. Department of Respiratory Medicine, Japanese Red Cross Nagasaki Genbaku Isahaya Hospital, Nagasaki, Japan. Electronic address: kiyofuku@isahaya.jrc.or.jp. 2. Department of Respiratory Medicine, Japanese Red Cross Nagasaki Genbaku Isahaya Hospital, Nagasaki, Japan. 3. Department of Laboratory Medicine, Japanese Red Cross Nagasaki Genbaku Isahaya Hospital, Nagasaki, Japan. 4. Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Abstract
OBJECTIVE: 1) to compare the QIAreachTM QuantiFERON-TB (QIAreach QFT) vs. QuantiFERON®-TB Gold Plus assay (QFT-Plus) to detect tuberculosis (TB) infection; 2) to evaluate diagnostic sensitivity of QIAreach QFT using active TB as surrogate for TB infection; 3) to preliminarily evaluate QIAreach QFT in immunocompromised individuals. METHODS: QIAreach QFT measures the level of interferon-γ (IFN-γ) in plasma specimens from blood stimulated by ESAT-6 and CFP-10 peptides in one blood collection tube (equivalent to the TB2 tube of the QFT-Plus). QIAreach QFT was applied to plasma samples from 41 patients with pulmonary TB and from 42 healthy or low-TB-risk individuals. RESULTS: Sensitivity and specificity of QIAreach QFT vs. QFT-Plus were 100% (41/41) and 97.6% (41/42), respectively; overall concordance was 98.8% (82/83). All samples were measured within 20 min. The time to result of each sample was significantly correlated with IFN-γ level with a natural logarithmic scale (r = -0.913, p < 0.001). Seven cases in the active TB group were immunocompromised (CD4 <200/μL) and tested positive by QIAreach QFT. CONCLUSIONS: QIAreach QFT provides an objective readout with a minimum blood sample volume (1 mL/subject), potentially being a useful point-of-care screening test for TB infection in high-TB-burden, low-resource countries and for immunocompromised patients.
OBJECTIVE: 1) to compare the QIAreachTM QuantiFERON-TB (QIAreach QFT) vs. QuantiFERON®-TB Gold Plus assay (QFT-Plus) to detect tuberculosis (TB) infection; 2) to evaluate diagnostic sensitivity of QIAreach QFT using active TB as surrogate for TB infection; 3) to preliminarily evaluate QIAreach QFT in immunocompromised individuals. METHODS: QIAreach QFT measures the level of interferon-γ (IFN-γ) in plasma specimens from blood stimulated by ESAT-6 and CFP-10 peptides in one blood collection tube (equivalent to the TB2 tube of the QFT-Plus). QIAreach QFT was applied to plasma samples from 41 patients with pulmonary TB and from 42 healthy or low-TB-risk individuals. RESULTS: Sensitivity and specificity of QIAreach QFT vs. QFT-Plus were 100% (41/41) and 97.6% (41/42), respectively; overall concordance was 98.8% (82/83). All samples were measured within 20 min. The time to result of each sample was significantly correlated with IFN-γ level with a natural logarithmic scale (r = -0.913, p < 0.001). Seven cases in the active TB group were immunocompromised (CD4 <200/μL) and tested positive by QIAreach QFT. CONCLUSIONS: QIAreach QFT provides an objective readout with a minimum blood sample volume (1 mL/subject), potentially being a useful point-of-care screening test for TB infection in high-TB-burden, low-resource countries and for immunocompromised patients.
Authors: G B Migliori; S J Wu; A Matteelli; D Zenner; D Goletti; S Ahmedov; S Al-Abri; D M Allen; M E Balcells; A L Garcia-Basteiro; E Cambau; R E Chaisson; C B E Chee; M P Dalcolmo; J T Denholm; C Erkens; S Esposito; P Farnia; J S Friedland; S Graham; Y Hamada; A D Harries; A W Kay; A Kritski; S Manga; B J Marais; D Menzies; D Ng; L Petrone; A Rendon; D R Silva; H S Schaaf; A Skrahina; G Sotgiu; G Thwaites; S Tiberi; N Tukvadze; J-P Zellweger; L D Ambrosio; R Centis; C W M Ong Journal: Int J Tuberc Lung Dis Date: 2022-03-01 Impact factor: 3.427