P27
: QIAreach QuantiFERON-TB for the diagnosis of tuberculosis: a systematic review
R Alagna(1) V Nikolayevskyy(2,4) M Destito(3) D manissero()
1:QIAGEN SRL; 2:QIAGEN Manchester Ltd; 3:QIAGEN AG,; 4:Imperial College London
Background
TB infection (TBI) diagnosis and treatment are crucial components of the End TB strategy. QIAreach QuantiFERON-TB (QIAreach-QFT) is a novel, portable, digital lateral flow immunoassay able to detect IFN-γ in plasma released by both CD4 and CD8 T cells without the need to perform an enzyme-linked immunosorbent assay. After incubation, samples are analyzed on a portable platform, the eHub, performing up to eight tests in 20 minutes for a final qualitative result. This study aimed to conduct a systematic review evaluating the clinical performance of QIAreach-QFT.
Methods
PubMed was used to identify records related to predefined strings from 2021 to 2022. Full text articles assessing the sensitivity and/or specificity of QIAreach-QFT for TBI diagnosis and level of agreement versus QuantiFERON-TB Gold Plus (QFT-Plus) were analyzed.
Results
Three cross-sectional studies were identified of which two assessed sensitivity and specificity. In these studies, sample size varied from 41 to 130 in the TB group, respectively, and 42 to 174 in the TBI group, respectively. Pooled sensitivity of QIAreach-QFT for active-TB was 96% (two-sided 95% CI 91.75% to 98.34%), whereas pooled specificity for healthy status was 98% (CI 94.68% to 99.24%). All three identified studies measured agreement of QIAreach-QFT vs QFT-Plus. The overall percentage of agreement versus QFT-Plus was 96.6% (CI 94.8-97.9%) with a Cohen’s κ of 0,93. The positive percent agreement was 99.56% (CI 97.6-99.99%) and a negative percent agreement was 94.74% (CI 91.9% to 96.8%).
Conclusion
The study shows QIAreach-QFT was accurate in detecting TBI with high levels of agreement compared to QFT-Plus.