Assessing the Diagnostic Performance of New Commercial Interferon-γ Release Assays forMycobacterium tuberculosisInfection: A Systematic Review and Meta-Analysis

Abstract

Background We compared six new IGRAs (hereafter index tests: QFT-Plus, QFT-Plus CLIA, QIAreach, Wantai TB-IGRA, Standard E TB-Feron, and T-SPOT.TB/T-Cell Select) with WHO-endorsed tests for tuberculosis infection (hereafter reference tests). Methods Data sources (2007/Jan/01-2021/Aug/18): Medline, EMBase, Web of Science, Cochrane Database of Systematic Reviews and manufacturers’ data. Study Selection: Cross-sectional and cohort studies comparing the diagnostic performance of index and reference tests. . Data synthesis: The primary outcomes of interest were the pooled differences in sensitivity and specificity between index and reference tests. The certainty of evidence (CoE) was summarized using the GRADE approach. Results Eighty-seven studies were included (44 evaluated the QFT-Plus, 4 QFT-Plus CLIA, 3 QIAreach, 26 TB-IGRA, 10 TB-Feron [1 assessing the QFT-Plus], and 1 T-SPOT.TB/T-Cell Select). Compared to the QFT-GIT, QFT Plus’s sensitivity was 0.1 percentage points lower (95% CI, -2.8, 2.6; CoE: moderate), and its specificity 0.9 percentage points lower (95% CI, -1.0, -0.9; CoE: moderate). Compared to the QFT-GIT, TB-IGRA’s sensitivity was 3.0 percentage points higher (95% CI, -0.2, 6.2; CoE: very low), and its specificity 2.6 percentage points lower (95% CI, -4.2, -1.0; CoE: low). Agreement between the QFT-Plus CLIA and QIAreach with QFT-Plus was excellent (pooled kappa statistics of 0.86 [95% CI, 0.78, 0.94; CoE: low]; and 0.96 [95% CI, 0.92, 1.00; CoE: low], respectively). The pooled kappa statistic comparing the TB-Feron and the QFT-Plus or QFT-GIT was 0.85 (95% CI, 0.79 to 0.92; CoE: low). Conclusions The QFT-plus and the TB-IGRA have very similar sensitivity and specificity as WHO-approved IGRAs.

Evaluating the diagnostic accuracy of QIAreach QuantiFERON-TB compared to QuantiFERON-TB Gold Plus for tuberculosis: a systematic review and meta-analysis

“…The QIAreach QFT is an entirely new test, so independent evaluations of their sensitivity and specificity compared to other IGRAs are limited 26 . Most previous reports have compared QIAreach with QFT-Plus.…”

Tuberculosis Immunoreactivity Surveillance in Malawi (Timasamala)—A protocol for a cross-sectional Mycobacterium tuberculosis immunoreactivity survey in Blantyre, Malawi

“…The QIAreach QFT requires a single 1mL blood sample, and minimal laboratory processing, using a semi-automated lateral flow immunoassay in a battery-powered device to measure IFN-g production [17]. Three previous analyses of QIAreach QFT have reported a high sensitivity and specificity relative to QFT-Plus [17,55,56], but the performance of the test has not previously been studied in children under 5, or in samples of population-representative individuals in a setting with high TB transmission [57]. A limitation of the study is that we are unable to also evaluate novel skin tests, due to the logistical demands of introducing a second visit for all participants [18], but we will save additional blood samples from participants which may allow future evaluation of other tests of Mtb infection.…”

Empfehlungen für die Umgebungsuntersuchungen bei Tuberkulose – Update 2023

“…des T-Spot.TB als kommerziell erhältliche IGRAs bei der Detektion behandlungsbedürftiger Tuberkulosefälle im Vergleich mit dem THT liegen inzwischen mehrere Meta-Analysen vor, die bei Erwachsenen eine mindestens vergleichbare Sensitivität [69][70][71][72], aber bessere Spezifität der IGRAs [70,72] dokumentieren. Eine Verbesserung der Sensitivität des 2019 neu eingeführten QFT-Plus-Tests gegenüber den früheren QFT-Gold in Tube (QFT) wurde nicht aufgezeigt [72,73]. Entsprechend der begrenzten Sensitivität auch der IGRAs schließt im Verdachtsfall ein negativer IGRA-Test eine LTBI oder auch eine aktive Tuberkulose nicht aus.…”