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Background We compared 6 new interferon-γ release assays (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 World Health Organization (WHO)–endorsed tests for tuberculosis infection (hereafter reference tests). Methods Data sources (1 January 2007–18 August 2021) were Medline, Embase, Web of Science, Cochrane Database of Systematic Reviews, and manufacturers' data. Cross-sectional and cohort studies comparing the diagnostic performance of index and reference tests were selected. 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% confidence interval [CI], −2.8 to 2.6; CoE: moderate), and its specificity 0.9 percentage points lower (95% CI, −1.0 to −.9; CoE: moderate). Compared to QFT-GIT, TB-IGRA's sensitivity was 3.0 percentage points higher (95% CI, −.2 to 6.2; CoE: very low), and its specificity 2.6 percentage points lower (95% CI, −4.2 to −1.0; CoE: low). Agreement between the QFT-Plus CLIA and QIAreach with QFT-Plus was excellent (pooled κ statistics of 0.86 [95% CI,.78 to.94; CoE: low]; and 0.96 [95% CI,.92 to 1.00; CoE: low], respectively). The pooled κ statistic comparing the TB-Feron and the QFT-Plus or QFT-GIT was 0.85 (95% CI,.79 to.92; CoE: low). Conclusions The QFT-Plus and the TB-IGRA have very similar sensitivity and specificity as WHO-approved IGRAs. [ABSTRACT FROM AUTHOR]

Background: There is consistent evidence that SARS-CoV-2 vaccines have statistical and clinical significant efficacy to prevent incident and severe cases of COVID-19, although different outcomes were analyzed and different risk reductions were observed. However, randomized control trials (RCT) were not designed or powered to assess whether the vaccines prevent deaths, even though this was a secondary or exploratory outcome across many studies. Early real-world observational data suggest that these vaccines are highly effective in reducing hospitalization and all-cause mortality. Our objective is to summarize and appraise—the existing evidence on the efficacy and real-world effectiveness of all SARS-CoV-2 vaccines currently approved for full or limited use to prevent all-cause and COVID-19-attributed mortality. Methods: The population consists of persons with a record of vaccination status and the outcome of interest. Randomized controlled trials, comparative cohort and case-control studies reporting vaccination with any of the vaccines approved (intervention) will be eligible. The primary outcome will be all cause deaths. COVID-19-attributed deaths and deaths attributable to the vaccination (adverse event deaths) will be secondary outcomes. We will compare deaths occurring in vaccinated persons versus those non-vaccinated or having received placebo. Studies in any language will be eligible. Two independent reviewers will screen for inclusion and assess quality of studies using the Cochrane Risk of Bias 2 and the ROBINS-1 tool, as appropriate. Hazard ratios will be calculated. Assessment of statistical heterogeneity amongst the studies will be done using I2 and prediction intervals, as well as visual inspection of the forest plots. Publication bias will be assessed using a funnel plot and Egger statistical test if we have more than 10 studies in a forest plot. We have followed the PRISMA-Protocol checklist for the current protocol, which is registered at Prospero (York University, CRD42021262211). [ABSTRACT FROM AUTHOR]