Diagnostic Accuracy of Tests for Hymenoptera Venom Hypersensitivity: A Systematic Review and Bayesian Meta-Analysis Protocol.

BACKGROUND AND AIMS: Hymenoptera venom hypersensitivity is a potentially life-threatening condition that may affect up to 7.5% of adults worldwide and can result in systemic allergic reactions ranging from generalized cutaneous symptoms to severe anaphylaxis. Accurate diagnosis following a systemic sting reaction is essential to guide initiation of venom immunotherapy, a highly effective but resource-intensive intervention. However, the diagnostic performance of commonly used tests, including venom skin testing, serum venom-specific IgE, and component-resolved diagnostics, varies across studies, contributing to uncertainty in clinical decision-making. Prior evidence syntheses have largely relied on frequentist meta-analytic approaches, which may be limited in handling sparse data and heterogeneity. This protocol describes a systematic review and Bayesian diagnostic test accuracy meta-analysis to estimate the performance of tests for identifying IgE-mediated Hymenoptera venom allergy in patients evaluated after systemic sting reactions.

METHODS: Electronic searches will be conducted in MEDLINE, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials. Eligible studies will include diagnostic accuracy studies enrolling patients of any age evaluated after a systemic Hymenoptera sting reaction. Index tests will include venom skin testing, serum venom-specific IgE (whole-extract and component-resolved diagnostics), and basophil activation testing. Study selection, data extraction, and risk of bias assessment using QUADAS-2 will be performed independently by two reviewers. Where sufficient comparable data are available, diagnostic accuracy will be synthesized using a Bayesian bivariate random-effects meta-analysis to jointly estimate sensitivity and specificity.

RESULTS: The review will summarize study characteristics and construct study-level 2×2 diagnostic tables for each index test family. When feasible, pooled estimates of sensitivity and specificity with 95% credible intervals will be generated.

CONCLUSIONS: This review aims to provide clinically interpretable estimates of diagnostic test performance to support evidence-based decision-making and improve consistency in the evaluation of suspected Hymenoptera venom hypersensitivity.