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To assess vaccine\/excipient ST accuracy in predicting all\u2010severity immediate allergic reactions upon re\u2010vaccination, systematic review was performed searching Medline, EMBASE, Web of Science, and the WHO global coronavirus database (inception\u2010Oct 4, 2021) for studies addressing immediate (\u22644\u00a0h post\u2010vaccination) all\u2010severity allergic reactions to 2nd mRNA COVID\u201019 vaccination in persons with 1st dose immediate allergic reactions. Cases evaluating delayed reactions, change of vaccine platform, or revaccination without vaccine\/excipient ST were excluded. Meta\u2010analysis of diagnostic testing accuracy was performed using Bayesian methods. The GRADE approach evaluated certainty of the evidence, and QUADAS\u20102 assessed risk of bias. Among 20 studies of mRNA COVID\u201019 first dose vaccine reactions, 317 individuals underwent 578 ST to any one or combination of vaccine, PEG, or PS, and were re\u2010vaccinated with the same vaccine. Test sensitivity for either mRNA vaccine was 0.2 (95%CrI 0.01\u20130.52) and specificity 0.97 (95%CrI 0.9\u20131). PEG test sensitivity was 0.02 (95%CrI 0.00\u20130.07) and specificity 0.99 (95%CrI 0.96\u20131). PS test sensitivity was 0.03 (95%CrI 0.00\u20130.0.11) and specificity 0.97 (95%CrI 0.91\u20131). Combined for use of any of the 3 testing agents, sensitivity was 0.03 (95%CrI 0.00\u20130.08) and specificity was 0.98 (95%CrI 0.95\u20131.00). Certainty of evidence was moderate. ST has low sensitivity but high specificity in predicting all\u2010severity repeat immediate allergic reactions to the same agent, among persons with 1st dose immediate allergic reactions to mRNA COVID\u201019 vaccines. mRNA COVID\u201019 vaccine or excipient ST has limited risk assessment utility.<\/jats:p>","DOI":"10.1111\/all.15571","type":"journal-article","created":{"date-parts":[[2022,11,2]],"date-time":"2022-11-02T13:05:15Z","timestamp":1667394315000},"page":"71-83","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Diagnostic accuracy of vaccine and vaccine excipient testing in the setting of allergic reactions to <scp>COVID<\/scp>\u201019 vaccines: A\u00a0systematic review and meta\u2010analysis"],"prefix":"10.1111","volume":"78","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2365-9372","authenticated-orcid":false,"given":"Matthew","family":"Greenhawt","sequence":"first","affiliation":[{"name":"Section of Allergy and Clinical Immunology, Children's Hospital Colorado University of Colorado School of Medicine  Aurora Colorado USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcus","family":"Shaker","sequence":"additional","affiliation":[{"name":"Dartmouth\u2010Hitchcock Medical Center, Section of Allergy and Immunology  Lebanon New Hampshire USA"},{"name":"Dartmouth Geisel School of Medicine  Hanover New Hampshire USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7596-3707","authenticated-orcid":false,"given":"David B. 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