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For persons with immediate allergic reactions to mRNA COVID-19 vaccines, skin testing (ST) to the vaccine/excipients (polyethylene glycol[PEG] and polysorbate 80 [PS]) has been recommended, but has unknown accuracy. To assess vaccine/excipient ST accuracy in predicting all-severity immediate allergic reactions upon re-vaccination, systematic review was performed searching Medline, EMBASE, Web of Science, and the WHO global coronavirus database (inception-Oct 4, 2021) for studies addressing immediate (≤4 h post-vaccination) all-severity allergic reactions to 2nd mRNA COVID-19 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-analysis of diagnostic testing accuracy was performed using Bayesian methods. The GRADE approach evaluated certainty of the evidence, and QUADAS-2 assessed risk of bias. Among 20 studies of mRNA COVID-19 first dose vaccine reactions, 317 individuals underwent 578 ST to any one or combination of vaccine, PEG, or PS, and were re-vaccinated with the same vaccine. Test sensitivity for either mRNA vaccine was 0.2 (95%CrI 0.01-0.52) and specificity 0.97 (95%CrI 0.9-1). PEG test sensitivity was 0.02 (95%CrI 0.00-0.07) and specificity 0.99 (95%CrI 0.96-1). PS test sensitivity was 0.03 (95%CrI 0.00-0.0.11) and specificity 0.97 (95%CrI 0.91-1). Combined for use of any of the 3 testing agents, sensitivity was 0.03 (95%CrI 0.00-0.08) and specificity was 0.98 (95%CrI 0.95-1.00). Certainty of evidence was moderate. ST has low sensitivity but high specificity in predicting all-severity repeat immediate allergic reactions to the same agent, among persons with 1st dose immediate allergic reactions to mRNA COVID-19 vaccines. mRNA COVID-19 vaccine or excipient ST has limited risk assessment utility.

Titel:	Diagnostic accuracy of vaccine and vaccine excipient testing in the setting of allergic reactions to COVID-19 vaccines: A systematic review and meta-analysis.
Autor/in / Beteiligte Person:	Greenhawt, M ; Shaker, M ; Golden, DBK ; Abrams, EM ; Blumenthal, KG ; Wolfson, AR ; Stone CA Jr ; Krantz, MS ; Chu, DK ; Dwamena, BA
Link:	Full Text Finder (Volltext)
Zeitschrift:	Allergy, Jg. 78 (2023), Heft 1, S. 71-83
Veröffentlichung:	Copenhagen : Wiley-Blackwell ; <i>Original Publication</i>: Copenhagen, Munksgaard., 2023
Medientyp:	academicJournal
ISSN:	1398-9995 (electronic)
DOI:	10.1111/all.15571
Schlagwort:	Humans Bayes Theorem COVID-19 Vaccines adverse effects Excipients adverse effects Polysorbates adverse effects Vaccine Excipients COVID-19 diagnosis COVID-19 prevention & control Hypersensitivity Hypersensitivity, Immediate Vaccines
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Meta-Analysis; Systematic Review; Research Support, Non-U.S. Gov't Language: English [Allergy] 2023 Jan; Vol. 78 (1), pp. 71-83. <i>Date of Electronic Publication: </i>2022 Nov 23. MeSH Terms: COVID-19* / diagnosis ; COVID-19* / prevention & control ; Hypersensitivity* ; Hypersensitivity, Immediate* ; Vaccines* ; Humans ; Bayes Theorem ; COVID-19 Vaccines / adverse effects ; Excipients / adverse effects ; Polysorbates / adverse effects ; Vaccine Excipients References: Ann Allergy Asthma Immunol. 2022 Jan;128(1):97-98. (PMID: 34487840) ; Allergy. 2022 Jul;77(7):2200-2210. (PMID: 34806775) ; Ann Intern Med. 2011 Oct 18;155(8):529-36. (PMID: 22007046) ; Ann Allergy Asthma Immunol. 2022 Jul;129(1):88-94.e1. (PMID: 35288274) ; Ann Intern Med. 2021 Aug;174(8):1177-1178. (PMID: 33819057) ; Ann Allergy Asthma Immunol. 2021 Jul;127(1):133-134. (PMID: 33781933) ; Allergy. 2021 Nov;76(11):3538-3540. (PMID: 34370884) ; Pediatr Blood Cancer. 2021 Nov;68(11):e29295. (PMID: 34398511) ; JAMA Netw Open. 2021 Sep 1;4(9):e2125524. (PMID: 34533570) ; J Allergy Clin Immunol. 2005 Aug;116(2):341-6. (PMID: 16108145) ; J Investig Allergol Clin Immunol. 2022 Oct 11;32(5):403-405. (PMID: 34907899) ; Ann Allergy Asthma Immunol. 2021 Jun;126(6):735-738. (PMID: 33775902) ; Front Allergy. 2021 Sep 29;2:715844. (PMID: 35387046) ; Med Decis Making. 2008 Sep-Oct;28(5):621-38. (PMID: 18591542) ; J Allergy Clin Immunol Pract. 2022 Feb;10(2):620-625.e1. (PMID: 34949564) ; J Allergy Clin Immunol Pract. 2021 Sep;9(9):3308-3320.e3. (PMID: 34166844) ; Ann Allergy Asthma Immunol. 2021 Apr;126(4):319-320. (PMID: 33493641) ; J Allergy Clin Immunol. 2021 Jul;148(1):173-181. (PMID: 33476673) ; MMWR Morb Mortal Wkly Rep. 2021 Jan 29;70(4):125-129. (PMID: 33507892) ; Allergy. 2023 Jan;78(1):71-83. (PMID: 36321821) ; Clin Infect Dis. 2021 Dec 6;73(11):2108-2111. (PMID: 33989390) ; Ann Allergy Asthma Immunol. 2022 Aug;129(2):182-188.e1. (PMID: 35609744) ; Clin Exp Allergy. 2021 Jun;51(6):861-863. (PMID: 33825239) ; J Allergy Clin Immunol Pract. 2021 Jun;9(6):2476-2477. (PMID: 33766582) ; Clin Transl Allergy. 2021 Jul;11(5):e12044. (PMID: 34331522) ; JAMA Intern Med. 2022 Apr 01;182(4):376-385. (PMID: 35188528) ; J Allergy Clin Immunol Pract. 2021 Jun;9(6):2135-2138. (PMID: 33866033) ; Allergy. 2021 Sep;76(9):2916-2920. (PMID: 34028041) ; Allergy. 2022 Jan;77(1):337-338. (PMID: 34965310) ; J Allergy Clin Immunol Pract. 2022 Mar;10(3):859-862. (PMID: 34979336) ; J Allergy Clin Immunol. 2012 Jul;130(1):25-43. (PMID: 22608573) ; J Allergy Clin Immunol Pract. 2022 Feb;10(2):630-632. (PMID: 34883262) ; J Clin Epidemiol. 2006 Dec;59(12):1331-2; author reply 1332-3. (PMID: 17098577) ; J Allergy Clin Immunol Pract. 2021 Apr;9(4):1423-1437. (PMID: 33388478) ; Ann Allergy Asthma Immunol. 2022 Jan;128(1):99-101. (PMID: 34648975) ; Open Forum Infect Dis. 2021 Oct 06;8(12):ofab507. (PMID: 34873577) ; Allergy. 2022 Mar;77(3):1048-1051. (PMID: 34779000) ; J Allergy Clin Immunol. 1998 Feb;101(2 Pt 1):153-6. (PMID: 9500746) ; Mil Med. 2022 Dec 5;187(9):e1556-e1558. (PMID: 33851711) ; J Allergy Clin Immunol Pract. 2021 Dec;9(12):4221-4230. (PMID: 34624540) ; J Allergy Clin Immunol Pract. 2022 Jan;10(1):322-325. (PMID: 34678498) ; Clin Exp Allergy. 2022 Jan;52(1):12-17. (PMID: 34822190) ; Ann Allergy Asthma Immunol. 2022 Sep;129(3):373-374. (PMID: 35595005) ; Clin Exp Allergy. 2022 Jun;52(6):812-819. (PMID: 35384115) ; J Investig Allergol Clin Immunol. 2021 Dec;31(6):507-508. (PMID: 34935617) ; J Allergy Clin Immunol Pract. 2021 Oct;9(10):3546-3567. (PMID: 34153517) ; Ann Allergy Asthma Immunol. 2022 Feb;128(2):161-168.e1. (PMID: 34699968) Grant Information: T32 HL087738 United States HL NHLBI NIH HHS Contributed Indexing: Keywords: COVID-19; allergic reactions; mRNA COVID-19 vaccine; test sensitivity; test specificity Substance Nomenclature: 0 (COVID-19 Vaccines) ; 0 (Excipients) ; 0 (Polysorbates) ; 0 (Vaccine Excipients) ; 0 (Vaccines) Entry Date(s): Date Created: 20221102 Date Completed: 20230104 Latest Revision: 20240314 Update Code: 20240314 PubMed Central ID: PMC9878056

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Diagnostic accuracy of vaccine and vaccine excipient testing in the setting of allergic reactions to COVID-19 vaccines: A systematic review and meta-analysis.