{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T00:42:46Z","timestamp":1792024966274,"version":"4.4.0"},"reference-count":87,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2023,8,10]],"date-time":"2023-08-10T00:00:00Z","timestamp":1691625600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,8,10]],"date-time":"2023-08-10T00:00:00Z","timestamp":1691625600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Bay-VOC"},{"name":"FOR-COVID"},{"DOI":"10.13039\/501100005722","name":"Ludwig-Maximilians-Universit\u00e4t M\u00fcnchen","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100005722","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Med Microbiol Immunol"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Since late 2021, the variant landscape of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been dominated by the variant of concern (VoC) Omicron and its sublineages. We and others have shown that the detection of Omicron-BA.1 and -BA.2-positive respiratory specimens by rapid antigen tests (RATs) is impaired compared to Delta VoC-containing samples. Here, in a single-center retrospective laboratory study, we evaluated the performance of ten most commonly used RATs for the detection of Omicron-BA.4 and -BA.5 infections. We used 171 respiratory swab specimens from SARS-CoV-2 RNA-positive patients, of which 71 were classified as BA.4 and 100 as BA.5. All swabs were collected between July and September 2022. 50 SARS-CoV-2 PCR-negative samples from healthy individuals, collected in October 2022, showed high specificity in 9 out of 10 RATs. When assessing analytical sensitivity using clinical specimens, the 50% limit of detection (LoD50) ranged from 7.6\u2009\u00d7\u200910<jats:sup>4<\/jats:sup> to 3.3\u2009\u00d7\u200910<jats:sup>6<\/jats:sup> RNA copies subjected to the RATs for BA.4 compared to 6.8\u2009\u00d7\u200910<jats:sup>4<\/jats:sup> to 3.0\u2009\u00d7\u200910<jats:sup>6<\/jats:sup> for BA.5. Overall, intra-assay differences for the detection of these two Omicron subvariants were not significant for both respiratory swabs and tissue culture-expanded virus isolates. In contrast, marked heterogeneity was observed among the ten RATs: to be positive in these point-of-care tests, up to 443-fold (BA.4) and up to 56-fold (BA.5) higher viral loads were required for the worst performing RAT compared to the best performing RAT. True-positive rates for Omicron-BA.4- or -BA.5-containing specimens in the highest viral load category (<jats:italic>C<\/jats:italic><jats:sub>t<\/jats:sub> values\u2009&lt;\u200925) ranged from 94.3 to 34.3%, dropping to 25.6 to 0% for samples with intermediate <jats:italic>C<\/jats:italic><jats:sub>t<\/jats:sub> values (25\u201330). We conclude that the high heterogeneity in the performance of commonly used RATs remains a challenge for the general public to obtain reliable results in the evolving Omicron subvariant-driven pandemic.<\/jats:p>","DOI":"10.1007\/s00430-023-00775-8","type":"journal-article","created":{"date-parts":[[2023,8,10]],"date-time":"2023-08-10T07:01:58Z","timestamp":1691650918000},"page":"323-337","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Ten rapid antigen tests for SARS-CoV-2 widely differ in their ability to detect Omicron-BA.4 and -BA.5"],"prefix":"10.1007","volume":"212","author":[{"given":"Franziska","family":"Krenn","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"D\u00e4chert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irina","family":"Badell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaia","family":"Lupoli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gamze Naz","family":"\u00d6ztan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tianle","family":"Feng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikolas","family":"Schneider","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Huber","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanna","family":"Both","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia M.","family":"Sp\u00e4th","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maximilian","family":"Muenchhoff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Graf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Krebs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helmut","family":"Blum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00fcrgen","family":"Durner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludwig","family":"Czibere","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars","family":"Kaderali","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver T.","family":"Keppler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanna-Mari","family":"Baldauf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5435-5972","authenticated-orcid":false,"given":"Andreas","family":"Osterman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,8,10]]},"reference":[{"issue":"3","key":"775_CR1","doi-asserted-by":"publisher","first-page":"162","DOI":"10.1038\/s41579-022-00841-7","volume":"21","author":"AM Carabelli","year":"2023","unstructured":"Carabelli AM, Peacock TP, Thorne LG, Harvey WT, Hughes J, de Silva TI et al (2023) SARS-CoV-2 variant biology: immune escape, transmission and fitness. Nat Rev Microbiol 21(3):162\u2013177. https:\/\/doi.org\/10.1038\/s41579-022-00841-7","journal-title":"Nat Rev Microbiol"},{"key":"775_CR2","unstructured":"Centers for Disease Control and Prevention. COVID data tracker. https:\/\/covid.cdc.gov\/covid-data-tracker\/#variant-proportions. Accessed 16 Feb 2023"},{"key":"775_CR3","unstructured":"European Centre for Disease Prevention and Control. Weekly COVID-19 country overview. https:\/\/www.ecdc.europa.eu\/en\/covid-19\/country-overviews. Accessed 16 Feb 2023"},{"key":"775_CR4","unstructured":"American Society for Microbiology. Supply Shortages Impacting COVID-19 and Non-COVID Testing. https:\/\/asm.org\/Articles\/2020\/September\/Clinical-Microbiology-Supply-Shortage-Collecti-1. Accessed 16 Feb 2023"},{"key":"775_CR5","unstructured":"outbreak.info. Lineage comparisons. https:\/\/gisaid.org\/lineage-comparison\/. Accessed 16 Feb 2023"},{"key":"775_CR6","unstructured":"World Health Organization. Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing. https:\/\/www.who.int\/publications\/i\/item\/WHO-2019-nCoV-Ag-RDTs-Self_testing-2022.1. Accessed 16 Feb 2023"},{"key":"775_CR7","unstructured":"Official Journal of the European Union. Council Recommendation on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the EU 2021\/C 24\/01. https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX:32021H0122(01)&from=EN. Accessed 16 Feb 2023"},{"issue":"8","key":"775_CR8","doi-asserted-by":"publisher","DOI":"10.1016\/s2666-5247(21)00147-6","volume":"2","author":"M Bekliz","year":"2021","unstructured":"Bekliz M, Adea K, Essaidi-Laziosi M, Sacks JA, Escadafal C, Kaiser L et al (2021) SARS-CoV-2 rapid diagnostic tests for emerging variants. Lancet Microbe. 2(8):e351. https:\/\/doi.org\/10.1016\/s2666-5247(21)00147-6. (Epub 2021\/07\/06)","journal-title":"Lancet Microbe."},{"issue":"7","key":"775_CR9","doi-asserted-by":"publisher","first-page":"e311","DOI":"10.1016\/s2666-5247(21)00056-2","volume":"2","author":"VM Corman","year":"2021","unstructured":"Corman VM, Haage VC, Bleicker T, Schmidt ML, M\u00fchlemann B, Zuchowski M et al (2021) Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study. Lancet Microbe. 2(7):e311\u2013e319. https:\/\/doi.org\/10.1016\/s2666-5247(21)00056-2. (Epub 2021\/04\/14)","journal-title":"Lancet Microbe."},{"issue":"1","key":"775_CR10","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1007\/s00430-020-00698-8","volume":"210","author":"A Osterman","year":"2021","unstructured":"Osterman A, Baldauf HM, Eletreby M, Wettengel JM, Afridi SQ, Fuchs T et al (2021) Evaluation of two rapid antigen tests to detect SARS-CoV-2 in a hospital setting. Med Microbiol Immunol 210(1):65\u201372. https:\/\/doi.org\/10.1007\/s00430-020-00698-8. (Epub 2021\/01\/17)","journal-title":"Med Microbiol Immunol"},{"issue":"5\u20136","key":"775_CR11","doi-asserted-by":"publisher","first-page":"263","DOI":"10.1007\/s00430-021-00719-0","volume":"210","author":"A Osterman","year":"2021","unstructured":"Osterman A, Iglhaut M, Lehner A, Sp\u00e4th P, Stern M, Autenrieth H et al (2021) Comparison of four commercial, automated antigen tests to detect SARS-CoV-2 variants of concern. Med Microbiol Immunol 210(5\u20136):263\u2013275. https:\/\/doi.org\/10.1007\/s00430-021-00719-0. (Epub 2021\/08\/21)","journal-title":"Med Microbiol Immunol"},{"key":"775_CR12","doi-asserted-by":"publisher","first-page":"870738","DOI":"10.3389\/fmed.2022.870738","volume":"9","author":"M Arshadi","year":"2022","unstructured":"Arshadi M, Fardsanei F, Deihim B, Farshadzadeh Z, Nikkhahi F, Khalili F et al (2022) Diagnostic accuracy of rapid antigen tests for COVID-19 detection: a systematic review with meta-analysis. Front Med (Lausanne). 9:870738. https:\/\/doi.org\/10.3389\/fmed.2022.870738. (Epub 2022\/04\/26)","journal-title":"Front Med (Lausanne)."},{"issue":"2","key":"775_CR13","doi-asserted-by":"publisher","DOI":"10.1016\/s2666-5247(21)00302-5","volume":"3","author":"M Bekliz","year":"2022","unstructured":"Bekliz M, Adea K, Essaidi-Laziosi M, Sacks JA, Escadafal C, Kaiser L et al (2022) SARS-CoV-2 antigen-detecting rapid tests for the delta variant. Lancet Microbe. 3(2):e90. https:\/\/doi.org\/10.1016\/s2666-5247(21)00302-5. (Epub 2021\/12\/02)","journal-title":"Lancet Microbe."},{"issue":"4","key":"775_CR14","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.00853-22","volume":"10","author":"M Bekliz","year":"2022","unstructured":"Bekliz M, Adea K, Puhach O, Perez-Rodriguez F, Marques Melancia S, Baggio S et al (2022) Analytical sensitivity of eight different SARS-CoV-2 antigen-detecting rapid tests for omicron-BA.1 variant. Microbiol Spectr. 10(4):e0085322. https:\/\/doi.org\/10.1128\/spectrum.00853-22. (Epub 2022\/08\/09)","journal-title":"Microbiol Spectr."},{"key":"775_CR15","doi-asserted-by":"publisher","DOI":"10.1093\/labmed\/lmac079","author":"M \u010cernila","year":"2022","unstructured":"\u010cernila M, Logar M, Mo\u017eina H, Osredkar J (2022) Comparison between the sofia SARS antigen FIA test and the PCR test in detection of SARS-CoV-2 infection. Lab Med. https:\/\/doi.org\/10.1093\/labmed\/lmac079. (Epub 2022\/08\/18)","journal-title":"Lab Med"},{"key":"775_CR16","doi-asserted-by":"publisher","first-page":"912138","DOI":"10.3389\/fmicb.2022.912138","volume":"13","author":"IA Corr\u00eaa","year":"2022","unstructured":"Corr\u00eaa IA, Faffe DS, Galliez RM, Gon\u00e7alves CCA, Maia RA, da Silva GP et al (2022) A SARS-CoV-2 negative antigen rapid diagnostic in RT-qPCR positive samples correlates with a low likelihood of infectious viruses in the nasopharynx. Front Microbiol 13:912138. https:\/\/doi.org\/10.3389\/fmicb.2022.912138. (Epub 2022\/08\/16)","journal-title":"Front Microbiol"},{"key":"775_CR17","doi-asserted-by":"publisher","DOI":"10.1101\/2022.03.03.22271766","author":"LA Cosimi","year":"2022","unstructured":"Cosimi LA, Kelly C, Esposito S, Seitz S, Sher-Jan C, Turcinovic J et al (2022) Evaluation of the role of home rapid antigen testing to determine isolation period after infection with SARS-CoV-2. medRxiv. https:\/\/doi.org\/10.1101\/2022.03.03.22271766","journal-title":"medRxiv."},{"issue":"7","key":"775_CR18","doi-asserted-by":"publisher","first-page":"Cd013705","DOI":"10.1002\/14651858.CD013705.pub3","volume":"7","author":"J Dinnes","year":"2022","unstructured":"Dinnes J, Sharma P, Berhane S, van Wyk SS, Nyaaba N, Domen J et al (2022) Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev 7(7):Cd013705. https:\/\/doi.org\/10.1002\/14651858.CD013705.pub3. (Epub 2022\/07\/23)","journal-title":"Cochrane Database Syst Rev"},{"issue":"5","key":"775_CR19","doi-asserted-by":"publisher","first-page":"e64","DOI":"10.1016\/j.jinf.2022.02.022","volume":"84","author":"P de Michelena","year":"2022","unstructured":"de Michelena P, Torres I, Ramos-Garc\u00eda \u00c1, Gozalbes V, Ruiz N, Sanmart\u00edn A et al (2022) Real-life performance of a COVID-19 rapid antigen detection test targeting the SARS-CoV-2 nucleoprotein for diagnosis of COVID-19 due to the Omicron variant. J Infect 84(5):e64\u2013e66. https:\/\/doi.org\/10.1016\/j.jinf.2022.02.022. (Epub 2022\/02\/27)","journal-title":"J Infect"},{"issue":"5","key":"775_CR20","doi-asserted-by":"publisher","first-page":"1281","DOI":"10.1007\/s15010-022-01810-1","volume":"50","author":"A Denzler","year":"2022","unstructured":"Denzler A, Jacobs ML, Witte V, Schnitzler P, Denkinger CM, Knop M (2022) Rapid comparative evaluation of SARS-CoV-2 rapid point-of-care antigen tests. Infection 50(5):1281\u20131293. https:\/\/doi.org\/10.1007\/s15010-022-01810-1. (Epub 2022\/04\/10)","journal-title":"Infection"},{"issue":"1","key":"775_CR21","doi-asserted-by":"publisher","first-page":"140","DOI":"10.1186\/s12985-022-01871-6","volume":"19","author":"L Dong","year":"2022","unstructured":"Dong L, Li W-F, Jiang Y (2022) Performance evaluation of antigen detection rapid diagnostic test (Ag-RDT) for COVID-19 diagnosis in a primary healthcare center during the Shanghai COVID-19 quarantine period. Virol J 19(1):140. https:\/\/doi.org\/10.1186\/s12985-022-01871-6","journal-title":"Virol J"},{"key":"775_CR22","doi-asserted-by":"publisher","first-page":"908127","DOI":"10.3389\/fmed.2022.908127","volume":"9","author":"\u00c1 Hamar","year":"2022","unstructured":"Hamar \u00c1, Filip\u00e1nits K, V\u00e1radi A, V\u00e1radi-R\u00e1cz R, Gell\u00e9n HO, Fut\u00e1cs K et al (2022) Diagnostic accuracy of SARS-CoV-2 Panbio\u2122 rapid antigen diagnostic tests in a 4,440-case clinical follow-up. Front Med (Lausanne). 9:908127. https:\/\/doi.org\/10.3389\/fmed.2022.908127. (Epub 2022\/08\/20)","journal-title":"Front Med (Lausanne)."},{"issue":"3","key":"775_CR23","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.01025-22","volume":"10","author":"J Hardick","year":"2022","unstructured":"Hardick J, Gallagher N, Sachithanandham J, Fall A, Siddiqui Z, Pekosz A et al (2022) Evaluation of four point of care (POC) antigen assays for the detection of the SARS-CoV-2 variant omicron. Microbiol Spectr. 10(3):e0102522. https:\/\/doi.org\/10.1128\/spectrum.01025-22. (Epub 2022\/05\/27)","journal-title":"Microbiol Spectr."},{"key":"775_CR24","doi-asserted-by":"publisher","first-page":"18","DOI":"10.22454\/PRiMER.2022.276354","volume":"6","author":"AM Indelicato","year":"2022","unstructured":"Indelicato AM, Mohamed ZH, Dewan MJ, Morley CP (2022) Rapid antigen test sensitivity for asymptomatic COVID-19 screening. PRiMER 6:18. https:\/\/doi.org\/10.22454\/PRiMER.2022.276354. (Epub 2022\/07\/12)","journal-title":"PRiMER"},{"issue":"5","key":"775_CR25","doi-asserted-by":"publisher","first-page":"778","DOI":"10.1515\/cclm-2021-1276","volume":"60","author":"HH Kessler","year":"2022","unstructured":"Kessler HH, Pr\u00fcller F, Hardt M, Stelzl E, F\u00f6derl-H\u00f6benreich E, Pailer S et al (2022) Identification of contagious SARS-CoV-2 infected individuals by Roche\u2019s Rapid Antigen Test. Clin Chem Lab Med 60(5):778\u2013785. https:\/\/doi.org\/10.1515\/cclm-2021-1276. (Epub 2022\/03\/09)","journal-title":"Clin Chem Lab Med"},{"issue":"7","key":"775_CR26","doi-asserted-by":"publisher","first-page":"1479","DOI":"10.3390\/v14071479","volume":"14","author":"J Kim","year":"2022","unstructured":"Kim J, Sung H, Lee H, Kim J-S, Shin S, Jeong S et al (2022) Clinical performance of rapid and point-of-care antigen tests for SARS-CoV-2 variants of concern: a living systematic review and meta-analysis. Viruses 14(7):1479","journal-title":"Viruses"},{"key":"775_CR27","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics12051048","author":"MA Kyritsi","year":"2022","unstructured":"Kyritsi MA, Speletas M, Mouchtouri V, Vachtsioli E, Babalis D, Kouliou O et al (2022) Performance evaluation of a rapid antigen test (RAT) during omicron pandemic wave in Greece, conducted by different personnel, and comparison with performance in previous wave (Alpha Variant) period. Diagnostics (Basel). https:\/\/doi.org\/10.3390\/diagnostics12051048. (Epub 2022\/05\/29)","journal-title":"Diagnostics (Basel)."},{"key":"775_CR28","doi-asserted-by":"publisher","DOI":"10.3390\/jpm12071172","author":"H Lee","year":"2022","unstructured":"Lee H, Kang H, Cho Y, Oh J, Lim TH, Ko BS et al (2022) Diagnostic performance of the rapid antigen test as a screening tool for SARS-CoV-2 infection in the emergency department. J Pers Med. https:\/\/doi.org\/10.3390\/jpm12071172. (Epub 2022\/07\/28)","journal-title":"J Pers Med."},{"key":"775_CR29","doi-asserted-by":"publisher","DOI":"10.1099\/acmi.0.000361","author":"G Leixner","year":"2022","unstructured":"Leixner G, Voill-Glaninger A, Krejci I, Gaugeler-Kurzweil J, Kusstatscher T, Krugluger W et al (2022) Performance study of the anterior nasal AMP SARS-CoV-2 rapid antigen test in comparison with nasopharyngeal rRT-PCR. Access Microbiol. https:\/\/doi.org\/10.1099\/acmi.0.000361","journal-title":"Access Microbiol"},{"issue":"10","key":"775_CR30","doi-asserted-by":"publisher","first-page":"5033","DOI":"10.1002\/jmv.27908","volume":"94","author":"GCK Mak","year":"2022","unstructured":"Mak GCK, Lau SSY, Wong KKY, Lau CS, Ng KHL, Lam ETK et al (2022) Analytical sensitivity of the Rapid Antigen Test kits for detection of SARS-CoV-2 Omicron variant BA.2 sublineage. J Med Virol 94(10):5033\u20135037. https:\/\/doi.org\/10.1002\/jmv.27908. (Epub 2022\/06\/04)","journal-title":"J Med Virol"},{"issue":"1","key":"775_CR31","doi-asserted-by":"publisher","first-page":"7355","DOI":"10.1038\/s41598-022-11284-8","volume":"12","author":"A Mane","year":"2022","unstructured":"Mane A, Jain S, Jain A, Pereira M, Sirsat A, Pathak G et al (2022) Diagnostic performance of oral swab specimen for SARS-CoV-2 detection with rapid point-of-care lateral flow antigen test. Sci Rep 12(1):7355. https:\/\/doi.org\/10.1038\/s41598-022-11284-8. (Epub 2022\/05\/06)","journal-title":"Sci Rep"},{"key":"775_CR32","doi-asserted-by":"publisher","DOI":"10.2139\/ssrn.4099425","author":"L Meiners","year":"2022","unstructured":"Meiners L, Horn J, M\u00fchlemann B, Schmidt ML, Walper F, Menzel P et al (2022) Rapid antigen test sensitivity and viral load in freshly symptomatic hospital employees, December 2020 to February 2022. SSRN. https:\/\/doi.org\/10.2139\/ssrn.4099425","journal-title":"SSRN"},{"issue":"2\u20133","key":"775_CR33","doi-asserted-by":"publisher","first-page":"105","DOI":"10.1007\/s00430-022-00730-z","volume":"211","author":"A Osterman","year":"2022","unstructured":"Osterman A, Badell I, Basara E, Stern M, Kriesel F, Eletreby M et al (2022) Impaired detection of omicron by SARS-CoV-2 rapid antigen tests. Med Microbiol Immunol 211(2\u20133):105\u2013117. https:\/\/doi.org\/10.1007\/s00430-022-00730-z. (Epub 2022\/02\/22)","journal-title":"Med Microbiol Immunol"},{"key":"775_CR34","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1016\/j.jclinepi.2022.01.002","volume":"145","author":"J Polechov\u00e1","year":"2022","unstructured":"Polechov\u00e1 J, Johnson KD, Payne P, Crozier A, Beiglb\u00f6ck M, Plevka P et al (2022) SARS-CoV-2 rapid antigen tests provide benefits for epidemic control-observations from Austrian schools. J Clin Epidemiol 145:14\u201319. https:\/\/doi.org\/10.1016\/j.jclinepi.2022.01.002. (Epub 2022\/01\/19)","journal-title":"J Clin Epidemiol"},{"key":"775_CR35","doi-asserted-by":"publisher","first-page":"810576","DOI":"10.3389\/fmicb.2022.810576","volume":"13","author":"D Ra\u00efch-Regu\u00e9","year":"2022","unstructured":"Ra\u00efch-Regu\u00e9 D, Mu\u00f1oz-Basagoiti J, Perez-Zsolt D, Noguera-Julian M, Pradenas E, Riveira-Mu\u00f1oz E et al (2022) Performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests for omicron and other variants of concern. Front Microbiol 13:810576. https:\/\/doi.org\/10.3389\/fmicb.2022.810576. (Epub 2022\/05\/28)","journal-title":"Front Microbiol"},{"issue":"4","key":"775_CR36","doi-asserted-by":"publisher","first-page":"1723","DOI":"10.1002\/jmv.27505","volume":"94","author":"S Roger","year":"2022","unstructured":"Roger S, Lefeuvre C, Pivert A, Ducancelle A, Savary D, Bouthry \u00c9 et al (2022) What is the true place of the SARS-CoV-2 rapid point-of-care antigen test in the hospital setting? Lessons learned from real life. J Med Virol 94(4):1723\u20131727. https:\/\/doi.org\/10.1002\/jmv.27505. (Epub 2021\/12\/08)","journal-title":"J Med Virol"},{"issue":"8","key":"775_CR37","doi-asserted-by":"publisher","first-page":"1412","DOI":"10.1093\/infdis\/jiac333","volume":"226","author":"N Samsunder","year":"2022","unstructured":"Samsunder N, de Vos M, Ngcapu S, Giandhari J, Lewis L, Kharsany ABM et al (2022) Clinical evaluation of severe acute respiratory syndrome coronavirus 2 rapid antigen tests during the omicron wave in South Africa. J Infect Dis 226(8):1412\u20131417. https:\/\/doi.org\/10.1093\/infdis\/jiac333. (Epub 2022\/08\/04)","journal-title":"J Infect Dis"},{"key":"775_CR38","doi-asserted-by":"publisher","DOI":"10.1101\/2022.08.05.22278466","author":"A Soni","year":"2022","unstructured":"Soni A, Herbert C, Lin H, Pretz C, Stamegna P, Orwig T et al (2022) Performance of screening for SARS-CoV-2 using rapid antigen tests to detect incidence of symptomatic and asymptomatic SARS-CoV-2 infection: findings from the test us at home prospective cohort study. medRxiv. https:\/\/doi.org\/10.1101\/2022.08.05.22278466","journal-title":"medRxiv."},{"key":"775_CR39","doi-asserted-by":"publisher","DOI":"10.1101\/2022.02.27.22271090","author":"A Soni","year":"2022","unstructured":"Soni A, Herbert C, Filippaios A, Broach J, Colubri A, Fahey N et al (2022) Comparison of rapid antigen tests\u2019 performance between delta (AYX) and omicron (BA1) Variants of SARS-CoV-2: secondary analysis from a serial home self-testing study. medRxiv. https:\/\/doi.org\/10.1101\/2022.02.27.22271090. (Epub 2022\/03\/10)","journal-title":"medRxiv."},{"issue":"19","key":"775_CR40","doi-asserted-by":"publisher","first-page":"6456","DOI":"10.12998\/wjcc.v10.i19.6456","volume":"10","author":"I Tabain","year":"2022","unstructured":"Tabain I, Cucevic D, Skreb N, Mrzljak A, Ferencak I, Hruskar Z et al (2022) Field evaluation of COVID-19 rapid antigen test: are rapid antigen tests less reliable among the elderly? World J Clin Cases. 10(19):6456\u20136463. https:\/\/doi.org\/10.12998\/wjcc.v10.i19.6456. (Epub 2022\/08\/19)","journal-title":"World J Clin Cases."},{"issue":"1","key":"775_CR41","doi-asserted-by":"publisher","first-page":"239","DOI":"10.1007\/s15010-022-01844-5","volume":"51","author":"S Jungnick","year":"2023","unstructured":"Jungnick S, Hobmaier B, Paravinja N, Mautner L, Hoyos M, Konrad R et al (2023) Analysis of seven SARS-CoV-2 rapid antigen tests in detecting omicron (B.1.1.529) versus delta (B.1.617.2) using cell culture supernatants and clinical specimens. Infection 51(1):239\u2013245. https:\/\/doi.org\/10.1007\/s15010-022-01844-5. (Epub 2022\/05\/21)","journal-title":"Infection"},{"issue":"1","key":"775_CR42","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1007\/s00430-022-00752-7","volume":"212","author":"A Osterman","year":"2023","unstructured":"Osterman A, Badell I, D\u00e4chert C, Schneider N, Kaufmann AY, \u00d6ztan GN et al (2023) Variable detection of Omicron-BA.1 and \u2013BA.2 by SARS-CoV-2 rapid antigen tests. Med Microbiol Immunol 212(1):13\u201323. https:\/\/doi.org\/10.1007\/s00430-022-00752-7. (Epub 2022\/11\/13)","journal-title":"Med Microbiol Immunol"},{"issue":"2","key":"775_CR43","doi-asserted-by":"publisher","first-page":"225","DOI":"10.1016\/j.cmi.2022.08.006","volume":"29","author":"I Wagenh\u00e4user","year":"2023","unstructured":"Wagenh\u00e4user I, Knies K, Hofmann D, Rauschenberger V, Eisenmann M, Reusch J et al (2023) Virus variant-specific clinical performance of SARS coronavirus two rapid antigen tests in point-of-care use, from November 2020 to January 2022. Clin Microbiol Infect 29(2):225\u2013232. https:\/\/doi.org\/10.1016\/j.cmi.2022.08.006. (Epub 2022\/08\/27)","journal-title":"Clin Microbiol Infect"},{"key":"775_CR44","unstructured":"Paul Ehrlich Institute. Sensitivit\u00e4t der Antigentests gegen\u00fcber der Omikron-Variante (in German). https:\/\/www.pei.de\/SharedDocs\/Downloads\/DE\/newsroom\/veranstaltungen\/2022\/presse-workshop-antigentests-praesentation-nuebling.pdf?__blob=publicationFile&v=4. Accessed 16 Feb 2023"},{"key":"775_CR45","unstructured":"European Commission. EU Common list of COVID-19 antigen tests. https:\/\/health.ec.europa.eu\/system\/files\/2023-02\/covid-19_eu-common-list-antigen-tests_en_0.pdf. Accessed 16 Feb 2023"},{"issue":"11","key":"775_CR46","doi-asserted-by":"publisher","DOI":"10.2196\/40175","volume":"8","author":"TH Kwan","year":"2022","unstructured":"Kwan TH, Wong NS, Chan CP, Yeoh EK, Wong SY, Lee SS (2022) Mass screening of SARS-CoV-2 With rapid antigen tests in a receding omicron wave: population-based survey for epidemiologic evaluation. JMIR Public Health Surveill 8(11):e40175. https:\/\/doi.org\/10.2196\/40175. (Epub 2022\/10\/15)","journal-title":"JMIR Public Health Surveill"},{"issue":"4","key":"775_CR47","doi-asserted-by":"publisher","first-page":"e02006","DOI":"10.1128\/spectrum.02006-22","volume":"10","author":"K Leuzinger","year":"2022","unstructured":"Leuzinger K, Roloff T, Egli A, Hirsch HH (2022) Impact of SARS-CoV-2 omicron on rapid antigen testing developed for early-pandemic SARS-CoV-2 variants. Microbiol Spectrum 10(4):e02006-e2022. https:\/\/doi.org\/10.1128\/spectrum.02006-22","journal-title":"Microbiol Spectrum"},{"issue":"10","key":"775_CR48","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2022.35844","volume":"5","author":"C Marquez","year":"2022","unstructured":"Marquez C, Kerkhoff AD, Schrom J, Rojas S, Black D, Mitchell A et al (2022) COVID-19 symptoms and duration of rapid antigen test positivity at a community testing and surveillance site during pre-delta, delta, and omicron BA.1 periods. JAMA Netw Open 5(10):e2235844. https:\/\/doi.org\/10.1001\/jamanetworkopen.2022.35844. (Epub 2022\/10\/11)","journal-title":"JAMA Netw Open"},{"key":"775_CR49","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.Es.2021.26.44.2100442","author":"A Puyskens","year":"2021","unstructured":"Puyskens A, Krause E, Michel J, N\u00fcbling CM, Scheiblauer H, Bourquain D et al (2021) Establishment of a specimen panel for the decentralised technical evaluation of the sensitivity of 31 rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021. Euro Surveill. https:\/\/doi.org\/10.2807\/1560-7917.Es.2021.26.44.2100442. (Epub 2021\/11\/06)","journal-title":"Euro Surveill"},{"key":"775_CR50","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.Es.2021.26.44.2100441","author":"H Scheiblauer","year":"2020","unstructured":"Scheiblauer H, Filomena A, Nitsche A, Puyskens A, Corman VM, Drosten C et al (2020) Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021. Euro Surveill. https:\/\/doi.org\/10.2807\/1560-7917.Es.2021.26.44.2100441. (Epub 2021\/11\/06)","journal-title":"Euro Surveill"},{"key":"775_CR51","unstructured":"European Commission. Technical working group on COVID-19 diagnostic tests. https:\/\/health.ec.europa.eu\/health-security-and-infectious-diseases\/crisis-management\/covid-19-diagnostic-tests_en. Accessed 16 Feb 2023"},{"key":"775_CR52","unstructured":"U.S. food & drug administration. In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2. https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2. Accessed 16 Feb 2023"},{"key":"775_CR53","unstructured":"Corona-Infos Ober\u00f6sterreich. Selbsttest zur Eigenanwendung (\"Wohnzimmertest\") (in German).[https:\/\/corona.ooe.gv.at\/antigen-schnelltests-46.htm. Accessed 16 Feb 2023"},{"issue":"5","key":"775_CR54","doi-asserted-by":"publisher","first-page":"e141","DOI":"10.1016\/j.dental.2020.04.001","volume":"36","author":"J Durner","year":"2020","unstructured":"Durner J, Burggraf S, Czibere L, Fleige T, Madejska A, Watts DC et al (2020) Fast and simple high-throughput testing of COVID 19. Dent Mater 36(5):e141\u2013e142. https:\/\/doi.org\/10.1016\/j.dental.2020.04.001. (Epub 2020\/04\/17)","journal-title":"Dent Mater"},{"key":"775_CR55","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.104906","volume":"141","author":"A Lind","year":"2021","unstructured":"Lind A, Barlinn R, Landaas ET, Andresen LL, Jakobsen K, Fladeby C et al (2021) Rapid SARS-CoV-2 variant monitoring using PCR confirmed by whole genome sequencing in a high-volume diagnostic laboratory. J Clin Virol 141:104906. https:\/\/doi.org\/10.1016\/j.jcv.2021.104906. (Epub 2021\/07\/18)","journal-title":"J Clin Virol"},{"key":"775_CR56","unstructured":"Robert Koch Institute. W\u00f6chentlicher Lagebericht des RKI zur Coronavirus-Krankheit-2019 (COVID-19), 06.10.2022 \u2013 AKTUALISIERTER STAND F\u00dcR DEUTSCHLAND (in German). https:\/\/www.rki.de\/DE\/Content\/InfAZ\/N\/Neuartiges_Coronavirus\/Situationsberichte\/Wochenbericht\/Wochenbericht_2022-10-06.pdf?__blob=publicationFile. Accessed 16 Feb 2023"},{"issue":"1","key":"775_CR57","doi-asserted-by":"publisher","first-page":"71","DOI":"10.1007\/s00430-022-00728-7","volume":"211","author":"C D\u00e4chert","year":"2022","unstructured":"D\u00e4chert C, Muenchhoff M, Graf A, Autenrieth H, Bender S, Mairhofer H et al (2022) Rapid and sensitive identification of omicron by variant-specific PCR and nanopore sequencing: paradigm for diagnostics of emerging SARS-CoV-2 variants. Med Microbiol Immunol 211(1):71\u201377. https:\/\/doi.org\/10.1007\/s00430-022-00728-7","journal-title":"Med Microbiol Immunol"},{"key":"775_CR58","unstructured":"Cov-lineages. pango-designation. https:\/\/github.com\/cov-lineages\/pango-designation\/issues\/. Accessed 16 Feb 2023"},{"key":"775_CR59","unstructured":"Our World in Data. SARS-CoV-2 sequences by variant, May 23, 2022. https:\/\/ourworldindata.org\/grapher\/covid-variants-bar?time=2022-05-23&country=USA~GBR~ESP~ZAF~ITA~DEU~FRA~CAN~BEL~AUS. Accessed 16 Feb 2023"},{"key":"775_CR60","unstructured":"Robert Koch Institute. W\u00f6chentlicher Lagebericht des RKI zur Coronavirus-Krankheit-2019 (COVID-19) 21.07.2022 \u2013 AKTUALISIERTER STAND F\u00dcR DEUTSCHLAND (in German). https:\/\/www.rki.de\/DE\/Content\/InfAZ\/N\/Neuartiges_Coronavirus\/Situationsberichte\/Wochenbericht\/Wochenbericht_2022-07-21.pdf?__blob=publicationFile. Accessed 16 Feb 2023"},{"key":"775_CR61","unstructured":"Die Bundesregierung. Die wichtigsten Fragen und Antworten zu Corona-Tests (in German). https:\/\/www.bundesregierung.de\/breg-de\/themen\/coronavirus\/corona-tests-faq-1872540. Accessed 16 Feb 2023"},{"key":"775_CR62","unstructured":"Medical Device Coordination Group Document. Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices. https:\/\/health.ec.europa.eu\/system\/files\/2022-02\/mdcg_2021-21_en.pdf. Accessed 16 Feb 2023"},{"key":"775_CR63","doi-asserted-by":"publisher","DOI":"10.3390\/jcm10163493","author":"SS Khandker","year":"2021","unstructured":"Khandker SS, Nik Hashim NHH, Deris ZZ, Shueb RH, Islam MA (2021) Diagnostic accuracy of rapid antigen test kits for detecting SARS-CoV-2: a systematic review and meta-analysis of 17,171 suspected COVID-19 patients. J Clin Med. https:\/\/doi.org\/10.3390\/jcm10163493. (Epub 2021\/08\/28)","journal-title":"J Clin Med"},{"key":"775_CR64","doi-asserted-by":"publisher","first-page":"201","DOI":"10.1016\/j.ijid.2021.04.087","volume":"107","author":"M Pe\u00f1a","year":"2021","unstructured":"Pe\u00f1a M, Ampuero M, Garc\u00e9s C, Gaggero A, Garc\u00eda P, Velasquez MS et al (2021) Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-PCR in asymptomatic individuals. Int J Infect Dis 107:201\u2013204. https:\/\/doi.org\/10.1016\/j.ijid.2021.04.087","journal-title":"Int J Infect Dis"},{"issue":"1","key":"775_CR65","doi-asserted-by":"publisher","first-page":"22863","DOI":"10.1038\/s41598-021-02197-z","volume":"11","author":"JG Routsias","year":"2021","unstructured":"Routsias JG, Mavrouli M, Tsoplou P, Dioikitopoulou K, Tsakris A (2021) Diagnostic performance of rapid antigen tests (RATs) for SARS-CoV-2 and their efficacy in monitoring the infectiousness of COVID-19 patients. Sci Rep 11(1):22863. https:\/\/doi.org\/10.1038\/s41598-021-02197-z","journal-title":"Sci Rep"},{"issue":"1","key":"775_CR66","doi-asserted-by":"publisher","first-page":"276","DOI":"10.1186\/s12879-022-07240-6","volume":"22","author":"C Jeewandara","year":"2022","unstructured":"Jeewandara C, Guruge D, Pushpakumara PD, Madhusanka D, Jayadas TT, Chaturanga IP et al (2022) Sensitivity and specificity of two WHO approved SARS-CoV2 antigen assays in detecting patients with SARS-CoV2 infection. BMC Infect Dis 22(1):276. https:\/\/doi.org\/10.1186\/s12879-022-07240-6","journal-title":"BMC Infect Dis"},{"issue":"3\u20134","key":"775_CR67","doi-asserted-by":"publisher","first-page":"70","DOI":"10.1007\/s10354-021-00883-1","volume":"172","author":"T von Ahnen","year":"2022","unstructured":"von Ahnen T, von Ahnen M, Wirth U, Schardey HM, Herdtle S (2022) Evaluation of a\u00a0rapid-antigen test for COVID-19 in an\u00a0asymptomatic collective\u202f: a\u00a0prospective study. Wien Med Wochenschr 172(3\u20134):70\u201373. https:\/\/doi.org\/10.1007\/s10354-021-00883-1. (Epub 2021\/09\/29)","journal-title":"Wien Med Wochenschr"},{"key":"775_CR68","unstructured":"ECDC Technical Report. Considerations for the use of saliva as sample material for COVID-19 testing. https:\/\/www.ecdc.europa.eu\/sites\/default\/files\/documents\/covid-19-use-saliva-sample-material-testing.pdf. Accessed 16 Feb 2023"},{"key":"775_CR69","unstructured":"AmonMed Schreiner Medical GmbH. COVID-19 Antigen-Schnelltest-Kit (kolloidales Gold), Gebrauchsanweisung f\u00fcr Speichelabstrichproben (in German). https:\/\/amonmed-schreiner.de\/wp-content\/uploads\/2022\/02\/Amonmed_Schreiner_IFU_Deutsch_v7.pdf. Accessed 16 Feb 2023"},{"issue":"3","key":"775_CR70","doi-asserted-by":"publisher","DOI":"10.1128\/Spectrum.00884-21","volume":"9","author":"ML van Ogtrop","year":"2021","unstructured":"van Ogtrop ML, van de Laar TJW, Eggink D, Vanhommerig JW, van der Reijden WA (2021) Comparison of the performance of the PanBio COVID-19 antigen test in SARS-CoV-2 B.1.1.7 (Alpha) variants versus non-B.1.1.7 Variants. Microbiol Spectr. 9(3):e0088421. https:\/\/doi.org\/10.1128\/Spectrum.00884-21. (Epub 2021\/11\/25)","journal-title":"Microbiol Spectr."},{"key":"775_CR71","doi-asserted-by":"publisher","first-page":"112","DOI":"10.1016\/j.ijid.2021.11.006","volume":"114","author":"MJ Jian","year":"2022","unstructured":"Jian MJ, Chung HY, Chang CK, Lin JC, Yeh KM, Chen CW et al (2022) SARS-CoV-2 variants with T135I nucleocapsid mutations may affect antigen test performance. Int J Infect Dis 114:112\u2013114. https:\/\/doi.org\/10.1016\/j.ijid.2021.11.006. (Epub 2021\/11\/11)","journal-title":"Int J Infect Dis"},{"issue":"1","key":"775_CR72","doi-asserted-by":"publisher","first-page":"23379","DOI":"10.1038\/s41598-021-02942-4","volume":"11","author":"K Davies","year":"2021","unstructured":"Davies K, Arnold U, Buczkowski H, Burton C, Welch SR, Green N et al (2021) Virucidal efficacy of guanidine-free inactivants and rapid test buffers against SARS-CoV-2. Sci Rep 11(1):23379. https:\/\/doi.org\/10.1038\/s41598-021-02942-4. (Epub 2021\/12\/05)","journal-title":"Sci Rep"},{"key":"775_CR73","doi-asserted-by":"publisher","first-page":"105062","DOI":"10.1016\/j.jcv.2021.105062","volume":"147","author":"C Conzelmann","year":"2022","unstructured":"Conzelmann C, Weil T, Olari LR, Gilg A, Rauch L, Albers DPJ et al (2022) Virucidal activity of SARS-CoV-2 rapid antigen extraction buffers. J Clin Virol 147:105062. https:\/\/doi.org\/10.1016\/j.jcv.2021.105062. (Epub 2022\/01\/08)","journal-title":"J Clin Virol"},{"key":"775_CR74","unstructured":"Robert Koch Institute. SARS-CoV-2-Seropr\u00e4valenz in der Allgemeinbev\u00f6lkerung in Deutschland \u2013 Aktualisierung September 2022 (in German). https:\/\/www.rki.de\/DE\/Content\/InfAZ\/N\/Neuartiges_Coronavirus\/AK-Studien\/Factsheet.pdf?__blob=publicationFile. Accessed 17 Feb 2023"},{"key":"775_CR75","unstructured":"Robert Koch Institute. AKTUELLE DATEN UND INFORMATIONEN ZU INFEKTIONSKRANKHEITEN UND PUBLIC HEALTH, Epidemiologisches Bulletin 22. September 2022 (in German). https:\/\/www.rki.de\/DE\/Content\/Infekt\/EpidBull\/Archiv\/2022\/Ausgaben\/38_22.pdf?__blob=publicationFile. Accessed 17 Feb 2023"},{"issue":"1","key":"775_CR76","doi-asserted-by":"publisher","first-page":"1036","DOI":"10.1186\/s12889-020-09164-9","volume":"20","author":"K Radon","year":"2020","unstructured":"Radon K, Saathoff E, Pritsch M, Guggenb\u00fchl Noller JM, Kroidl I, Olbrich L et al (2020) Protocol of a population-based prospective COVID-19 cohort study Munich, Germany (KoCo19). BMC Public Health 20(1):1036. https:\/\/doi.org\/10.1186\/s12889-020-09164-9","journal-title":"BMC Public Health"},{"key":"775_CR77","unstructured":"KoCo19-Studie. Prospektive COVID-19 Kohorte M\u00fcnche, Zusammenfassung der Ergebnisse, 5. Studienrunde (in German). https:\/\/cdn0.scrvt.com\/4d3e519fe5939342b95c7312343779ef\/cad12e4b048f94e5\/9459ed8bbd22\/KoCo19_Zusammenfassung_Runde5_StandJuni2022.pdf. Accessed 17 Feb 2023"},{"key":"775_CR78","unstructured":"Bundesministerium f\u00fcr Gesundheit. impfdashboard - Aktueller Impfstatus (in German). https:\/\/impfdashboard.de\/. Accessed 17 Feb 2023"},{"key":"775_CR79","unstructured":"Robert Koch Institute. COVID-19-Dashboard (in German). https:\/\/experience.arcgis.com\/experience\/478220a4c454480e823b17327b2bf1d4. Accessed 17 Feb 2023"},{"issue":"10","key":"775_CR80","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0263861","volume":"17","author":"O Nickel","year":"2022","unstructured":"Nickel O, Rockstroh A, Wolf J, Landgraf S, Kalbitz S, Kellner N et al (2022) Evaluation of the systemic and mucosal immune response induced by COVID-19 and the BNT162b2 mRNA vaccine for SARS-CoV-2. PLoS ONE 17(10):e0263861. https:\/\/doi.org\/10.1371\/journal.pone.0263861. (Epub 2022\/10\/19)","journal-title":"PLoS ONE"},{"key":"775_CR81","doi-asserted-by":"publisher","DOI":"10.1016\/j.ebiom.2022.104435","volume":"88","author":"L Azzi","year":"2023","unstructured":"Azzi L, Dalla Gasperina D, Veronesi G, Shallak M, Maurino V, Baj A et al (2023) Mucosal immune response after the booster dose of the BNT162b2 COVID-19 vaccine. EBioMedicine 88:104435. https:\/\/doi.org\/10.1016\/j.ebiom.2022.104435. (Epub 2023\/01\/12)","journal-title":"EBioMedicine"},{"key":"775_CR82","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciad032","author":"MK Hayden","year":"2023","unstructured":"Hayden MK, Hanson KE, Englund JA, Lee F, Lee MJ, Loeb M et al (2023) The infectious diseases Society of America guidelines on the diagnosis of COVID-19: antigen testing. Clin Infect Dis. https:\/\/doi.org\/10.1093\/cid\/ciad032","journal-title":"Clin Infect Dis"},{"key":"775_CR83","doi-asserted-by":"publisher","DOI":"10.1007\/s15010-022-01947-z.P","author":"PR Wratil","year":"2022","unstructured":"Wratil PR, Kotter K, Bischof ML, Hollerbach S, Apak E, Kalteis AL et al (2022) Vaccine-hesitant individuals accumulate additional COVID-19 risk due to divergent perception and behaviors related to SARS-CoV-2 testing: a population-based, cross-sectional study. Infection. https:\/\/doi.org\/10.1007\/s15010-022-01947-z.P. (Epub 2022\/11\/11)","journal-title":"Infection"},{"key":"775_CR84","unstructured":"Bundesministerium f\u00fcr Gesundheit. Coronavirus-Testverordnung (TestV) (in German). https:\/\/www.bundesgesundheitsministerium.de\/service\/gesetze-und-verordnungen\/detail\/coronavirus-testverordnung-testv.html. Accessed 27 June 2023"},{"issue":"12","key":"775_CR85","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pgph.0000040","volume":"1","author":"A Abdul-Mumin","year":"2021","unstructured":"Abdul-Mumin A, Abubakari A, Agbozo F, Abdul-Karim A, Nuertey BD, Mumuni K et al (2021) Field evaluation of specificity and sensitivity of a standard SARS-CoV-2 antigen rapid diagnostic test: A prospective study at a teaching hospital in Northern Ghana. PLOS Glob Public Health. 1(12):e0000040. https:\/\/doi.org\/10.1371\/journal.pgph.0000040. (Epub 2021\/12\/07)","journal-title":"PLOS Glob Public Health."},{"key":"775_CR86","unstructured":"Akkreditierte Labore in der Medizin e.V. Faktencheck zu SARS-CoV-2-PCR-Tests: Zu den Berichten von WDR\/NDR\/SZ \u201eHinweise auf m\u00f6gliche Milliardenverschwendung\u201c (in German). Available from: https:\/\/www.alm-ev.de\/wp-content\/uploads\/2023\/01\/230110-ALM-eV-Faktencheck-SARS-CoV-2-PCR-Tests.pdf. Accessed 16 June 2013"},{"key":"775_CR87","unstructured":"outbreak.info. SARS-CoV-2 (hCoV-19) Mutation reports-lineage mutation tracker. https:\/\/outbreak.info\/situation-reports. Accessed 23 Feb 2023"}],"container-title":["Medical Microbiology and Immunology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00430-023-00775-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00430-023-00775-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00430-023-00775-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T14:09:55Z","timestamp":1694700595000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00430-023-00775-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,10]]},"references-count":87,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2023,10]]}},"alternative-id":["775"],"URL":"https:\/\/doi.org\/10.1007\/s00430-023-00775-8","relation":{},"ISSN":["0300-8584","1432-1831"],"issn-type":[{"value":"0300-8584","type":"print"},{"value":"1432-1831","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,10]]},"assertion":[{"value":"16 March 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 July 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 August 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare that they have no conflict of interest. This validation study was performed by an independent laboratory at a German University, which is not operated or controlled by the sponsor or manufacturer of a test by ownership, familial, contractual, or other relationships.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"Ethical approval was not required because all samples used were residual samples. Samples were identified in the laboratory and assigned a number without reference to patient or clinical details. Results from testing using the study assays did not impact on clinical care. Data for specificity testing were obtained from volunteers who provided written informed consent. The corresponding study protocol follows the ethical principles for medical research involving human subjects of the Declaration of Helsinki and was approved by the Ethics Committee of the Medical Faculty of the LMU Munich (no: 22\u20130292).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}}]}}