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10.1002/cti2.1312

http://scihub22266oqcxt.onion/10.1002/cti2.1312
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suck abstract from ncbi


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pmid34295471      Clin+Transl+Immunology 2021 ; 10 (7): e1312
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  • Systematic evaluation of SARS-CoV-2 antigens enables a highly specific and sensitive multiplex serological COVID-19 assay #MMPMID34295471
  • Hober S; Hellstrom C; Olofsson J; Andersson E; Bergstrom S; Jernbom Falk A; Bayati S; Mravinacova S; Sjoberg R; Yousef J; Skoglund L; Kanje S; Berling A; Svensson AS; Jensen G; Enstedt H; Afshari D; Xu LL; Zwahlen M; von Feilitzen K; Hanke L; Murrell B; McInerney G; Karlsson Hedestam GB; Lendel C; Roth RG; Skoog I; Svenungsson E; Olsson T; Fogdell-Hahn A; Lindroth Y; Lundgren M; Maleki KT; Lagerqvist N; Klingstrom J; Da Silva Rodrigues R; Muschiol S; Bogdanovic G; Arroyo Muhr LS; Eklund C; Lagheden C; Dillner J; Sivertsson A; Havervall S; Thalin C; Tegel H; Pin E; Manberg A; Hedhammar M; Nilsson P
  • Clin Transl Immunology 2021[]; 10 (7): e1312 PMID34295471show ga
  • OBJECTIVE: The COVID-19 pandemic poses an immense need for accurate, sensitive and high-throughput clinical tests, and serological assays are needed for both overarching epidemiological studies and evaluating vaccines. Here, we present the development and validation of a high-throughput multiplex bead-based serological assay. METHODS: More than 100 representations of SARS-CoV-2 proteins were included for initial evaluation, including antigens produced in bacterial and mammalian hosts as well as synthetic peptides. The five best-performing antigens, three representing the spike glycoprotein and two representing the nucleocapsid protein, were further evaluated for detection of IgG antibodies in samples from 331 COVID-19 patients and convalescents, and in 2090 negative controls sampled before 2020. RESULTS: Three antigens were finally selected, represented by a soluble trimeric form and the S1-domain of the spike glycoprotein as well as by the C-terminal domain of the nucleocapsid. The sensitivity for these three antigens individually was found to be 99.7%, 99.1% and 99.7%, and the specificity was found to be 98.1%, 98.7% and 95.7%. The best assay performance was although achieved when utilising two antigens in combination, enabling a sensitivity of up to 99.7% combined with a specificity of 100%. Requiring any two of the three antigens resulted in a sensitivity of 99.7% and a specificity of 99.4%. CONCLUSION: These observations demonstrate that a serological test based on a combination of several SARS-CoV-2 antigens enables a highly specific and sensitive multiplex serological COVID-19 assay.
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