. 2021 Aug 18;599e0028821. doi Epub 2021 Aug 18. Affiliations PMID 34260272 PMCID PMC8373017 DOI Free PMC article Performance of the Abbott SARS-CoV-2 IgG II Quantitative Antibody Assay Including the New Variants of Concern, VOC 202012/V1 United Kingdom and VOC 202012/V2 South Africa, and First Steps towards Global Harmonization of COVID-19 Antibody Methods Emma English et al. J Clin Microbiol. 2021. Free PMC article Abstract In the initial stages of the severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 COVID-19 pandemic, a plethora of new serology tests were developed and introduced to the global market. Many were not evaluated rigorously, and there is a significant lack of concordance in results across methods. To enable meaningful clinical decisions to be made, robustly evaluated, quantitative serology methods are needed. These should be harmonized to a primary reference material, allowing for the comparison of trial data and improved clinical decision making. A comprehensive evaluation of the new Abbott IgG II anti-SARS-CoV-2 IgG method was undertaken using CLSI-based protocols. Two different candidate primary reference materials and verification panels were assessed with a goal to move toward harmonization. The Abbott IgG II method performed well across a wide range of parameters with excellent imprecision < and was linear throughout the positive range tested to 38,365 AU/ml. The sensitivity based on â„14-day post-positive reverse transcription-PCR [RT-PCR] samples and specificity were to and to 100%, respectively. The candidate reference materials showed poor correlation across methods, with mixed responses noted in methods that use the spike protein versus the nucleocapsid proteins as their binding antigen. The Abbott IgG II anti-SARS-CoV-2 measurement appears to be the first linear method potentially capable of monitoring the immune response to natural infection, including from new emerging variants. The candidate reference materials assessed did not generate uniform results across several methods, and further steps are needed to enable the harmonization process. Keywords COVID-19; SARS-CoV-2; analytical performance; antibody assay; evaluation; harmonization; serology; variants. Figures FIG 1 Linearity of method over the complete working range of the Abbott IgG II assay using a range of dilutions of a high positive mean, 38,365 AU/ml in the Abbott diluent. Dash-dot line indicates the identity line. The darker dotted line represents the 95% likelihood asymmetrical CI of the slope. FIG 2 Cohenâs kappa concordance analysis of the assays and overall all samples included agreement of results given as percent. Equivocal results were considered negative. FIG 3 Representative examples of the quantitative immune response in three different variants of the SARS-CoV-2 virus, including the âUKâ and âSouth Africaâ variants. The days post-PCR do not necessarily correlate to the day of onset of symptoms or the day of hospitalization. FIG 4 Comparison graphs of the values obtained for the Technopath positive panel with different methods A Abbott IgG II versus DiaSorin Liaison XL; B Abbott IgG II versus EDI; C Abbott IgG II quantitative S versus Abbott IgG qualitative R. Only the Abbott quantitative assay showed linearity r2 = and was plotted against DiaSorin, quadratic r2 = A, EDI, 4-PL r2 = B, and Abbott qualitative, 4-PL r2 = C. FIG 5 Dilution of NIBSC working standard 20/162 using the Abbott diluent. Dash-dot line indicates the identity line. The darker dotted line represents the 95% likelihood asymmetrical CI of the slope. Similar articles Clinical and analytical evaluation of the Abbott AdviseDx quantitative SARS-CoV-2 IgG assay and comparison with two other serological tests. Maine GN, Krishnan SM, Walewski K, Trueman J, Sykes E, Sun Q. Maine GN, et al. J Immunol Methods. 2022 Apr;503113243. doi Epub 2022 Feb 16. J Immunol Methods. 2022. PMID 35181288 Free PMC article. SARS-CoV-2 Antibody Testing in Health Care Workers A Comparison of the Clinical Performance of Three Commercially Available Antibody Assays. Allen N, Brady M, Carrion Martin AI, Domegan L, Walsh C, Houlihan E, Kerr C, Doherty L, King J, Doheny M, Griffin D, Molloy M, Dunne J, Crowley V, Holmes P, Keogh E, Naughton S, Kelly M, O'Rourke F, Lynagh Y, Crowley B, de Gascun C, Holder P, Bergin C, Fleming C, Ni Riain U, Conlon N; PRECISE Study Steering Group. Allen N, et al. Microbiol Spectr. 2021 Oct 31;92e0039121. doi Epub 2021 Sep 29. Microbiol Spectr. 2021. PMID 34585976 Free PMC article. A Qualitative Comparison of the Abbott SARS-CoV-2 IgG II Quant Assay against Commonly Used Canadian SARS-CoV-2 Enzyme Immunoassays in Blood Donor Retention Specimens, April 2020 to March 2021. Abe KT, Rathod B, Colwill K, Gingras AC, Tuite A, Robbins NF, Orjuela G, Jenkins C, Conrod V, Yi QL, O'Brien SF, Drews SJ. Abe KT, et al. Microbiol Spectr. 2022 Jun 29;103e0113422. doi Epub 2022 Jun 2. Microbiol Spectr. 2022. PMID 35652636 Free PMC article. Efficacy of frontline chemical biocides and disinfection approaches for inactivating SARS-CoV-2 variants of concern that cause coronavirus disease with the emergence of opportunities for green eco-solutions. Rowan NJ, Meade E, Garvey M. Rowan NJ, et al. Curr Opin Environ Sci Health. 2021 Oct;23100290. doi Epub 2021 Jul 3. Curr Opin Environ Sci Health. 2021. PMID 34250323 Free PMC article. Review. Recapping the Features of SARS-CoV-2 and Its Main Variants Status and Future Paths. Ortega MA, GarcĂa-Montero C, Fraile-Martinez O, Colet P, Baizhaxynova A, Mukhtarova K, Alvarez-Mon M, Kanatova K, AsĂșnsolo A, SarrĂa-Santamera A. Ortega MA, et al. J Pers Med. 2022 Jun 18;126995. doi J Pers Med. 2022. PMID 35743779 Free PMC article. Review. Cited by The changing profile of SARS-CoV-2 serology in Irish blood donors. Coyne D, Butler D, Meehan A, Keogh E, Williams P, Carterson A, Hervig T, O'Flaherty N, Waters A. Coyne D, et al. Glob Epidemiol. 2023 Dec;5100108. doi Epub 2023 Apr 21. Glob Epidemiol. 2023. PMID 37122774 Free PMC article. Mix-and-match COVID-19 vaccines trigger high antibody response after the third dose vaccine in Moroccan health care workers. Amellal H, Assaid N, Akarid K, Maaroufi A, Ezzikouri S, Sarih M. Amellal H, et al. Vaccine X. 2023 Aug;14100288. doi Epub 2023 Mar 25. Vaccine X. 2023. PMID 37008956 Free PMC article. Impact of MERS-CoV and SARS-CoV-2 Viral Infection on Immunoglobulin-IgG Cross-Reactivity. AlKhalifah JM, Seddiq W, Alshehri MA, Alhetheel A, Albarrag A, Meo SA, Al-Tawfiq JA, Barry M. AlKhalifah JM, et al. Vaccines Basel. 2023 Feb 26;113552. doi Vaccines Basel. 2023. PMID 36992136 Free PMC article. Dynamics of Anti-S IgG Antibodies Titers after the Second Dose of COVID-19 Vaccines in the Manual and Craft Worker Population of Qatar. Bansal D, Atia H, Al Badr M, Nour M, Abdulmajeed J, Hasan A, Al-Hajri N, Ahmed L, Ibrahim R, Zamel R, Mohamed A, Pattalaparambil H, Daraan F, Chaudhry A, Oraby S, El-Saleh S, El-Shafie SS, Al-Farsi AF, Paul J, Ismail A, Al-Romaihi HE, Al-Thani MH, Doi SAR, Zughaier SM, Cyprian F, Farag E, Farooqui HH. Bansal D, et al. Vaccines Basel. 2023 Feb 21;113496. doi Vaccines Basel. 2023. PMID 36992080 Free PMC article. Quantification of Severe Acute Respiratory Syndrome Coronavirus 2 Binding Antibody Levels To Assess Infection and Vaccine-Induced Immunity Using WHO Standards. Pernet O, Balog S, Kawaguchi ES, Lam CN, Anthony P, Simon P, Kotha R, Sood N, Hu H, Kovacs A. Pernet O, et al. Microbiol Spectr. 2023 Feb 14;111e0370922. doi Epub 2023 Jan 23. Microbiol Spectr. 2023. PMID 36688648 Free PMC article. References Worldometer. 2021. COVID-19 coronavirus pandemic. Dover, DE, USA. Accessed 10 January 2021. World Health Organization. 2021. Weekly epidemiological update on COVID-19 â 16 March 2021. World Health Organization, Geneva, Switzerland. Krammer F. 2020. SARS-CoV-2 vaccines in development. Nature 586516â527. - DOI - PubMed Department of Health and Social Care. 2021. UK COVID-19 vaccines delivery plan. Department of Health and Social Care, London, United Kingdom. Khoury DS, Wheatley AK, Ramuta MD, Reynaldi A, Cromer D, Subbarao K, O'Connor DH, Kent SJ, Davenport MP. 2020. Measuring immunity to SARS-CoV-2 infection comparing assays and animal models. Nat Rev Immunol 20727â738. - DOI - PMC - PubMed Publication types MeSH terms Substances LinkOut - more resources Full Text Sources Atypon Europe PubMed Central PubMed Central Medical Genetic Alliance MedlinePlus Health Information Miscellaneous NCI CPTAC Assay PortalTheAccess SARS -CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the virus in the form of anti -SARS-CoV-2
. 2021 Dec;93126813-6817. doi Epub 2021 Aug 5. Affiliations PMID 34314037 PMCID PMC8427121 DOI Free PMC article The dynamics of quantitative SARS-CoV-2 antispike IgG response to BNT162b2 vaccination Shun Kaneko et al. J Med Virol. 2021 Dec. Free PMC article Abstract Vaccination for SARS-CoV-2 is necessary to overcome coronavirus disease 2019 COVID-19. However, the time-dependent vaccine-induced immune response is not well understood. This study aimed to investigate the dynamics of SARS-CoV-2 antispike immunoglobulin G IgG response. Medical staff participants who received two sequential doses of the BNT162b2 vaccination on days 0 and 21 were recruited prospectively from the Musashino Red Cross Hospital between March and May 2021. The quantitative antispike receptor-binding domain RBD IgG antibody responses were measured using the Abbott SARS-CoV-2 IgGII Quant assay cut off â„50 AU/ml. A total of 59 participants without past COVID-19 history were continuously tracked with serum samples. The median age was 41 22-75 years, and 14 participants were male The median antispike RBD IgG and seropositivity rates were 0 AU/ml, AU/ml, AU/ml, 18, AU/ml, and 0%, 0%, and 100% on days 0, 3, 14, and 28 after the first vaccination, respectively. The antispike RBD IgG levels were significantly increased after day 14 from vaccination p < The BNT162b2 vaccination led almost all participants to obtain serum antispike RBD IgG 14 days after the first dose. Keywords COVID-19; SARS-Cov-2; mRNA vaccine; quantitative antispike RBD IgG. © 2021 Wiley Periodicals LLC. Conflict of interest statement The authors declare that there are no conflict of interests. Figures Figure 1 Dynamics of SARSâCoVâ2 antispike RBD IgG response after vaccination. A Schema of the schedule for vaccination and blood test. B Antispike RBD IgG titer AU/ml and seropositive rate of antispike RBD IgG and antinucleocapsid IgG in a timeâdependent manner. RBD, receptorâbinding domain Similar articles Evaluation of Humoral Immune Response after SARS-CoV-2 Vaccination Using Two Binding Antibody Assays and a Neutralizing Antibody Assay. Nam M, Seo JD, Moon HW, Kim H, Hur M, Yun YM. Nam M, et al. Microbiol Spectr. 2021 Dec 22;93e0120221. doi Epub 2021 Nov 24. Microbiol Spectr. 2021. PMID 34817223 Free PMC article. Healthcare Workers in South Korea Maintain a SARS-CoV-2 Antibody Response Six Months After Receiving a Second Dose of the BNT162b2 mRNA Vaccine. Choi JH, Kim YR, Heo ST, Oh H, Kim M, Lee HR, Yoo JR. Choi JH, et al. Front Immunol. 2022 Jan 31;13827306. doi eCollection 2022. Front Immunol. 2022. PMID 35173736 Free PMC article. Evaluation of Seropositivity Following BNT162b2 Messenger RNA Vaccination for SARS-CoV-2 in Patients Undergoing Treatment for Cancer. Massarweh A, Eliakim-Raz N, Stemmer A, Levy-Barda A, Yust-Katz S, Zer A, Benouaich-Amiel A, Ben-Zvi H, Moskovits N, Brenner B, Bishara J, Yahav D, Tadmor B, Zaks T, Stemmer SM. Massarweh A, et al. JAMA Oncol. 2021 Aug 1;781133-1140. doi JAMA Oncol. 2021. PMID 34047765 Free PMC article. Evaluation of the SARS-CoV-2 Antibody Response to the BNT162b2 Vaccine in Patients Undergoing Hemodialysis. Yau K, Abe KT, Naimark D, Oliver MJ, Perl J, Leis JA, Bolotin S, Tran V, Mullin SI, Shadowitz E, Gonzalez A, Sukovic T, Garnham-Takaoka J, de Launay KQ, Takaoka A, Straus SE, McGeer AJ, Chan CT, Colwill K, Gingras AC, Hladunewich MA. Yau K, et al. JAMA Netw Open. 2021 Sep 1;49e2123622. doi JAMA Netw Open. 2021. PMID 34473256 Free PMC article. Review of SARS-CoV-2 Antigen and Antibody Testing in Diagnosis and Community Surveillance. Nerenz RD, Hubbard JA, Cervinski MA. Nerenz RD, et al. Clin Lab Med. 2022 Dec;424687-704. doi Clin Lab Med. 2022. PMID 36368790 Free PMC article. Review. No abstract available. Cited by Higher Immunological Response after BNT162b2 Vaccination among COVID-19 Convalescents-The Data from the Study among Healthcare Workers in an Infectious Diseases Center. Skrzat-KlapaczyĆska A, Kowalska JD, Paciorek M, PuĆa J, BieĆkowski C, Krogulec D, Stengiel J, PaweĆczyk A, Perlejewski K, Osuch S, Radkowski M, Horban A. Skrzat-KlapaczyĆska A, et al. Vaccines Basel. 2022 Dec 15;10122158. doi Vaccines Basel. 2022. PMID 36560567 Free PMC article. Measurements of Anti-SARS-CoV-2 Antibody Levels after Vaccination Using a SH-SAW Biosensor. Cheng CH, Peng YC, Lin SM, Yatsuda H, Liu SH, Liu SJ, Kuo CY, Wang RYL. Cheng CH, et al. Biosensors Basel. 2022 Aug 4;128599. doi Biosensors Basel. 2022. PMID 36004995 Free PMC article. Relationship between changes in symptoms and antibody titers after a single vaccination in patients with Long COVID. Tsuchida T, Hirose M, Inoue Y, Kunishima H, Otsubo T, Matsuda T. Tsuchida T, et al. J Med Virol. 2022 Jul;9473416-3420. doi Epub 2022 Mar 8. J Med Virol. 2022. PMID 35238053 Free PMC article. The Comparability of Anti-Spike SARS-CoV-2 Antibody Tests is Time-Dependent a Prospective Observational Study. Perkmann T, Mucher P, Perkmann-Nagele N, Radakovics A, Repl M, Koller T, Schmetterer KG, Bigenzahn JW, Leitner F, Jordakieva G, Wagner OF, Binder CJ, Haslacher H. Perkmann T, et al. Microbiol Spectr. 2022 Feb 23;101e0140221. doi Epub 2022 Feb 23. Microbiol Spectr. 2022. PMID 35196824 Free PMC article. References Guan WJ, Ni ZY, Hu Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. 2020;382181708â1720. - PMC - PubMed Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVIDâ19 in Wuhan, China a retrospective cohort study. Lancet. 2020;395102291054â1062. - PMC - PubMed Zheng Z, Peng F, Xu B, et al. Risk factors of critical & mortal COVIDâ19 cases a systematic literature review and metaâanalysis. J Infect. 2020;8116. - PMC - PubMed Hu Y, Sun J, Dai Z, et al. Prevalence and severity of corona virus disease 2019 COVIDâ19 a systematic review and metaâanalysis. J Clin Virol. 2020;127104371. - PMC - PubMed World Health Organization . Coronavirus disease COVIDâ19. Situation report. Accessed, May 17th, MeSH terms Substances LinkOut - more resources Full Text Sources Europe PubMed Central Ovid Technologies, Inc. PubMed Central Wiley Medical Genetic Alliance MedlinePlus Health Information Miscellaneous NCI CPTAC Assay Portal
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