NovelCoronavirus (SARS-Cov-2) Netralisasi Alat Uji Rapid Antibodi Alat Uji Rapid IgG/IgM 2019-nCOV (Getih lengkep/Serum/Plasma) Novel Coronavirus （SARS-Cov ayocek kekebalan tubuh kita paska vaksinasi covid-19 dengan pemeriksaan anti sars cov-2 kuantitatif hanya di laboratorium klinik probest. see all. photos. see all. coronavirus2 (SARS-CoV-2) atau lebih umum dikenal dengan corona virus.Virus corona bisa menyebabkan gangguan ringan pada sistem pernapasan, infeksi paru-paru yang berat, hingga kematian (Fadli, 2020). Pada manusia SARS-CoV-2 terutama menginfeksi sel-sel pada saluran napas yang melapisi alveoli (Susilo et al, 2020). Efek Vay Tiền Nhanh Chỉ Cần Cmnd. Estimates of SARS-CoV-2 Seroprevalence and Incidence of Primary SARS-CoV-2 Infections Among Blood Donors, by COVID-19 Vaccination Status — United States, April 2021–September 2022 Jefferson M. Jones, MD1; Irene Molina Manrique, MS2; Mars S. Stone, PhD3; Eduard Grebe, PhD3; Paula Saa, PhD4; Clara D. Germanio, PhD3; Bryan R. Spencer, PhD4; Edward Notari, MPH4; Marjorie Bravo, MD3; Marion C. Lanteri, PhD5; Valerie Green, MS5; Melissa Briggs-Hagen, MD1; Melissa M. Coughlin, PhD1; Susan L. Stramer, PhD4; Jean Opsomer, PhD2; Michael P. Busch, MD, PhD3 View author affiliations View suggested citationSummary What is already known about this topic? SARS-CoV-2 hybrid immunity immunity derived from both previous infection and vaccination has been reported to provide better protection than that from infection or vaccination alone. What is added by this report? By the third quarter of 2022, an estimated of persons aged ≥16 years in a longitudinal blood donor cohort had SARS-CoV-2 antibodies from previous infection or vaccination, including from infection alone and from vaccination alone; had hybrid immunity. Hybrid immunity prevalence was lowest among adults aged ≥65 years. What are the implications for public health practice? Low prevalence of infection-induced and hybrid immunity among older adults, who are at increased risk for severe disease if infected, reflects the success of public health infection prevention efforts while also highlighting the importance of this group staying up to date with recommended COVID-19 vaccination, including at least 1 bivalent dose. Altmetric Citations Views Views equals page views plus PDF downloads Changes in testing behaviors and reporting requirements have hampered the ability to estimate the SARS-CoV-2 incidence 1. Hybrid immunity immunity derived from both previous infection and vaccination has been reported to provide better protection than that from infection or vaccination alone 2. To estimate the incidence of infection and the prevalence of infection- or vaccination-induced antibodies or both, data from a nationwide, longitudinal cohort of blood donors were analyzed. During the second quarter of 2021 April–June, an estimated of persons aged ≥16 years had infection- or vaccination-induced SARS-CoV-2 antibodies, including from vaccination alone, from infection alone, and from both. By the third quarter of 2022 July–September, had SARS-CoV-2 antibodies from previous infection or vaccination, including from infection alone and from vaccination alone; had hybrid immunity. Prevalence of hybrid immunity was lowest among persons aged ≥65 years the group with the highest risk for severe disease if infected, and was highest among those aged 16–29 years Low prevalence of infection-induced and hybrid immunity among older adults reflects the success of public health infection prevention efforts while also highlighting the importance of older adults staying up to date with recommended COVID-19 vaccination, including at least 1 bivalent dose.*,† Since July 2020, SARS-CoV-2 seroprevalence in the United States has been estimated by testing blood donations 3. CDC, in collaboration with Vitalant, American Red Cross, Creative Testing Solutions, and Westat, established a nationwide cohort of 142,758 blood donors in July 2021; the cohort included persons who had donated blood two or more times in the preceding year.§ All blood donations collected during April–June 2021 were tested for antibodies against the spike S and nucleocapsid N proteins. Beginning in 2022, up to one blood donation sample per donor was randomly selected each quarter and tested using the Ortho VITROS SARS-CoV-2 Quantitative S immunoglobulin G¶ and total N antibody** tests. Both SARS-CoV-2 infection and COVID-19 vaccination result in production of anti-S antibodies, whereas anti-N antibodies only result from infection. At each donation, blood donors were asked if they had received a COVID-19 vaccine. Using vaccination history and results of antibody testing, the prevalence of the population aged ≥16 years with vaccine-induced, infection-induced, or hybrid immunity was estimated for four 3-month periods April–June 2021, January–March 2022, April–June 2022, and July–September 2022; in addition, the proportion of persons who transitioned from one immune status to another by quarter was estimated. Analysis was limited to 72,748 donors for whom it was possible to ascertain immune status during each period using their prior classification previously infected or vaccinated, antibody testing results, and their vaccination status at the time of each donation.†† The sample data were weighted to account for selection into the study cohort, for nonresponse during the four analysis periods, and for demographic differences between the blood donor population and the overall population. The weights were obtained through a combination of stratification and raking, an iterative weighting adjustment procedure 4. Rates of infection among those previously uninfected were estimated for each period by determining the percentage of anti-N–negative persons seroconverting to anti-N–positive from one 3-month period included in the study to the next. Estimates were stratified by age group 16–29, 30–49, 50–64, and ≥65 years and race and ethnicity§§ Asian, Black or African American [Black], White, Hispanic or Latino [Hispanic], and other. SAS version SAS Institute was used to compute the final weights, and R version R Foundation was used to calculate all the estimates and create the plots.¶¶ Seroprevalence and infection rates were estimated as weighted means and compared by demographic group and vaccination status using two-sided t-tests with a significance level of α = This activity was reviewed by CDC and conducted consistent with applicable federal law and CDC policy.*** During the first quarter examined April–June 2021, an estimated 95% CI = of persons aged ≥16 years had SARS-CoV-2 antibodies from previous infection or vaccination, including 95% CI = from vaccination alone, 95% CI = from infection alone, and 95% CI = from both Figure 1 Supplementary Figure 1, During January–March 2022, 95% CI = of persons aged ≥16 years had antibodies from previous infection or vaccination, including 95% CI = from vaccination alone, 95% CI = from infection alone, and 95% CI = from both. During July–September 2022, 95% CI = of persons had antibodies from previous infection or vaccination, including 95% CI = with vaccine-induced immunity alone, 95% CI = with infection-induced immunity alone, and 95% CI = with hybrid immunity. During July–September 2022, the prevalence of infection-induced immunity was 95% CI = among unvaccinated persons and 95% CI = among vaccinated persons. During July–September 2022, the lowest prevalence of hybrid immunity, 95% CI = was observed in persons aged ≥65 years, and the highest, 95% CI = in adolescents and young adults aged 16–29 years Figure 2 Supplementary Figure 2, During all periods, higher prevalences of hybrid immunity were observed among Black and Hispanic populations than among White and Asian populations Supplementary Figure 3, Among persons with no previous infection, the incidence of first infections during the study period conversion from anti-N–negative to anti-N–positive was higher among unvaccinated persons Table. From April–June 2021 through January–March 2022, the incidence of first SARS-CoV-2 infections among unvaccinated persons was compared with among vaccinated persons p< From January–March 2022 through April–June 2022, the incidence among unvaccinated persons was and was among vaccinated persons. Between April–June 2022 and July–September 2022, the incidence among unvaccinated persons was compared with among vaccinated persons p< Incidence of first SARS-CoV-2 infections was higher among younger than among older persons and was lower among Asian persons than among other racial and ethnic populations, but the differences among groups narrowed over time. Discussion Both infection-induced and hybrid immunity increased during the study period. By the third quarter of 2022, approximately two thirds of persons aged ≥16 years had been infected with SARS-CoV-2 and one half of all persons had hybrid immunity. Compared with vaccine effectiveness against any infection and against severe disease or hospitalization, the effectiveness of hybrid immunity against these outcomes has been shown to be higher and wane more slowly 2. This increase in seroprevalence, including hybrid immunity, is likely contributing to lower rates of severe disease and death from COVID-19 in 2022–2023 than during the early pandemic.††† The prevalence of hybrid immunity is lowest in adults aged ≥65 years, likely due to higher vaccination coverage and earlier availability of COVID-19 vaccines for this age group, as well as to higher prevalences of behavioral practices to avoid infection 5. However, lower prevalences of infection-induced and hybrid immunity could further increase the risk for severe disease in this group, highlighting the importance for adults aged ≥65 years to stay up to date with COVID-19 vaccination and have easy access to antiviral medications. COVID-19 vaccine efficacy studies have reported reduced effectiveness against SARS-CoV-2 infection during the Omicron-predominant period compared with earlier periods and have shown that protection against infection wanes more rapidly than does protection against severe disease 6,7. In this study, unvaccinated persons had higher rates of infection as evidenced by N antibody seroconversion than did vaccinated persons, indicating that vaccination provides some protection against infection. The differences in incidence could also be due to systematic differences between vaccinated and unvaccinated persons in terms of the prevalence of practicing prevention behaviors such as masking and physical distancing. The relative difference in infection rates narrowed during the most recent months, possibly because of waning of vaccine-induced protection against infection in the setting of increased time after vaccination or immune evasion by the SARS-CoV-2 Omicron variant. The narrowing of difference in infection rates might also be attributable to increasing similarities in behavior among vaccinated and unvaccinated persons during late 2022 8. The findings in this report are subject to at least six limitations. First, although COVID-19 booster vaccine doses and reinfections can strengthen immunity 9,10, this analysis did not account for these effects because blood donor vaccination history did not include the number of doses received, and data on reinfections were not captured. Second, immunity wanes over time, but time since vaccination or infection was not included in the analysis 2. Third, vaccination status was self-reported, potentially leading to misclassification. Fourth, although the results were adjusted based on differences in blood donor and general population demographics, estimates from blood donors might not be representative of the general population; thus, these results might not be generalizable. Fifth, vaccinated and unvaccinated persons might differ in other ways not captured by this analysis 8, nor can causality be inferred from the results on relative infection incidence. Finally, if both vaccination and infection occurred between blood donations included in the study, the order of occurrence could not be determined, and some unvaccinated donors might have been vaccinated before infection and thus misclassified; in 2022, this was uncommon and occurred in < of donors during any 3-month period. This report found that the incidence of first-time SARS-CoV-2 infection was lower among persons who had received COVID-19 vaccine than among unvaccinated persons and that infection-induced and hybrid immunity have increased but remain lowest in adults aged ≥65 years. These adults have consistently had a higher risk for severe disease compared with younger age groups, underscoring the importance of older adults staying up to date with recommended COVID-19 vaccination, including at least 1 bivalent dose. Acknowledgments Brad Biggerstaff, Matthew McCullough, CDC; Roberta Bruhn, Brian Custer, Xu Deng, Zhanna Kaidarova, Kathleen Kelly, Anh Nguyen, Graham Simmons, Hasan Sulaeman, Elaine Yu, Karla Zurita-Gutierrez, Vitalant Research Institute; Akintunde Akinseye, Jewel Bernard-Hunte, Robyn Ferg, Rebecca Fink, Caitlyn Floyd, Isaac Lartey, Sunitha Mathews, David Wright, Westat; Jamel Groves, James Haynes, David Krysztof, American Red Cross; Ralph Vassallo, Vitalant; Sherri Cyrus, Phillip Williamson, Creative Testing Solutions; Paul Contestable, QuidelOrtho; Steve Kleinman, University of British Columbia; CDC, Vitalant Research Institute, Westat, American Red Cross, and Creative Testing Solutions staff members; blood donors whose samples were analyzed and who responded to surveys for this study. Corresponding author Jefferson M. Jones, ioe8 Center for Immunization and Respiratory Diseases, CDC; 2Westat, Rockville, Maryland; 3Vitalant Research Institute, San Francisco, California; 4American Red Cross, Washington, DC; 5Creative Testing Solutions, Tempe, authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed. * † § Blood donors who donated at least twice during the year before July 2021 were included in the cohort, because they might represent persons who were more likely to donate frequently. Among donors who donated more than once during a quarter, one sample was selected at random for testing. ¶ ** †† §§ Persons of Hispanic origin might be of any race but are categorized as Hispanic; all racial groups are non-Hispanic. ¶¶ Jackknife replication was used to compute replicate weights. Weights were adjusted for nonresponse using adjustment cells created by age category, vaccination and previous infection status, and blood collection organization Vitalant or American Red Cross. Raking was used to further adjust the weights to account for demographic differences between the blood donor population and population. The demographic variables used for raking were sex female and male, age group 16–24, 25–34, 35–44, 45–54, 55–64, and ≥65 years, and race and ethnicity Asian, Black, White, Hispanic, and other. *** 45 part 46, 21 part 56; 42 Sect. 241d; 5 Sect. 552a; 44 Sect. 3501 et seq. ††† Accessed May 25, 2023. References Rader B, Gertz A, Iuliano AD, et al. Use of at-home COVID-19 tests—United States, August 23, 2021–March 12, 2022. MMWR Morb Mortal Wkly Rep 2022;71489–94. PMID35358168 Bobrovitz N, Ware H, Ma X, et al. Protective effectiveness of previous SARS-CoV-2 infection and hybrid immunity against the Omicron variant and severe disease a systematic review and meta-regression. Lancet Infect Dis 2023;23556–67. PMID36681084 Jones JM, Stone M, Sulaeman H, et al. Estimated US infection- and vaccine-induced SARS-CoV-2 seroprevalence based on blood donations, July 2020–May 2021. JAMA 2021;3261400–9. PMID34473201 Deville J-C, Särndal C-E, Sautory O. Generalized raking procedures in survey sampling. J Am Stat Assoc 1993;881013–20. Steele MK, Couture A, Reed C, et al. Estimated number of COVID-19 infections, hospitalizations, and deaths prevented among vaccinated persons in the US, December 2020 to September 2021. JAMA Netw Open 2022;5e2220385. PMID35793085 Higdon MM, Wahl B, Jones CB, et al. A systematic review of coronavirus disease 2019 vaccine efficacy and effectiveness against severe acute respiratory syndrome coronavirus 2 infection and disease. Open Forum Infect Dis 2022;9ofac138. PMID35611346 Feikin DR, Higdon MM, Abu-Raddad LJ, et al. Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease results of a systematic review and meta-regression. Lancet 2022;399924–44. PMID35202601 Thorpe A, Fagerlin A, Drews FA, Shoemaker H, Scherer LD. Self-reported health behaviors and risk perceptions following the COVID-19 vaccination rollout in the USA an online survey study. Public Health 2022;20868–71. PMID35717747 Sette A, Crotty S. Immunological memory to SARS-CoV-2 infection and COVID-19 vaccines. Immunol Rev 2022;31027–46. PMID35733376 Atti A, Insalata F, Carr EJ, et al.; SIREN Study Group and the Crick COVID Immunity Pipeline Consortium. Antibody correlates of protection from SARS-CoV-2 reinfection prior to vaccination a nested case-control within the SIREN study. J Infect 2022;85545–56. PMID36089104 FIGURE 1. Prevalences of vaccine-induced, infection-induced, and hybrid* immunity† against SARS-CoV-2 among blood donors aged ≥16 years — United States, April 2021–September 2022 * Immunity derived from a combination of vaccination and infection. † Ascertained by the presence of anti-spike antibodies present in both COVID-19–vaccinated and SARS-CoV-2–infected persons and anti-nucleocapsid antibodies present only in previously infected persons and self-reported history of vaccination. FIGURE 2. Prevalences of vaccine-induced, infection-induced, and hybrid* immunity† against SARS-CoV-2 among blood donors aged ≥16 years, by age group — United States, April 2021–September 2022 * Immunity derived from a combination of vaccination and infection. † Ascertained by the presence of anti-spike antibodies present in both COVID-19–vaccinated and SARS-CoV-2–infected persons and anti-nucleocapsid antibodies present only in previously infected persons and self-reported history of vaccination. TABLE. Estimated percentage* of persons infected with SARS-CoV-2 for the first time among blood donors, by analysis quarter, sociodemographic characteristics, and vaccination status — United States, April 2021–September 2022 Characteristic Period, % 95% CI Apr–Jun 2021 to Jan–Mar 2022 Jan–Mar 2022 to Apr–Jun 2022 Apr–Jun 2022 to Jul–Sep 2022 Overall Total Unvaccinated Vaccinated Age group, yrs 16–29 Total Unvaccinated Vaccinated 30–49 Total Unvaccinated Vaccinated 50–64 Total Unvaccinated Vaccinated ≥65 Total Unvaccinated Vaccinated Race and ethnicity§ Asian Total Unvaccinated Vaccinated Black or African American Total Unvaccinated Vaccinated White Total Unvaccinated Vaccinated Hispanic or Latino Total Unvaccinated Vaccinated Other and multiple races¶ Total Unvaccinated Vaccinated * Percentage of uninfected persons anti-nucleocapsid–negative in the previous 3-month period seroconverting to anti-nucleocapsid–positive. If both vaccination and infection occurred between donations included in the study, the order could not be determined, and some unvaccinated donors might have been vaccinated before infection and thus misclassified. † If donors who transitioned from no antibodies to hybrid immunity between April–June 2021 and January–March 2022 were excluded, an estimated 95% CI = of unvaccinated donors were infected. For other periods, exclusion did not substantially change results. Between January–March and April–June 2022, of persons shifted from no antibodies to hybrid immunity. Between April–June and July–September 2022, of persons shifted from no antibodies to hybrid immunity. § Persons of Hispanic or Latino Hispanic origin might be of any race but are categorized as Hispanic; all racial groups are non-Hispanic. ¶ Includes American Indian or Alaska Native and non-Hispanic persons of other races. Suggested citation for this article Jones JM, Manrique IM, Stone MS, et al. Estimates of SARS-CoV-2 Seroprevalence and Incidence of Primary SARS-CoV-2 Infections Among Blood Donors, by COVID-19 Vaccination Status — United States, April 2021–September 2022. MMWR Morb Mortal Wkly Rep 2023;72601–605. DOI MMWR and Morbidity and Mortality Weekly Report are service marks of the Department of Health and Human Services. Use of trade names and commercial sources is for identification only and does not imply endorsement by the Department of Health and Human Services. References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication. All HTML versions of MMWR articles are generated from final proofs through an automated process. This conversion might result in character translation or format errors in the HTML version. Users are referred to the electronic PDF version and/or the original MMWR paper copy for printable versions of official text, figures, and tables. Questions or messages regarding errors in formatting should be addressed to mmwrq Evaluation of Three Quantitative Anti-SARS-CoV-2 Antibody Immunoassays Sabine Chapuy-Regaud et al. Microbiol Spectr. 2021. Free PMC article Abstract The severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 emerged in December 2019 and caused a dramatic pandemic. Serological assays are used to check for immunization and assess herd immunity. We evaluated commercially available assays designed to quantify antibodies directed to the SARS-CoV-2 Spike S antigen, either total Wantaï SARS-CoV-2 Ab ELISA or IgG SARS-CoV-2 IgG II Quant on Alinity, Abbott, and Liaison SARS-CoV-2 TrimericS IgG, Diasorin. The specificities of the Wantaï, Alinity, and Liaison assays were evaluated using 100 prepandemic sera and were 98, 99, and 97%, respectively. The sensitivities of all three were around 100% when tested on 35 samples taken 15 to 35 days postinfection. They were less sensitive for 150 sera from late infections >180 days. Using the first WHO international standard NIBSC, we showed that the Wantai results were concordant with the NIBSC values, while Liaison and Alinity showed a proportional bias of and 7, respectively. The results of the 3 immunoassays were significantly globally pairwise correlated and for late infection sera P < They were correlated for recent infection sera measured with Alinity and Liaison P < However, the Wantai results of recent infections were not correlated with those from Alinity or Liaison. All the immunoassay results were significantly correlated with the neutralizing antibody titers obtained using a live virus neutralization assay with the SARS-CoV-2 strain. These assays will be useful once the protective anti-SARS-CoV-2 antibody titer has been determined. IMPORTANCE Standardization and correlation with virus neutralization assays are critical points to compare the performance of serological assays designed to quantify anti-SARS-CoV-2 antibodies in order to identify their optimal use. We have evaluated three serological immunoassays based on the virus spike antigen that detect anti-SARS-CoV-2 antibodies a microplate assay and two chemiluminescent assays performed with Alinity Abbott and Liaison Diasorin analysers. We used an in-house live virus neutralization assay and the first WHO international standard to assess the comparison. This study could be useful to determine guidelines on the use of serological results to manage vaccination and treatment with convalescent plasma or monoclonal antibodies. Keywords COVID; SARS-CoV-2; binding antibodies; immunoassay; neutralizing antibodies. Conflict of interest statement The authors declare no conflict of interest. Figures FIG 1 Distribution of the results. A Wantaï, B Liaison, and C Alinity assays according to patient groups. Black lines = median of each group. Red lines = manufacturer’s negative/positive threshold. Zero 0 values in the Liaison negative group n = 92, the Liaison late infection group n = 15, the Alinity negative group n = 14, and the Alinity late infection group n = 7 are not shown. FIG 2 ROC curves for Wantaï black line, Liaison green line and Alinity red line. Gray line y = x. The AUROCs were Wantaï 95% CI to Liaison 95% CI to and Alinity 95% CI to indicating their capacity to accurately detect anti-SARS-CoV-2 antibodies. FIG 3 Quantification of anti-SARS-CoV-2 antibodies relative to the NIBSC international standard. Serial dilutions of the NIBSC 20/136 standard were assayed with the A Wantaï, B Liaison, and C Alinity assay. Neutralizing antibodies NAb were also determined with a live method D. The black line represents the regression line and the dashed lines its 95% CI. The dashed red line represents the y = x line. AU arbitrary units. BAU binding antibody unit. The equations were y = x − slope 95% CI to y-intercept 95% CI − to for Wantaï; y = x − slope 95% CI to y-intercept 95% CI − to for Liaison; y = x - slope 95% CI to y-intercept 95% CI − to for Alinity and y = x + slope 95% CI to y-intercept 95% CI − to for NAb titers. FIG 4 Correlation between the immunoassay results. Pairwise distribution of the Wantaï, Liaison, and Alinity assays values for all positive results A to C, recent infections D to F, and late infections G to I. When the Spearman rank coefficient r indicated a significant correlation, the regression line was drawn. Dashed lines 95% CI limits. FIG 5 Immunoassays results and neutralizing antibody titers. Distribution of the Wantaï, Liaison, and Alinity assay values and the NAb titers for all positive results A to C The NAb titers were determined in a live virus neutralization assay using the B strain. Spearman’s rank coefficients r and their P value are indicated. The box extends from the 25th to 75th percentiles and whiskers from minimal to maximal values. Similar articles Performance evaluation of three automated quantitative immunoassays and their correlation with a surrogate virus neutralization test in coronavirus disease 19 patients and pre-pandemic controls. Jung K, Shin S, Nam M, Hong YJ, Roh EY, Park KU, Song EY. Jung K, et al. J Clin Lab Anal. 2021 Sep;359e23921. doi Epub 2021 Aug 8. J Clin Lab Anal. 2021. PMID 34369009 Free PMC article. Inference of SARS-CoV-2 spike-binding neutralizing antibody titers in sera from hospitalized COVID-19 patients by using commercial enzyme and chemiluminescent immunoassays. Valdivia A, Torres I, Latorre V, Francés-Gómez C, Albert E, Gozalbo-Rovira R, Alcaraz MJ, Buesa J, Rodríguez-Díaz J, Geller R, Navarro D. Valdivia A, et al. Eur J Clin Microbiol Infect Dis. 2021 Mar;403485-494. doi Epub 2021 Jan 6. Eur J Clin Microbiol Infect Dis. 2021. PMID 33404891 Free PMC article. Serological Assays for Assessing Postvaccination SARS-CoV-2 Antibody Response. Mahmoud SA, Ganesan S, Naik S, Bissar S, Zamel IA, Warren KN, Zaher WA, Khan G. Mahmoud SA, et al. Microbiol Spectr. 2021 Oct 31;92e0073321. doi Epub 2021 Sep 29. Microbiol Spectr. 2021. PMID 34585943 Free PMC article. Overview of Neutralization Assays and International Standard for Detecting SARS-CoV-2 Neutralizing Antibody. Liu KT, Han YJ, Wu GH, Huang KA, Huang PN. Liu KT, et al. Viruses. 2022 Jul 18;1471560. doi Viruses. 2022. PMID 35891540 Free PMC article. Review. Recent Developments in SARS-CoV-2 Neutralizing Antibody Detection Methods. Banga Ndzouboukou JL, Zhang YD, Fan XL. 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PMID 36146666 Free PMC article. Review. References Zhou P, Yang X-L, Wang X-G, Hu B, Zhang L, Zhang W, Si H-R, Zhu Y, Li B, Huang C-L, Chen H-D, Chen J, Luo Y, Guo H, Jiang R-D, Liu M-Q, Chen Y, Shen X-R, Wang X, Zheng X-S, Zhao K, Chen Q-J, Deng F, Liu L-L, Yan B, Zhan F-X, Wang Y-Y, Xiao G-F, Shi Z-L. 2020. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature 579270–273. doi - DOI - PMC - PubMed Olbrich L, Castelletti N, Schälte Y, Garí M, Pütz P, Bakuli A, Pritsch M, Kroidl I, Saathoff E, Guggenbuehl Noller JM, Fingerle V, Le Gleut R, Gilberg L, Brand I, Falk P, Markgraf A, Deák F, Riess F, Diefenbach M, Eser T, Weinauer F, Martin S, Quenzel E-M, Becker M, Durner J, Girl P, Müller K, Radon K, Fuchs C, Wölfel R, Hasenauer J, Hoelscher M, Wieser A, On Behalf Of The KoCo-Study Group null. 2021. Head-to-head evaluation of seven different seroassays including direct viral neutralisation in a representative cohort for SARS-CoV-2. J Gen Virol 102. doi - DOI - PMC - PubMed Montesinos I, Dahma H, Wolff F, Dauby N, Delaunoy S, Wuyts M, Detemmerman C, Duterme C, Vandenberg O, Martin C, Hallin M. 2021. Neutralizing antibody responses following natural SARS-CoV-2 infection Dynamics and correlation with commercial serologic tests. J Clin Virol 144104988. doi - DOI - PMC - PubMed Favresse J, Cadrobbi J, Eucher C, Elsen M, Laffineur K, Dogné J-M, Douxfils J. 2021. Clinical performance of three fully automated anti-SARS-CoV-2 immunoassays targeting the nucleocapsid or spike proteins. J Med Virol 932262–2269. doi - DOI - PMC - PubMed Liu W, Liu L, Kou G, Zheng Y, Ding Y, Ni W, Wang Q, Tan L, Wu W, Tang S, Xiong Z, Zheng S. 2020. Evaluation of nucleocapsid and spike protein-based enzyme-linked immunosorbent assays for detecting antibodies against SARS-CoV-2. J Clin Microbiol 58e00461-20. doi - 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 Portal . 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 ≥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 Cohen’s 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 “UK” and “South Africa” 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, García-Montero C, Fraile-Martinez O, Colet P, Baizhaxynova A, Mukhtarova K, Alvarez-Mon M, Kanatova K, Asúnsolo A, Sarría-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 – 16 March 2021. World Health Organization, Geneva, Switzerland. Krammer F. 2020. SARS-CoV-2 vaccines in development. Nature 586516–527. - 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 20727–738. - 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 Portal

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