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
ABSTRACT Our group has previously used laboratory and commercially developed assays to understand the IgG responses to SARS-CoV-2 antigens, including nucleocapsid (N), spike (S), and receptor binding domain (RBD), in Canadian blood donors. In this current study, we analyzed 17,428 available and prev...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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American Society for Microbiology
2022-06-01
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| Series: | Microbiology Spectrum |
| Subjects: | |
| Online Access: | https://journals.asm.org/doi/10.1128/spectrum.01134-22 |
| _version_ | 1811238482782191616 |
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| author | Kento T. Abe Bhavisha Rathod Karen Colwill Anne-Claude Gingras Ashleigh Tuite Ninette F. Robbins Guillermo Orjuela Craig Jenkins Valerie Conrod Qi-Long Yi Sheila F. O’Brien Steven J. Drews |
| author_facet | Kento T. Abe Bhavisha Rathod Karen Colwill Anne-Claude Gingras Ashleigh Tuite Ninette F. Robbins Guillermo Orjuela Craig Jenkins Valerie Conrod Qi-Long Yi Sheila F. O’Brien Steven J. Drews |
| author_sort | Kento T. Abe |
| collection | DOAJ |
| description | ABSTRACT Our group has previously used laboratory and commercially developed assays to understand the IgG responses to SARS-CoV-2 antigens, including nucleocapsid (N), spike (S), and receptor binding domain (RBD), in Canadian blood donors. In this current study, we analyzed 17,428 available and previously characterized retention samples collected from April 2020 to March 2021. The analysis compared the characteristics of the Abbott SARS-CoV-2 IgG II Quant assay (Abbott anti-spike [S], Abbott, Chicago, IL) against four other IgG assays. The Abbott anti-S assay has a qualitative threshold of 50 AU/mL. The four comparator assays were the Abbott anti-nucleocapsid (N) assay and three commonly used Canadian in-house IgG enzyme-linked immunosorbent assays (ELISAs) recognizing distinct recombinant viral antigens, full-length spike glycoprotein, glycoprotein RBD, and nucleocapsid. The strongest qualitative relationship was between Sinai RBD and the Abbott anti-S assay (kappa, 0.707; standard error [SE] of kappa, 0.018; 95% confidence interval, 0.671 to 0.743). We then scored each previously characterized specimen as positive when two anti-SARS-COV-2 assays identified anti-SARS-CoV-2 IgG in the specimen. Using this composite reference standard approach, the sensitivity of the Abbott anti-S assay was 95.96% (95% confidence interval [CI], 93.27 to 97.63%). The specificity of the Abbott anti-S assay was 99.35% (95% CI, 99.21 to 99.46%). Our study provides context on the use of commonly used SARS-CoV-2 serologies in Canada and identifies how these assays qualitatively compare to newer commercial assays. Our next steps are to assess how well the Abbott anti-S assays quantitatively detect wild-type and SARS-CoV-2 variants of concern. IMPORTANCE We describe the qualitative test characteristics of the Abbott SARS-CoV-2 IgG II Quant assay against four other anti-SARS-CoV-2 IgG assays commonly used in Canada. Although there is no gold standard for identifying anti-SARS-CoV-2 seropositivity, aggregate standards can be used to assess seropositivity. In this study, we used a specimen bank of previously well-characterized specimens collected between April 2020 and March 2021. The Abbott anti-S assay showed the strongest qualitative relationship with a widely used laboratory-developed IgG assay for the SARS-CoV-2 receptor binding domain. Using the composite reference standard approach, we also showed that the Abbott anti-S assay was highly sensitive and specific. As new anti-SARS-CoV-2 assays are developed, it is important to compare their test characteristics against other assays that have been extensively used in prior research. |
| first_indexed | 2024-04-12T12:42:14Z |
| format | Article |
| id | doaj.art-ef5564a89fd54ae8954f40d0ea33902f |
| institution | Directory Open Access Journal |
| issn | 2165-0497 |
| language | English |
| last_indexed | 2024-04-12T12:42:14Z |
| publishDate | 2022-06-01 |
| publisher | American Society for Microbiology |
| record_format | Article |
| series | Microbiology Spectrum |
| spelling | doaj.art-ef5564a89fd54ae8954f40d0ea33902f2022-12-22T03:32:45ZengAmerican Society for MicrobiologyMicrobiology Spectrum2165-04972022-06-0110310.1128/spectrum.01134-22A 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 2021Kento T. Abe0Bhavisha Rathod1Karen Colwill2Anne-Claude Gingras3Ashleigh Tuite4Ninette F. Robbins5Guillermo Orjuela6Craig Jenkins7Valerie Conrod8Qi-Long Yi9Sheila F. O’Brien10Steven J. Drews11Lunenfeld-Tanenbaum Research Institute at Mt. Sinai Hospital, Sinai Health, Toronto, Ontario, CanadaLunenfeld-Tanenbaum Research Institute at Mt. Sinai Hospital, Sinai Health, Toronto, Ontario, CanadaDepartment of Molecular Genetics, University of Toronto, Toronto, Ontario, CanadaLunenfeld-Tanenbaum Research Institute at Mt. Sinai Hospital, Sinai Health, Toronto, Ontario, CanadaDalla Lana School of Public Health, University of Toronto, Toronto, Ontario, CanadaScientific Affairs, Abbott Transfusion Medicine, Chicago, Illinois, USAScientific Affairs, Abbott Transfusion Medicine, Bogotá, ColombiaCOVID-19 Serological Screening Laboratory, Canadian Blood Services, Ottawa, Ontario, CanadaCOVID-19 Serological Screening Laboratory, Canadian Blood Services, Ottawa, Ontario, CanadaEpidemiology and Surveillance, Canadian Blood Services, Ottawa, Ontario, CanadaEpidemiology and Surveillance, Canadian Blood Services, Ottawa, Ontario, CanadaCanadian Blood Services, Microbiology, Edmonton, Alberta, CanadaABSTRACT Our group has previously used laboratory and commercially developed assays to understand the IgG responses to SARS-CoV-2 antigens, including nucleocapsid (N), spike (S), and receptor binding domain (RBD), in Canadian blood donors. In this current study, we analyzed 17,428 available and previously characterized retention samples collected from April 2020 to March 2021. The analysis compared the characteristics of the Abbott SARS-CoV-2 IgG II Quant assay (Abbott anti-spike [S], Abbott, Chicago, IL) against four other IgG assays. The Abbott anti-S assay has a qualitative threshold of 50 AU/mL. The four comparator assays were the Abbott anti-nucleocapsid (N) assay and three commonly used Canadian in-house IgG enzyme-linked immunosorbent assays (ELISAs) recognizing distinct recombinant viral antigens, full-length spike glycoprotein, glycoprotein RBD, and nucleocapsid. The strongest qualitative relationship was between Sinai RBD and the Abbott anti-S assay (kappa, 0.707; standard error [SE] of kappa, 0.018; 95% confidence interval, 0.671 to 0.743). We then scored each previously characterized specimen as positive when two anti-SARS-COV-2 assays identified anti-SARS-CoV-2 IgG in the specimen. Using this composite reference standard approach, the sensitivity of the Abbott anti-S assay was 95.96% (95% confidence interval [CI], 93.27 to 97.63%). The specificity of the Abbott anti-S assay was 99.35% (95% CI, 99.21 to 99.46%). Our study provides context on the use of commonly used SARS-CoV-2 serologies in Canada and identifies how these assays qualitatively compare to newer commercial assays. Our next steps are to assess how well the Abbott anti-S assays quantitatively detect wild-type and SARS-CoV-2 variants of concern. IMPORTANCE We describe the qualitative test characteristics of the Abbott SARS-CoV-2 IgG II Quant assay against four other anti-SARS-CoV-2 IgG assays commonly used in Canada. Although there is no gold standard for identifying anti-SARS-CoV-2 seropositivity, aggregate standards can be used to assess seropositivity. In this study, we used a specimen bank of previously well-characterized specimens collected between April 2020 and March 2021. The Abbott anti-S assay showed the strongest qualitative relationship with a widely used laboratory-developed IgG assay for the SARS-CoV-2 receptor binding domain. Using the composite reference standard approach, we also showed that the Abbott anti-S assay was highly sensitive and specific. As new anti-SARS-CoV-2 assays are developed, it is important to compare their test characteristics against other assays that have been extensively used in prior research.https://journals.asm.org/doi/10.1128/spectrum.01134-22IgGSARS-CoV-2 antibodymethods comparisonsnucleocapsidreceptor binding domainspike |
| spellingShingle | Kento T. Abe Bhavisha Rathod Karen Colwill Anne-Claude Gingras Ashleigh Tuite Ninette F. Robbins Guillermo Orjuela Craig Jenkins Valerie Conrod Qi-Long Yi Sheila F. O’Brien Steven J. Drews 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 Microbiology Spectrum IgG SARS-CoV-2 antibody methods comparisons nucleocapsid receptor binding domain spike |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | IgG SARS-CoV-2 antibody methods comparisons nucleocapsid receptor binding domain spike |
| url | https://journals.asm.org/doi/10.1128/spectrum.01134-22 |
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