Evaluation of Ortho VITROS and Roche Elecsys S and NC Immunoassays for SARS-CoV-2 Serosurveillance Applications
ABSTRACT SARS-CoV-2 seroprevalence studies are instrumental in monitoring epidemic activity and require well-characterized, high-throughput assays, and appropriate testing algorithms. The U.S. Nationwide Blood Donor Seroprevalence Study performed monthly cross-sectional serological testing from July...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
American Society for Microbiology
2023-08-01
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| Series: | Microbiology Spectrum |
| Subjects: | |
| Online Access: | https://journals.asm.org/doi/10.1128/spectrum.03234-22 |
| _version_ | 1797741765297438720 |
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| author | Hasan Sulaeman Eduard Grebe Honey Dave Lily McCann Clara Di Germanio Aditi Sanghavi Victoria Sclar Daniel W. Bougie Garrick Chatelain Brad J. Biggerstaff Jefferson M. Jones Natalie J. Thornburg Steve Kleinman Mars Stone Michael P. Busch |
| author_facet | Hasan Sulaeman Eduard Grebe Honey Dave Lily McCann Clara Di Germanio Aditi Sanghavi Victoria Sclar Daniel W. Bougie Garrick Chatelain Brad J. Biggerstaff Jefferson M. Jones Natalie J. Thornburg Steve Kleinman Mars Stone Michael P. Busch |
| author_sort | Hasan Sulaeman |
| collection | DOAJ |
| description | ABSTRACT SARS-CoV-2 seroprevalence studies are instrumental in monitoring epidemic activity and require well-characterized, high-throughput assays, and appropriate testing algorithms. The U.S. Nationwide Blood Donor Seroprevalence Study performed monthly cross-sectional serological testing from July 2020 to December 2021, implementing evolving testing algorithms in response to changes in pandemic activity. With high vaccine uptake, anti-Spike (S) reactivity rates reached >80% by May 2021, and the study pivoted from reflex Roche anti-nucleocapsid (NC) testing of Ortho S-reactive specimens to parallel Ortho S/NC testing. We evaluated the performance of the Ortho NC assay as a replacement for the Roche NC assay and compared performance of parallel S/NC testing on both platforms. Qualitative and quantitative agreement of Ortho NC with Roche NC assays was evaluated on preselected S/NC concordant and discordant specimens. All 190 Ortho S+/Roche NC+ specimens were reactive on the Ortho NC assay; 34% of 367 Ortho S+/Roche NC- specimens collected prior to vaccine availability and 43% of 37 Ortho S-/Roche NC+ specimens were reactive on the Ortho NC assay. Performance of parallel S/NC testing using Ortho and Roche platforms was evaluated on 200 specimens collected in 2019 and 3,903 study specimens collected in 2021. All 200 pre-COVID-19 specimens tested negative on the four assays. Cross-platform agreement between Roche and Ortho platforms was 96.4% (3,769/3,903); most discordant results had reactivity close to the cutoffs on the alternate assays. These findings, and higher efficiency and throughput, support the use of parallel S/NC testing on either Roche or Ortho platforms for large serosurveillance studies. IMPORTANCE Seroprevalence studies like the U.S. Nationwide Blood Donor Seroprevalence Study (NBDS) have been critical in monitoring SARS-CoV-2 epidemic activity. These studies rely on serological assays to detect antibodies indicating prior infection. It is critical that the assays and testing algorithms used in seroprevalence studies have adequate performance (high sensitivity, high specificity, ability to discriminate vaccine-induced and infection-induced antibodies, etc.), as well as appropriate characteristics to support large-scale studies, such as high throughput and low cost. In this study we evaluated the performance of Ortho’s anti-nucleocapsid assay as a replacement for the Roche anti-nucleocapsid assay and compared performance of parallel anti-spike and anti-nucleocapsid testing on both platforms. These data demonstrate similar performance of the Ortho and Roche anti-nucleocapsid assays and that parallel anti-spike and anti-nucleocapsid testing on either platform could be used for serosurveillance applications. |
| first_indexed | 2024-03-12T14:31:23Z |
| format | Article |
| id | doaj.art-68a9e887ac7c480fb77c0e23177d10dc |
| institution | Directory Open Access Journal |
| issn | 2165-0497 |
| language | English |
| last_indexed | 2024-03-12T14:31:23Z |
| publishDate | 2023-08-01 |
| publisher | American Society for Microbiology |
| record_format | Article |
| series | Microbiology Spectrum |
| spelling | doaj.art-68a9e887ac7c480fb77c0e23177d10dc2023-08-17T13:04:14ZengAmerican Society for MicrobiologyMicrobiology Spectrum2165-04972023-08-0111410.1128/spectrum.03234-22Evaluation of Ortho VITROS and Roche Elecsys S and NC Immunoassays for SARS-CoV-2 Serosurveillance ApplicationsHasan Sulaeman0Eduard Grebe1Honey Dave2Lily McCann3Clara Di Germanio4Aditi Sanghavi5Victoria Sclar6Daniel W. Bougie7Garrick Chatelain8Brad J. Biggerstaff9Jefferson M. Jones10Natalie J. Thornburg11Steve Kleinman12Mars Stone13Michael P. Busch14Vitalant Research Institute, San Francisco, California, USAVitalant Research Institute, San Francisco, California, USAVitalant Research Institute, San Francisco, California, USAVitalant Research Institute, San Francisco, California, USAVitalant Research Institute, San Francisco, California, USAVitalant Research Institute, San Francisco, California, USAVitalant Research Institute, San Francisco, California, USAVersiti Blood Center, Milwaukee, Wisconsin, USAThe Blood Center, New Orleans, Louisiana, USACenters for Disease Control and Prevention, Fort Collins, Colorado, USACOVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia, USACOVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia, USAUniversity of British Columbia, Victoria, British Columbia, CanadaVitalant Research Institute, San Francisco, California, USAVitalant Research Institute, San Francisco, California, USAABSTRACT SARS-CoV-2 seroprevalence studies are instrumental in monitoring epidemic activity and require well-characterized, high-throughput assays, and appropriate testing algorithms. The U.S. Nationwide Blood Donor Seroprevalence Study performed monthly cross-sectional serological testing from July 2020 to December 2021, implementing evolving testing algorithms in response to changes in pandemic activity. With high vaccine uptake, anti-Spike (S) reactivity rates reached >80% by May 2021, and the study pivoted from reflex Roche anti-nucleocapsid (NC) testing of Ortho S-reactive specimens to parallel Ortho S/NC testing. We evaluated the performance of the Ortho NC assay as a replacement for the Roche NC assay and compared performance of parallel S/NC testing on both platforms. Qualitative and quantitative agreement of Ortho NC with Roche NC assays was evaluated on preselected S/NC concordant and discordant specimens. All 190 Ortho S+/Roche NC+ specimens were reactive on the Ortho NC assay; 34% of 367 Ortho S+/Roche NC- specimens collected prior to vaccine availability and 43% of 37 Ortho S-/Roche NC+ specimens were reactive on the Ortho NC assay. Performance of parallel S/NC testing using Ortho and Roche platforms was evaluated on 200 specimens collected in 2019 and 3,903 study specimens collected in 2021. All 200 pre-COVID-19 specimens tested negative on the four assays. Cross-platform agreement between Roche and Ortho platforms was 96.4% (3,769/3,903); most discordant results had reactivity close to the cutoffs on the alternate assays. These findings, and higher efficiency and throughput, support the use of parallel S/NC testing on either Roche or Ortho platforms for large serosurveillance studies. IMPORTANCE Seroprevalence studies like the U.S. Nationwide Blood Donor Seroprevalence Study (NBDS) have been critical in monitoring SARS-CoV-2 epidemic activity. These studies rely on serological assays to detect antibodies indicating prior infection. It is critical that the assays and testing algorithms used in seroprevalence studies have adequate performance (high sensitivity, high specificity, ability to discriminate vaccine-induced and infection-induced antibodies, etc.), as well as appropriate characteristics to support large-scale studies, such as high throughput and low cost. In this study we evaluated the performance of Ortho’s anti-nucleocapsid assay as a replacement for the Roche anti-nucleocapsid assay and compared performance of parallel anti-spike and anti-nucleocapsid testing on both platforms. These data demonstrate similar performance of the Ortho and Roche anti-nucleocapsid assays and that parallel anti-spike and anti-nucleocapsid testing on either platform could be used for serosurveillance applications.https://journals.asm.org/doi/10.1128/spectrum.03234-22COVID-19SARS-CoV-2antibodiesserologyserosurveillanceserosurvey |
| spellingShingle | Hasan Sulaeman Eduard Grebe Honey Dave Lily McCann Clara Di Germanio Aditi Sanghavi Victoria Sclar Daniel W. Bougie Garrick Chatelain Brad J. Biggerstaff Jefferson M. Jones Natalie J. Thornburg Steve Kleinman Mars Stone Michael P. Busch Evaluation of Ortho VITROS and Roche Elecsys S and NC Immunoassays for SARS-CoV-2 Serosurveillance Applications Microbiology Spectrum COVID-19 SARS-CoV-2 antibodies serology serosurveillance serosurvey |
| title | Evaluation of Ortho VITROS and Roche Elecsys S and NC Immunoassays for SARS-CoV-2 Serosurveillance Applications |
| title_full | Evaluation of Ortho VITROS and Roche Elecsys S and NC Immunoassays for SARS-CoV-2 Serosurveillance Applications |
| title_fullStr | Evaluation of Ortho VITROS and Roche Elecsys S and NC Immunoassays for SARS-CoV-2 Serosurveillance Applications |
| title_full_unstemmed | Evaluation of Ortho VITROS and Roche Elecsys S and NC Immunoassays for SARS-CoV-2 Serosurveillance Applications |
| title_short | Evaluation of Ortho VITROS and Roche Elecsys S and NC Immunoassays for SARS-CoV-2 Serosurveillance Applications |
| title_sort | evaluation of ortho vitros and roche elecsys s and nc immunoassays for sars cov 2 serosurveillance applications |
| topic | COVID-19 SARS-CoV-2 antibodies serology serosurveillance serosurvey |
| url | https://journals.asm.org/doi/10.1128/spectrum.03234-22 |
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