Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests

Mary A. Rodgers; Ana Olivo; Barbara J. Harris; Chris Lark; Xinxin Luo; Michael G. Berg; Todd V. Meyer; Aurash Mohaimani; Gregory S. Orf; Yitz Goldstein; Amy S. Fox; Julie Hirschhorn; William B. Glen; Frederick Nolte; Alan Landay; Cheryl Jennings; James Moy; Venice Servellita; Charles Chiu; Rahul Batra; Luke B. Snell; Gaia Nebbia; Sam Douthwaite; Amilcar Tanuri; Lavanya Singh; Tulio de Oliveira; Ambroise Ahouidi; Souleymane Mboup; Gavin A. Cloherty

doi:10.1016/j.jcv.2022.105080

Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests

Mary A. Rodgers, Ana Olivo, Barbara J. Harris, Chris Lark, Xinxin Luo, Michael G. Berg, Todd V. Meyer, Aurash Mohaimani, Gregory S. Orf, Yitz Goldstein, Amy S. Fox, Julie Hirschhorn, William B. Glen, Frederick Nolte, Alan Landay, Cheryl Jennings, James Moy, Venice Servellita, Charles Chiu, Rahul BatraLuke B. Snell, Gaia Nebbia, Sam Douthwaite, Amilcar Tanuri, Lavanya Singh, Tulio de Oliveira, Ambroise Ahouidi, Souleymane Mboup, Gavin A. Cloherty

Research output: Contribution to journal › Article › peer-review

Abstract

Background:: Viral diversity presents an ongoing challenge for diagnostic tests, which need to accurately detect all circulating variants. The Abbott Global Surveillance program monitors severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants and their impact on diagnostic test performance. Objectives:: To evaluate the capacity of Abbott molecular, antigen, and serologic assays to detect circulating SARS-CoV-2 variants, including all current variants of concern (VOC): B.1.1.7 (alpha), B.1.351 (beta), P.1 (gamma) and B.1.617.2 (delta). Study design:: Dilutions of variant virus cultures (B.1.1.7, B.1.351, B.1.429, B.1.526.1, B.1.526.2, B.1.617.1, B.1.617.2, P.1, R.1 and control isolate WA1) and a panel of N = 248 clinical samples from patients with sequence confirmed variant infections (B.1.1.7, B.1.351, B.1.427, B.1.429, B.1.526, B.1.526.1, B.1.526.2, P.1, P.2, R.1) were evaluated on at least one assay: Abbott ID NOW COVID-19, m2000 RealTime SARS-CoV-2, Alinity m SARS-CoV-2, and Alinity m Resp-4-Plex molecular assays; the BinaxNOW COVID-19 Ag Card and Panbio COVID-19 Ag Rapid Test Device; and the ARCHITECT/Alinity i SARS-CoV-2 IgG and AdviseDx IgM assays, Panbio COVID-19 IgG assay, and ARCHITECT/Alinity i AdviseDx SARS-CoV-2 IgG II assay. Results:: Consistent with in silico predictions, each molecular and antigen assay detected VOC virus cultures with equivalent sensitivity to the WA1 control strain. Notably, 100% of all tested variant patient specimens were detected by molecular assays (N = 197 m2000, N = 88 Alinity m, N = 99 ID NOW), and lateral flow assays had a sensitivity of >94% for specimens with genome equivalents (GE) per device above 4 log (85/88, Panbio; 54/57 Binax). Furthermore, Abbott antibody assays detected IgG and IgM in 94–100% of sera from immune competent B.1.1.7 patients 15–26 days after symptom onset. Conclusions:: These data confirm variant detection for 11 SARS-CoV-2 assays, which is consistent with each assay target region being highly conserved. Importantly, alpha, beta, gamma, and delta VOCs were detected by molecular and antigen assays, indicating that these tests may be suitable for widescale use where VOCs predominate.

Original language	English (US)
Article number	105080
Journal	Journal of Clinical Virology
Volume	147
DOIs	https://doi.org/10.1016/j.jcv.2022.105080
State	Published - Feb 2022
Externally published	Yes

Keywords

Antibody assays
Molecular diagnostics
Rapid antigen tests
SARS-CoV-2
Variant of concern

ASJC Scopus subject areas

Virology
Infectious Diseases

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10.1016/j.jcv.2022.105080

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Rodgers, M. A., Olivo, A., Harris, B. J., Lark, C., Luo, X., Berg, M. G., Meyer, T. V., Mohaimani, A., Orf, G. S., Goldstein, Y., Fox, A. S., Hirschhorn, J., Glen, W. B., Nolte, F., Landay, A., Jennings, C., Moy, J., Servellita, V., Chiu, C., ... Cloherty, G. A. (2022). Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests. Journal of Clinical Virology, 147, Article 105080. https://doi.org/10.1016/j.jcv.2022.105080

Rodgers, MA, Olivo, A, Harris, BJ, Lark, C, Luo, X, Berg, MG, Meyer, TV, Mohaimani, A, Orf, GS, Goldstein, Y, Fox, AS, Hirschhorn, J, Glen, WB, Nolte, F, Landay, A, Jennings, C, Moy, J, Servellita, V, Chiu, C, Batra, R, Snell, LB, Nebbia, G, Douthwaite, S, Tanuri, A, Singh, L, de Oliveira, T, Ahouidi, A, Mboup, S & Cloherty, GA 2022, 'Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests', Journal of Clinical Virology, vol. 147, 105080. https://doi.org/10.1016/j.jcv.2022.105080

@article{3da64ccf33e144c4862c731a493ab0f3,

title = "Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests",

abstract = "Background:: Viral diversity presents an ongoing challenge for diagnostic tests, which need to accurately detect all circulating variants. The Abbott Global Surveillance program monitors severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants and their impact on diagnostic test performance. Objectives:: To evaluate the capacity of Abbott molecular, antigen, and serologic assays to detect circulating SARS-CoV-2 variants, including all current variants of concern (VOC): B.1.1.7 (alpha), B.1.351 (beta), P.1 (gamma) and B.1.617.2 (delta). Study design:: Dilutions of variant virus cultures (B.1.1.7, B.1.351, B.1.429, B.1.526.1, B.1.526.2, B.1.617.1, B.1.617.2, P.1, R.1 and control isolate WA1) and a panel of N = 248 clinical samples from patients with sequence confirmed variant infections (B.1.1.7, B.1.351, B.1.427, B.1.429, B.1.526, B.1.526.1, B.1.526.2, P.1, P.2, R.1) were evaluated on at least one assay: Abbott ID NOW COVID-19, m2000 RealTime SARS-CoV-2, Alinity m SARS-CoV-2, and Alinity m Resp-4-Plex molecular assays; the BinaxNOW COVID-19 Ag Card and Panbio COVID-19 Ag Rapid Test Device; and the ARCHITECT/Alinity i SARS-CoV-2 IgG and AdviseDx IgM assays, Panbio COVID-19 IgG assay, and ARCHITECT/Alinity i AdviseDx SARS-CoV-2 IgG II assay. Results:: Consistent with in silico predictions, each molecular and antigen assay detected VOC virus cultures with equivalent sensitivity to the WA1 control strain. Notably, 100% of all tested variant patient specimens were detected by molecular assays (N = 197 m2000, N = 88 Alinity m, N = 99 ID NOW), and lateral flow assays had a sensitivity of >94% for specimens with genome equivalents (GE) per device above 4 log (85/88, Panbio; 54/57 Binax). Furthermore, Abbott antibody assays detected IgG and IgM in 94–100% of sera from immune competent B.1.1.7 patients 15–26 days after symptom onset. Conclusions:: These data confirm variant detection for 11 SARS-CoV-2 assays, which is consistent with each assay target region being highly conserved. Importantly, alpha, beta, gamma, and delta VOCs were detected by molecular and antigen assays, indicating that these tests may be suitable for widescale use where VOCs predominate.",

keywords = "Antibody assays, Molecular diagnostics, Rapid antigen tests, SARS-CoV-2, Variant of concern",

author = "Rodgers, {Mary A.} and Ana Olivo and Harris, {Barbara J.} and Chris Lark and Xinxin Luo and Berg, {Michael G.} and Meyer, {Todd V.} and Aurash Mohaimani and Orf, {Gregory S.} and Yitz Goldstein and Fox, {Amy S.} and Julie Hirschhorn and Glen, {William B.} and Frederick Nolte and Alan Landay and Cheryl Jennings and James Moy and Venice Servellita and Charles Chiu and Rahul Batra and Snell, {Luke B.} and Gaia Nebbia and Sam Douthwaite and Amilcar Tanuri and Lavanya Singh and {de Oliveira}, Tulio and Ambroise Ahouidi and Souleymane Mboup and Cloherty, {Gavin A.}",

note = "Publisher Copyright: {\textcopyright} 2022 Abbott Laboratories",

year = "2022",

month = feb,

doi = "10.1016/j.jcv.2022.105080",

language = "English (US)",

volume = "147",

journal = "Journal of Clinical Virology",

issn = "1386-6532",

publisher = "Elsevier B.V.",

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TY - JOUR

T1 - Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests

AU - Rodgers, Mary A.

AU - Olivo, Ana

AU - Harris, Barbara J.

AU - Lark, Chris

AU - Luo, Xinxin

AU - Berg, Michael G.

AU - Meyer, Todd V.

AU - Mohaimani, Aurash

AU - Orf, Gregory S.

AU - Goldstein, Yitz

AU - Fox, Amy S.

AU - Hirschhorn, Julie

AU - Glen, William B.

AU - Nolte, Frederick

AU - Landay, Alan

AU - Jennings, Cheryl

AU - Moy, James

AU - Servellita, Venice

AU - Chiu, Charles

AU - Batra, Rahul

AU - Snell, Luke B.

AU - Nebbia, Gaia

AU - Douthwaite, Sam

AU - Tanuri, Amilcar

AU - Singh, Lavanya

AU - de Oliveira, Tulio

AU - Ahouidi, Ambroise

AU - Mboup, Souleymane

AU - Cloherty, Gavin A.

PY - 2022/2

Y1 - 2022/2

N2 - Background:: Viral diversity presents an ongoing challenge for diagnostic tests, which need to accurately detect all circulating variants. The Abbott Global Surveillance program monitors severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants and their impact on diagnostic test performance. Objectives:: To evaluate the capacity of Abbott molecular, antigen, and serologic assays to detect circulating SARS-CoV-2 variants, including all current variants of concern (VOC): B.1.1.7 (alpha), B.1.351 (beta), P.1 (gamma) and B.1.617.2 (delta). Study design:: Dilutions of variant virus cultures (B.1.1.7, B.1.351, B.1.429, B.1.526.1, B.1.526.2, B.1.617.1, B.1.617.2, P.1, R.1 and control isolate WA1) and a panel of N = 248 clinical samples from patients with sequence confirmed variant infections (B.1.1.7, B.1.351, B.1.427, B.1.429, B.1.526, B.1.526.1, B.1.526.2, P.1, P.2, R.1) were evaluated on at least one assay: Abbott ID NOW COVID-19, m2000 RealTime SARS-CoV-2, Alinity m SARS-CoV-2, and Alinity m Resp-4-Plex molecular assays; the BinaxNOW COVID-19 Ag Card and Panbio COVID-19 Ag Rapid Test Device; and the ARCHITECT/Alinity i SARS-CoV-2 IgG and AdviseDx IgM assays, Panbio COVID-19 IgG assay, and ARCHITECT/Alinity i AdviseDx SARS-CoV-2 IgG II assay. Results:: Consistent with in silico predictions, each molecular and antigen assay detected VOC virus cultures with equivalent sensitivity to the WA1 control strain. Notably, 100% of all tested variant patient specimens were detected by molecular assays (N = 197 m2000, N = 88 Alinity m, N = 99 ID NOW), and lateral flow assays had a sensitivity of >94% for specimens with genome equivalents (GE) per device above 4 log (85/88, Panbio; 54/57 Binax). Furthermore, Abbott antibody assays detected IgG and IgM in 94–100% of sera from immune competent B.1.1.7 patients 15–26 days after symptom onset. Conclusions:: These data confirm variant detection for 11 SARS-CoV-2 assays, which is consistent with each assay target region being highly conserved. Importantly, alpha, beta, gamma, and delta VOCs were detected by molecular and antigen assays, indicating that these tests may be suitable for widescale use where VOCs predominate.

AB - Background:: Viral diversity presents an ongoing challenge for diagnostic tests, which need to accurately detect all circulating variants. The Abbott Global Surveillance program monitors severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants and their impact on diagnostic test performance. Objectives:: To evaluate the capacity of Abbott molecular, antigen, and serologic assays to detect circulating SARS-CoV-2 variants, including all current variants of concern (VOC): B.1.1.7 (alpha), B.1.351 (beta), P.1 (gamma) and B.1.617.2 (delta). Study design:: Dilutions of variant virus cultures (B.1.1.7, B.1.351, B.1.429, B.1.526.1, B.1.526.2, B.1.617.1, B.1.617.2, P.1, R.1 and control isolate WA1) and a panel of N = 248 clinical samples from patients with sequence confirmed variant infections (B.1.1.7, B.1.351, B.1.427, B.1.429, B.1.526, B.1.526.1, B.1.526.2, P.1, P.2, R.1) were evaluated on at least one assay: Abbott ID NOW COVID-19, m2000 RealTime SARS-CoV-2, Alinity m SARS-CoV-2, and Alinity m Resp-4-Plex molecular assays; the BinaxNOW COVID-19 Ag Card and Panbio COVID-19 Ag Rapid Test Device; and the ARCHITECT/Alinity i SARS-CoV-2 IgG and AdviseDx IgM assays, Panbio COVID-19 IgG assay, and ARCHITECT/Alinity i AdviseDx SARS-CoV-2 IgG II assay. Results:: Consistent with in silico predictions, each molecular and antigen assay detected VOC virus cultures with equivalent sensitivity to the WA1 control strain. Notably, 100% of all tested variant patient specimens were detected by molecular assays (N = 197 m2000, N = 88 Alinity m, N = 99 ID NOW), and lateral flow assays had a sensitivity of >94% for specimens with genome equivalents (GE) per device above 4 log (85/88, Panbio; 54/57 Binax). Furthermore, Abbott antibody assays detected IgG and IgM in 94–100% of sera from immune competent B.1.1.7 patients 15–26 days after symptom onset. Conclusions:: These data confirm variant detection for 11 SARS-CoV-2 assays, which is consistent with each assay target region being highly conserved. Importantly, alpha, beta, gamma, and delta VOCs were detected by molecular and antigen assays, indicating that these tests may be suitable for widescale use where VOCs predominate.

KW - Antibody assays

KW - Molecular diagnostics

KW - Rapid antigen tests

KW - SARS-CoV-2

KW - Variant of concern

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DO - 10.1016/j.jcv.2022.105080

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ER -

Detection of SARS-CoV-2 variants by Abbott molecular, antigen, and serological tests

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