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. 2022 Feb:147:105080.
doi: 10.1016/j.jcv.2022.105080. Epub 2022 Jan 20.

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

Mary A Rodgers  1 , Ana Olivo  2 , Barbara J Harris  2 , Chris Lark  2 , Xinxin Luo  2 , Michael G Berg  2 , Todd V Meyer  2 , Aurash Mohaimani  2 , Gregory S Orf  2 , Yitz Goldstein  3 , Amy S Fox  3 , Julie Hirschhorn  4 , William B Glen  4 , Frederick Nolte  4 , Alan Landay  5 , Cheryl Jennings  5 , James Moy  5 , Venice Servellita  6 , Charles Chiu  6 , Rahul Batra  7 , Luke B Snell  7 , Gaia Nebbia  7 , Sam Douthwaite  7 , Amilcar Tanuri  8 , Lavanya Singh  9 , Tulio de Oliveira  9 , Ambroise Ahouidi  10 , Souleymane Mboup  10 , Gavin A Cloherty  2
Affiliations

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

Mary A Rodgers et al. J Clin Virol. 2022 Feb.

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.

PubMed Disclaimer

Conflict of interest statement

MAR, AO, BH, CL, XL, MGB, TVM, AM, GSO, and GC are employees and shareholders of Abbott Laboratories.This work was funded by Abbott Laboratories.

Figures

Fig. 1
Fig. 1
Characteristics of clinical specimen panel. The percentage of N = 228 total remnant respiratory samples collected from each of the indicated countries (country two letter codes, BR – Brazil, SA – South Africa, SN – Senegal, UK – United Kingdom, US – United States) and US states (CA – California, FL – Florida, IL – Illinois, NY – New York, SC – South Carolina) are shown in panel A. The total number of specimens (N) for each lineage in the panel of 228 remnant respiratory samples are shown in panel B.
Fig. 2
Fig. 2
Clinical variant specimen panel. Remnant clinical specimens from patients with sequence-confirmed VOI/VOC infections were tested on at least one diagnostic assay –m2000 RealTime SARS-CoV-2 (A), Abbott ID NOW COVID-19 (B), Alinity m SARS-CoV-2 (C), the BinaxNOW COVID-19 Ag Card (D) and Panbio COVID-19 Ag Rapid Test Device (E-F). Genome equivalents (GE).
See this image and copyright information in PMC

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