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Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho.
J Clin Microbiol. 2020 07 23; 58(8)JC

Abstract

Coronavirus disease 2019 (COVID-19), the novel respiratory illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is associated with severe morbidity and mortality. The rollout of diagnostic testing in the United States was slow, leading to numerous cases that were not tested for SARS-CoV-2 in February and March 2020 and necessitating the use of serological testing to determine past infections. Here, we evaluated the Abbott SARS-CoV-2 IgG test for detection of anti-SARS-CoV-2 IgG antibodies by testing 3 distinct patient populations. We tested 1,020 serum specimens collected prior to SARS-CoV-2 circulation in the United States and found one false positive, indicating a specificity of 99.90%. We tested 125 patients who tested reverse transcription-PCR (RT-PCR) positive for SARS-CoV-2 for whom 689 excess serum specimens were available and found that sensitivity reached 100% at day 17 after symptom onset and day 13 after PCR positivity. Alternative index value thresholds for positivity resulted in 100% sensitivity and 100% specificity in this cohort. We tested specimens from 4,856 individuals from Boise, ID, collected over 1 week in April 2020 as part of the Crush the Curve initiative and detected 87 positives for a positivity rate of 1.79%. These data demonstrate excellent analytical performance of the Abbott SARS-CoV-2 IgG test as well as the limited circulation of the virus in the western United States. We expect that the availability of high-quality serological testing will be a key tool in the fight against SARS-CoV-2.

Authors+Show Affiliations

Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington, USA.Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington, USA.Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington, USA. Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA.Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington, USA.Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington, USA.Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington, USA.Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington, USA. Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington, USA. Department of Biomedical Informatics and Medical Education, University of Washington School of Medicine, Seattle, Washington, USA.Department of Laboratory Medicine, University of Washington School of Medicine, Seattle, Washington, USA agrening@uw.edu. Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32381641

Citation

Bryan, Andrew, et al. "Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho." Journal of Clinical Microbiology, vol. 58, no. 8, 2020.
Bryan A, Pepper G, Wener MH, et al. Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho. J Clin Microbiol. 2020;58(8).
Bryan, A., Pepper, G., Wener, M. H., Fink, S. L., Morishima, C., Chaudhary, A., Jerome, K. R., Mathias, P. C., & Greninger, A. L. (2020). Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho. Journal of Clinical Microbiology, 58(8). https://doi.org/10.1128/JCM.00941-20
Bryan A, et al. Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho. J Clin Microbiol. 2020 07 23;58(8) PubMed PMID: 32381641.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho. AU - Bryan,Andrew, AU - Pepper,Gregory, AU - Wener,Mark H, AU - Fink,Susan L, AU - Morishima,Chihiro, AU - Chaudhary,Anu, AU - Jerome,Keith R, AU - Mathias,Patrick C, AU - Greninger,Alexander L, Y1 - 2020/07/23/ PY - 2020/04/29/received PY - 2020/05/06/accepted PY - 2020/5/10/pubmed PY - 2020/8/6/medline PY - 2020/5/9/entrez KW - Abbott KW - COVID KW - COVID-19 KW - Idaho KW - SARS KW - SARS-CoV-2 KW - coronavirus KW - serology JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 58 IS - 8 N2 - Coronavirus disease 2019 (COVID-19), the novel respiratory illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is associated with severe morbidity and mortality. The rollout of diagnostic testing in the United States was slow, leading to numerous cases that were not tested for SARS-CoV-2 in February and March 2020 and necessitating the use of serological testing to determine past infections. Here, we evaluated the Abbott SARS-CoV-2 IgG test for detection of anti-SARS-CoV-2 IgG antibodies by testing 3 distinct patient populations. We tested 1,020 serum specimens collected prior to SARS-CoV-2 circulation in the United States and found one false positive, indicating a specificity of 99.90%. We tested 125 patients who tested reverse transcription-PCR (RT-PCR) positive for SARS-CoV-2 for whom 689 excess serum specimens were available and found that sensitivity reached 100% at day 17 after symptom onset and day 13 after PCR positivity. Alternative index value thresholds for positivity resulted in 100% sensitivity and 100% specificity in this cohort. We tested specimens from 4,856 individuals from Boise, ID, collected over 1 week in April 2020 as part of the Crush the Curve initiative and detected 87 positives for a positivity rate of 1.79%. These data demonstrate excellent analytical performance of the Abbott SARS-CoV-2 IgG test as well as the limited circulation of the virus in the western United States. We expect that the availability of high-quality serological testing will be a key tool in the fight against SARS-CoV-2. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/32381641/Performance_Characteristics_of_the_Abbott_Architect_SARS_CoV_2_IgG_Assay_and_Seroprevalence_in_Boise_Idaho_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=32381641 DB - PRIME DP - Unbound Medicine ER -