Test performance evaluation of SARS-CoV-2 serological assays

Details

• Alternative Title:
  Nat Biotechnol
• Personal Author:
  Whitman, Jeffrey D. ; Hiatt, Joseph ; Mowery, Cody T. ; Shy, Brian R. ; Yu, Ruby ; Yamamoto, Tori N. ; Rathore, Ujjwal ; Goldgof, Gregory M. ; Whitty, Caroline ; Woo, Jonathan M. ; Gallman, Antonia E. ; Miller, Tyler E. ; Levine, Andrew G. ; Nguyen, David N. ; Bapat, Sagar P. ; Balcerek, Joanna ; Bylsma, Sophia A. ; Lyons, Ana M. ; Li, Stacy ; Wong, Allison Wai-yi ; Gillis-Buck, Eva Mae ; Steinhart, Zachary B. ; Lee, Youjin ; Apathy, Ryan ; Lipke, Mitchell J. ; Smith, Jennifer Anne ; Zheng, Tina ; Boothby, Ian C. ; Isaza, Erin ; Chan, Jackie ; Acenas, Dante D. ; Lee, Jinwoo ; Macrae, Trisha A. ; Kyaw, Than S. ; Wu, David ; Ng, Dianna L. ; Gu, Wei ; York, Vanessa A. ; Eskandarian, Haig Alexander ; Callaway, Perri C. ; Warrier, Lakshmi ; Moreno, Mary E. ; Levan, Justine ; Torres, Leonel ; Farrington, Lila A. ; Loudermilk, Rita ; Koshal, Kanishka ; Zorn, Kelsey C. ; Garcia-Beltran, Wilfredo F. ; Yang, Diane ; Astudillo, Michael G. ; Bernstein, Bradley E. ; Gelfand, Jeffrey A. ; Ryan, Edward T. ; Charles, Richelle C. ; Iafrate, A. John ; Lennerz, Jochen K. ; Miller, Steve ; Chiu, Charles Y. ; Stramer, Susan L. ; Wilson, Michael R. ; Manglik, Aashish ; Ye, Chun Jimmie ; Krogan, Nevan J. ; Anderson, Mark S. ; Cyster, Jason G. ; Ernst, Joel D. ; Wu, Alan H. B. ; Lynch, Kara L. ; Bern, Caryn ; Hsu, Patrick D. ; Marson, Alexander
• Description:
  Appropriate use and interpretation of serological tests for assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure, infection and potential immunity require accurate data on assay performance. We conducted a head-to-head evaluation of ten point-of-care-style lateral flow assays (LFAs) and two laboratory-based enzyme-linked immunosorbent assays to detect anti-SARS-CoV-2 IgM and IgG antibodies in 5-d time intervals from symptom onset and studied the specificity of each assay in pre-coronavirus disease 2019 specimens. The percent of seropositive individuals increased with time, peaking in the latest time interval tested (>20 d after symptom onset). Test specificity ranged from 84.3% to 100.0% and was predominantly affected by variability in IgM results. LFA specificity could be increased by considering weak bands as negative, but this decreased detection of antibodies (sensitivity) in a subset of SARS-CoV-2 real-time PCR-positive cases. Our results underline the importance of seropositivity threshold determination and reader training for reliable LFA deployment. Although there was no standout serological assay, four tests achieved more than 80% positivity at later time points tested and more than 95% specificity.
• Keywords:
  Adult Aged Aged, 80 And Over Antibodies, Viral Betacoronavirus Biotechnology Chromatography, Affinity Clinical Laboratory Techniques Coronavirus Infections COVID-19 COVID-19 Testing Enzyme-Linked Immunosorbent Assay Female Humans Immunoglobulin G Immunoglobulin M Male Middle Aged Pandemics Pneumonia, Viral Point-of-Care Testing Reverse Transcriptase Polymerase Chain Reaction SARS-CoV-2 Sensitivity And Specificity Young Adult

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• Source:
  Nat Biotechnol. 38(10):1174-1183
• Pubmed ID:
  32855547
• Pubmed Central ID:
  PMC7740072
• Document Type:
  Journal Article
• Funding:
  R38 HL143581/HL/NHLBI NIH HHSUnited States/ ; F30AI150061/U.S. Department of Health & Human Services ; National Institutes of Health (NIH)International/ ; T32GM007618/U.S. Department of Health & Human Services ; National Institutes of Health (NIH)International/ ; 1F31NS106868-01/U.S. Department of Health & Human Services ; National Institutes of Health (NIH)International/ ; F31 NS106868/NS/NINDS NIH HHSUnited States/ ; F30 AI147364/AI/NIAID NIH HHSUnited States/ ; R01 AI040098/AI/NIAID NIH HHSUnited States/ ; T32 AI007334/AI/NIAID NIH HHSUnited States/ ; R38HL143581/U.S. Department of Health & Human Services ; NIH ; National Heart, Lung, and Blood Institute (NHLBI)International/ ; T32 GM007618/GM/NIGMS NIH HHSUnited States/ ; 1F30HD093116/U.S. Department of Health & Human Services ; National Institutes of Health (NIH)International/ ; U19 AI135990/AI/NIAID NIH HHSUnited States/ ; L40 AI140341/AI/NIAID NIH HHSUnited States/ ; F30 AI150061/AI/NIAID NIH HHSUnited States/ ; U01 CK000490/CK/NCEZID CDC HHSUnited States/ ; K38 HL154203/HL/NHLBI NIH HHSUnited States/ ; U01CK000490/ACL/ACL HHSUnited States/ ; F30 HD093116/HD/NICHD NIH HHSUnited States/
• Volume:
  38
• Issue:
  10
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:9fec1e51c26cb42b4b8e0234777f95591e76718bf3c8e81917009243f5fe9b43
• Download URL:
  https://stacks.cdc.gov/view/cdc/112436/cdc_112436_DS1.pdf
• File Type:
  [PDF - 775.47 KB ]