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Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.

  • Author(s): 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 P;
  • 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 HB;
  • Lynch, Kara L;
  • Bern, Caryn;
  • Hsu, Patrick D;
  • Marson, Alexander
  • et al.
Abstract

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.

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