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Test performance evaluation of SARS-CoV-2 serological assays.
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.
Affiliation
  • Whitman JD; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Hiatt J; Medical Scientist Training Program, University of California, San Francisco, CA 94143, USA.
  • Mowery CT; Biomedical Sciences Graduate Program, University of California, San Francisco, CA 94143, USA.
  • Shy BR; J. David Gladstone Institutes, San Francisco, CA 94158, USA.
  • Yu R; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Yamamoto TN; Innovative Genomics Institute, University of California, Berkeley, CA 94720, USA.
  • Rathore U; Diabetes Center, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Goldgof GM; Medical Scientist Training Program, University of California, San Francisco, CA 94143, USA.
  • Whitty C; Biomedical Sciences Graduate Program, University of California, San Francisco, CA 94143, USA.
  • Woo JM; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Gallman AE; Innovative Genomics Institute, University of California, Berkeley, CA 94720, USA.
  • Miller TE; Diabetes Center, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Levine AG; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Nguyen DN; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Bapat SP; Diabetes Center, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Balcerek J; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Bylsma SA; Innovative Genomics Institute, University of California, Berkeley, CA 94720, USA.
  • Lyons AM; Diabetes Center, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Li S; J. David Gladstone Institutes, San Francisco, CA 94158, USA.
  • Wong AW; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Gillis-Buck EM; Innovative Genomics Institute, University of California, Berkeley, CA 94720, USA.
  • Steinhart ZB; Diabetes Center, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Lee Y; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Apathy R; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Lipke MJ; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Smith JA; Diabetes Center, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Zheng T; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Boothby IC; Innovative Genomics Institute, University of California, Berkeley, CA 94720, USA.
  • Isaza E; Diabetes Center, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Chan J; Medical Scientist Training Program, University of California, San Francisco, CA 94143, USA.
  • Acenas DD; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Lee J; Howard Hughes Medical Institute, University of California, San Francisco.
  • Macrae TA; Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.
  • Kyaw TS; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Wu D; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Ng DL; Innovative Genomics Institute, University of California, Berkeley, CA 94720, USA.
  • Gu W; Department of Medicine, Division of Infectious Diseases, University of California, San Francisco, San Francisco, CA 94143, USA.
  • York VA; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Eskandarian HA; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Callaway PC; Diabetes Center, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Warrier L; Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Moreno ME; Department of Bioengineering, University of California, Berkeley, Berkeley CA 94720 USA.
  • Levan J; Department of Integrative Biology, University of California, Berkeley, Berkeley CA 94720 USA.
  • Torres L; Department of Integrative Biology, University of California, Berkeley, Berkeley CA 94720 USA.
  • Farrington LA; Medical Scientist Training Program, University of California, San Francisco, CA 94143, USA.
  • Loudermilk R; Department of Surgery, University of California, San Francisco, CA 94143, USA.
  • Koshal K; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Zorn KC; Diabetes Center, University of California, San Francisco, San Francisco, CA 94143, USA.
  • Garcia-Beltran WF; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
  • Yang D; Department of Microbiology and Immunology, University of California, San Francisco, CA 94143, USA.
medRxiv ; 2020 May 17.
Article in En | MEDLINE | ID: mdl-32511497
ABSTRACT

BACKGROUND:

Serological tests are crucial tools for assessments of SARS-CoV-2 exposure, infection and potential immunity. Their appropriate use and interpretation require accurate assay performance data.

METHOD:

We conducted an evaluation of 10 lateral flow assays (LFAs) and two ELISAs to detect anti-SARS-CoV-2 antibodies. The specimen set comprised 128 plasma or serum samples from 79 symptomatic SARS-CoV-2 RT-PCR-positive individuals; 108 pre-COVID-19 negative controls; and 52 recent samples from individuals who underwent respiratory viral testing but were not diagnosed with Coronavirus Disease 2019 (COVID-19). Samples were blinded and LFA results were interpreted by two independent readers, using a standardized intensity scoring system.

RESULTS:

Among specimens from SARS-CoV-2 RT-PCR-positive individuals, the percent seropositive increased with time interval, peaking at 81.8-100.0% in samples taken >20 days after symptom onset. Test specificity ranged from 84.3-100.0% in pre-COVID-19 specimens. Specificity was higher when weak LFA bands were considered negative, but this decreased sensitivity. IgM detection was more variable than IgG, and detection was highest when IgM and IgG results were combined. Agreement between ELISAs and LFAs ranged from 75.7-94.8%. No consistent cross-reactivity was observed.

CONCLUSION:

Our evaluation showed heterogeneous assay performance. Reader training is key to reliable LFA performance, and can be tailored for survey goals. Informed use of serology will require evaluations covering the full spectrum of SARS-CoV-2 infections, from asymptomatic and mild infection to severe disease, and later convalescence. Well-designed studies to elucidate the mechanisms and serological correlates of protective immunity will be crucial to guide rational clinical and public health policies.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Qualitative_research Language: En Journal: MedRxiv Year: 2020 Type: Article Affiliation country: United States
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Qualitative_research Language: En Journal: MedRxiv Year: 2020 Type: Article Affiliation country: United States