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

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Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.
Nature Biotechnology ( IF 33.1 ) Pub Date : 2020-08-27 , DOI: 10.1038/s41587-020-0659-0
Jeffrey D Whitman ₁ , Joseph Hiatt _{2,

3,

4,

5,

6,

7} , Cody T Mowery _{2,

3,

5,

6,

7} , Brian R Shy ₁ , Ruby Yu _{5,

7} , Tori N Yamamoto _{5,

7} , Ujjwal Rathore _{4,

5,

6,

7} , Gregory M Goldgof ₁ , Caroline Whitty _{1,

5,

7} , Jonathan M Woo _{5,

6,

7} , Antonia E Gallman _{2,

5,

8} , Tyler E Miller ₉ , Andrew G Levine ₁ , David N Nguyen _{5,

6,

10} , Sagar P Bapat _{1,

5,

7} , Joanna Balcerek ₁ , Sophia A Bylsma ₁₁ , Ana M Lyons ₁₂ , Stacy Li ₁₂ , Allison Wai-Yi Wong ₂ , Eva Mae Gillis-Buck ₁₃ , Zachary B Steinhart _{5,

7} , Youjin Lee ₅ , Ryan Apathy _{5,

6,

7} , Mitchell J Lipke _{5,

7} , Jennifer Anne Smith ₇ , Tina Zheng _{2,

3,

14,

15} , Ian C Boothby _{2,

16} , Erin Isaza _{2,

17} , Jackie Chan ₅ , Dante D Acenas ₅ , Jinwoo Lee _{2,

18} , Trisha A Macrae _{2,

18} , Than S Kyaw _{2,

5} , David Wu _{2,

3} , Dianna L Ng _{15,

19} , Wei Gu ₁ , Vanessa A York ₂₀ , Haig Alexander Eskandarian ₂₀ , Perri C Callaway _{20,

21} , Lakshmi Warrier ₂₀ , Mary E Moreno ₂₀ , Justine Levan ₂₀ , Leonel Torres ₂₀ , Lila A Farrington ₂₀ , Rita P Loudermilk ₂₂ , Kanishka Koshal ₂₂ , Kelsey C Zorn ₂₃ , Wilfredo F Garcia-Beltran ₉ , Diane Yang ₉ , Michael G Astudillo ₉ , Bradley E Bernstein ₉ , Jeffrey A Gelfand ₂₄ , Edward T Ryan ₂₄ , Richelle C Charles ₂₄ , A John Iafrate ₉ , Jochen K Lennerz ₉ , Steve Miller ₁ , Charles Y Chiu _{1,

10,

25} , Susan L Stramer ₂₆ , Michael R Wilson _{3,

22} , Aashish Manglik _{27,

28} , Chun Jimmie Ye _{29,

30,

31,

32,

33,

34} , Nevan J Krogan _{4,

35,

36} , Mark S Anderson ₇ , Jason G Cyster _{5,

8} , Joel D Ernst ₂₀ , Alan H B Wu ₁ , Kara L Lynch ₁ , Caryn Bern ₃₄ , Patrick D Hsu _{6,

11,

37} , Alexander Marson _{4,

5,

6,

7,

10,

15,

29,

30,

31,

32}

Affiliation

Department of Laboratory Medicine, University of California, San Francisco, San Francisco, CA, USA.
Medical Scientist Training Program, University of California, San Francisco, San Francisco, CA, USA.
Biomedical Sciences Graduate Program, University of California, San Francisco, San Francisco, CA, USA.
J. David Gladstone Institutes, San Francisco, CA, USA.
Department of Microbiology and Immunology, University of California, San Francisco, San Francisco, CA, USA.
Innovative Genomics Institute, University of California, Berkeley, Berkeley, CA, USA.
Diabetes Center, University of California, San Francisco, San Francisco, CA, USA.
Howard Hughes Medical Institute, University of California, San Francisco, San Francisco, USA.
Department of Pathology, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.
Department of Medicine, Division of Infectious Diseases, University of California, San Francisco, San Francisco, CA, USA.
Department of Bioengineering, University of California, Berkeley, Berkeley, CA, USA.
Department of Integrative Biology, University of California, Berkeley, Berkeley, CA, USA.
Department of Surgery, University of California, San Francisco, San Francisco, CA, USA.
Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.
Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA.
Department of Dermatology, University of California, San Francisco, San Francisco, CA, USA.
Program in Quantitative Biology, University of California, San Francisco, San Francisco, CA, USA.
School of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Department of Pathology, University of California, San Francisco, San Francisco, CA, USA.
Division of Experimental Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Infectious Diseases and Immunity Graduate Group, University of California, Berkeley, Berkeley, CA, USA.
Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.
Department of Biochemistry and Biophysics, University of California, San Francisco, San Francisco, CA, USA.
Division of Infectious Diseases, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.
UCSF-Abbott Viral Diagnostics and Discovery Center, San Francisco, CA, USA.
Scientific Affairs, American Red Cross, Gaithersburg, MD, USA.
Department of Anesthesia and Perioperative Care, University of California, San Francisco, San Francisco, CA, USA.
Department of Pharmaceutical Chemistry, University of California, San Francisco, San Francisco, CA, USA.
Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA.
Chan Zuckerberg Biohub, San Francisco, CA, USA.
Institute for Human Genetics, University of California, San Francisco, San Francisco, CA, USA.
Division of Rheumatology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Institute of Computational Health Sciences, University of California, San Francisco, San Francisco, CA, USA.
Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA.
Department of Cellular and Molecular Pharmacology, University of California, San Francisco, San Francisco, CA, USA.
Quantitative Biosciences Institute, University of California, San Francisco, San Francisco, CA, USA.
Center for Computational Biology, University of California, Berkeley, Berkeley, CA, USA.

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.

中文翻译：

SARS-CoV-2 血清学检测的评估揭示了一系列检测性能。

正确使用和解释血清学检测来评估严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 暴露、感染和潜在免疫力需要准确的检测性能数据。我们对 10 种护理点侧向层析测定 (LFA) 和两种基于实验室的酶联免疫吸附测定进行了头对头评估，以检测 5 种患者中的抗 SARS-CoV-2 IgM 和 IgG 抗体d 从症状出现开始的时间间隔，并研究了 2019 年冠状病毒疾病前样本中每种检测的特异性。血清反应阳性个体的百分比随着时间的推移而增加，在最近测试的时间间隔内达到峰值（症状出现后％3E20天）。测试特异性范围为 84.3% 至 100.0%，主要受 IgM 结果变异性的影响。通过将弱条带视为阴性可以提高 LFA 特异性，但这会降低 SARS-CoV-2 实时 PCR 阳性病例子集中抗体的检测（敏感性）。我们的结果强调了血清阳性阈值确定和读者培训对于可靠的 LFA 部署的重要性。尽管没有出色的血清学检测，但四项测试在后来的测试时间点取得了超过 80% 的阳性率和超过 95% 的特异性。

更新日期：2020-08-27

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