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Original Article

Evaluation of diagnostic application of different severe acute respiratory syndrome coronavirus 2 specific antibody detection kits

  • LI Haicong ,
  • WANG Qianying ,
  • HAN Weijing ,
  • ZHOU Yi ,
  • CAO Dan ,
  • ZHU Zhaoqin
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  • Department of Clincial Laboratory, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China

Received date: 2020-07-30

  Online published: 2021-08-25

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Abstract

To evaluate the performances of severe acute respiratory syndrome coronavirus 2 (SARS­CoV­2) specific antibody detection assays from six manufacturers and give directions for clinical application, serum samples from 245 patients (122 SARS­CoV­2 confirmed infection cases and 123 SARS­CoV­2 negative cases) admitted in Shanghai Public Health Clinical Centre from Jan 30th to May 11th 2020 were collected and tested by SARS­CoV­2 antibody detection assays purchased from six manufactures, including 3 uses colloidal gold strips while others are chemiluminescence immunoassays (CLIA). SARS­Cov­2 nucleic acid was detected by PCR Simultaneously. Clinical sensitivity, clinical specificity, PPV, NPV and other parameters were analyzed to evaluate and compare the performances of different assays. Assays had similar performances in terms of clinical specificity, but differ in clinical sensitivity. Compared to IgM detection, IgG detection seems more sensitive. CLIA assays had a sensitivity of 72.1%~85.2% which was superior to that of colloidal gold (47.5%~84.4%). All assays were determined to have statistically significant difference from PCR. The sensitivity of antibody detection increased over time, the sensitivity reached 96% after ≥16 days after PCR confirmation. SARS­CoV­2 antibody detection can serve as an auxiliary method to PCR in diagnosis. IgG and IgM joint detection may increase sensitivity in SARS­CoV­2 diagnosis. Performances of different assays varied a lot. Use of assays should depend on clinical requirement and application scenarios.

Cite this article

LI Haicong , WANG Qianying , HAN Weijing , ZHOU Yi , CAO Dan , ZHU Zhaoqin . Evaluation of diagnostic application of different severe acute respiratory syndrome coronavirus 2 specific antibody detection kits[J]. Journal of Microbes and Infections, 2021 , 16(4) : 235 -241 . DOI: 10.3969/j.issn.1673-6184.2021.04.002

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