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| 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 |
| Department of Clincial Laboratory, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China |
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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.
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Received: 30 July 2020
Published: 25 August 2021
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Corresponding Authors:
ZHU Zhaoqin
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2021, Vol. 16 
