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J Appl Lab Med . Correlation of SARS-CoV-2 neutralizing antibodies to an automated chemiluminescent serological immunoassay

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  • J Appl Lab Med . Correlation of SARS-CoV-2 neutralizing antibodies to an automated chemiluminescent serological immunoassay


    J Appl Lab Med


    . 2020 Oct 24;jfaa195.
    doi: 10.1093/jalm/jfaa195. Online ahead of print.
    Correlation of SARS-CoV-2 neutralizing antibodies to an automated chemiluminescent serological immunoassay


    David G Grenache 1 2 , Chunyan Ye 3 , Steven B Bradfute 3



    Affiliations

    Abstract

    Introduction: Neutralizing antibodies (NAbs) are capable of binding to a virus to render incapable of infection. The ability of commercially available SARS-CoV-2 serological tests to detect NAbs has not been widely reported. We sought to correlate the antibodies detected by an automated chemiluminescent immunoassay with NAbs.
    Methods: Residual serum samples from 35 patients that had a positive antibody test using the LIAISONŽ SARS-CoV-2 S1/S2 IgG chemiluminescent immunoassay and two antibody-negative control sera were tested for NAbs using a plaque reduction neutralization test (PRNT).
    Results: NAbs were detected in 66% (23/35) of the antibody-positive samples. The immunoassay signal value ranged from 21.7 to 131.3 AU/mL (median, 90.5) with significant correlation between it and the PRNT (r = 0.61, p = 0.002). In the samples without NAbs, the immunoassay signal ranged from 16.3 to 66.2 AU/mL (median, 27.2). An immunoassay signal cutoff of > 41 AU/mL was 91% sensitive and 92% specific for the detection of NAbs.
    Discussion: It is important that correlates of immunity to SARS-CoV-2 be identified and NAbs are considered to be central indicators of such. PRNT is the gold-standard test for identifying NAbs but it cannot be used for large-scale testing of populations. It is necessary to establish relationships between it and widely used commercial serological assays for SARS-CoV-2.

    Keywords: SARS-CoV-2; neutralizing antibodies; novel coronavirus; serology.

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