Performance verification of anti-SARS-CoV-2-specific antibody detection by using four chemiluminescence immunoassay systems

Ann Clin Biochem. 2020 Nov;57(6):429-434. doi: 10.1177/0004563220963847.

Abstract

Objectives: The purpose of the current study was to evaluate the analytical performance of seven kits for detecting IgM/IgG antibodies against coronavirus (SARS-CoV-2) by using four chemiluminescence immunoassay systems.

Methods: Fifty patients diagnosed with SARS-CoV-2 infection and 130 controls without coronavirus infection from the General Hospital of Chongqing were enrolled in the current retrospective study. Four chemiluminescence immunoassay systems, including seven IgM/IgG antibody detection kits for SARS-CoV-2 (A_IgM, A_IgG, B_IgM, B_IgG, C_IgM, C_IgG and D_Ab), were employed to detect antibody concentrations. The chi-square test, the receiver operating characteristic (ROC) curve and Youden's index were determined to verify the cut-off value of each detection system.

Results: The repeatability verification results of the A, B, C and D systems are all qualified. D_Ab performed best (92% sensitivity and 99.23% specificity), and B_IgM performed worse than the other systems. Except for the A_IgM and C_IgG systems, the optimal diagnostic thresholds and cut-off values of the other kits and their recommendations are inconsistent with each other. B_IgM had the worst AUC, and C_IgG had the best diagnostic accuracy. More importantly, the B_IgG system had the highest false-positive rate for testing patients with AIDS, tumours and pregnancies. The A_IgM system test showed the highest false-positive rates among elderly individuals over 90 years old. COVID-2019 IgM/IgG antibody test systems exhibit performance differences.

Conclusions: The Innodx Biotech Total Antibody serum diagnosis kit is the most reliable detection system for anti-SARS-CoV-2 antibodies, which can be used together with nucleic acid tests as an alternative method for SARS-CoV-2 detecting.

Keywords: COVID-19; SARS-CoV-2; antibody; chemiluminescence immunoassay; performance verification.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Viral / analysis*
  • Antibodies, Viral / blood
  • Antibodies, Viral / immunology
  • Antibody Specificity*
  • Betacoronavirus / immunology*
  • Female
  • Humans
  • Immunoassay / methods*
  • Limit of Detection
  • Luminescence*
  • Male
  • Middle Aged
  • SARS-CoV-2

Substances

  • Antibodies, Viral