Performance and correlation of ten commercial immunoassays for the detection of SARS-CoV-2 antibodies
Dewi Lokida,
Muhammad Karyana,
Herman Kosasih,
Yan Mardian,
Retna Indah Sugiyono,
Dona Arlinda,
Nurhayati Lukman,
Gustiani Salim,
Deni Pepy Butar butar,
Adhella Menur Naysilla,
Irmansyah
Affiliations
Dewi Lokida
Department of Clinical Pathology, Tangerang District Hospital, Jl. Jend. Ahmad Yani No.9, Sukaasih, Banten 15111, Indonesia
Muhammad Karyana
National Institute of Health Research and Development, Ministry of Health, Jalan Percetakan Negara No. 29, Jakarta 10560, Indonesia
Herman Kosasih
Indonesia Research Partnership on Infectious Disease (INA-RESPOND), Building 6, Center 3, 3rd Floor, Jalan Percetakan Negara No. 29, Jakarta 10560, Indonesia; Corresponding author.
Yan Mardian
Indonesia Research Partnership on Infectious Disease (INA-RESPOND), Building 6, Center 3, 3rd Floor, Jalan Percetakan Negara No. 29, Jakarta 10560, Indonesia
Retna Indah Sugiyono
National Institute of Health Research and Development, Ministry of Health, Jalan Percetakan Negara No. 29, Jakarta 10560, Indonesia
Dona Arlinda
National Institute of Health Research and Development, Ministry of Health, Jalan Percetakan Negara No. 29, Jakarta 10560, Indonesia
Nurhayati Lukman
Indonesia Research Partnership on Infectious Disease (INA-RESPOND), Building 6, Center 3, 3rd Floor, Jalan Percetakan Negara No. 29, Jakarta 10560, Indonesia
Gustiani Salim
Indonesia Research Partnership on Infectious Disease (INA-RESPOND), Building 6, Center 3, 3rd Floor, Jalan Percetakan Negara No. 29, Jakarta 10560, Indonesia
Deni Pepy Butar butar
Indonesia Research Partnership on Infectious Disease (INA-RESPOND), Building 6, Center 3, 3rd Floor, Jalan Percetakan Negara No. 29, Jakarta 10560, Indonesia
Adhella Menur Naysilla
Indonesia Research Partnership on Infectious Disease (INA-RESPOND), Building 6, Center 3, 3rd Floor, Jalan Percetakan Negara No. 29, Jakarta 10560, Indonesia
Irmansyah
National Institute of Health Research and Development, Ministry of Health, Jalan Percetakan Negara No. 29, Jakarta 10560, Indonesia
Accurate immunoassays with a good correlation to neutralizing antibodies are required to support SARS-CoV-2 diagnosis, management, vaccine deployment, and epidemiological investigation. We conducted a study to evaluate the performance and correlation of the surrogate virus neutralization test (sVNT) and other commercial immunoassays. We tested 107 sera of COVID-19 confirmed cases from three different time points, 58 confirmed non-COVID-19 sera, and 52 sera collected before the pandemic with two sVNTs, seven chemiluminescent assays, and one fluorescein assay. All assays achieved excellent sensitivity (95%–100%, ≥15 days after onset of illness), specificity (95.5%–100%), and showed moderate to high correlation with GenScript sVNT (r = 0.58 to r = 0.98), except Roche total antibodies (r = 0.48). Vazyme sVNT and Siemens total antibodies showed the highest correlation with GenScript sVNT (r = 0.98 and 0.88, respectively). Median indexes that may be used to estimate sera with the highest ability to inhibit SARS-CoV-2 and ACE-2 receptor attachment (GenScript sVNT inhibition 90%–100%) were 6.9 S/C (Abbott IgG), 161.9 COI (FREND™ IgG), 16.8 AU/ml (Snibe IgG), 40.1 S/CO (Beckman IgG), 281.9 U/ml (Mindray IgG), 712.2 U/ml (Mindray total antibodies), >10 index (Siemens total antibodies), and 95.3% inhibition (Vazyme sVNT). All ten commercial COVID-19 serology assays, with different targeting antigens, demonstrated a reliable performance, supporting the utility of those assays in clinical and research settings. However, further studies using more samples are needed to refine the results of evaluating the performances of these marketed serological assays. Reliable serological assays would be useful for clinicians, researchers and epidemiologists in confirming SARS-CoV-2 infections, observing SARS-CoV-2 transmission, and immune response post infection and vaccination, leading to better management and control of the disease.
