Performance of SARS-CoV-2 Antigens in a Multiplex Bead Assay for Integrated Serological Surveillance of Neglected Tropical and Other Diseases

View More View Less
  • 1 Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, Georgia;
  • | 2 Institute of Human Virology, Abuja, Nigeria;
  • | 3 Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta, Georgia;
  • | 4 Division of Laboratory Systems, Centers for Disease Control and Prevention, Atlanta, Georgia;
  • | 5 Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia;
  • | 6 Nigeria Centre for Disease Control, Abuja, Nigeria;
  • | 7 Division of Global HIV and TB, Centers for Disease Control and Prevention, Abuja, Nigeria;
  • | 8 National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia

Serosurveillance can provide estimates of population-level exposure to infectious pathogens and has been used extensively during the COVID-19 pandemic. Simultaneous, serological testing for multiple pathogens can be done using bead-based immunoassays to add value to disease-specific serosurveys. We conducted a validation of four SARS-CoV-2 antigens—full-length spike protein, two receptor binding domain proteins, and the nucleocapsid protein—on our existing multiplex bead assay (MBA) for enteric diseases, malaria, and vaccine preventable diseases. After determining the optimal conditions for coupling the antigens to microsphere beads, the sensitivity and specificity of the assay were determined on two instruments (Luminex-200 and MAGPIX) when testing singly (monoplex) versus combined (multiplex). Sensitivity was assessed using plasma from 87 real-time reverse transcription polymerase chain reaction (rRT-PCR) positive persons collected in March–May of 2020 and ranged from 94.3% to 96.6% for the different testing conditions. Specificity was assessed using 98 plasma specimens collected prior to December 2019 and plasma from 19 rRT-PCR negative persons and ranged from 97.4% to 100%. The positive percent agreement was 93.8% to 97.9% using 48 specimens collected > 21 days post-symptom onset, while the negative percent agreement was ≥ 99% for all antigens. Test performance was similar using monoplex or multiplex testing. Integrating SARS-CoV-2 serology with other diseases of public health interest could add significant value to public health programs that have suffered severe programmatic setbacks during the COVID-19 pandemic.

Author Notes

Address correspondence to Sarah Gwyn, Centers for Disease Control and Prevention, 1600 Clifton Rd. NE B23, Room 10-113, Atlanta, GA. E-mail: yme8@cdc.gov

Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention. Use of trade names is for identification only and does not imply endorsement by the Centers for Disease Control and Prevention, the Public Health Service, or the US Department of Health and Human Services.

Authors’ addresses: Sarah Gwyn and Diana L. Martin, Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, E-mails: yme8@cdc.gov and hzx3@cdc.gov. Ado Abubakar, Oluwaseun Akinmulero, Ugboaja Nkechi Blessing, Ayuba B. Dawurung, Felicia Nwatu Dickson, Mudiaga Esiekpe, Thomas Andrew Naanpoen, Loveth Napoloen, Ifeanyichukwu Odoh, Temitope Olaleye, and Awala Samuel, Institute of Human Virology, Abuja, Nigeria, E-mails: gabubakar@ihvnigeria.org, ofadairo@ihvnigeria.org, bugboaja@ihvnigeria.org, adawurung@ihvnigeria.org, fnwatu@ihvnigeria.org, mesiekpe@ihvnigeria.org, athomas@ihvnigeria.org, lnapoleon@ihvnigeria.org, iodoh@ihvnigeria.org, tolaleye@ihvnigeria.org, and sawala@ihvnigeria.org. Eric Bergeron, Markus H. Kainulainen, and Amy J. Schuh, Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention, Atlanta, GA, E-mails: exj8@cdc.gov, ydm9@cdc.gov, and wuc2@cdc.gov. Jasmine Chaitram, Division of Laboratory Systems, Centers for Disease Control and Prevention, Atlanta, GA, E-mail: zoa6@cdc.gov. Melissa M. Coughlin, Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, GA, E-mail: htq4@cdc.gov. Erasogie Evbuomwan, Nigeria Centre for Disease Control, Abuja, Nigeria, E-mail: erasogie.evbuomwan@ncdc.gov.ng. Stacie M. Greby, Nnaemeka C. Iriemenam, and McPaul Okoye, Division of Global HIV and TB, Centers for Disease Control and Prevention, Abuja, Nigeria, E-mails: sig6@cdc.gov, iqd4@cdc.gov, and luo9@cdc.gov. S. Michele Owen, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, GA, E-mail: smo2@cdc.gov.

Save