1. Efficient Identification of High-Titer Anti–Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibody Plasma Samples by Pooling Method
- Author
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Suchitra Pandey, Scott D. Boyd, Oliver F. Wirz, Lorna L. Tolentino, Tho D. Pham, Katharina Röltgen, and Khoa D. Nguyen
- Subjects
Emergency Use Authorization ,Coronavirus disease 2019 (COVID-19) ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Blood Donors ,Enzyme-Linked Immunosorbent Assay ,Antibodies, Viral ,Sensitivity and Specificity ,COVID-19 Serological Testing ,Pathology and Forensic Medicine ,Serology ,Seroepidemiologic Studies ,Humans ,Medicine ,Seroprevalence ,High titer ,Pandemics ,Plasma samples ,biology ,SARS-CoV-2 ,business.industry ,COVID-19 ,Reproducibility of Results ,General Medicine ,Medical Laboratory Technology ,Immunoglobulin G ,Immunology ,biology.protein ,Antibody ,business - Abstract
Context.— The ongoing COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has elicited a surge in demand for serologic testing to identify previously infected individuals. In particular, antibody testing is crucial in identifying COVID-19 convalescent plasma, which has been approved by the Food and Drug Administration under the Emergency Use Authorization for use as passive immunotherapy for hospitalized patients infected with COVID-19. Currently, high-titer COVID-19 convalescent plasma can be qualified by Ortho's Vitros COVID-19 IgG antibody test. Objective.— To explore the use of an efficient testing method to identify high-titer COVID-19 convalescent plasma for use in treating COVID-19–infected patients and track COVID-19 positivity over time. Design.— We evaluated an enzyme-linked immunosorbent assay (ELISA)–based method that detects antibodies specific to the SARS-CoV-2 receptor binding domain (RBD) with individual and pooled plasma samples and compared its performance against the Vitros COVID-19 IgG antibody test. Using the pooled RBD-ELISA (P-RE) method, we also screened more than 10 000 longitudinal healthy blood donor samples to assess seroprevalence. Results.— P-RE demonstrates 100% sensitivity in detecting Food and Drug Administration–defined high-titer samples when compared with the Vitros COVID-19 IgG antibody test. Overall sensitivity of P-RE when compared with the Vitros COVID-19 IgG antibody test and our individual sample RBD-ELISA (I-RE) were 83% and 56%, respectively. When screening 10 218 healthy blood donor samples by P-RE, we found the seroprevalence correlated with the local infection rates with a correlation coefficient of 0.21 (P < .001). Conclusions.— Pooling plasma samples can be used to efficiently screen large populations for individuals with high-titer anti–RBD antibodies, important for COVID-19 convalescent plasma identification.
- Published
- 2021