Abstract
Serology provides tools for epidemiologic studies, and may have a role in vaccine prioritization and selection. Automated serologic testing of saliva, especially specimens that are self-collected at home and sent to a laboratory via the mail without refrigeration, could be a highly-scalable strategy for population-wide testing. In this prospective study, non-vaccinated patients were recruited after PCR testing to self-collect saliva and return their specimens via mail. Longitudinal specimens were analyzed in order to monitor seroconversion in the weeks after a diagnostic PCR test for SARS-CoV-2. Diverse users self-collected saliva and returned specimens via mail in compliance with shipping regulations. At our pre-established threshold (0.963 AU/mL), salivary IgG reactivity to full-length spike protein achieved 95.8% sensitivity and 92.4% specificity at 2-4 weeks after diagnostic testing, which is comparable to the typical sensitivity and specificity achieved for serum testing. Reactivity to N antigen also was detected with 92.6% sensitivity and 90.7% specificity at 4-8 weeks after diagnostic testing. Moreover, serologic testing for endemic coronaviruses performed in multiplex with SARS-CoV-2 antigens has the potential to identify samples that may require retesting due to effects of pre-analytical factors. The easy-to-use saliva collection kit, coupled with thresholds for positivity and methods of flagging samples for retest, provides a framework for large-scale serosurveillance of SARS-CoV-2.
【초록키워드】 SARS-CoV-2, IgG, Saliva, Vaccine, serology, Prospective Study, diagnostic, Spike protein, Laboratory, serum, sensitivity, specificity, PCR testing, Seroconversion, Sensitivity and specificity, Patient, diagnostic testing, Compliance, Factors, SARS-CoV-2 antigen, multiplex, PCR test, threshold, longitudinal, serologic testing, SARS-CoV-2 antigens, Endemic, framework, specimen, thresholds, full-length spike protein, mail, MONITOR, refrigeration, Effect, salivary, N antigen, analyzed, identify, performed, recruited, provide, coronavirus, comparable, reactivity, returned, 【제목키워드】 SARS-CoV-2, returned,