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Int J Infect Dis . Parallel detection of SARS-CoV-2 RNA and nucleocapsid antigen in nasopharyngeal specimens from a COVID-19 patient screening cohor

tetano

Editor, Senior Moderator
Int J Infect Dis


. 2021 Jun 3;S1201-9712(21)00486-0.
doi: 10.1016/j.ijid.2021.05.082. Online ahead of print.
Parallel detection of SARS-CoV-2 RNA and nucleocapsid antigen in nasopharyngeal specimens from a COVID-19 patient screening cohort


Nikolay Mayanskiy[SUP] 1 [/SUP], Ekaterina Brzhozovskaya[SUP] 2 [/SUP], Natalia Fedorova[SUP] 2 [/SUP], Yuri Lebedin[SUP] 3 [/SUP]



Affiliations

Abstract

Objectives: Reverse-transcription PCR (RT-PCR) is considered the most sensitive method in detecting severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2). However, this method is relatively resource- and time-consuming. Here, we compared SARS-CoV-2 nucleocapsid antigen (N-Ag) testing using an enzyme-linked immunosorbent assay (ELISA) with SARS-CoV-2 RNA detection.
Methods: Parallel SARS-CoV-2 RT-PCR and quantitative N-Ag ELISA analysis was executed in nasopharyngeal specimens obtained during SARS-CoV-2 screening in a cohort of pre-hospitalization patients.
Results: In total, 277 specimens were examined, including 182 (65.7%) RT-PCR-positive specimens, which demonstrated a median cycle threshold (Ct) value of 27 (interquartile range [IQR], 23-35). The SARS-CoV-2 N-Ag was detected in 164/182 RT-PCR-positive specimens (overall sensitivity, 90.1%). Among 95 RT-PCR-negative specimens, 72 were N-Ag-negative (specificity, 75.8%). SARS-CoV-2 RT-PCR and N-Ag ELISA results demonstrated a strong agreement (Cramer's V, 0.668; p < 0.001). N-Ag concentrations spanned from 5.4 to 296,000 pg/mL (median, 901 pg/mL; IQR, 43-1407 pg/mL) and were inversely correlated with Ct values (Spearman's r=-0.720; p < 0.001).
Conclusions: SARS-CoV-2 N-Ag ELISA results were in close agreement with RT-PCR results, and N-Ag concentrations were proportional to viral loads. Thus, SARS-CoV-2 quantitative antigen testing could be an additional diagnostic instrument for SARS-CoV-2.

Keywords: RNA; SARS-CoV-2; antigen; concentration; concordance.
 
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