Performance evaluation of antigen test (iFlash-2019-nCoV Antigen®) for
detection of SARS-CoV-2 virus in serum samples
Abstract
Molecular assays from nasopharyngeal swabs are the current reference
method to diagnose COVID-19. As an alternative, we evaluated the
performance of the iFlash-2019-nCoV Antigen® (YHLO, Shenzhen, China),
developed for SARS-CoV-2 N-antigen detection in serum samples.
Specificity, determined on 50 pre-pandemic samples, was 100%. Overall
sensitivity, evaluated on 40 sera from patients with RT-PCR confirmed
infection, was 67.5%. However, sensitivity reached 73% in symptomatic
patients, 80% in patients with high and medium nasopharyngeal (NP)
viral loads (samples with Ct≤33) and, 90% in samples collected within
the first week after symptoms onset. These sera were further analyzed
with the COV-QUANTO® ELISA and COVID-VIRO® LFIA assays (AAZ,
Boulogne-Billancourt, France). EIA Ag assays from Yhlo and AAZ had
comparable performances, and both were more sensitive than the LFIA.
These findings suggest that SARS-CoV-2 N-antigen detection in serum
could be an alternative to PCR from NP swabs, at least early after onset
of symptoms. Further studies are required to confirm these results.