Diagnostics (May 2021)

Analytical Validation and Clinical Application of Rapid Serological Tests for SARS-CoV-2 Suitable for Large-Scale Screening

  • Amedeo De Nicolò,
  • Valeria Avataneo,
  • Jessica Cusato,
  • Alice Palermiti,
  • Jacopo Mula,
  • Elisa De Vivo,
  • Miriam Antonucci,
  • Stefano Bonora,
  • Andrea Calcagno,
  • Giovanni Di Perri,
  • Francesco Giuseppe De Rosa,
  • Antonio D’Avolio

DOI
https://doi.org/10.3390/diagnostics11050869
Journal volume & issue
Vol. 11, no. 5
p. 869

Abstract

Read online

Recently, large-scale screening for COVID-19 has presented a major challenge, limiting timely countermeasures. Therefore, the application of suitable rapid serological tests could provide useful information, however, little evidence regarding their robustness is currently available. In this work, we evaluated and compared the analytical performance of a rapid lateral-flow test (LFA) and a fast semiquantitative fluorescent immunoassay (FIA) for anti-nucleocapsid (anti-NC) antibodies, with the reverse transcriptase real-time PCR assay as the reference. In 222 patients, LFA showed poor sensitivity (55.9%) within two weeks from PCR, while later testing was more reliable (sensitivity of 85.7% and specificity of 93.1%). Moreover, in a subset of 100 patients, FIA showed high sensitivity (89.1%) and specificity (94.1%) after two weeks from PCR. The coupled application for the screening of 183 patients showed satisfactory concordance (K = 0.858). In conclusion, rapid serological tests were largely not useful for early diagnosis, but they showed good performance in later stages of infection. These could be useful for back-tracing and/or to identify potentially immune subjects.

Keywords