首页|Two rapid SARS-CoV-2 disposable devices for semi-quantitative S-RBD antibody levels determination compared with CLIA and ELISA assays at different protective thresholds
Two rapid SARS-CoV-2 disposable devices for semi-quantitative S-RBD antibody levels determination compared with CLIA and ELISA assays at different protective thresholds
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NSTL
Elsevier
Background and aims: Performance of two disposable devices for identifying subjects with low anti-SARS-CoV-2 protection was compared with that of automated enzyme-linked immunosorbent (ELISA) and chemiluminescent (CLIA) assay. Materials and Methods: In July 2021, 123 healthcare workers (HCW), twice vaccinated by BNT162b2/Comirnaty mRNA (BioNTech-Pfizer), underwent Ab iRapid COVID-19 Quant "Neutralizing" Self-test (iRapid Self-test) and "Neutralizing" Professional-use (iRapid pro) (DIESSE, Diagnostica Senese, Siena, Italy). Simultaneously, serum Ab were determined by Maglumi 2000 plus (anti S-RBD CLIA assay, Snibe Diagnostics, Shenzhen, China) and SARS-CoV-2 "Neutralizing" Ab Chorus ELISA (DIESSE, Siena, Italy). Results were evaluated against two "protective-thresholds", 90 kBAU/L and 506 kBAU/L. Results: HCW mean age, 46.2 (+/- 12.6) years; 26 (20.5%), males, 101 (79.5%), females. The mean time interval (and standard deviation) between the first vaccine dose and Ab determination was 129.5 (+/- 36.4) days and was neither gender (p = 0.879) nor age (p = 0.341) related. With Maglumi, 114 (89.7%) and 43 (33.8%) HCW presented Ab >= 90 kBAU/L and Ab >= 506 kBAU/L, respectively; with Chorus, 96 (75.6%) presented Ab values =506 kBAU/L. CLIA and ELISA agreement was 56.7%. At 90 kBAU/L, iRapid self-test and Pro sensitivities were 98.2% (95% CI: 92.7-99.8), specificity 69.2% (95% CI: 38.6-90.9%) and 76.9% (46.2-95%), respectively. At 506 kBAU/L, iRapid sensitivities were 58.1-91.6%, and specificities, 89-96.6%. On evaluating Ab at <4 and >= 4 months, protective titers had decreased. Conclusions: iRapid semi-quantitative devices had very good overall agreements of 95.1% and 95.9% for detecting individuals with low anti-SARS-CoV-2 protection.
SARS-CoV-2AntibodiesPoint of care deviceiRapidCLIAELISARapid antibody testProtective thresholds
Padoan, Andrea、Cosma, Chiara、Galla, Luisa、Basso, Daniela、Plebani, Mario
NSTL
Elsevier
