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
| Autor: | Andrea Padoan, Chiara Cosma, Luisa Galla, Daniela Basso, Mario Plebani |
|---|---|
| Rok vydání: | 2022 |
| Předmět: |
Male
Rapid antibody test SARS-CoV-2 Health Personnel Biochemistry (medical) Clinical Biochemistry COVID-19 iRapid Enzyme-Linked Immunosorbent Assay Protective thresholds General Medicine Middle Aged Antibodies CLIA ELISA Point of care device Antibodies Viral BNT162 Vaccine Female Humans Biochemistry Viral |
| Zdroj: | Clinica Chimica Acta. 529:104-108 |
| ISSN: | 0009-8981 |
| DOI: | 10.1016/j.cca.2022.02.014 |
| Popis: | 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.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.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 at4 and ≥4 months, protective titers had decreased.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. |
| Databáze: | OpenAIRE |
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