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Résumé
OBJECTIVES: Several serological SARS-CoV-2 immunoassays have been developed recently but require external validation before widespread use. This study aims at assessing the analytical and clinical performance of the iFlash® anti-SARS-CoV-2 chemiluminescence assay for the detection of both IgM and IgG antibodies. The kinetics of the antibody response was also evaluated.
DESIGN & METHODS: The precision, carry-over, linearity, limit of blank, detection and quantification were assessed. Sensitivity analysis was performed by using 178 sera collected from 154 RT-PCR confirmed COVID-19 patients. The specificity analysis was performed from 75 selected non-SARS-CoV-2 sera with a potential cross-reaction to the SARS-CoV-2 immunoassay.
RESULTS: This iFlash® SARS-CoV-2 assay showed excellent analytical performance. After 2 weeks since symptom onset, the sensitivities for IgM and IgG were 62.2% (95% CI: 52.3-71.2%) and 92.9%% (95% CI: 85.7-96.7%), respectively by using the cut-off provided by the manufacturer. After cut-off optimization (i.e. >2.81 for IgM and >4.86 for IgG), the sensitivity for IgM and IgG were 81.6 (95% CI: 72.7-88.1%) and 95.9% (95% CI: 89.4-98.7%), respectively. Optimized cut-off for IgG improved the sensitivity to reach 100% (95%CI: 87.6-100) from 28 days since symptom onset.
CONCLUSIONS: This study shows that the iFlash® SARS-CoV-2 assay from YHLO biotechnology, has satisfactory analytical performance. Nevertheless, the sensitivity of the IgM is limited for a proper clinical use compared to IgG. The determination of anti-SARS-CoV-2 IgG antibodies from 28 days since symptom onset was associated with high sensitivity, especially using optimized cut-offs (i.e. 100%).
langue originale | Anglais |
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Pages (de - à) | 23-27 |
Nombre de pages | 5 |
journal | Clinical biochemistry |
Volume | 86 |
Date de mise en ligne précoce | 2020 |
Les DOIs | |
Etat de la publication | Publié - déc. 2020 |
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The COVILAB project : Clinical laboratory investigations related to COVID-19
Douxfils, J. (Promoteur), Dogné, J.-M. (Co-Promoteur), FAVRESSE, J. (Co-investigateur), Tre-Hardy, M. (Co-investigateur), Mullier, F. (Co-investigateur), Haguet, H. (Chercheur), Hardy, M. (Chercheur), Melchionda, S. (Chercheur), BOUVY, C. (Chercheur), Morimont, L. (Chercheur), Gillot, C. (Chercheur), Djokoto, H. (Chercheur), Alpan, L. (Technicien), Devel, P. (Technicien), Modaffari, E. (Technicien) & Maloteau, V. (Technicien)
13/03/20 → …
Projet: Recherche