Details

Autor(en) / Beteiligte

• Younes, Nadin
• Al-Sadeq, Duaa W
• Shurrab, Farah M
• Zedan, Hadeel T
• Abou-Saleh, Haissam
• Abo-Halawa, Bushra Y
• AlHamaydeh, Fatima M
• Elsharafi, Amira E
• Daas, Hanin I
• Thomas, Swapna
• Aboalmaaly, Sahar
• Al Farsi, Afra
• Al-Buainain, Reeham
• Ataelmannan, Samar
• Paul, Jiji
• Al Saadi, Amana Salih
• Yassine, Hadi M
• Majdalawieh, Amin F
• Ismail, Ahmed
• Abu-Raddad, Laith J
• Nasrallah, Gheyath K

Titel

Validation of a Novel Fluorescent Lateral Flow Assay for Rapid Qualitative and Quantitative Assessment of Total Anti-SARS-CoV-2 S-RBD Binding Antibody Units (BAU) from Plasma or Fingerstick Whole-Blood of COVID-19 Vaccinees

Ist Teil von

• Vaccines (Basel), 2022-08, Vol.10 (8), p.1318

Ort / Verlag

Switzerland: MDPI AG

Erscheinungsjahr

2022

Quelle

Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals

Beschreibungen/Notizen

• Background: Limited commercial LFA assays are available to provide a reliable quantitative measurement of the total binding antibody units (BAU/mL) against the receptor-binding domain of the SARS-CoV-2 spike protein (S-RBD). Aim: This study aimed to evaluate the performance of the fluorescence LFA FinecareTM 2019-nCoV S-RBD test along with its reader (Model No.: FS-113) against the following reference methods: (i) the FDA-approved GenScript surrogate virus-neutralizing assay (sVNT); and (ii) three highly performing automated immunoassays: BioMérieux VIDAS®3, Ortho VITROS®, and Mindray CL-900i®. Methods: Plasma from 488 vaccinees was tested by all aforementioned assays. Fingerstick whole-blood samples from 156 vaccinees were also tested by FinecareTM. Results and conclusions: FinecareTM showed 100% specificity, as none of the pre-pandemic samples tested positive. Equivalent FinecareTM results were observed among the samples taken from fingerstick or plasma (Pearson correlation r = 0.9, p < 0.0001), suggesting that fingerstick samples are sufficient to quantitate the S-RBD BAU/mL. A moderate correlation was observed between FinecareTM and sVNT (r = 0.5, p < 0.0001), indicating that FinecareTM can be used for rapid prediction of the neutralizing antibody (nAb) post-vaccination. FinecareTM BAU results showed strong correlation with VIDAS®3 (r = 0.6, p < 0.0001) and moderate correlation with VITROS® (r = 0.5, p < 0.0001) and CL-900i® (r = 0.4, p < 0.0001), suggesting that FinecareTM can be used as a surrogate for the advanced automated assays to measure S-RBD BAU/mL.