Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

AuNP Coupled Rapid Flow-Through Dot-Blot Immuno-Assay for COVID-19 (SARS-CoV-2) Explicit IgG Antibody Revelation

Version 1 : Received: 18 April 2021 / Approved: 20 April 2021 / Online: 20 April 2021 (11:36:09 CEST)

How to cite: Sil, B.K.; Jamiruddin, M.R.; Haq, M.A.; Khondoker, M.U.; Jahan, N.; Khandker, S.S.; Ali, T.; Oishee, M.J.; Kaitsuka, T.; Mie, M.; Tomizawa, K.; Kobatake, E.; Haque, M.; Adnan, N. AuNP Coupled Rapid Flow-Through Dot-Blot Immuno-Assay for COVID-19 (SARS-CoV-2) Explicit IgG Antibody Revelation. Preprints 2021, 2021040534 (doi: 10.20944/preprints202104.0534.v1). Sil, B.K.; Jamiruddin, M.R.; Haq, M.A.; Khondoker, M.U.; Jahan, N.; Khandker, S.S.; Ali, T.; Oishee, M.J.; Kaitsuka, T.; Mie, M.; Tomizawa, K.; Kobatake, E.; Haque, M.; Adnan, N. AuNP Coupled Rapid Flow-Through Dot-Blot Immuno-Assay for COVID-19 (SARS-CoV-2) Explicit IgG Antibody Revelation. Preprints 2021, 2021040534 (doi: 10.20944/preprints202104.0534.v1).

Abstract

Background: Flow-through dot-blot assay (FT-DBA) for SARS-CoV-2 specific IgG detection will provide a reliable and affordable immunoassay for the rapid serosurveillance against COVID-19. Method: SARS-CoV-2 antigens were immobilized on nitrocellulose membrane to capture IgG immunoglobulins, which were then detected with AuNP anti-human IgG. A total of 181 samples were characterized with in-house and commercial immunoassay. The positive panel consisted of RT-PCR positive samples from patients with both <14 days and >14 days from the onset of symptoms, while the negative panel contained samples collected either from the pre-pandemic era dengue patients from healthy donors during the pandemic period. Results: In-house ELISA selected a total of 79 true seropositive and 100 seronegative samples. The sensitivity of samples with <14 days using FT-DBA was 94.7% which increased to 100% for samples >14 days. The overall detection sensitivity and specificity were 98.8% and 98%, respectively, whereas the overall PPV and NPV were 97.6% and 99%. Moreover, comparative analysis between ELISA and FT-DBA revealed clinical agreement of Cohen’s Kappa value of 0.944. Conclusion: The assay can confirm past SARS-CoV-2 infection with high accuracy within 2 minutes compared to ELISA. It can help track SARS-CoV-2 disease progression, population screening, and vaccination response.

Subject Areas

COVID-19, SARS-CoV-2, Serological test, Sensitivity, Specificity, Serosurveillance.

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