A multi-target lateral flow immunoassay enabling the specific and sensitive detection of total antibodies to SARS COV-2

一种多目标横向流动免疫测定法,能够特异性和灵敏地检测 SARS COV-2 总抗体

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作者:Simone Cavalera, Barbara Colitti, Sergio Rosati, Gianmarco Ferrara, Luigi Bertolotti, Chiara Nogarol, Cristina Guiotto, Celeste Cagnazzo, Marco Denina, Franca Fagioli, Fabio Di Nardo, Matteo Chiarello, Claudio Baggiani, Laura Anfossi

Abstract

A rapid test for detecting total immunoglobulins directed towards the nucleocapsid protein (N) of severe acute syndrome coronavirus 2 (SARS CoV-2) was developed, based on a multi-target lateral flow immunoassay comprising two test lines. Both test lines bound to several classes of immunoglobulins (G, M, and A). Specific anti-SARS immunoglobulins were revealed by a colorimetric probe formed by N and gold nanoparticles. Targeting the total antibodies response to infection enabled achieving 100% diagnostic specificity (95.75-100, C.I. 95%, n = 85 healthy and with other infections individuals) and 94.6% sensitivity (84.9-98.9, C.I. 95%, n = 62 SARS CoV-2 infected subjects) as early as 7 days post confirmation of positivity. Agreeing results with a reference serological ELISA were achieved, except for the earlier detection capability of the rapid test. Follow up of the three seroconverting patients endorsed the hypothesis of the random rise of the different immunoglobulins and strengthened the 'total antibodies' approach for the trustworthy detection of serological response to SARS CoV-2 infection.

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