Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Development and Validation of A Rapid Lateral Flow E1/E2-Antigen Test and ELISA in Patients Infected with Emerging Asian Strain of Chikungunya Virus in The Americas

Version 1 : Received: 9 August 2020 / Approved: 14 August 2020 / Online: 14 August 2020 (04:55:47 CEST)

How to cite: Reddy, A.; Bosch, I.; Salcedo, N.; Herrera, B.B.; de Puig, H.; Narváez, C.; Maria Caicedo-Borrero, D.; Lorenzana, I.; Parham, L.; García, K.; Mercado, M.; Maria Rico Turca, A.; Villar-Centeno, L.; Gélvez-Ramirez, M.; Andrea Gómez Rios, N.; Hiley, M.; García, D.; Diamond, M.; Gehrke, L. Development and Validation of A Rapid Lateral Flow E1/E2-Antigen Test and ELISA in Patients Infected with Emerging Asian Strain of Chikungunya Virus in The Americas. Preprints 2020, 2020080309 (doi: 10.20944/preprints202008.0309.v1). Reddy, A.; Bosch, I.; Salcedo, N.; Herrera, B.B.; de Puig, H.; Narváez, C.; Maria Caicedo-Borrero, D.; Lorenzana, I.; Parham, L.; García, K.; Mercado, M.; Maria Rico Turca, A.; Villar-Centeno, L.; Gélvez-Ramirez, M.; Andrea Gómez Rios, N.; Hiley, M.; García, D.; Diamond, M.; Gehrke, L. Development and Validation of A Rapid Lateral Flow E1/E2-Antigen Test and ELISA in Patients Infected with Emerging Asian Strain of Chikungunya Virus in The Americas. Preprints 2020, 2020080309 (doi: 10.20944/preprints202008.0309.v1).

Abstract

Since its 2013 emergence in the Americas, chikungunya virus (CHIKV) has posed a serious threat to public health. Early and accurate diagnosis of the disease, though currently lacking in clinics, is integral to enable timely care and epidemiological response. We developed a dual detection system: a CHIKV antigen E1/E2-based enzyme-linked immunosorbent assay (ELISA) and a lateral flow test using high-affinity anti-CHIKV antibodies. The ELISA was validated with 100 PCR-tested acute Chikungunya fever samples from Honduras. The assay had an overall sensitivity and specificity of 51% and 96.67%, respectively, with accuracy reaching 95.45% sensitivity and 92.03% specificity at a Ct cutoff of 22. As the Ct value increased from 22, ELISA sensitivity decreased. We then developed and validated two lateral flow tests using independent antibody pairs. The sensitivity and specificity reached 100% for both lateral flow tests using 39 samples from Colombia and Honduras at Ct cutoffs of 20 and 27, respectively. For both lateral flow tests, sensitivity decreased as the Ct increased after 27. Because CHIKV E1/E2 are exposed in the virion surfaces in serum during the acute infection phase, these sensitive and specific assays demonstrate opportunities for early detection of this emerging human pathogen.

Subject Areas

Chikungunya fever; ELISA; lateral flow; E1/E2 antigen detection; alphavirus; Latin America; acute phase diagnosis; rapid diagnosis

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