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

• DOI: 10.20944/preprints202008.0309.v1
• Publication Date: 2020-08-15T08:22:02Z
• Authors: Ankita Reddy; Irene Bosch; Nol Salcedo; Bobby Brooke Herrera; Helena de Puig; Carlos Narváez; Diana Maria Caice...; Ivette Lorenzana; Leda Parham; Kimberly García; Marcela Mercado; Angélica Maria Ri...; Luis Villar-Centeno; Margarita Gélvez-...; Natalia Andrea Gó...; Megan Hiley; Dawlyn García; Michael Diamond; Lee Gehrke
• Keywords: 0301 basic medicine; 610; Enzyme-Linked Immunosorbent Assay; Colombia; Antibodies, Viral; Microbiology; Sensitivity and Specificity; Article; E1/E2 antigen detection; 03 medical and health sciences; Viral Envelope Proteins; alphavirus; Humans; Serologic Tests; Chikungunya fever; Antigens, Viral; rapid diagnosis; Immunoassay; other; QR1-502; 3. Good health; acute phase diagnosis; Latin America; lateral flow; Honduras; Chikungunya Fever; ELISA; Chikungunya virus

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