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
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
DOI:
10.20944/preprints202008.0309.v1
Publication Date:
2020-08-15T08:22:02Z
AUTHORS (19)
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.
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