Two hundred and fifty six (256) retrospective sera from individuals of various ages and both genders were tested on the Dengue Early ELISA as part of an in-house study. The sera included samples from the following groups: 69 endemic negative specimens from Thailand, 144 non-endemic negative specimens from Australia and the USA and 43 positive specimens from patients in Honduras and Thailand with early dengue infection. These samples were masked and tested on Dengue Early ELISA. The results were compared as the positive and negative agreement to a commercially available dengue NS1 antigen detection assay.The data is summarised in Table 1.Table 1 Sensitivity and Specificity of Dengue Early ELISA
95% CI*Patients with early dengue infections
Agreement = 39/43 = 90.7% 77.9-97.4%Normal Patients (Endemic and Non-Endemic)
Agreementb = 212/212 = 100.0% 98.3-100.0%Total Agreement
= 251/255 = 98.4% 96.0-99.6%
a Retesting of equivocal sample was not conducted.
b Equivocal not included as retesting was not conducted.CROSS-REACTIVITY
A panel of 95 specimens from patients with confirmed diseases other than dengue was tested to establish the analytical specificity of the Dengue Early ELISA. The specimens were from patients with diseases that have potential for crossreactivity. Each of the specimens included in the study was characterised with respect to disease diagnosis prior to analysis with the Dengue Early ELISA. Minimal crossreactivity was observed across 95 specimens. Refer to Table 3 for a summary of results.