Diagnostic capture/detection antibody pairs specific for the Zika virus NS1 protein
1 in 3 infants infected with Zika virus (ZIKV) in utero will develop fetal abnormalities, while there is a reported 2.5- to 40-fold increase in acute flaccid paralysis rates during ZIKV outbreaks. ZIKV infection is also associated with the development of the incurable auto-immune neurological disorder Guillain-Barre syndrome. The increased rates of neurological complications in adults, and brain defects in fetuses and newborn infants resulted in the Zika virus been declared a public health emergency of international concern by the WHO and the U.S Department of Health and Human Services. ZIKV diagnosis is critical since Zika infections can display no symptoms or symptoms similar to other viral infections. ZIKV diagnostic tools are also important in tracking the spread of the infection and in developing treatments and vaccines. The current ZIKV diagnostic assays are either based on molecular ZIKV RNA amplification testing or serologic ZIKV-specific IgG/IgM testing. Molecular ZIKV diagnostic tests have low sensitivity and are mostly reliable only during the acute phase of infection (only lasts about 14 days) in symptomatic patients. Serologic ZIKV diagnostic tests have higher sensitivities but they have low specificity to ZIKV due to cross-reactivity to similar flaviviruses such as Dengue and West Nile viruses. The lack of reliable ZIKV diagnostic testing highlighted by the low sensitivity and specificity of the currently available ZIKV diagnostic kits has led to increased efforts aimed at developing improved diagnostic tests that can also be used at point-of-care facilities especially in regions where there is a high incidence of other similar flaviviruses such as Dengue and Chikungunya.
The technology is composed of a pair of engineered ZIKV NS1 protein capture and detection antibodies that are only specific to and bind with high affinity to the ZIKV NS1 protein. Thus, this invention has the potential to improve the specificity and sensitivity of serologic ZIKV diagnostic tests that rely on the capture and detection of ZIKV-specific antibodies in patient specimen samples.
- Enhances the specificity of the ZIKV serologic diagnostic testing by reducing cross-reactivity to other similar flaviviruses such as Dengue virus