Diagnostic Assay to Detect Group C Rotavirus in Humans and Animals—Monoclonal Antibody-based ELISA (Enzyme-linked Immunosorbent Assay)

Rotaviruses cause severe gastroenteritis in humans and animals globally. Currently, there are eight known serogroups (A-H) of rotaviruses. Group C rotavirus (GpC RV) causes sporadic cases and outbreaks of acute diarrhea in children and adults worldwide. GpC RV is also associated with diarrhea in swine. Currently, no simple and reliable diagnostic test exists for GpC RV, so disease prevalence remains unknown.

CDC has developed a monoclonal antibody (mAb) against the GpC RV VP6 protein. Scientists used the mAb to develop an immunoassay with sensitivity and specificity to human and animal GpC rotavirus, but not with GpA rotavirus, adenovirus, astrovirus, and other enteric viruses. We evaluated and validated this ELISA by testing fecal samples from children who were admitted to hospitals for treatment of diarrhea with nested PCR using primers specific to GpC rotavirus VP7 protein.

With the implementation of widespread vaccine campaigns against group A rotavirus—a once highly prevalent serogroup—and the reduction of GpA RV infection among children worldwide, other gastrointestinal virus agents like this GpC RV may emerge. This technology offers a simple and reliable diagnostic test for determining GpC RV disease incidence in the post-introduction era of GpA RV vaccines. CDC’s new assay may allow us to determine the burden of GpC RV disease in humans and animals.