Notice of Intent to Sole Source - Meridian Bioscience -

This intended procurement is for An Enzyme Immunoassay for the detection of rotavirus antigen in human fecal samples. These supplies will support detection of rotavirus infection by supplying reagent inventory to the International Reagents Resource, (IRR), created by the CDC to support global surveillance of emerging pathogens and emergency response through centralized distribution of diagnostic test kits.

As the surveillance for enteric viruses progresses, CDC requires validated and quality controlled assays to test samples for rotavirus disease, prevention, and control. PREMIER Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of rotavirus antigen in human fecal specimens. The Rotavirus Surveillance and Molecular Epidemiology Team (RSMET) at CDC is the Global Reference Laboratory (GRL) for the World Health Organization (WHO)-coordinated Global Rotavirus Surveillance Network (GRSN).

RSMET provides reagents and supplies to GRSN labs through the IRR at no cost for rotavirus surveillance projects. Supplying these kits to the IRR continues to support CDC’s surveillance and study of enteric viruses. The Meridian Bioscience Premiere Rotaclone EIA kit is the only available EIA kit that has been validated for use in the CDC rotavirus detection assay and is necessary for program continuity.