New PCR Assays Expand Cyclospora Testing for Outbreak Surveillance

Cyclospora cayetanensis, a food- and waterborne intestinal parasite, can cause prolonged diarrhea, fatigue, and abdominal cramping, placing added strain on urgent care and emergency departments during outbreaks. As a multistate Cyclospora outbreak continues in the United States, laboratories face growing pressure to expand testing capacity and adapt molecular panels to different sample volumes and clinical needs. Rapid, reliable detection remains critical for surveillance and outbreak response. New real-time PCR assays now provide laboratories with additional options for detecting Cyclospora.

Roche, in collaboration with subsidiary TIB MOLBIOL, has introduced two research-use PCR assays for Cyclospora detection: LightMix Modular Cyclospora and LightMix OneTube Gastro Para 2. Both assays run on the LightCycler 480 and LightCycler PRO instruments and are positioned to address varied throughput and menu needs across U.S. laboratories during ongoing public health investigations.

The LightMix Modular Cyclospora assay is designed for specific detection of Cyclospora using hydrolysis probe chemistry in a real-time PCR format. For broader gastrointestinal parasite testing, the LightMix OneTube Gastro Para 2 assay enables multiplex real-time PCR detection of six targets in a single reaction: Entamoeba histolytica, Giardia, Dientamoeba fragilis, Cryptosporidium, Blastocystis, and Cyclospora cayetanensis.

These assays complement the existing UC-TIB-Gastro-PARA-2 multiplex test for high-throughput research, which detects Dientamoeba fragilis, Blastocystis hominis, and Cyclospora cayetanensis in a single reaction on the cobas 5800, 6800, and 8800 systems.

All three assays are designated Research Use Only and are not intended for diagnostic procedures. The portfolio is supported by the cobas omni utility channel, allowing laboratories to consolidate research assays alongside in vitro diagnostic (IVD) testing on the cobas 5800/6800/8800 systems and expand the range of testing available on a single platform.

“Understanding disease outbreaks and how they spread can have a huge impact on public health. Our robust testing infrastructure and strong scientific partnerships enable us to provide solutions that help labs rapidly respond to evolving public health needs,” said Dan Malarek, President and CEO, Roche Diagnostics North America.

“The cyclospora portfolio provides the option of panel size and platform type and the economics of one, three or six targets, offering flexible and cost-effective tests,” said Marcus Droege, CEO of TIB MOLBIOL.