The new research assays provide flexible options for detecting the Cyclospora cayetanensis parasite and other gastrointestinal pathogens.
Roche, in collaboration with its subsidiary TIB MOLBIOL, has released two new research polymerase chain reaction (PCR) testing options designed to help laboratories address the impact of the Cyclospora cayetanensis parasite.
The release comes as a cyclospora outbreak continues to spread across the United States. Cyclospora cayetanensis is a food and waterborne parasite that can cause serious gastrointestinal illness, including severe diarrhea, fatigue, and cramping, which can increase pressure on local emergency departments.
“Understanding disease outbreaks and how they spread can have a huge impact on public health,” says Dan Malarek, president and CEO, Roche Diagnostics North America, in a release. “Our robust testing infrastructure and strong scientific partnerships enable us to provide solutions that help labs rapidly respond to evolving public health needs.”
The two new offerings are designed for use with the LightCycler 480 and LightCycler PRO instruments. The LightMix Modular Cyclospora assay is for the specific detection of cyclospora using hydrolysis probe chemistry. The second option, the LightMix OneTube Gastro Para 2 assay, features multiplex, real-time PCR detection of Entamoeba histolytica, Giardia, Dientamoeba fragilis, Cryptosporidium, Blastocystis, and Cyclospora cayetanensis.
These tests join an existing assay, the UC-TIB-Gastro-PARA-2, which is a multiplex, real-time PCR test for high-throughput research. That assay detects Dientamoeba fragilis, Blastocystis hominis, and Cyclospora cayetanensis in a single reaction and is used with the cobas 5800, 6800, and 8800 systems.
“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,” says Marcus Droege, CEO of TIB MOLBIOL, in a release.
TIB MOLBIOL develops these assays for research use with LightCycler instruments and the cobas omni utility channel. This channel is an open channel on the cobas 5800, 6800, and 8800 systems that allows laboratories to consolidate research testing with Roche in vitro diagnostic assays on a single platform. Roche acquired TIB MOLBIOL in December 2021 to expand its PCR test portfolio for infectious diseases.
The LightMix Modular Cyclospora assay, the LightMix OneTube Gastro Para 2 assay, and the UC-TIB-Gastro-PARA-2 assay are for research use only and are not for use in diagnostic procedures.
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