A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel
Launched by LUMINEX MOLECULAR DIAGNOSTICS · Mar 29, 2011
Trial Information
Current as of June 07, 2025
Completed
Keywords
ClinConnect Summary
The xTAG GPP assay is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify bacterial (and toxins), viral, and parasitic pathogens extracted from human stool specimens collected from patients with signs and symptoms of infectious colitis or gastroenteritis.
The objective of this study is to establish the diagnostic accuracy of xTAG GPP through a multi-site, method comparison study on prospectively collected, left-over, and anonymized stool specimens. The prospective sample set will also be supplemented with pre-selected archived left-over specimens (for l...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • The specimen is stool.
- • The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
- • The specimen is from a patient exhibiting clinical signs and symptoms of infectious colitis or gastroenteritis.
- Exclusion Criteria:
- • The specimen is a preserved stool, stool in Cary-Blair media or rectal swab.
About Luminex Molecular Diagnostics
Luminex Molecular Diagnostics is a leading biotechnology company specializing in the development and commercialization of innovative diagnostic solutions for healthcare providers. With a focus on enhancing patient outcomes through advanced molecular testing, Luminex leverages its proprietary xMAP Technology to deliver multiplex assays that facilitate the simultaneous detection of various pathogens and biomarkers. Committed to advancing precision medicine, the company collaborates with clinical laboratories and research institutions to provide reliable, high-quality diagnostics that empower clinicians with critical information for informed decision-making. Luminex's dedication to innovation and excellence positions it at the forefront of the molecular diagnostics field.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Temple, Texas, United States
Toronto, Ontario, Canada
Hamilton, Ontario, Canada
Tucson, Arizona, United States
Toronto, Ontario, Canada
St. Louis, Missouri, United States
Nashville, Tennessee, United States
Patients applied
Trial Officials
Jeremy Liu, Ph.D
Study Director
Luminex Molecular Diagnostics
Tony Mazzulli, M.D., F.R.C.P.(C), FACP
Principal Investigator
MOUNT SINAI HOSPITAL
Robert C. Fader, Ph.D
Principal Investigator
Scott and White Hospital & Clinic
James Mahony, Ph.D, FCCM, FAAM
Principal Investigator
St. Joseph's Hospital
Yi-Wei Tang, M.D., Ph.D
Principal Investigator
Vanderbilt University Medical Centre
Richard Buller, Ph.D., D(ABMM)
Principal Investigator
St. Louis Children's Hospital
Donna M. Wolk, Ph.D., D.(ABMM)
Principal Investigator
University of Arizona
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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