A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients
NCT ID: NCT02862262
Last Updated: 2018-10-04
Study Results
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Basic Information
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COMPLETED
NA
1052 participants
INTERVENTIONAL
2016-07-31
2016-11-14
Brief Summary
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Detailed Description
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Clinical nasopharyngeal swab specimens collected using nasopharyngeal swab in transport media will be processed according to the routine procedure followed at the clinical collection site and as ordered by the referring physician. The leftover specimen will be blinded and assigned a unique clinical study specimen number. In order to preserve the confidentiality of subjects, the following procedures will be implemented at each site:
* Clinical specimens will be individually numbered by an honest broker who is not involved in investigational testing so that the identity of the subject may not be readily ascertained by the investigator, investigational testing staff, or study Sponsor.
* Available clinical information accompanying the specimens will be provided in such a way that it does not make the specimen source identifiable to the investigator or any other individuals associated with investigational testing, including the Sponsor.
* No personal identifier (protected health information) will be included on the case report form (CRF) so that the confidentiality of each subject is protected.
Multiple aliquots of each left-over specimen will be generated. One aliquot of each specimen will be shipped to a laboratory where the reference method (two validated real-time PCR methods for each, B. pertussis and B. parapertussis) will be performed. A second aliquot of each specimen will be used by the clinical sites for ARIES Bordetella Assay testing. Additional aliquots of each specimen will be stored frozen (-65 to -95°C) at the clinical sites and sent separately on dry ice to the Sponsor upon Sponsor's request.
The prospective data set will be supplemented with banked, pre-selected clinical specimens and contrived specimens that tested positive by a comparator method for B. pertussis and B. parapertussis. If contrived specimens are required, these specimens will be prepared then blinded, aliquoted, randomized and frozen (-65 to -95°C) until distributed to the clinical testing sites by the Sponsor.
The clinical data will be automatically generated from the ARIES System software. The system will report the specimen as B. pertussis and B. parapertussis positive (Co-infection), B. pertussis positive, B. parapertussis positive, B. pertussis and B. parapertussis negative or Invalid. Invalid results will be retested and both the original data and the retest data will be reported. The clinical data will be compared to the reference data and recorded in the clinical study reports.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
Arm 1: Blinded, Prospective Arm Primary arm comprised of prospectively collected, de-identified, left-over nasopharyngeal swab specimens.
Arm 2: Blinded, Pre-selected Arm Because both B. pertussis and B. parapertussis exhibited low prevalence rates in the prospective study cohort, the prospective sample set was supplemented with banked (pre-selected) positive specimens collected at selected sites.
Arm 3: Contrived Specimens Because the number of B. parapertussis positive clinical specimens tested in Arm 1 and Arm 2 of the study was insufficient for accurate estimate of positive percent agreement (PPA) for this target, fifty (50) contrived specimens spiked with relevant B. parapertussis strains at different levels were also prepared. The analyte concentrations covered clinically relevant titers.
DIAGNOSTIC
NONE
Study Groups
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Blinded, Prospective Arm (1)
Clinical performance of the ARIES Bordetella Assay for the detection of B. pertussis and B. parapertussis will be evaluated in prospectively collected, de-identified, left-over, clinical specimens.
ARIES Bordetella Assay
Blinded, Pre-selected Arm (2)
In the event that an insufficient number of positive specimens are acquired for B. pertussis / B. parapertussis in Arm 1, clinical performance of the ARIES Bordetella Assay will be tested using banked, pre-selected, positive clinical specimens.
ARIES Bordetella Assay
Blinded, Contrived Arm (3)
Contrived specimens will be tested using the ARIES Bordetella Assay to evaluate detection of B. parapertussis in the event that an insufficient number of positive specimens are acquired in Arm 2.
ARIES Bordetella Assay
Interventions
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ARIES Bordetella Assay
Eligibility Criteria
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Inclusion Criteria
2. The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinica or resident of a long term care facility.
3. The specimen is from a patient for whom a requisition has been made for B. pertussis and/or B. parapertussis testing.
4. The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection consistent with B. pertussis or B. parapertussis.
5. The specimen was received in good condition (no leakage or drying of the specimen).
6. The specimen contains a minimum volume of 1000 μL.
Exclusion Criteria
2. The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 10 below.
3. The specimen volume is \<1000 μL.
4. Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.
ALL
No
Sponsors
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Luminex Molecular Diagnostics
INDUSTRY
Responsible Party
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Principal Investigators
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Ronald Dunn
Role: STUDY_DIRECTOR
Luminex Molecular Diagnostics
Timothy S Uphoff, PhD
Role: PRINCIPAL_INVESTIGATOR
Marshfield Labs
Stephen Young, PhD
Role: PRINCIPAL_INVESTIGATOR
Tricore Reference Lab
Ryan Relich, PhD
Role: PRINCIPAL_INVESTIGATOR
IU Health Pathology Laboratory
Ted E Schutzbank, PhD
Role: PRINCIPAL_INVESTIGATOR
St. John Hospital & Medical Center
Amy L Leber, PhD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital Laboratory
Locations
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Indiana University Health
Indianapolis, Indiana, United States
St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Tricore
Albuquerque, New Mexico, United States
Nationwide Children's Hospital Laboratory
Columbus, Ohio, United States
Marshfield Labs
Marshfield, Wisconsin, United States
Luminex Molecular Diagnostics
Toronto, Ontario, Canada
Countries
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References
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Relich RF, Leber A, Young S, Schutzbank T, Dunn R, Farhang J, Uphoff TS. Multicenter Clinical Evaluation of the Automated Aries Bordetella Assay. J Clin Microbiol. 2019 Jan 30;57(2):e01471-18. doi: 10.1128/JCM.01471-18. Print 2019 Feb.
Other Identifiers
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LMA-BRD-01-CS-001
Identifier Type: -
Identifier Source: org_study_id
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