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The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05846360
Collaborator
(none)
120
Enrollment
1
Location
4.9
Anticipated Duration (Months)
24.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is for the research team to become familiar with and evaluate the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer by testing 120 archived specimens that were previously tested at the Wisconsin State Laboratory of Hygiene (WSLH) by RT-PCR and multiplex respiratory pathogen panel within the last year.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To test the technical and operational performance of the QuidelOrtho Savanna RVP4 analyzer, the investigator proposes to test samples archived from the ORegon CHild Absenteeism due to Respiratory Disease Study (ORCHARDS) study (HSC 2013-1357), a study that had the goal to "develop and implement a system for daily school-based monitoring of ILI (influenza-like illness) and CLI (COVID-like illness) student absenteeism in kindergarten (K) through grade 12 schools, and assess the system's usability for early detection of accelerated influenza, SARS-CoV-2 and other respiratory pathogen transmission in schools and surrounding communities".

    The deidentified paired (WSLH vs. Savanna RVP4) results will be used by QuidelOrtho Corporation to evaluate the technical and operational performance of the analyzer.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer
    Actual Study Start Date :
    May 5, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    ORCHARDS Study Specimens

    Archived ORCHARDS study specimens

    Outcome Measures

    Primary Outcome Measures

    1. Number of Samples with Matching Results [up to 6 months]

      There were a number of viruses detected in the ORCHARDS study [Ad, adenovirus; CoV, coronavirus; Flu, influenza virus; hMPV, human metapneumovirus; PIV, parainfluenza virus; R/E, rhinovirus/enterovirus; RSV, respiratory syncytial virus]. Reported here are the number of samples for which the Savanna RVP4 results match the WSLH results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Previously collected specimens from the ORCHARDS study.
    Exclusion Criteria:
    • Specimens not collected as part of the ORCHARDS study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin-Madison Madison Wisconsin United States 53705

    Sponsors and Collaborators

    • University of Wisconsin, Madison

    Investigators

    • Principal Investigator: Jonathan Temte, MD, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT05846360
    Other Study ID Numbers:
    • 2023-0318
    • SMPH/FAMILY MED/CLINIC WINGRA
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 9, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Virus Diseases

    Study Results

    No Results Posted as of May 9, 2023