The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer

NCT ID: NCT05846360

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-05

Study Completion Date

2023-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Viral Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ORCHARDS Study Specimens

Archived ORCHARDS study specimens

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Previously collected specimens from the ORCHARDS study.

Exclusion Criteria

* Specimens not collected as part of the ORCHARDS study.
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonathan Temte, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Temte JL, Barlow S, Goss M, Temte E, Bell C, He C, Hamer C, Schemmel A, Maerz B, Comp L, Arnold M, Breunig K, Clifford S, Reisdorf E, Shult P, Wedig M, Haupt T, Conway J, Gangnon R, Fowlkes A, Uzicanin A. The Oregon Child Absenteeism Due to Respiratory Disease Study (ORCHARDS): Rationale, objectives, and design. Influenza Other Respir Viruses. 2022 Mar;16(2):340-350. doi: 10.1111/irv.12920. Epub 2021 Oct 8.

Reference Type BACKGROUND
PMID: 34623760 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SMPH/FAMILY MED/CLINIC WINGRA

Identifier Type: OTHER

Identifier Source: secondary_id

2023-0318

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.