NCT05846360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

May 5, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

April 26, 2023

Last Update Submit

October 25, 2023

Conditions

Respiratory Viral Infection

Outcome Measures

Primary Outcomes (1)

  • Number of Samples with Matching Results

    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.

    up to 6 months

Study Arms (1)

ORCHARDS Study Specimens

Archived ORCHARDS study specimens

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

School-aged children

You may qualify if:

  • Previously collected specimens from the ORCHARDS study.

You may not qualify if:

  • Specimens not collected as part of the ORCHARDS study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • 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.

    PMID: 34623760BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal swabs

Study Officials

  • Jonathan Temte, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

May 5, 2023

Primary Completion

August 24, 2023

Study Completion

October 10, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)