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NCT05846360 Clinical Trial

The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer

Respiratory Viral Infection Clinical Trial

Official title:
The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05846360
Other study ID # 2023-0318
Secondary ID SMPH/FAMILY MED/
Status Completed
Phase
First received
Last updated
Start date May 5, 2023
Est. completion date October 10, 2023

Study information
Verified date October 2023
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date October 10, 2023
Est. primary completion date August 24, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria: - Previously collected specimens from the ORCHARDS study. Exclusion Criteria: - Specimens not collected as part of the ORCHARDS study.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Wisconsin-Madison Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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