The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer

Completed

• Conditions: Respiratory Viral Infection

• Registration Number: NCT05846360
• Lead Sponsor: University of Wisconsin, Madison

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.

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 Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-04-26
• Study Start: 2023-05-05
• Study First Posted: 2023-05-06
• Primary Completion: 2023-08-24
• Status Verified: 2023-10
• Study Completion: 2023-10-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Previously collected specimens from the ORCHARDS study.

Exclusion Criteria

• Specimens not collected as part of the ORCHARDS study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States