The Technical and Operational Performance of the QuidelOrtho Savanna RVP4 Analyzer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05846360

Enrollment

120

Registered

2023-05-06

Start date

2023-05-05

Completion date

2023-10-10

Last updated

2023-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Viral Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Previously collected specimens from the ORCHARDS study.

Exclusion criteria

* Specimens not collected as part of the ORCHARDS study.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results