POC SARS-CoV-2 Diagnostic PCR Device Comparison to FDA Approved Reference PCR Test
- Conditions
- Covid19
- Registration Number
- NCT04981769
- Lead Sponsor
- Anavasi Diagnostics
- Brief Summary
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites.
- Detailed Description
Study will assess sensitivity and specificity of AnavasiDx POC PCR device for detection of Covid-19 in patients presenting for testing a clinical sites using a national laboratory PCR Covid-19 test as reference. This study is following FDA EUA molecular test approval criteria. Study will be conducted in 3 or more geographically diverse clinical sites.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Subjects presenting to clinical site for Covid-19 testing. Completion of signed written informed consent process.
Exclusion Criteria
- Inability to complete signed written informed consent process. Younger than 2 years of age. Any contraindication to Covid-19 swab testing
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Covid-19 PCR test result 90 minutes Molecular Covid-19 testing
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does the AnavasiDx POC PCR device use to detect SARS-CoV-2 viral RNA?
How does the AnavasiDx POC PCR device compare to RT-PCR assays like those from Thermo Fisher or Roche in terms of sensitivity and specificity for SARS-CoV-2 detection?
What are the key biomarkers used for patient selection in point-of-care PCR testing for SARS-CoV-2 compared to FDA-approved reference tests?
Are there any known false negative/positive rates or cross-reactivity issues with the AnavasiDx POC PCR device in diverse patient populations?
What are the advantages of point-of-care PCR testing over centralized lab-based RT-PCR for SARS-CoV-2 in clinical settings?