COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Communicable Disease
- Coronavirus
- COVID-19
- Infectious Disease
- SARS COV2
- Virus
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subject that have experienced symptoms consistent with COVID-19 and have been tested at the point of care (POC) with a molecular diagnostic test (e.g. PCR or isothermal LAMP) or clinical diagnosis, and have been determined to be positive or negative will undergo testing for antibodies or antigen or viral RNA. Roughly three times more subjects testing negative for SARS-CoV-2 compared to positive subjects are expected to be tested from NP samples gathered at the POC by POC staff or self-swab.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
Two Nasopharyngeal (NP) swabs will be collected from opposite nares by health care professionals at the POC from minimally 155 subjects enrolled at a minimum of 2 point- of-care (POC) clinical sites. One swab will be tested for the presence of SARS-CoV-2 responsible for COVID -19 using antigen-based...
Two Nasopharyngeal (NP) swabs will be collected from opposite nares by health care professionals at the POC from minimally 155 subjects enrolled at a minimum of 2 point- of-care (POC) clinical sites. One swab will be tested for the presence of SARS-CoV-2 responsible for COVID -19 using antigen-based tests. A second swab will be placed in transport media and transferred to a laboratory for testing using a high sensitivity EUA real-time (RT) PCR assay as the comparator method and the Ct values used to determine positive or negative. The order of sample collection will be randomized. Minimally 35 positive and 120 negative NP specimens are required. Two to 4 health care professional operators per site, with a range of education and training, at a point of care setting will perform a COVID-19 Rapid test assay utilizing the Instructions for Use and/or Quick Reference Instruction. Sample Population: Men and women, age 18 and older, with symptoms consistent with SARS-CoV-2 infection (COVID-19). Outcome measures: 1) Sensitivity and specificity will be calculated for comparison of results between the Rapid test and the high sensitivity EUA real-time (RT) PCR assay comparator. 2) Evidence that a Health Care Professional (HCP) at Point of Care (POC) can safely and effectively utilize the Rapid test and the COVIDscanDX reader after reading the Instructions For Use (IFU) and/or brief instruction video. Antibody testing will be performed after PCR/antigen testing or after vaccination with and FDA EUA allowed SARS-CoV-2 vaccine. A finger-stick blood drop, nasopharyngeal swab or saliva sample in buffer is applied to a lateral flow test to measure either SARS-CoV-2 antigen or IgM and IgG antibodies either once or up to five times separated by a week for 35 days after vaccination. Follow-up tests may be performed to measure the longevity of the antibody response over time up to a year.
Tracking Information
- NCT #
- NCT04348864
- Collaborators
- Neuroganics Diagnostics LLC
- Artron Laboratories Inc
- Cellex, Inc.
- AllBio Science Inc.
- Investigators
- Principal Investigator: Donald Cooper, Ph.D. Neuroganics LLC
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