Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- detection of viral infection using serology and viral-RNA detection kits
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.
Detailed Description
The investigators hypothesize that viral-RNA test using sputum will be equally efficient as the test performed in NP swab. Moreover, the serology test and the PCR-based test will be comparable in efficacy for detection of infection
Investigators
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation
Eligibility Criteria
Inclusion Criteria
- •• Male or female over 18 years of age at the time of enrollment
- •Current symptoms of COVID-19 ; fever alone or fever and at least one of the following symptoms need to be present
- •Dry cough
- •Sore throat
- •Shortness of breath
- •Muscle pain
- •New loss of taste or smell
- •Chills with repeated shaking
Exclusion Criteria
- •• Unwilling to provide informed consent
- •Unwilling to undergo bi-weekly serological test during the 1-month enrollment
Outcomes
Primary Outcomes
detection of viral infection using serology and viral-RNA detection kits
Time Frame: 1 day
Detection of viral infection in the two test platforms using 3 specimen (blood, nasal swab and sputum) from the same subject, in detecting COVID-19 infection
Secondary Outcomes
- Temporal trend of antibodies in blood(1 month)