Evaluation of the performance of novel rapid diagnostics for COVID-19 at point-of-care

• Conditions: COVID-19; U07.1; COVID-19, virus identified

• Registration Number: DRKS00021220
• Lead Sponsor: niversitätsklinikum Heidelberg Sektion Klinische Tropenmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study Completion: 2021-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 11368

Inclusion Criteria

Suspected COVID-19 cases; preselected by local Public Health department

Exclusion Criteria

o Hemodynamic instability as determined by the treating physician
o Patient unable to cooperate with respiratory sample collection
o Patient unable to give informed consent
o Recent history of excessive nose bleeds

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using an RT-PCR reference standard

Secondary Outcome Measures

Name	Time	Method
1. Time to proficiency, implementation issues, design related issues at POC<br><br>2. Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using an RT-PCR reference standard<br><br>3. Survival analysis for the outcome of death within 2-3 months by COVID and Antigen test status