Rapid Diagnostic Test for COVID-19 Based on Antibody Detection (YCOVID) (YCOVID)

Rapid Diagnostic Test for COVID-19 Based on Antibody Detection

Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices. This test will be developed using innovative technology developed at the Parc Taulí University Hospital, which increases the immunogenicity of SARS-CoV-2 differential antigens. The increased immunogenicity of these antigens will allow to detect, with a high sensitivity and specificity, the antibodies in the serum of patients infected with SARS-CoV-2. This test will serve to confirm dubious results as well as reduce false negatives from the PCR test, which will ultimately help reduce transmission of the infection.

Study Overview

• Status: Completed
• Conditions: Covid-19
• Intervention / Treatment: Diagnostic test: ELISA and Rapid test to detect antibodies against COVID-19

• Study Type: Observational
• Enrollment (Actual): 3500

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Parc Tauli University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with COVID-19 infection Professionals of an University Hospital

Description

Inclusion Criteria:

• Professional from Parc Taulí University Hospital
• Patients with clinical, radiological and/or PCR COVID-19 positive

Exclusion Criteria:

• Patients or professionals who do not sign informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 positive; Patients with clinical, radiological and/or PCR positive for COVID-19 infection	Diagnostic test: ELISA and Rapid test to detect antibodies against COVID-19; Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices
Normal; Normal human serum from blood donnors before COVID-19 pandemia	Diagnostic test: ELISA and Rapid test to detect antibodies against COVID-19; Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices
Pathological controls; Patients with other positive virological serologies	Diagnostic test: ELISA and Rapid test to detect antibodies against COVID-19; Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IgG anti-COVID-19	IgG antibodies against COVID-19 RBD	From May to July
IgM anti-COVID-19	IgM antibodies against COVID-19 RBD	From May to July
IgA anti-COVID-19	IgA antibodies against COVID-19 RBD	From May to July

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of onset symptoms		From May to July
COVID-19 PCR results	Qualitative result to clasify patients into PCR COVID-19 positive patients and PCR COVID-19 negative patients	From May to July
Radiological studies	The presence or abcense of the typical image of the pneumonia caused by COVID-19	From May to July

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Covid-19; Antibodies; Rapid test; RBD
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 2020/587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No