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

Study Overview
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Brief Summary
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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.

Official Title
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Rapid Diagnostic Test for COVID-19 Based on Antibody Detection

Conditions
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Covid-19

Intervention / Treatment
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* Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 positive<br>Patients with clinical, radiological and/or PCR positive for COVID-19 infection | Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19<br>* 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<br>|
| Normal<br>Normal human serum from blood donnors before COVID-19 pandemia | Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19<br>* 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<br>|
| Pathological controls<br>Patients with other positive virological serologies | Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibodies, RBD, Covid-19, Rapid test