Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: diagnostic tests for COVID-19 infection


Participation Criteria
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Eligibility Criteria
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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 Chills Muscle pain Headache 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each subject will be tested using 3 different samples on two testing platforms (serology and viral-RNA detection)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Viral RNA test using nasopharyngeal swab<br> | Diagnostic Test: diagnostic tests for COVID-19 infection<br>* Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA<br>|
| Active Comparator: Viral RNA test using sputum<br> | Diagnostic Test: diagnostic tests for COVID-19 infection<br>* Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA<br>|
| Active Comparator: Serology test using blood<br> | Diagnostic Test: diagnostic tests for COVID-19 infection<br>* Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of viral infection using serology and viral-RNA detection kits | 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 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temporal trend of antibodies in blood | Temporal trend of the IgM and IgG production in response to the infection by conducting serial serology tests at bi-weekly interval | 1 month |