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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viral RNA test using nasopharyngeal swab | Active Comparator |
| |
| Viral RNA test using sputum | Active Comparator |
| |
| Serology test using blood | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diagnostic tests for COVID-19 infection | Diagnostic Test | Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA |
|
| 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 |
| 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 |
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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
Exclusion Criteria:
• Unwilling to provide informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MITRA Mohanty, MD | Contact | 5127842651 | mitra1989@gmail.com | |
| Deb Cardinal, RN MBA | Contact | 512) 807-3150 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Cardiac Arrhythmia Institute | Recruiting | Austin | Texas | 78705 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003955 | Diagnostic Tests, Routine |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Each subject will be tested using 3 different samples on two testing platforms (serology and viral-RNA detection)
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |