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| Name | Class |
|---|---|
| Syntactx | NETWORK |
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The purpose of this study is to determine if the TekiTrust Enzyme-Linked Immunosorbent Assay (ELISA) Kit and TekiTrust Rapid Test can accurately determine the amount of antibodies to fight the COVID-19 virus in sampled blood compared to the standard Plaque Reduction Neutralization Test (PRNT) test.
When a person has COVID-19 they develop antibodies to the virus which are contained in their blood stream. After a certain period, the number of antibodies to fight (neutralize) the virus begin to decrease. One common way to measure the amount of antibodies in the blood is to use a test called the PRNT. The focus of this study is to compare the ability of the TekiTrust ELISA Kit and the TekiTrust Rapid Test with the PRNT to determine if these tests can measure the antibodies equally well.
Participants who have been previously diagnosed with COVID-19 within the past 3 months through any FDA emergency use approved (EUA) assay test will eligible for inclusion in the study. A blood and fingerstick sample will be obtained from the participant and for subjects with a positive test and symptom onset of less than 30 days a repeat RT-PCR nasal pharyngeal swab sample will be taken. The fingerstick sample will be used onsite by qualified site staff to test the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test. These results will be compared to the whole blood sample sent to the lab which will be analysed for SARS CoV-2 neutralizing antibodies using the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit and the comparator Plaque Reduction Neutralization Test (PRNT) test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current COVID-19 symptoms or SARS-CoV-2 in the last 30 days with a positive RT-PCR test | 75 subjects will be enrolled who were diagnosed as SARS-CoV-2 with a positive RT-PCR nasal pharangeal test or are suspected of having a COVID-19 infection with symptom onset in the last 30 days. (Symptom onset 0-30 days) This group of subjects will receive:
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| Diagnosed with SARS-CoV-2 (COVID-19) in the past 3 months with a positive RT-PCR test | 30 subjects will be enrolled who have been diagnosed with COVID-19 in the past 3 months and had a prior positive RT-PCR nasal pharangeal test. (Symptom onsent 31-90 days) This group of subjects will receive:
|
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical agreement between TekiTrust SARS-CoV-2 Neutralizing Antibody ELISA Kit and Rapid Detection test and the comparator PRNT assay. |
| Day one |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: adverse events | Number of adverse events related to blood sample testing in tested participants. | Single study visit |
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Inclusion Criteria:
Exclusion Criteria:
1. Any significant medical, psychological, or social condition which in the opinion of the investigator may preclude the subject from participating in the trial
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| Name | Affiliation | Role |
|---|---|---|
| Jay Hahn, PhD | MiCo BioMed | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mississippi State University | Starkville | Mississippi | 39762 | United States | ||
| Joy Internal Medicine |
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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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| Englewood Cliffs |
| New Jersey |
| 07632 |
| United States |
| WellNow Urgent Care | Cincinnati | Ohio | 45215 | United States |
| WellNow Urgent Care | Columbus | Ohio | 43214 | United States |
| WellNow Urgent Care | Dayton | Ohio | 45424 | United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |