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This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biozek Covid-19 Antigen Rapid Test (Saliva) | Diagnostic Test | Self-collection of nasopharyngeal and saliva samples and self test performance - Biozek Covid-19 Antigen Rapid Test (Saliva) and Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab). Both procedures are supervised by trained study personnel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva) | The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula. | 6 months |
| Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab) | The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula. | 6 months |
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Inclusion Criteria:
Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.
Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria may not be enrolled in this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Covid Services LLC | Flushing | New York | 11354 | United States | ||
| Quality Research and Invention LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | BIOZEK COVID-19 Antigen Rapid Test | BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) was performed by subjects on samples that were self-collected; In addition, RT-PCR test (performed prior enrollment) results were obtained. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) | BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva) | The Biozek Antigen Rapid Tests performed by subjects on the self-collected, oral fluid samples . Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula. | Posted | Number | percentage - Sensitivity and specificity | 6 months |
|
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1 visit - up to 2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) | BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zanetta Malanowska-Stega | Quality Research and Invention LLC | 6462718593 | jstega@optonline.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2021 | Nov 4, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Southampton |
| New York |
| 11968 |
| United States |
| Participants |
|
| Sex: Female, Male | Data was not captured for 3 participants. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab) | The Biozek Antigen Rapid Tests performed by subjects on the self-collected, nasopharyngeal samples . Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula. | Posted | Number | percentage - Sensitivity and specificity | 6 months |
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| 0 |
| 185 |
| 0 |
| 185 |
| 0 |
| 185 |
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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 |
| D005247 | Feeding Behavior |
| D001519 | Behavior |