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This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on samples collected by a healthcare professional versus self-collection; 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 | Diagnostic Test | The BIOZEK COVID-19 Antigen Rapid Test is used for the detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals who are suspected of having COVID-19. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals. | The Biozek Antigen Rapid Tests performed by the trained study personnel on the samples collected by the trained study personnel. Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula. | 1 visit, up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples. | The Biozek Antigen Rapid Tests self-performed performed by the subject on the self - collected samples by the subjects. Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula. | 1 visit, up to 2 hours |
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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 |
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Single site study was performed by Mobile Covid Services, a COVID-19 testing concierge service. Enrollment and testing took place at the subject's home. The Enrollment population consisted of symptomatic and asymptomatic subjects scheduled for an appointment to perform an RT-PCR test for SARS-CoV-2 as the standard of care procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | BIOZEK COVID-19 Antigen Rapid Test | BIOZEK COVID-19 Antigen Rapid Test as compared to standard testing technique. Test performed by a professional versus self-collection and standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BIOZEK COVID-19 Antigen Rapid Test | BIOZEK COVID-19 Antigen Rapid Test as compared to standard testing technique. Test performed by a professional versus self-collection and standard of care. |
| 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 on a Sample Collected by Healthcare Professionals. | The Biozek Antigen Rapid Tests performed by the trained study personnel on the samples collected by the trained study personnel. Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula. | One subject was excluded from the analysis due to inconclusive results. | Posted | Number | percentage - Sensitivity and specificity | 1 visit, up to 2 hours |
|
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 Test | No adverse events were reported. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zanetta Malanowska-Stega | Quality Research and Invention LLC | 6464001204 | 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 | Mar 5, 2021 | Feb 25, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2021 | Feb 25, 2023 | ICF_001.pdf |
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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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples. | The Biozek Antigen Rapid Tests self-performed performed by the subject on the self - collected samples by the subjects. Sensitivity was calculated using (TP/TP+FN)*100% formula. Specificity was calculated using (TN/TN+FP)*100% formula. | One subject was excluded from the analysis due to inconclusive results. | Posted | Number | percentage - Sensitivity and specificity | 1 visit, up to 2 hours |
|
|
|
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
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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 |