N/A
N=185
Study Utilizing BIOZEK COVID-19 Antigen Rapid Test
Covid-19 Testing
Bottom Line
View on ClinicalTrials.gov: NCT04926779 ↗Enrolled (actual)
185
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva) — 97.5; 100 percentage - Sensitivity and specificity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biozek Covid-19 Antigen Rapid Test (Saliva) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mach-E B.V.
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva) |
97.5; 100 | — |
| PRIMARY Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab) |
97.8; 100 | — |
Summary
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.
Eligibility Criteria
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:
- Currently experiencing symptoms of COVID-19.
- Be clinically diagnosed or suspected to have COVID-19.
- Recent past (3 weeks) exhibited symptoms of COVID-19.
- Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.
- Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection kit.
- Interacted with a COVID-19 positive individual.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria may not be enrolled in this study:
- Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
- Cannot perform self-collection of an oral fluid sample with use of oral fluid collection kit.
- Have a deviated nasal septum.
- Cognitively impaired individuals resulting in the inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT04926779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.