Covid-19 Testing
Conditions
Keywords
Covid-19, Antigen, Rapid, Test
Brief 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.
Interventions
DIAGNOSTIC_TESTBiozek Covid-19 Antigen Rapid Test (Saliva)
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.
Sponsors
Mach-E B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva) | 6 months | 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. |
| Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab) | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 185 |
| Total | 185 |
Baseline characteristics
| Characteristic | BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) |
|---|---|
| Age, Customized 18-24 years | 36 Participants |
| Age, Customized 25-64 years | 128 Participants |
| Age, Customized 65-87 years | 19 Participants |
| Age, Customized Unknown | 2 Participants |
| Race/Ethnicity, Customized Arabic | 1 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants |
| Race/Ethnicity, Customized Black | 51 Participants |
| Race/Ethnicity, Customized Caucasian | 74 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 31 Participants |
| Race/Ethnicity, Customized Indian | 1 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants |
| Race/Ethnicity, Customized Pacific Islander | 4 Participants |
| Race/Ethnicity, Customized Unknown | 10 Participants |
| Region of Enrollment United States | 185 participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 185 |
| other Total, other adverse events | 0 / 185 |
| serious Total, serious adverse events | 0 / 185 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) | Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab) | Sensitivity | 97.8 percentage - Sensitivity and specificity |
| BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) | Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab) | Specificity | 100 percentage - Sensitivity and specificity |
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.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) | Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva) | Sensitivity | 97.5 percentage - Sensitivity and specificity |
| BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid) | Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva) | Specifity | 100 percentage - Sensitivity and specificity |