Covid19
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTBIOZEK COVID-19 Antigen Rapid 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.
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. * 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 on a Sample Collected by Healthcare Professionals. | 1 visit, up to 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples. | 1 visit, up to 2 hours | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 84 |
| Total | 84 |
Baseline characteristics
| Characteristic | BIOZEK COVID-19 Antigen Rapid Test |
|---|---|
| Age, Customized Age 18 - 85 years | 84 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 39 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 84 participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 84 |
| other Total, other adverse events | 0 / 84 |
| serious Total, serious adverse events | 0 / 84 |
Outcome results
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.
Time frame: 1 visit, up to 2 hours
Population: One subject was excluded from the analysis due to inconclusive results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIOZEK COVID-19 Antigen Rapid Test | Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals. | Sensitivity - Test performed by trained study personnel | 100 percentage - Sensitivity and specificity |
| BIOZEK COVID-19 Antigen Rapid Test | Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on a Sample Collected by Healthcare Professionals. | Specifity - Test performed by trained study personnel | 98 percentage - Sensitivity and specificity |
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.
Time frame: 1 visit, up to 2 hours
Population: One subject was excluded from the analysis due to inconclusive results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIOZEK COVID-19 Antigen Rapid Test | Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples. | Sensitivity - Test performed by the subject | 100 percentage - Sensitivity and specificity |
| BIOZEK COVID-19 Antigen Rapid Test | Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test on Self - Collected Samples. | Specificity - Test performed by the subject | 98 percentage - Sensitivity and specificity |