Trial Outcomes & Findings for Study Utilizing BIOZEK COVID-19 Antigen Rapid Test. (NCT NCT04805892)

Last Updated: 2023-06-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

84 participants

Primary outcome timeframe

1 visit, up to 2 hours

Results posted on

2023-06-29

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	84
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Utilizing BIOZEK COVID-19 Antigen Rapid Test.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BIOZEK COVID-19 Antigen Rapid Test n=84 Participants BIOZEK COVID-19 Antigen Rapid Test as compared to standard testing technique. Test performed by a professional versus self-collection and standard of care.
Age, Customized Age 18 - 85 years	84 Participants n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	39 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	84 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 visit, up to 2 hours

Population: One subject was excluded from the analysis due to inconclusive results.

Outcome measures

Outcome measures
Measure	BIOZEK COVID-19 Antigen Rapid Test n=83 Participants BIOZEK COVID-19 Antigen Rapid Test as compared to standard testing technique. Test performed by a professional versus self-collection and standard of care.
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
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 outcome

Timeframe: 1 visit, up to 2 hours

Population: One subject was excluded from the analysis due to inconclusive results.

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.

Outcome measures

Outcome measures
Measure	BIOZEK COVID-19 Antigen Rapid Test n=83 Participants BIOZEK COVID-19 Antigen Rapid Test as compared to standard testing technique. Test performed by a professional versus self-collection and standard of care.
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
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

Adverse Events

Biozek Covid-19 Antigen Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zanetta Malanowska-Stega

Quality Research and Invention LLC

Phone: 6464001204

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place