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Trial Outcomes & Findings for Study Utilizing BIOZEK COVID-19 Antigen Rapid Test (NCT NCT04926779)

NCT ID: NCT04926779

Last Updated: 2023-12-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

185 participants

Primary outcome timeframe

6 months

Results posted on

2023-12-20

Participant Flow

Participant milestones

Participant milestones
Measure
BIOZEK COVID-19 Antigen Rapid Test
BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) was performed by subjects on samples that were self-collected; In addition, RT-PCR test (performed prior enrollment) results were obtained.
Overall Study
STARTED
185
Overall Study
COMPLETED
185
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data was not captured for 3 participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid)
n=185 Participants
BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR.
Age, Customized
18-24 years
36 Participants
n=185 Participants
Age, Customized
25-64 years
128 Participants
n=185 Participants
Age, Customized
65-87 years
19 Participants
n=185 Participants
Age, Customized
Unknown
2 Participants
n=185 Participants
Sex: Female, Male
Female
111 Participants
n=182 Participants • Data was not captured for 3 participants.
Sex: Female, Male
Male
71 Participants
n=182 Participants • Data was not captured for 3 participants.
Race/Ethnicity, Customized
Arabic
1 Participants
n=185 Participants
Race/Ethnicity, Customized
Asian
12 Participants
n=185 Participants
Race/Ethnicity, Customized
Black
51 Participants
n=185 Participants
Race/Ethnicity, Customized
Caucasian
74 Participants
n=185 Participants
Race/Ethnicity, Customized
Hispanic/Latino
31 Participants
n=185 Participants
Race/Ethnicity, Customized
Indian
1 Participants
n=185 Participants
Race/Ethnicity, Customized
Native American
1 Participants
n=185 Participants
Race/Ethnicity, Customized
Pacific Islander
4 Participants
n=185 Participants
Race/Ethnicity, Customized
Unknown
10 Participants
n=185 Participants
Region of Enrollment
United States
185 participants
n=185 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid)
n=185 Participants
BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR.
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)
Sensitivity
97.5 percentage - Sensitivity and specificity
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)
Specifity
100 percentage - Sensitivity and specificity

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid)
n=185 Participants
BIOZEK COVID-19 Antigen Rapid Test performed by subjects on self-collected, oral fluid samples compared to RT-PCR.
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
Sensitivity
97.8 percentage - Sensitivity and specificity
Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
Specificity
100 percentage - Sensitivity and specificity

Adverse Events

BIOZEK COVID-19 Antigen Rapid Test (Oral Fluid)

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: 6462718593

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place