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Antigen Test

At least 30 children between 2 - 13 years of age for COVID-19

N/A
Waitlist Available
Led By Enrique Villa, MD
Research Sponsored by BioTeke USA, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

Study Summary

This trialwill test the accuracy of a home COVID-19 test compared to a lab test, to see if it can be used safely in homes.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Negative Percent Agreement - Specificity
Positive Percent Agreement - Sensitivity

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subjects 14 - 90 years of ageExperimental Treatment3 Interventions
The subject will self collect and test using the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.
Group II: At least 30 children between 2 - 13 years of ageExperimental Treatment3 Interventions
Subjects less than 14 years of age, where the Parent or legal guardian collects a sample from their child (e.g., ages 2-13) and performs the Bio-Self COVID-19 antigen home test. The standard of care test and the RT-PCR test samples will be collected by the study team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bio-Self COVID-19 Antigen Home Test
2022
N/A
~290
Standard of Care COVID-19 Test
2022
N/A
~290
RT-PCR Test
2022
N/A
~1600

Find a Location

Who is running the clinical trial?

BioTeke USA, LLCLead Sponsor
CSSi Life SciencesIndustry Sponsor
6 Previous Clinical Trials
393 Total Patients Enrolled
4 Trials studying COVID-19
334 Patients Enrolled for COVID-19
Enrique Villa, MDPrincipal InvestigatorL&A Morales Healthcare
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying COVID-19
30 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
2022. "Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05334758.
~97 spots leftby Apr 2025
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