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OpenTrials
Completed

NCT Number: NCT05334758

Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test

The purpose of this study is to evaluate the performance of the Bio-Self COVID-19 Antigen Home Test. The study will evaluate the accuracy (sensitivity and specificity) in a simulated home use environment when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year–94 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

L&A Morales Healthcare, Inc., Miami, Florida, United States

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About this study

The Bio-Self COVID-19 Antigen Home Test is immunochromatographic and uses double-antibody sandwich method to detect SARS-CoV-2 antigen from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. The test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult collected anterior nares swab samples from individuals ages 2 to 13.

The primary objective of this study is to determine the accuracy of the Bio-Self COVID-19 Antigen Home Test when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • An Institutional Review Board (IRB) approved informed consent and assent, if applicable, is signed and dated prior to any study-related activities.
  • Male and female Subjects 2 years of age and older.
  • Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.)
  • Subject is willing to have a nasal swab collected by a healthcare professional.
  • Subject agrees to complete all aspects of the study.

Exclusion criteria

  • Subject has a visual impairment that cannot be restored with glasses or contact lenses.
  • Subject has prior medical or laboratory training.
  • Subject had a positive COVID-19 test in past three (3) months.
  • Subject uses home diagnostics, e.g., HIV Tests, glucose meters, etc.

Treatment and study plan

Bio-Self COVID-19 Antigen Home Test

Device

At home COVID-19 antigen test kit

Standard of Care COVID-19 Test

Device

Standard of care

RT-PCR Test

Diagnostic Test

High Sensitivity RT-PCR COVID-19 Test

Primary outcomes

  1. Positive Percent Agreement - Sensitivity

    Time frame: 48 hours

    The sensitivity is computed as the proportion of positive samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also positive as called by the Bio-Self COVID-19 Antigen Home Test.

  2. Negative Percent Agreement - Specificity

    Time frame: 48 hours

    The specificity is computed as the proportion of negative samples as called by the EUA SARS-CoV-2 RT-PCR assay, which are also negative as called by the Bio-Self COVID-19 Antigen Home Test.

Sponsors and collaborators

Lead sponsor

BioTeke USA, LLC

Industry

Collaborators

  • CSSi Life Sciences

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2022
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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