Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BioTeke USA, LLC
With
CSSi Life Sciences
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.
Age
2–94
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. An Institutional Review Board (IRB) approved informed consent and assent, if applicable, is signed and dated prior to any study-related activities.
2. Male and female Subjects 2 years of age and older.
3. 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.)
4. Subject is willing to have a nasal swab collected by a healthcare professional.
5. Subject agrees to complete all aspects of the study.
You may not be if
1. Subject has a visual impairment that cannot be restored with glasses or contact lenses.
2. Subject has prior medical or laboratory training.
3. Subject had a positive COVID-19 test in past three (3) months.
4. Subject uses home diagnostics, e.g., HIV Tests, glucose meters, etc.
