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

In the initial PEUA, the Agency confirmed that the EUA authorized high-sensitivity PerkinElmer New Coronavirus Nucleic Acid Detection Kit was an acceptable RT-PCR comparator for this study. In a follow-up email to the Agency on 18 July 2022, BioTeke asked if the chosen PerkinElmer RT-PCR kit could be utilized with a separately authorized extraction method (i.e., ThermoFisher KingFisher), which had been internally validated by the CLIA laboratory but was not included in the PerkinElmer's Instructions for Use. Of note, the initial subject samples had been tested using this extraction kit. The FDA responded that this would not be an acceptable approach, as the comparator method had to use the authorized extraction method outlined in the manufacturer's authorized instructions. In response to the Agency's decision, the central CLIA testing laboratory, DevLab Bio, internally validated the extraction method using the Chemagic 360 as specified in the PerkinElmer instructions. The intent was to re-test those samples previously tested using the ThermoFisher extraction method and test all future samples using only this authorized process. When preparing to re-test the initial subject samples, it was found that a number of samples had been discarded in error. These samples were not included in the performance analysis. Performance analysis was based on 253 subjects rather than the 282 enrolled.