INDICAID, PCR, and Sequencing Study Design
The INDICAID COVID-19 Rapid Antigen Test was evaluated in the hands of the lay user at four (4) US-based clinical study sites that were representative of home-use test settings. Samples were collected between November – December 2021 by patients who experienced at least one COVID-19 symptom within 6 days or less from the date of the test. Each patient self-tested with the INDICAID test, while and a second nasal sample was collected by a healthcare professional for subsequent analysis by RT-PCR and sequencing.
The presence of SARS-CoV-2 was determined by RT-PCR with the FDA EUA SARS-CoV-2 Hologic Panther Assay. The samples were then subjected to a variant ID detection workflow that closely resembles the Illumina COVIDSeq NGS Test.
In total, 242 patients were enrolled in the clinical study. The INDICAID COVID-19 Rapid Antigen Test detected 58 patients who were confirmed positive for the B.1.1.529 variant. Cycle threshold (Ct) values for each sample are shown in (Figure 1). The average Ct value was 23.8 (range 17.2 to 33.2).
Figure 1. RT-PCR cycle thresholds for 58 SARS-CoV-2 positive samples that were detected by the INDICAID® COVID-19 Rapid Antigen Test.
The INDICAID® COVID-19 Rapid Antigen Test was able to detect the B.1.1.529 variant, confirmed by whole genome sequencing, in specimens with a wide range of viral loads (RT-PCR Ct range 17.2 to 33.2). Therefore, it can be concluded that the B.1.1.529 (Omicron) variant does not impact the performance of the INDICAID® COVID-19 Rapid Antigen test.
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