We will determine the LoD of the device utilizing the entire test system from sample preparation to detection. We will obtain gamma irradiated SARS-CoV-2 virus (BSL-1) from the NIH repository and spike this inactivated virus into a real clinical matrix (e.g. nasal swab and saliva) for LoD determination. A 2-3 fold dilution series of 3-5 replicates per concentration will be tested. The LoD will be confirmed by running the candidate LoD concentration 20 times. Note, the FDA defines LoD as the lowest concentration at which 19 of 20 replicates are positive. We will perform these tests for each nasal swab and saliva matrices with and without viral transport media. The LOD will be determined and the sensitivity/ specificity of the assay will be calculated. Also, we will evaluate the high-dose hook effect, which refers to false negative results when very high levels of target are present in a tested sample. We will conduct studies to evaluate if a hook effect occurs by testing increasing antigen concentrations and, if applicable, indicate the concentration which begins to affect assay performance.
|Effective start/end date||1/11/21 → 5/31/22|
- Zylem Biosciences, Inc. (Agmt 03/23/2022)
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