Validation of a direct-to-PCR COVID-19 detection protocol utilizing mechanical homogenization: A model for reducing resources needed for accurate testing.

Efficient and effective viral detection methodologies are a critical piece in the global response to COVID-19, with PCR-based nasopharyngeal and oropharyngeal swab testing serving as the current gold standard. With over 100 million confirmed cases globally, the supply chains supporting these PCR testing efforts are under a tremendous amount of stress, driving the need for innovative and accurate diagnostic solutions. Herein, the utility of a direct-to-PCR method of SARS-CoV-2 detection grounded in mechanical homogenization is examined for reducing resources needed for testing while maintaining a comparable sensitivity to the current gold standard workflow of nasopharyngeal and oropharyngeal swab testing. In a head-to-head comparison of 30 patient samples, this initial clinical validation study of the proposed homogenization-based workflow demonstrated significant agreeability with the current extraction-based method utilized while cutting the total resources needed in half.

Déclaration de conflit d'intérêts

Z.P.M., C.M.P., G.L.R., and R.J.N. disclose that they are all currently employed by Omni International Inc, A PerkinElmer Company in some capacity, however, none of the authors have any personal financial interests in the success or failure of the company. R.J.N. also discloses that he is the founder and CEO of Jeevan BioSciences with personal financial interests in its success or failure. All authors declare that their our competing interests do not alter our adherence to PLOS ONE policies on sharing data and materials.