User:Shawndouglas/sandbox/sublevel1
High- and moderate-complexity CLIA testing
Non-reagent consumables for high- and moderate-complexity CLIA testing include PCR tubes and plates; pipettes and tips; films, foils, and sealing mats; swabs; and viral transport media, among others. Some like Kellner et al. have experimented with methods to make isothermal amplifications methods more approachable in resource-poor environments by, for example, developing a pipette-free version of LAMP.[1]
CLIA-waived testing
The FDA EUA devices (Table 1 and 2) may require a few extra consumables. For example, the Accula SARS-CoV-2 test kit comes with swabs[2] and the Xpert Xpress SARS-CoV-2 kit comes with disposable transfer pipettes.[3] Refer to the IFU for the waived test kit to determine what additional consumables you'll require.
References
- ↑ Kellner, M.J.; Ross, J.J.; Schnabl, J. et al. (2020). "A rapid, highly sensitive and open-access SARS-CoV-2 detection assay for laboratory and home testing". bioRxiv. doi:10.1101/2020.06.23.166397.
- ↑ "Accula Test" (PDF). Mesa Biotech, Inc. April 2020. https://www.fda.gov/media/136355/download. Retrieved 16 August 2020.
- ↑ "Xpert Xpress SARS-CoV-2" (PDF). Cepheid. March 2020. https://www.fda.gov/media/136315/download. Retrieved 16 August 2020.
