Abstract
Introduction
Impact of COVID-19 in Boston and Boston University
Commissioner, O. of the. Emergency Use Authorization. FDAhttps://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization (2021).
Major decision points


Materials and methods
Identifying a space for CTL for high throughput automated testing
On campus sample collection sites
Ideation and development of assay and sample testing process flow
Biosafety and personal protective equipment
High-throughput automation concept and system design
Hamilton Microlab STAR Robotic Systems

Compatibility of anterior nares swabs and collection vials for automation
Manual Inactivation, accessioning, and automated sample aliquoting

Automated magnetic bead-based RNA extraction
User Guide: MagMAX Viral/Pathogen II Nucleic Acid Isolation Kit. 2022 https://www.thermofisher.com/document-connect/document-connect.html?url=https%3A%2F%2Fassets.thermofisher.com%2FTFS-Assets%2FLSG%-2Fmanuals-%2FMAN0024756_MVPII_RUO_UG.pdf&title=VXNlciBHdWlkZTogTWFnTUFYIFZ-pcmFsL1BhdGhvZ2VuIElJIE51Y2xlaWMgQWNpZCBJc29sYXRpb24gS2l0.
High-throughput qPCR preparation for 384-well plates
Quality control, process scheduling, and SOPs
Clinical laboratory data and integration of LIMS

Legal and regulations
CLIA and MA clinical laboratory license
FDA emergency use authorization
Results and discussion
Limit of detection for SARS-CoV-2 plasmid
Concentration | Result |
---|---|
1 × 105 copies/µl | Positive |
1 × 104 copies/µl | Positive |
1 × 103 copies/µl | Positive |
1 × 102 copies/µl | Positive |
1 × 101 copies/µl | Positive |
1 copies/µl | Negative |
Concentration | Result |
---|---|
85 copies/µl | Positive |
42.5 copies/µl | Positive |
21.3 copies/µl | Positive |
10.6 copies/µl | Positive |
5.3 copies/µl | Negative |
2.7 copies/µl | Negative |
Concentration | Result |
---|---|
21.3 copies/µl | 20/20 |
10.6 copies/µl | 20/20 |
5.3 copies/µl | 17/20 |
Annual maintenance and assay validation
Modifying existing testing for pooled sample testing
SARS-CoV-2 research emerging from the BU CTL and the research community
- Landaverde L.
- et al.
- Petros B.A.
- et al.
- Landaverde L.
- et al.
- Kuhfeldt K.
- et al.
- Bouton T.C.
- et al.
Considerations and future research opportunities
Author contributions
Declaration of interests
Acknowledgements
Appendix. Supplementary materials
References
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