Ok so some spare time. Apologies for those well versed in this type of thing. Setting up a diagnostic PCR is not simplistic. Chief issues are safety, reagents, cleanliness, methodologies and reporting
Safety- SARS-CoV-2 is a highly transmissible virus with considerable mortality. Therefore, the samples need to be handled and processed in a suitable containment facility. This is dependent on how the swab is taken and PHE guidelines.
Reagents- these are dependent on local equipment. The swabs need to be extracted to remove the viral Nucleic acid. The Nucleic acid is then amplified to detect presence of the virus. These methods are similar and everyone is demanding the same reagents.
Cleanliness- Whilst all research lab work “clean”, diagnostics need a specific workflow and trained staff to be “super clean”. We need to keep reagents and people separate to avoid any contamination. False positive results are bad.
Methodologies- essentially we are all doing the same thing. Extraction of RNA, turning into cDNA then amplifying it. But.... each method and piece of equipment has its own subtleties and the methods need to established, appropriately validated and tested.
Reporting- We are a research lab and not a certified diagnostics lab. We ensure our methods are validated and run appropriate controls. But then need the interaction with an approved diagnostic lab to handle the data and approve or results.
In Summary- setting up to run COVID diagnostics at scale from nothing is possible but takes time, effort, money, support from other labs, trained staff, expertise, equipment and enough reagents.
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