HTM01:01 Compliance; “As technologies become available that are able to detect residual protein in situ to ≤5 μg per instrument side, they should be adopted”.
This sentence describes the ProReveal technology and currently the ProReveal is the only Protein Detection Test that is fully compliant to all the protein detection requirements.
The HTM01:01 reference to swabbing
“Protein levels on an instrument should be measured directly on the surface rather than by swabbing or elution”
“Prion proteins are very hydrophobic and will, once dry, adhere strongly to surfaces and resist removal by swabbing or elution for the purpose of protein detection.”
CE Marking Status
“The manufacturer will need to have CE-marked the product under the Medical Devices Regulations and issued a declaration of conformity to demonstrate that the device has met all relevant essential requirements for the medical device and that they have followed an appropriate conformity assessment route.
The CE documentation for the ProReveal is in the process of being completed for registration.
P.C.D. (Process Challenge Device)
“Commercial process challenge devices are being developed whose challenge simulates the attachment of prion protein to instruments and whose analysis is quantitative”.
Synoptics Health are in the process of developing a PCD tag that can be measured in the ProReveal, giving the required quantitative result.
Residual Protein Trend Analysis.
“There should also be a specific record that relates to residual protein trend analysis”.
