1. When and how were the samples gathered and processed by the phlebotomists?
Full paper trail about gathering of samples (for each sample, patient and controls, with original sample number and reported sample number):
Background:
VIPdx lab required the samples to be received within 24 hours after blood draw – this seemed to be important and the question is if the study followed this protocol.
Furthermore, 100 of the control samples were bought from a company specializing in supplying control samples for studies. Any differences between these samples and the other samples would be interesting.
2. When and how were the samples received, processed and stored at the lab?
Full paper trail about the gathering of the samples (for each sample, patient and controls, with original sample number and reported sample number)
Background:
VIPdx lab required the samples to be received within 24 hours after blood draw, supposedly to be immediately processed at the lab – this seemed to be important and the question is what processing was done at the lab after receiving the samples.
3. When were the samples tested, in what lab, with what method and with what result?
Full paper trail of all tests performed (for each sample, patient and controls, with original sample number and reported sample number)
Background:
The study itself did not answer how the samples that Silverman received were selected. In the Addendum it was mentioned for the first time that. It would be interesting to find out how the testing regime was.
Furthermore there are many conflicting results reported by Mikovits as to how many samples were positive, so this would be needed to reconcile the reports with the actual testing. The handling of the control samples would be interesting as well.
With this, one would need to compile the following table for each sample:
- When was the sample drawn and how was it handled (materials used, etc.)?
- When was the sample received by the lab(s)
- How was the sample processed and stored by the lab
- What test(s) were performed, when, at which lab and with what results?
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