Still not clear on process to develop standardized testing for CLINICAL use
Can anyone help out on this one? When will tests be available for actual patient use?
I'm still not clear (as per post #8) if/when the "winning assay(s)" to detect XMRV will be made available for clinical use. Keep in mind the terms of reference for this Working Group are ultimately focused on safety of the blood supply, not acceleration of access of diagnostics for patients. So my question remains: what is the process proposed (if there is one at all) to translate what this working group learns into bona fide tests available clinically? What is the process to approve and licence the tests (eg. FDA-approved), so that insurers will cover it, and other countries will adopt it? I am not at all certain whether the finding of a validated test automatically translates into its availability on the market. Does anyone know how long will this take? And how does this tie in with VIPDx plans for availability of the XMRV serology test?
Clinical vs analytical panels
Perhaps one of the sources of confusion is the discussion of clinical panels vs analytical panels. These panels are merely an array of samples of XMRV - the clinical ones blood from "real" infected patients; the analytical ones "spiked" normal blood or water with designated amounts of XMRV, against which the various labs will test their detection assays. An important differentiator for the real world is whether a lab can detect XMRV in a clinical panel (a proxy for a patient) - and what their detection threshold is. The CDC may well be able to detect XMRV in spiked analytical samples. But when presented with a sample of unstimulated blood from a bona fide ME/CFS patient, they may miss the elephant in the room with their assays. I totally agree with Sickofcfs that some face-saving may well be taking place with the Working Group's carefully worded line: "All the labs were able to detect at least some amount of XMRV". What is unsaid is that some labs (hazarding a guess here - the CDC?) may have to be hit over the head with XMRV to find it.
What are the rate-limiting steps before we have an available CLINICAL XMRV test?
Which brings me back to the crux of the matter. What are the steps before a validated test for blood safety purposes is translated to an available clinical test for us patients? I am not at all certain that a validated test for the Blood Working Group = a validated test for clinical use. Presumably we have to wait for patent processes, licencing and some commercialization. FDA approval? Other hurdles? How long might that take?
Blood safety remains a HUGE issue
I agree with RustyJ that blood issues have unwittingly raised the profile of ME/CFS. But I also agree with dsdmom that blood safety remains a huge issue for ME/CFS patients. If those 3-7% figures hold up, we are looking at a crisis of mammoth proportions in both the availability and safety of our blood supply.
I kind of think of it as the larger issue of preventing transmission of an infectious retrovirus that simply devastates our lives, by any means. Just how vigilant do we need to be to spare our loved ones the painful journey of ME/CFS? Does food preparation connote danger? Given the infectivity in cluster outbreaks of ME/CFS, and the finding of XMRV in respiratory secretions, is this retrovirus THAT infective (eg. via respiratory droplets... coughing, sneezing)? Or are cluster outbreaks the result of infectivity of an opportunistic virus (eg. EBV). While there are some people out there who might benefit spiritually from contracting XMRV, I frankly wouldn't wish it on my worst enemy.
And what about when we ultimately get antiretrovirals (if indeed XMRV is "it), or possibly B-cell depletion therapy or other means to eliminate viral reservoir. How readily might we re-contract XMRV - recognizing that retroviruses are embedded in our genome? Will immune modulating therapy render us "immune" to re-infection? Could massive re-exposure cause an XMRV relapse? What measures do we need to take to prevent re-infection?
Also, look at where our population is at age-wise. The boomers are flocking to cardiologists en masse to get bypass surgeries... all of which typically require blood products. And at the end of the day, all of us are vulnerable to sudden trauma - and the possibility of a need for blood transfusions. I'm with the vampires... blood issues for ME/CFS and XMRV remain extremely important - to us patients, our loved ones, and the community at large.