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VIPdx Statement from Vince Lombardi re: Testing

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
No date but assumed recent: http://www.vipdx.com/

STATEMENT OF VINCENT LOMBARDI, PhD CLINICAL LAB DIRECTOR VIP Dx


'A number of recent publications and individuals have mischaracterized the nature of certain clinical laboratory results reported by VIP Dx, a CLIA certified clinical laboratory.

VIP Dx has met the required CLIA Program standards and is certified to offer and perform only clinically validated laboratory tests.

The XMRV test offered by VIP Dx is clinically validated and performed under rigorous protocols to ensure the accuracy and reliability of the test results.

XMRV testing was offered based upon the existing scientific knowledge at the time. The original assays for XMRV testing were based on the 2009 Science publication.

Those assays, as well as all subsequent modifications, were internally validated prior to being used to process patients samples. WPIs Research Director was instrumental in the decision to make such a test available to physicians.


The interpretation of the XMRV test results, as with all laboratory tests, is the responsibility of the ordering physician.

Before offering any test to the public, VIP Dx established comprehensive performance specifications including accuracy, precision, analytical sensitivity, specificity, and others required for test performance.

If you have any questions regarding tests that you have pending at VIP Dx, please contact customer service at info@vipdx.com. '

Err.. who's court is the ball back in now? I have lost track. ;)
 

Lee

Messages
82
"clinically validated and performed under rigorous protocols to ensure the accuracy and reliability of the test results."

How? What validation? What protocols? There is no additional information on their web site. None. At all. That is an empty claim.

This is interesting, though:
"WPIs Research Director was instrumental in the decision to make such a test available to physicians."
 

barbc56

Senior Member
Messages
3,657
Wow, talk about "PRspeak"*.

So he's saying the lab goes by the 2009 study, I would assume that the test is not valid except for contamination?



*public relations.
 

kurt

Senior Member
Messages
1,186
Location
USA
I would like to know what Lombardi means by 'internally validated'. Maybe he meant to say they employed standard quality control procedures. But validation in the general scientific context requires external testing, and as we know, the test has failed to be validated. He should define his terms better, some patients who do not understand the scientific process may believe he said something meaningful by claiming internal validation. That was a misleading statement.
 

barbc56

Senior Member
Messages
3,657
I would like to know what Lombardi means by 'internally validated'. Maybe he meant to say they employed standard quality control procedures. But validation in the general scientific context requires external testing, and as we know, the test has failed to be validated. He should define his terms better, some patients who do not understand the scientific process may believe he said something meaningful by claiming internal validation. That was a misleading statement.

I also wondered about the loose definition of a validated test. Could there be legal issues curtailing what he can say? I guess time will tell.
 

Megan

Senior Member
Messages
233
Location
Australia
I had a doctor explain to me that tests could be validated by testing the samples, sending them to another lab to be retested to see if they get the same/similar results. Maybe this happened between VIPdx and the WPI or between Redlabs and the WPI, or som other lab?

Of course, as far as I can see, this would not resolve the issue of contamination if the samples themselves were contaminated.
 

Nielk

Senior Member
Messages
6,970
This statement reeks PR and cover up. They are trying to cover themselves against negligence litigation.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
There was something on the WPI Facebook page (It has gone down again so I can't post a link but will later), stating that Unevx were not offering the XMRV/HGRV test and referring people to VIPdx or offering a refund.

Of course VIPdx are hardly in a position to offer a 'test' either - especially not since the BWG study and results and with a possible full retraction pending of Lombardi et al.

There does seem to be something of a three-way tug-of-war going on: VIPdx --- WPI --- Mikovits

I guess what patients really want to know is what the test results they received actually now mean or rather don't mean. About time they all pulled their collective fingers out and remember just who they have been kidding.

Yes, with the 'threat' or reality of litigation comes the inevitable period of silence but it is a disgrace regardless.
 

Nielk

Senior Member
Messages
6,970
In the whole statement, not once does it state that the tests of patients who paid good money with confidence of the WPI's backing, are accurate and can be relied upon.
The interpretation of the XMRV test results, as with all laboratory tests, is the responsibility of the ordering physician.

Really? how do you read POSITIVE/NEGATIVE? It's the "responsibility" of the ordering physician?
i.e. It's not OUR responsibility?
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
I never was 'tested' Nielk, but do you know if they simply said 'Positive' or 'Negative'? I mean if they did it would not require anyone else to interpret. As I think you are saying.

It certainly sounds like an excuse to me. Especially when you read those proclamations from Mikovits/WPI about the number of 'positives' being 'found' and what it meant for the safety of the human population :rolleyes:

Pass the buck time methinks...
 
Messages
118
Do to the situation on the validity of the VIPdx tests. Also since VIPdx have not been forthcoming, and have actually been giving patients the runaround, regarding the reliability of their xmrv tests. Anyone that was tested at VIP dx should ask for a full refund of their money.
 

Nielk

Senior Member
Messages
6,970
I never was 'tested' Nielk, but do you know if they simply said 'Positive' or 'Negative'? I mean if they did it would not require anyone else to interpret. As I think you are saying.

It certainly sounds like an excuse to me. Especially when you read those proclamations from Mikovits/WPI about the number of 'positives' being 'found' and what it meant for the safety of the human population :rolleyes:

Pass the buck time methinks...

Firestorm,

I was never tested either but, it was obvious from patients who did(and they can confirm this/or not), when they got the results it was either positive or negative. There never was a difficulty in interpretation. It seemed pretty clear cut.
 

Jemal

Senior Member
Messages
1,031
I think with interpretation they also mean in a broader sense what a doctor would do with the result? It could have been part of a series of tests for example and the results could indicate a specific treatment. Not that it really matters. XMRV was and is controversial and most doctors would not act on a positive result. I think most patients just saw it as validation of their illness and were hoping for the rest of the medical world to catch up, so treatment could begin? At least that's how I looked at this test: possible validation and maybe some treatment a few years into the future. I deemed it too expensive at the time...
 

liquid sky

Senior Member
Messages
371
I was never tested either. I was waiting for the next test to come out at the new lab. That never happened because the VIPx lab's tests were not validated in the BWG.

I have read statements from WPI that said they changed the test from the original ones used in the Science paper related to making them more cost effective. It sounds like they put money ahead of accuracy. I know people who were tested and they did get negative or positive results per serology or culture. The tests were also marked experimental, so I doubt there is any legal recourse.

When the codes were broken from the BWG, Judy stated publicly that the test could no longer be sold because it was not shown to be validated. I believe that is the insubordination that actually got her fired. IMHO
 
Messages
118
Wouldn't matter if it was claimed to be experimental. It all depends on how the tests were supposedly validated. They are claiming it was done within the clinic. It is still worth asking for a refund. I would also think it be worth asking if they did same testing that was done at the research lab. They did have a press announcement that stated they had modified changes to make the test more affordable. I would think patients would have a right to know exactly what test methods they had paid for.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
I think with interpretation they also mean in a broader sense what a doctor would do with the result? It could have been part of a series of tests for example and the results could indicate a specific treatment. Not that it really matters. XMRV was and is controversial and most doctors would not act on a positive result. I think most patients just saw it as validation of their illness and were hoping for the rest of the medical world to catch up, so treatment could begin? At least that's how I looked at this test: possible validation and maybe some treatment a few years into the future. I deemed it too expensive at the time...

Good points Jemal.
 
Messages
28
Have just tried to ring Vipdx. The call is met with the statement - "The number you have dialled has been disconnected or is not assigned."
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
Thanks for resurrecting this thread. I forgot I had posted that statement and had to search for it the other day - doh!

I did look at their website as it happens and it was 'under development'. In terms of the XMRV test I dare say that the retraction of Lombardi et al may well impact on its' availability - though to what extent is an interesting question I think.

Were you trying to contact them for any reason in particular? Only WPI's FB page were directing traffic elsewhere if I recall (only don't ask me where because I have forgotten that as well!)

What does Unevx have to say about XMRV testing I wonder...?
 

Daffodil

Senior Member
Messages
5,875
the lab is 775 682 8280

unvex does not know if they will ever be doing xmrv/mlv testing again - at least that's what i was last told. i guess that could all change depending on what is found by lipkin....