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XMRV test by Cooperative Diagnostics

Discussion in 'XMRV Testing, Treatment and Transmission' started by imready, Oct 26, 2009.

  1. oerganix

    oerganix Senior Member

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    Dr Coffin's response

    I asked him to explain his negative reaction to the offering of an XMRV test by Cooperative Diagnostics and whether he doesn't credit their mathmatical/computer aided construction process for PCR tests; he didn't answer the last but this is what he did say:

    "In a nutshell:
    1. They do not say what the test is, nor provide any information to evaluate its accuracy, false positive, or false negative rate.
    2. At present, no one, no scientist or physician, knows how to interpret any results that the test might yield. I have real concerns that a negative result might be seen as license to donate blood, for example, and a positive result might cause patients to seek unnecessary and potentially harmful treatments.
    3. No studies evaluating the accuracy of this or any XMRV test on dried blood have been done."

    (CD's response to me in my next post addresses #1, but I don't know whether it is an adequate response.)

    I don't see concern for the blood supply as a reason not to get tested. I don't know of any PWC who, if they answered honestly, would be allowed to donate blood, nor do I personally know of any who would want to, for various reasons.

    But I certainly agree that a positive result could encourage people to seek unnecessary and potentially harmful treatments. And CD acknowledges that, too. In the end, though, I think people ought to be able to decide that for themselves. So the main reason for not getting this test, IMO, is that we can't be sure it is accurate; we don't know how to interpret ANY test of XMRV; we don't yet know if XMRV is as important in ME/CFS as the current brouhaha infers; we don't yet know if/what the appropriate treatment(s) might be.
  2. oerganix

    oerganix Senior Member

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    Cooperative Diagnostics response

    I asked for information on accuracy and they quoted the answer that is already on their website. I asked if the test could be accessed from outside the US and whether there would be additional cost and they said, Yes to the first and NO to the second.

    "Thank you for contacting us about the XMRV test.

    Answer Question 1: We have run over 400 samples without any false positives, giving us a specificity of 100% (99.1 100%, 95% Confidence Interval). Clinical sensitivity is a little more difficult to determine given the absence of adequate controls and commercial diagnostics. Our XMRV test is capable of detecting a single XMRV infected cell in a background of 2.5 ug genomic DNA, which is 10 times better performance than the PCR test reported by WPI in the Science publication. Even with a better performance than WPI's PCR test, until there are more commercial tests for comparison of results, it will be difficult to estimate the prevalence of false negatives.

    Answer Question 2: Yes, you can get the test sent to Nicaragua at no additional charge.



    If you suffer from Chronic Fatigue Syndrome please read the following.

    Important note for people with Chronic Fatigue Syndrome

    Data from the Science publication by WPI showing XMRV in CFS patients has been highly publicized by the media. Many people in the CFS community have taken this information to mean that XMRV will be found in every person with CFS and that it is most likely the underlying cause of the disease. Cooperative Diagnostics would like to caution the CFS community that the WPI publication is a first scientific publication and has not been validated independently by the scientific community. XMRV may or may not be present in the general CFS community, let alone be the cause.

    While XMRV is an infectious retrovirus and will certainly impact the medical community, people with CFS may be better served by waiting for further studies connecting XMRV to CFS prior to investing in a diagnostic. Those who choose to take the test anyway should understand that any testing at this point is research only in aiding to establish the actual prevalence of the virus in the CFS community.

    There is no extra cost for your area.

    Please let me know if you have further concerns or questions. Thanks for your interest in Cooperative Diagnostics."
  3. Cort

    Cort Phoenix Rising Founder

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    I have to say that was a high quality communication; they highlight the uncertainty involved, etc. A good sign from CD - they sound like a very professional company.

    Thanks Kurt for all the information on CD - we know nothing about them; they just came out of the blue and I think that played on peoples worst fears.

    If they are committed to uncovering whats going on and are that good at what they do - its all gravy for us. This kind of multi-group competitive process is precisely whats missing in much ME/CFS research and that is what the scientific method is all about isn't it? hacking away at something unmercilessly until its true essence is revealed.

    I hope they all keep hacking and hacking. That saves time - our most precious resource - for all of us; we don't take as many wrong turns and get on the right road that much more quickly.

    This is going to be much more exciting (draining?) than the original announcement. That was fun - now that we know whats at stake - its going to be a 'little' tense.
  4. A few of us on here are anxiously waiting for our results from this company - even if it's a first preliminary step to the world of XMRV as more XMRV tests would be needed after this PCR XMRV DNA test, namely the antibody test that WPI/VipDX is developing.......

    Even if this test does prove to be a waste of money I don't mind at all.

    A month or so has passed and that's a month closer to the WPI/VipDX tests becoming available for people outside the USA which will be the real nail biter of course. :p This DIY kitchen table job has offered more hope than the deafening silence we've heard from our respective health agencies around the world regarding XMRV.

    Being pushed out of a race in the lead, is better than being denied entry - in my view. Even if it costs $$$, it was fun whilst it lasted. False dawn? Hopefully we can tell you guys soon. Realistically, I'm betting on a negative and looking forward to the 'proper' tests in 2010 - but we shall see.
  5. Cort

    Cort Phoenix Rising Founder

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    Q and A from Cooperative Diagnostics on XMRV Testing

    Q&A from their website. http://codiagnostics-globalhealth.com/XMRV/faq.php

    Did Cooperative Diagnostics develop the testing specifics?

    Yes. Cooperative Diagnostics’ primary expertise is in real-time PCR test design. We do all of our test development activities at Cooperative Diagnostics.

    Should I expect false negative or false positive results?

    We have run over 400 samples without any false positives, giving us a specificity of 100% (99.1 – 100%, 95% Confidence Interval). Clinical sensitivity is a little more difficult to determine given the absence of adequate controls and commercial diagnostics. Our XMRV test is capable of detecting a single XMRV infected cell in a background of 2.5 ug genomic DNA, which is 10 times better performance than the PCR test reported by WPI in the Science publication. Even with a better performance than WPI's PCR test, until there are more commercial tests for comparison of results, it will be difficult to estimate the prevalence of false negatives.

    How was Cooperative Diagnostics able to react so fast to an article published by Science Magazine on October 8th, 2009?


    Cooperative Diagnostics’ hallmark is its application of engineering design to molecular processes. We can literally screen millions of possible diagnostic designs mathematically in a matter of minutes, yielding the best possible design for each component of the test. We know before building the diagnostic whether it will work or not, and what the probability is that it will not only detect all strains of virus currently in existence, but all strains that may emerge. This combination of biophysics and bioinformatics algorithms in the design process allows us to create tests that work the first time. Like engineers designing a bridge, this is not something we want to leave to chance. It is something that can and should be designed correctly the first time. We routinely design and validate tests in a rapid time frame because of our unique approach.

    Who else will have access to my diagnostic test result?

    For efficiency in processing the samples, we have contracted a reference laboratory to run the tests. They provide the data to us, and we report the results to the patient. No one else will have access to the results. However, the patient will receive a report of the results and may, at their own discretion, choose to share the results with a physician or others.

    Are you affiliated with WPI?

    We currently have no direct association with the Whittemore Peterson Institute (WPI). We are deeply appreciative for what they have contributed and continue to contribute to the field of knowledge on CFS/ME and other neuro-immune diseases. We are just happy to help this effort keep moving forward by providing the first test for XMRV.


    Is the XMRV DNA test reimbursable by any insurance policy?


    At present the test is not reimbursable by any insurance policies. However, this may change in the future as the clinical significance of XMRV and testing for it gain greater acceptance.
  6. oerganix

    oerganix Senior Member

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    Samples

    I really have no idea, except for fantastical speculations as follows:

    (Fact) Dr. Satterfield was at the U of AZ, his alma mater, on Sept 14 to give a paper entitled: Brent C. Satterfield, Jay A. A. West, Michael R. Caplan (2007) Tentacle Probes: eliminating false positives without sacrificing sensitivity Nucleic Acids Research, 35(10): e76; doi:10.1093/nar/gkm113.
    http://nar.oxfordjournals.org.ezproxy1.library.arizona.edu/cgi/content/full/35/10/e76

    (Fantasy) Since some scientists already had received leaked information about the WPI paper about to come out in Science, maybe he knew about it, too. Maybe before or after the Biomedical Engineering Seminar at U of AZ he popped over to NV and whipped out his company credit card and said "I'll take 400 samples of your XMRV virus, please."

    (More fantasy)Between Sept 14 and Oct 24, when they announced the test for sale, they developed their superfast diagnostics in the manner they have described, using proprietary algorithms, etc.

    Fact, according to their website: they have specialized in very fast design of diagnostics for bioweapons, where time is of the essence.

    I don't have the expertise to evaluate any of this. It's only interesting because we are in an information vacuum at the moment.

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