VIP Dx MAJOR ANNOUNCEMENT on Jun 1 !

[jackie]

Do you have any idea how much you've been missed, Georgie? Even The Poms missed you.....and you're really not their "type"...but still!

 

[Lynn]

I thought I wpuld get a jump on the serology test, so I ordered a XMRV test kit today from VIP (without the serology test). It will ship the 1st week of July.

I asked about the serology test and was told by the person at VIP to "Check with me before the test kit is scheduled to ship and we will determine if the serology test is ready and we can include tubes for that test if it is available."

So it sounds like they may still be doing multiple tests.

Lynn

 

[parvofighter]

George!

Welcome back George!

Here's a little something for you that a few of us dug up:

​

Slurp,

Parvo:Retro smile:

PS: As for the VIPDx news - well, that just pales in comparison. It's all good though, eh?

 

[txfriend]

Good News, first that George is back; I'd like one of those bones to
gnaw on while I await the FDA approval for this test and insurance
paying for it! There are three of us here in our home, all with CFS
diagnoses, and who can afford the antibody and culture tests for
us all?

 

[natasa778]

That might be true, but I can think of some criticisms of an antibody test as well. Antibodies can cross react, and there is always the possibility that everyone has them (ie the infection isn't specific to CFS). There actually are some scenarios where people can test HIV+ by antibody, but not be - thats why they confirm it with the PCR. Personally, I doubt that any of these negative scenarios are true. Given the other evidence in the Science paper, they have even more credibility that their findings are real and specific to this illness.

as far as HIV tests, a positive ELISA antibody one is always followed by a Western Blot. If WB is negative that means ELISA picked up something else instead of HIV, if it is positive than you are HIV positive.

Third possibility is if WB is ambiguous/unclear, then additional tests need to be done (PCR? culture?)

I posted a link the other day but cannot find it now, if anyone has saved it please repost.

 

[ixchelkali]

"So, Michelle, we've just launched an anti-body test for the new human retrovirus, XMRV. We're hoping that researchers, such as those at the CDC, will use it in their studies and also that the AABB may start a screening programme using the technology. Could you pass the salt? Thank you."

 

[natasa778]

Welcome back George! You've found your way home :Retro smile:

 

[julius]

Anybody know what they mean by "multiplex" serological assay.

 

[natasa778]

Julius, have a look at my post above on ELISA and WB tests.

probably something along the lines of:
Currently, detection of HIV-1 infection in the blood bank and clinical settings is based on serologic detection of p24 antigen and antiviral antibodies by enzyme immunoassay. Confirmation of antibody-positive samples is done by supplemental antibody tests such as Western blot or immunofluorescence assays, while confirmation of p24 positivity is done by neutralization. Follow-up of a positive result typically involves antiviral treatment and monitoring of the HIV-1 RNA titer by quantitative HIV-1 assays (2, 3, 15). Although the sensitivity of HIV antibody tests has increased and sensitive tests for p24 antigen have been developed and implemented, a window period still exists between infection and the appearance of detectable serological markers. Addition of the p24 antigen test has reduced the average window period from 22 days to approximately 16 days, since detectable antigenemia generally precedes seroconversion (2, 15). However, p24 antigen tests have a high false-positive rate and are less sensitive than nucleic acid-based amplification testing (NAT) (36). HIV-1 p24 antigen screening of blood donations, implemented in 1996, has only yielded six cases of antigen-positive, HIV-1 antibody-negative donors within more than 24 million donations screened (37). Several studies suggest that use of NAT could reduce the window period by 6 to 11 days, further reducing the risk of acquiring HIV from blood transfusions...


.... Detection of HCV, like that of HIV-1, is also based on serologic screening for antiviral antibodies, using enzyme-linked immunosorbent assays and confirmation with a recombinant strip immunoblot assay...


http://jcm.asm.org/cgi/content/full/40/7/2408

 

[Otis]

I thought I wpuld get a jump on the serology test, so I ordered a XMRV test kit today from VIP (without the serology test). It will ship the 1st week of July.

I asked about the serology test and was told by the person at VIP to "Check with me before the test kit is scheduled to ship and we will determine if the serology test is ready and we can include tubes for that test if it is available."

So it sounds like they may still be doing multiple tests.

Lynn

Lynn,

You did much better than I. Did you call and order the test kit?

I can't kind anything on the website right now (as far as ordering tests) and when I emailed a request to get on a waiting list I was told there wasn't one yet for the new test, check back in 30 days. Ug, too tired to call today...

Thanks,
Otis

 

[consuegra]

De Meirleir mentioned to me that he might be looking for XMRV with stomach biopsies. He believes that it can be found in the stomach. I had not heard this before, or anything like it. I assume that he was speaking of patients who tested negative to the various blood tests.

Chris

http://cfspatientadvocate.blogspot.com

 

[julius]

Julius, have a look at my post above on ELISA and WB tests.

Your post was the reason I asked. So, the test they will offer will be an all in one, rather than having to do a second test if the antibody is neg. Am I getting that right?

 

[Stone]

I have a technical question. When it comes out next month, obviously there will be hundreds of thousands of people getting it done all at the same time.

What is the probability of lab errors with that kind of a heavy load? Any lab techs reading?

I am wondering if it would be better to wait a couple more months, just to make sure they don't actually mix up my results with someone else's, or something like that.

I used to be a lab tech and accessioner. I used to basically do 'intake' on gazillions of specimens each day. Most of these systems are set up to prevent or greatly minimize such errors. Every requisition (order form) has a unique number and the patient's info is put on that uniquely numbered form, which mathches the stickers on the tubes with the same numbers. That's why you have to order their form and their tubes before you have the blood drawn. It should be fine. The possibility for errors consists mainly in, mixing reagents hastily because the machines are going through them like Grant through Richmond, dropping a try full of specimens and breaking them because you're in a hurry (did that myself once), techs not taking the time to properly calibrate things because they're behind, things like that, but these are highly unlikely and they use plastic tubes now, too There's no need to worry excessively about accuracy because of the heavy volume. Yes, any kind of mistake can happen but it usually doesn't and probably won't. Rest easy.

 

[Dr. Yes]

as far as HIV tests, a positive ELISA antibody one is always followed by a Western Blot. If WB is negative that means ELISA picked up something else instead of HIV, if it is positive than you are HIV positive.

Third possibility is if WB is ambiguous/unclear, then additional tests need to be done (PCR? culture?)

Yes, that is the standard procedure for HIV testing: ELISA positive, then usually WB (IFA is more rarely done these days). These are all types of serology (antibody) tests. If the WB is indeterminate, depending on the case, some doctors go straight to PCR and some re-do the WB a month later; if it is still indeterminate, I assume they usually go for PCR after that.

"NAT", for anyone who was wondering, just means PCR testing for either RNA or DNA.

ELISA tests only take a few hours, so the turnover rate is much higher than for standard PCR or anything requiring culture. Western Blots take a little longer, but still not as long as culture tests.

If a lab is properly set up and managed, has sufficient resources, and knows its limitations, ELISA tests can be run en masse with a lower probability of laboratory error than mass PCR testing. Generally speaking, PCR tests are more sensitive to laboratory error than ELISA. Julius (if you're out there..), I don't think there is much risk of increased error rates in the initial months of testing, assuming VIPdx meets the conditions I mentioned above.

The true reliability of any new serology tests will probably take a while to ascertain. HIV is an easier target than XMRV, obviously. Because ELISA tests have the potential to give false positives (not as likely false negatives when viral antigen is present in the blood), I would be surprised if VIPdx dropped their culture test (which to my understanding is a PCR test). Because so much is unknown about XMRV - how likely it is to be present in the blood, etc - I don't think they know yet for sure whether they will be setting up a 'reflex' procedure and what the reflex test will be (for HIV the reflex test for a positive ELISA is a WB; that approach may or may not prove useful in the case of XMRV).

 

[Lynn]

Lynn,

You did much better than I. Did you call and order the test kit?

I can't kind anything on the website right now (as far as ordering tests) and when I emailed a request to get on a waiting list I was told there wasn't one yet for the new test, check back in 30 days. Ug, too tired to call today...

Thanks,
Otis

Hi Otis,

I just wanted to beat the rush!

I emailed VIP last night to request an XMRV test kit (just the regular one) for my Doctor's appointment in mid July. I also am counting on the fact that the serology test will be ready by the time they ship the kit (in the first week of July).

Lynn

 

[Adam]

Poms love George

Do you have any idea how much you've been missed, Georgie? Even The Poms missed you.....and you're really not their "type"...but still!

Us Poms love George.

In fact we formed the Poms Love George Society just to show all the non-Poms how much we love George.



So there. :Retro tongue: :Retro tongue:

 

[JT1024]

I used to be a lab tech and accessioner. I used to basically do 'intake' on gazillions of specimens each day. Most of these systems are set up to prevent or greatly minimize such errors. Every requisition (order form) has a unique number and the patient's info is put on that uniquely numbered form, which mathches the stickers on the tubes with the same numbers. That's why you have to order their form and their tubes before you have the blood drawn. It should be fine. The possibility for errors consists mainly in, mixing reagents hastily because the machines are going through them like Grant through Richmond, dropping a try full of specimens and breaking them because you're in a hurry (did that myself once), techs not taking the time to properly calibrate things because they're behind, things like that, but these are highly unlikely and they use plastic tubes now, too There's no need to worry excessively about accuracy because of the heavy volume. Yes, any kind of mistake can happen but it usually doesn't and probably won't. Rest easy.

Stone, I disagree...

I work in a lab (I'm in one now!) and errors can occur very easily. The majority of tests may be fine but a sudden influx of specimens can make the workload unmanageable. Also, the people that have been performing the tests will need to train new techs in the new procedures. I've trained many techs and I've seen a lot that you really don't want to know about.

Hopefully, VIPDx and WPI have planned for the imminent surge in testing. I suspect Abbott Labs will be coming out shortly with their automated version for large volume testing of the blood supply.

As Stone stated, labs use barcoded tubes for specimen identification but it appears to date that the VIPDx methods are more manual or semi-automated. There will have to be significant planning going forward to handle the demand for testing.

Just my two cents! Back to work.....

 

[Forbin]

Just curious if anyone knows if an antibody test (generally speaking) would be less affected by things such as the age of the sample and/or whether it has been frozen, etc... than a PCR test.

I'm obviuolsy wondering what the outcome would be if the new antibody test were run on the same samples that were used in the European studies which found no positives (and which, of course, did not culture their samples).

I'm not exactly holding my breath waiting for the authors of those studies to do this, however. :Retro smile:

 

[Rrrr]

i emailed VIP and asked the cost and the turn around time once our blood was sent to them. the answer is below. -- rrrr

We have not yet determined cost or turn-around time.

Marguerite Ross, Director
Marketing & Client Relations
VIP Dx / RedLabs
5625 Fox Ave - Rm 369
Reno, NV 89506
775-351-1890
Fax: 775-682-8517

 

[JT1024]

Forbin,

Sample integrity (age of specimen, temperature (ambient, refrigerated, frozen), and presence or absence of anticoagulant can make a huge difference.

Not sure about the test developed by WPI/VIPDx but I suspect they've been testing old samples as well as new ones.

The samples in the German study of respiratory samples was successful in finding XMRV and those samples were from 2006 - 2009.

My guess is that it is not the samples that are the problem.... :innocent1: