spontaneous clearance or false pos?

I tested positive for antibodies during prenatal testing in Feb.  Much to my dismay, I was told the ratio was too high to be a false positive.  

With further testing:
Liver function was normal
Viral load: <615
Genotype: undetectable

I was told that I had cleared and had nothing else to worry about.  

Still concerned, I went to see a gastro and he retested me with Heptimax.  
Viral load: 103
Genotype: undetectable

He suggested that I might clear, but if not after the birth to do 6 months of treatment.  

I retested about 3 weeks before I gave birth (Heptimax again)
All results negative

My doc wants me to retest after 6 months to make sure I am still negative.  I have never had a RIBA test.  My doc also thinks it is possible I never really had it, as I have no obvious risk factors.  (I know, there are other people who fit this catagory)

Of course, I am concerned for myself but my main concern is my baby.  I'm hoping since my viral load was so low and undetectable by the time I gave birth that my baby will be fine.  

What do you guys think?  Am I just one of the "lucky few" who cleared without treatment?  Or false positive?  

[jmjm530]

A recent analysis of differrent studies showed that 40% of women clear the virus spontaneously.Also, since you didn't have the riba, it may have been a false positive. Further testing may be prudent, but I think you have every reason to believe things are OK.

-- Jim

[onlythroughgrace]

Thanks for your response Jim.    

I have been lurking here for a while but haven't had the courage to post.  My story sounds rather pathetic in comparison to what I have read here.  I have the utmost respect for all of you.  

[goldenrule]

I love you screen name!!
I too probaly had very low to no virus when giving birth, only I did not know I had it. My baby was born healthy and after several tests, he was never even exposed to the virus.. I am sure that no matter what, your baby will be healthy. The cahnces of passing it are very low. Just make sure the delivery Dr knows what is going on...

[jmjm530]

On re-reading your post, I now realize you did have a very low positive viral load which means that perhaps the antibody test was correct. Still, you were negative last time via sensitive TMA (Heptimax) so I'd still be very hopeful, but definitely test again as your doctor suggested.

-- Jim

[jmjm530]

Of course, the "103" could have been a false positive as your doctor suggests. Some things we can only guess at.

[willing]

only: 103 is a *very* low VL reading. It's possible (a) you cleared between tests (b) one of the two heptimax's is lying (c) you are maintaining a chronic infection with a very low level of VL, possibly a spontaneous clearance in progress. Others on this forum have reported chronic infection with very low VL.  Serum VL normally bounces around so distinguishing (a) from (c) on the basis of one test seems doubtful. You'll probably need to keep checking for a while. It may be reassuring that the rate of HCV transmission through birth is very low (around 5%, but I haven't checked).

jim: seems a suspiciously high rate of false positive reports for tmas...

[Jakied]

Transmission from mother to unborn baby is VERY rare but possible.  I am a little  confused about your second Pcr test.  You wrote that the viral load was 103, NOT <103.  Is this a positive result?

Also, is the hepitamax test a Pcr test ?  I believe it is.  If so, then have you taken three pcr tests with the first one neg, second one pos and third neg?  If so, then I believe you are neg for the virus.

As for your antibody status, i would ask your Doctor for the Riba test.  It is very specific for the hep c antibody.  If that is pos, then you definitely were exposed to hep c at some point in your past and cleared on your own.  Be thankful for that.  Most people on this forum would give their right arm to clear without treatment.

Good luck with this.  Hope for a neg riba and then you will be home free.

[jmjm530]

Willing:  (40% for Women) seems a suspiciously high rate of false positive reports for tmas...
--------------------------------------
I was speaking to "spontaneous clearance", not "false positives" unless you are using the terms here interchangeably.

http://www.hivandhepatitis.com/hep_c/news/2007/121107_b.html
http://www.medscape.com/viewarticle/521187_1 (Free Mescape Reg Required)

[nygirl7]

Since no one in here really can have anything but a good guess you are going to have to keep testing for a while with a very sensitive test.  

I gave birth to two children when I didn't know I had the disease and they are both fine.  I wouldn't jump the gun at all - just relax and enjoy the time with your baby and then see what happens.  February was quite a while ago now and if you do keep testing positive with a low level VL then you do have chronic hep but it's not very active.  Perhaps the pregnancy hormones did something to keep it down I really have no idea.

[onlythroughgrace]

From what I understand the first test was sensitive down to 615, so my result was negative (<615).  the next two were more sensitive (I believe down to 5).  So, my 2nd test showed a VL of 103.  The 3rd test was <5.  

[Jakied]

well, it sounds to me as though your first pcr test was, in reality, a pos reading at some level below 615, say 500.  Your second pcr was definitely pos, at 103.  At this point, your viral load is declining, on your way to clearence.  Your third pcr is neg, so at this point i would say you have cleared the virus but will be pos for antibody.  GOOD NEWS!

I believe your riba test, if you have one, will be pos for antibody.  This is NOT a health problem but you cannot donate blood or organs.  The important thing is you are neg for virus.  

your doctor may suggest a 4th pcr in 3 months or so but I believe that will be neg, conclusive and final.

Do you have a risk factor for Hcv?  Blood transfusion or drug use?

symptoms are dark urine,stomach pain and fatigue.

Be honest with yourself about the risk factors.

[onlythroughgrace]

I have none of the CDC's risk factors (no drugs, no tattoos, no body piercings, no risky sex, no transfusions, nada).  

I have on occasion gotten pedicures/manicures. I have had only one surgery.  All doctors have said that these are not likely.  But, I know I have read posts here from people who say they got it from a pedicure.  

I was told to retest 6 months from my last test date to make sure I am still negative.

Thanks for your responses, everyone.      

[willing]

I was  referring to tma false positive rate, not clearance. Since you seem to be  a proponent of tma amplification technology and quest's heptimax packaging of it, I thought this might start to trouble you a bit.. but mostly just giving you a hard time.)

As I've noted before, I think there is some merit in using the "stock" test kits developed by Roche/Bayer rather than a lab's in-house developed  test like Heptimax. The former are routinely tested by independent labs and the results published for comparison. However researchers don't seem to have access to the latter (eg can you find a peer-reviewed pub that compares heptimax's false positive/negative rates?). Quest does offer a high-sensitivity Roche qual  test as I recall.

[jmjm530]

Willing: but mostly just giving you a hard time.)
------------------
But I would expect nothing less and frankly be disappointed if anything less, esp with this particular subject that has you now hanging on some very thin threads :)
---------------
Curious, what high false positive rates are you referring to? Did I miss something you posted, intentionally or not :)

Also, what is the sensitivity of the "stock kits" that you are referring to?

You should also know that Quest's "In House" tests -- even Heptimax I believe -- does use some Bayer -- perhaps even the idential Bayer technology. With Heptimax, that would probably be in the TMA quantiative portion (part 2) with a dynamic range of 5 -50 IU/ml.

With the test I think you're referring to -- Quest's "HCV RNA TMA QUAL" that def uses Bayer Versant Technology and is the test I've taken post treatment. Only done at Quest's Nichol's Institute I believe, although you can have blood drawn for it at any center.

The reason I often suggest "Heptimax" is because :(1) It's available all over the place and covered by a lot of insurance policies; (2) The name is so simple to specify that even a doctor can do it without messing up; (3) It's a one-test-for-all stages (pre, during and post tx) because of its sensitivity and wide dynamic range (5-50 million);'and lastly because it's a pretty good test based on conversations I've had with several trial directors who personally use this test with their private patients -- although one such trial director did mention the false positive issue with Heptimax (it was anecdotal) and partly based on that I did switch to the Qual post treatment. If you have any other tests that seem to fit this criteria -- Quantasure Plus by LabCorp is another -- let me know. "Heptimax" certainly isn;'t the be all and end all, but it does have its place.

-- Jim

[willing]

if in fact, the low end of heptimax is Bayer's Versant that would remove my heptimax quibbles (which amount to the fact that the false positive/negative rates don't seem to be published); are you sure that's the case?  The performance of Versant v3 along with that of Roche's Monitor and Taqman tests has been extensively analyzed and compared, eg:

Gorrin G, Friesenhahn M, Lin P, Sanders M, Pollner R, Eguchi B, Pham J, Roma G, Spidle J, Nicol S, Wong C, Bhade S, Comanor L.

Performance evaluation of the VERSANT HCV RNA qualitative assay by using transcription-mediated amplification.
J Clin Microbiol. 2003 Jan;41(1):310-7.
PMID: 12517866

[jmjm530]

I hope not, because then we would have no quibbles :) I'll check it out later or tomorrow and see what I come up with.

Be well,

-- Jim

[jmjm530]

OK. Seems like 5 IU/ml isn't sensitive enough for you anymore.LOL. How times have changed :)
--------------------
Here's what I have on Quest's "HCV RNA TMA QUAL"
http://tinyurl.com/3as4q6
"This test was performed using the Versant(R) HCV RNA
Qualitative Assay (TMA)."
I'm pretty sure that "Versant" means Bayer Versant Technology which is probably being licensed.

I'll post same on "Heptimax" as soon as I find a fact sheet with the info on it.

[jmjm530]

Best I can do on "Heptimax" is this '01 release. You would probably have to research more or contact Quest to see if current:

"The new test was developed by Quest Diagnostics at Nichols Institute and is offered exclusively through Quest Diagnostics' national laboratory network. The highly sensitive HEPTIMAX(TM) HCV assay utilizes reagents from Bayer Diagnostics, based on proprietary TMA technology made available through Bayer's exclusive agreement with Gen-Probe, San Diego, CA.
http://tinyurl.com/2k94gq

[willing]

>Seems like 5 IU/ml isn't sensitive enough for you anymore
all depends what you're looking for, and, even more importantly, what you're comparing your answer to. For purposes of detecting residual post svr infection 5IU/ml is clearly  way too rough a measuring stick..

I had seen that language before and took "utilizing reagents" to mean Quest licensed part of Bayer's technology rather than use the Versant test outright - as is done when ordering the "HCV RNA TMA QUAL".  Hard to be sure though. Anyway - thanks for checking - and be well!

[jmjm530]

Willing: For purposes of detecting residual post svr infection 5IU/ml is clearly  way too rough a measuring stick..
-----------------------------------
OK. Let's say for agument's sake that you are SVR via Heptimax at month 6.  And let's asume, again for argument's same, that some virons may exist in the serum of some SVRs. And say you are offered a test that through multiple vial submissions, or whatever, could measure your blood way below even 1 IU/ml. Would you take the test?

Not sure I would because if UND, that's nice, but if detectible what does that really tell me? How can I relate it to the SVR population as a whole? Does it mean I'm a "normal" SVR, or a "positive" SVR? And more importantly, other than worry myself sick, what am I to do about it? Treat again with interferon. LOL. Not thank you here.

Hopefully, you won't take this as an Ostrich stance, but I just don't see the value of that test right now. Maybe down the road when a few  things are in place.

First, some studies to show how my results might fit into the SVR population as a whole; something that would tell me what those virions mean on a *clinical* level. In other words, are they a real threat or not? And lastly, if they are a threat some reasonable plan in place to do something about it. Like a more thorough treatment for example, whose benefits (if there are any) outweigh its toxicity.

Right now, SVR appears to confer better histology and a reduction in HCC. It appears durable, and if some persistent virus remains under the radar, so far there is no clinical signficance. So, guess what I'm saying is that for now, until more research is done, I'm content with the measuring stick as is.

That said, if the measuring stick could be made better -- to help predict SVR's while treating -- then I say let's go for the more sensitive tests. But I think those tests would have to be a lot more sensitive than 2 IU/ml to confer the kind of certainty we'd all like before stopping the drugs. Maybe techniques like HR suggests -- dividing the dose -- would make that difference. But right now, who is going to order those tests and who is going to pay for ten tests every time around? Hopefully there will be studies in this area.

Be well,

-- Jim

[willing]

well, well, so there might be times when more accurate tests might not contribute useful clinical information, and it might even be hard to interpret the results given an absence of comparable data.. what an interesting argument!

If  one is fanatical enough, it shouldn't be hard to find lower bounds  on how much sensitivity is predictive even at the magical 12 weeks. After all, at say 65ml/kg of blood,  I should have about 5000ml to test on. Say I was willing to undergo a complete transfusion and have all 5000 tested (yeah, it might be hard to get insurance to pay for this). Surely detecting even an average of one virion/ml would not affect my SVR outlook?

[jmjm530]

Speaking of complete transfusions, many years ago I was obsessed with body fat combination and went beyond the usual charts and caliphers. Actually went into the water tank, but even that had limitations due to the air we keep in our lungs, bowels etc. Finally, through research, I found the one perfect system to measure exact body fat composition. Unfortunatly, it required incinerating the entire body as part of the process. But look, if you need a letter for the insurance company, let me know and I'll be glad to help :)

-- Jim

[jmjm530]

More seriously, the "perfect" test that would determine with 100 per cent accuracy when one could stop treatment would be great.

Would it be a very sensitive viral load test, or would it be some sort of test that determined whether the T-Cell response was for real or simply interferon aided?

For a number of reasons, I don't see these tests coming along very soon and there's a good chance they  will become academic as newer generations of tx drugs will hopefully have a sure fire mechanism to knock the virus out for the count. But speaking of transfusions, have you read about some of those transfusing type device s where the blood is treated with some sort of light to kill virons? I've read about some such methodology both here and in Japan. Doesn't get an SVR but if it can lower viral load enough prior to tx, it can certainly help set the plate.

-- Jim

-- Jim