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233616 tn?1312790796

hepatitis Researcher crazy test ordered

how crazy is this....my sons last test was for a VL of 27, no genotype detectible.

so I asked for a more sensitive test, say a TMA Hepimax..

instead they did a quantitative PCR  >25....

how is this supposed to help define is he has the virus? He had  A VL of 27, so to confirm the doc orders a test only sensitive to 25.........

is it just me, or is this crazy making??

Mary
18 Responses
233616 tn?1312790796

Tests: (1) Hep C PCR Quantitative O=BENNER, KENT GEORGE (44652)
HCV Quant PCR <25 IU/mL
HCV Quant PCR Interpretive Comment:
This test is performed using Cobas HCV TaqMan ASR Assay.
The lowar limit of sensitivity of this assay is 25 IU/mL.  Analyte Specific Reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration approval.  This test was developed and its performance characteristics determined by Providence Health System Infectious Diseases and Molecular Diagnostics Lab.  It has not been approved by the U.S. Food and Drug Administration. This test should not be regarded as investigational or for research use.
Avatar universal
Yeh it probably would have been better if your son had a test that had a lower sensiivity.
But the ordered test will provide usefull information.

If it comes back with a VL result then this would confirm the previous test.

If it comes back negative then it is likely that the previous test was a false positive.
However if this was the case you would wonder whether his VL was just below the limit of detection.
In my view this would be unlikely as he is not taking Interferon so his VL would be in the 1000s at a minimum or more likkely in the milloions if he did have HCV.

In other words this test should confirm whether or not he has HCV or not.

All the Best
CS
Avatar universal
As CS says, a positive would add significant weight to your son having HCV, but personally, I would not be satisfied with a negative, given your son's previous "27".

Obviously, there is some sort of communication issue going on with your medical team and what you report is not that uncommon. Many doctors office tend to order what they are familiar ordering, regardless of input, unless you are very specific and follow through.

Moving forward, what you will have to do is speak to the person in charge -- preferably the doctor -- and specify the exact test you want. And better than that, is to personally look at the laboratory requisition form and make sure that the test you want is wriitten down. I always did that for all my labs. If your medical team for some reason is resistent, maybe your primary or another doctor can order another test for you.

Two sensitive tests that would work for your son are:

Quest Diagnositcs:  "HCV RNA TMA QUALITATIVE"

(or) HCV NGI ultraqual" LC#140609  

----------------------------
Again, make sure that the tests are written exactly as above on the requistion form, including the test number for the LabCorp test. And again, ask to look at the lab requisition.

Hoping you an otherwise Happy New Year.

-- Jim




Avatar universal
Just re-read your post, and it appears that you already have the result from your son's last test.

Overall, excellent news that the test shows UND, but again, I'd personally want a follow-up with one of the two more sensitive tests mentioned before.

It might be helpful for you to post exactly how many HCV antibody and viral load tests your son has had, the exact names of those tests and the dates of those tests.

-- Jim
Avatar universal
I missed the Less than sign so oops.
Basically it looks like the first test was a false positive. So tahts something to be pleased about.

However after reading Jims post i immediately thought of a previous post by Jim that gave a link on Clinical Care by Shiffman on acutes going in and out of the limit of detection.

As Jim says seeing the results of ALT and anitibody tests would be helpful.
If these are normal then the chances of him having HepC are fairly slim.

If you are going to do a more sensitive test i would leave it for a few months just to make double sure that he is out of the acute phase. But then you would think at least his ALTs would be high or be AntiBody pos, by now.

CS

Avatar universal
CS: by Shiffman on acutes going in and out of the limit of detection.
---------------
Yes, for this reason and others, it's very important to analyze what were names, dates and results of all tests taken. That and any other data (liver enzyme levels, physical exam, etc) that might suggest whether or not her son was/is in an acute stage. We, here, can do our best to be helpful, but ideally all this would be presented to a good liver specialist (hepatologist) to analyze. It's unclear from what MB has posted as to whether her doctor fits that bill.

MB -- but all said, given the last UND, I still think you have every reason to be optimistic that your son does not have HCV, but obviously you want to be sure. Getting the more sensitive test you want and/or a second consult seem to be good next steps.

-- Jim
233616 tn?1312790796
thanks for the input both of you.

my point was based on the back history, of normal ALT's all along etc.
but a pos antibody test, and an UND in sept,
followed a Pos. with VL 27 and undetectible Genotype in Nov ,
followed now by an UND?????? but only on the least accurate test....how was that supposed to help?

Given that this was his 3rd round of testing I went in with my son this time and indeed DID insist on the TMA Hepimax (as this was before Jim and HR had the long discourse on the other tests but there had been discussion of the TMA so I went in armed....)
yet
STILL Benner did not order the TMA but ordered a much inferior test.

And yes, it would be wonderful to think positve, obviously we all want that.....
but I guess with a test that's accurate to only >25
and a previous count of only 27, it's hard to put ANY faith in either that test, or at this point the person that ordered it.  
I keep wondering if it was his son, would he have ordered that test....nope is all one can answer!!!.

sorry, I'm just venting.....it seems even when you go in knowing what to ask for, especially if you are female you'll be dismissed, at least,........ that's the way this feels, again.

I did articulate which test he should have!!!!!!!

and on the 7th I'll go back and have to pitch a fit to get him the right test I guess....it would be nice if the gentle matter of fact type discourse "here's what I've read works best"....would work with some of these docs, but it seems to almost never work, in fact, us telling them what test to do, or what may be wrong, or could be done differently only affronts the ego and causes most, not all, but most I've known, to dig in deeper to their "what could you know" behaviors. I think in spite of saying "we want people to be health conscious" most docs really want us to just sit at their feet and act stupid.
Let them know everything and don't ask too many questions or dare to discuss treatments is the way it always seems to go.

Ex: I mentioned a couple of things HR recommends for liver conservation...PPC etc, and got only a "what's that??" response.  


I'll have to go dig out the tests and scan them for you.
  


Avatar universal
Some doctors are like this. I was lucky with mine. When they wanted to order an in-house bDNA VL (sensitivity 615 IU/ml) early-on in treatment, I asked for Heptimax. The doc said, "no problem" and grabbed a Quest requisition form. No doc ego involved at all. Like I said, I was lucky.

Ideally, you would find another liver specialist who you are more comfortable with and who can review all of your son's labs and give this some closure. Next best, might be to find another doctor -- maybe your PCP -- to write the rx for a more sensitive test, because sometimes it's easier to start over with a doc than to wring something out of one who is resistant.

From what you re-stated, it sounds like most of the weight suggests your son doesn't have HCV, acue or chronic.  However, given the positive antibody combined with a very low VL (27) on one test -- the prudent thing would be to re-test again with a very sensitive viral load. Either once more, or perhaps more than once.

I say, "it sounds like" because you haven't provided a complete  list of specific test names, dates, and test sensitivities which have to be reviewed in a methodical manner by a liver specialist who might spot something that we can't in this format.

All the best,

-- Jim

233616 tn?1312790796
above you have the most recent test,

below are the 2 oldest...one showing antibodies, one showing no detectable virus...these were the september tests.

the middle ones I'll dig out and scan in tonight.

Lab: HEPATITIS C RNA, Quantitative BY PCR, ULTRASENSITIVE
Accession ID:
Order Date: 09/07/2007 Collection Date: 09/07/2007 Time: 11:31:00
Specimen Source: Specimen Description:
Report Date: 09/12/2007

Name Value
Hep C RNA NOT DETECTED
INTERPRETATION See detail
The expected reference range for an individual not infected with HCV
RNA virus is HCV RNA not detected. Assay method is polymerase chain
reaction (PCR) using the Roche Cobas TaqMan HCV Test. This assay is
an ultrasensitive quantitative HCV RNA test with an analytical
measurement range from 10-25,000,000 IU/mL (1.0-7.39 log IU/mL). A
positive hepatitis C RNA PCR result (HCV RNA detected) is consistent
with a hepatitis C virus infection. A negative hepatitis C RNA PCR
result (HCV RNA not detected) is consistent with the absence of a
hepatitis C virus infection. A negative hepatitis C RNA PCR result
(HCV RNA not detected) does not rule out the presence of PCR
inhibitors in the patient specimen or HCV RNA concentrations below
the level of detection of the assay.
This test uses a kit designated by the manufacturer as for research
use, not for clinical use. The performance characteristics of this
test were validated by Oregon Medical Laboratories. The U.S. Food and
Drug Administration (FDA) has not approved or cleared this test. The
results are not intended to be used as the sole means for clinical
diagnosis or patient management decisions. Oregon Medical
Laboratories is authorized under Clinical Laboratory Improvement
Amendments (CLIA) to perform high-complexity testing.
Performed at Oregon Medical Labs 123 International Way, Springfield OR 97477

Lab: HEPATITIS C AB
Accession ID:
Order Date: 09/07/2007 Collection Date: 09/07/2007 Time: 11:31:00
Specimen Source: Specimen Description:
Report Date: 09/08/2007

Name
ANTI-HCV
HCV INTERPRETATION
– Repeatedly REACTIVE Anti-HCV. – infection. Recommend HCV RNA,
Value
POSITIVE
See detail
Consistent with recent or past HCV
Quantitative PCR, Ultrasensitive to
Reference Range A Negative

– confirm HCV infection. If HCV RNA, Quantitative PCR, Ultrasensitive
– is negative, additional testing with RIBA is necessary to verify anti-
– HCV result and determine the need for counseling and medical
– evaluation.
– Performed at Oregon Medical Labs 123 International Way, Springfield OR 97477

Avatar universal
I'll be gone for part of today so I'll make an assumption about the missing test which shows a viral load or "27".

In summary, this is what I have, and hopefully it's correct. I'm also assuming your son has had  normal bloodwork, including normal liver enzymes during this period and no outward symptons of acute HCV such as jaundice, etc.

1. Sept 07 -- Antibody DETECTED
2. Sept 07  --- Virus UND via the Roche Cobas TaqMan  (Sensitivity 10 IU/ml)
3. Sept -- Dec?  27 IU/ml Virus DETECTED via RNA Quat
4. December 07 -- Virus UND via obas HCV TaqMan (Sensitivity 25 IU/ml)

--------------
First, you'll note that the lab notes state that if the ultrasensitive quantitative (see #2 above) is UND, then a RIBA is to be performed in case viral load is below test sensitivity. Was a RIBA done?

Second, and I'm not familiar with the TaqMan assays -- it appears that the TaqMan test was done twice, but each had a different sensitivity. I'm not familiar with these tests so maybe there are several in the family. Probably it's that, but if the same test than one of the sensitivities is incorrect.

In any event, my advice is as before -- you really need to see a liver specialist you feel comfortable with who can review all the test results, and then follow-thru with additional testing if necessary.

In the meanwhile, what I'd personally do is have your current doctor -- or better maybe your PCP -- order up one of the two very sensitive  tests mentioned earlier in the post, and also order a RIBA as mentioned in the lab notes.

With these two additional tests, you will have two additional dots to join which should make the puzzle a lot easier for the new doctor to interpret.

But what you really have to do is move forward and not focus or look for logic in whatever mistakes or studpidities your current doctor may or may not have made.

Hope this helps some.

-- Jim

Avatar universal
Fourth paragraph from bottom, should have read in part:

"... or better maybe your PCP -- order up one of the two very sensitive  tests mentioned earlier in the THREAD, and also order a RIBA as mentioned in the lab notes.
----------
Again, those two test would be:

Quest Diagnositcs:  "HCV RNA TMA QUALITATIVE"

(or) HCV NGI ultraqual" LC#140609  
92903 tn?1309908311
MB suggests: "here's what I've read works best"....

This would NOT be my approach. Say what you will - but the Dr patient relationship is founded on your paying him for information and expertise. So ask him why he would not recomend TestX or TestY - don't tell him why he's wrong, ask him why he's right. And poke holes in his answers by asking more questions -- but let the information flow come from him. Ask him whether hee feels a study holds water - or why he prefers Course A over Course B.

As I see it, you've signed up for his expertise - now focus it on the very specific issues at hand - like why hios test is superior over some other test. If you do his inquisically, he'll liekly appreciate the conversation more and be more receptive to new ideas and approaches.    

Them's my two cents.
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