Input on test results?

[Marc1955]

I just received back my most recent HCV load test. I'm a little confused because the two findings appear to be contradictory. Here is what the test says:

 Hepatitis C RNA-PCR: Positive, HCV RNA detected
 
 
   Comment:
 
 
   Patient's specimen is POSITIVE for Hepatitis C Virus RNA by the Polymerase Chain Reaction (PCR) Amplification and DNA Probe detection method.  PCR results should be used in conjunction with other laboratory test results and the patient's clinical profile.
 
Hepatitis C Quantitation 
< 10
 IU/mL 
   
   Less than 10 IU/mL indicates either complete absence of HCV RNA or in rare cases, low copy number below the detectable limit of the assay.

Thanks in advance for any light you can shed.

[Marc1955]

Thanks to everyone who responded. I don't know the name of the test, but it is LabCorp's quantitative test. The second part I quoted does seem to suggest that the HCV quantitative is <10. There's a subsequent part of the report which gives the range of sensitivity of the test. But that seems contradicted by the first statement.

It all seems confusing. The nurse practitioner with whom I interface didn't know what to make of it. He's going to check with my Dr. When I get an answer I'll let you know.

[jmjm530]

Your profile suggests this could be a week 24 test out of a projected 48 (or more) given your genotype. Have you tested UND before and if so what was the test sensitvity. Being detectible at week 24 does not favor SVR -- and certainly not with only 48 weeks of tx -- something you should seriously factor in when deciding whether its worth continuing or not, esp since you dont hv significant liver damage. Again, a lot of speculation here as to test results, test history, etc.

[jmjm530]

Results clearly state you are positive by PCR.

The "<10" appears to be the sensitvity of test used. What appears to be missing is your exact viral load which leads me to believe this is a qualitative PCR with a limit of 10 IU/ml.

You should confirm all of the above with both the lab and a hepatologist who has the actual report in front of him. Do you know the name of the test used

Is this a post treatment test or during treatment and what week was it taken? In general, one doesn't order a qualitative until previously UND by a quantitative, but I'm speculating here.

Jim

-- Jim

[portann]

Hi Marc,

I was just declared UND by a qualitative test sensitive to 50 IU/ml but for all I know I had 49 IU/ml. Had I had your test, my 'official' outcome would have been different, even if I'd had 10 or 11 IU/ml. So you are fortunate to have access to better testing, even if at this moment, you must be reeling from the news. Perhaps you have 11 IU/ml and I have 49 but here we both are, on different sides of the fence due to testing inconsistencies.

Do you have to get a quantitative test now? That's what I would have had next, if I'd been detectable via my first and much cruder test than yours.

[mikesimon]

I don't think a PCR result could be Positive and undetectable.
I am not sure about this but when the results state:

"Hepatitis C RNA-PCR: Positive, HCV RNA detected

Comment:

Patient's specimen is POSITIVE for Hepatitis C Virus RNA by the Polymerase Chain Reaction (PCR) Amplification and DNA Probe detection method.  PCR results should be used in conjunction with other laboratory test results and the patient's clinical profile"

I would be worried about it. I have had a lot of PCRs and I have never seen anything like this. That's why I thought the <10 IU/ml was the sensitivity of the test. If, in fact, the patient was undetectable I would expect to see The word "Negative" in place of "Positive". But I admit that the way his test results appear they are confusing. So, I can't be sure about this patient and I would definitely ask for clarification.
Mike
  

[Trinity4]

Oh, ok.  I just figured because this was his 24 wk PCR according to his profile that the HEPC Quantitation results were showing <10 therefore, unable to measure.  He didn't give us an actual number so could easily not be UND.  Thanks for clarifying.  Can a PCR say positive for virus and still be UND?    

[mikesimon]

I am not sure about that Trinity. It states that the patient's specimen is positive fo Hepatitis C.
I think the <10 is stating the test's sensitivity rather than the patient's results. It is confusing and I would ask for clarification but I think he is detectable even though his viral load is not shown.
Mike

[Trinity4]

It means for all practical purposes you are UND.  Is this your 24 wk PCR?  If so, congrats, you are UND.  Some tests are sensitive down to 2 IU/ml and apparently the one your were given does not calculate under 10.  You are there my friend - good news.
I hope I get the same results in a couple of weeks!!
Trin