Positive RIBA, Indeterminate Antibody, Negative PCR RNA

[cdnab]

Hi there,

I have seen (read) some great support in this Hep C forum and i'm hoping someone can help me as well with my situation. A point to make is that i live in Canada. I'm not sure if the test results show differently in any way.

Had a physical for Life Insurance in December 2010. The tests were performed on December 20. ALT level was 47 with a normal range of 0-45. Hep B was negative. Hep C Ab (RIBA 3.0) was positive stating that a positive result meant that an "antibody was detected to at least two HCV proteins". There was also a band intensity given to which i have no clue what this means. Hopefully the formatiing works on this forum so this is what the result looked like. The results were a photocopy of a photocpy so i'm not sure if the Band intensity names are spelled correctly. Here are the results:

Band Intensity:
5-1-1B/C100B Band: Abnormal value of 2
CBBC Band: Normal value of 0
C22P Band: Abnormal value of 2
NS5 Band: Normal value of 0
DSOD Band: Normal value of 0

Chiron recombinant immunoblot assay HCV 3.0 Band Intensity (0=non-detected... ...4=strongly detected)

So i went to my doctor with horror and she made me do another bloodtest on about February 20, 2011. I had an anti-HCV test and an HCV PCR RNA test.

Anti-HCV results: Indeterminate. "Serology findings are equivocal for HCV infection. A follow up specimen of TWO SST blood is requested to test for HCV RNA by qualitative RT-PCR to define status of infection" My doctor followed up with a virologist ( i think thats the name). The 1st anti-HCV test was 1.2 which i was told is considered positive and the 2nd anti-HCV test was 0.9 which i was told is considered negative hence the indeterminate result.

HCV PCR-RNA: Negative. "Result was determined by Cobas Amplicor HCV v2.0 Qualitative  (Roche Diagnostics System)

I have never done drugs and i don't believe i've ever had a blood transfusion. I was born overseas in Central Europe and my doctor had made a comment that perhaps the anti-bodies could have been passed on from my mother which i doubt. I have had unprotected sex (not much but i know that doesn't matter) but that was far back.

Questions:
1. My ALT level is 47 but my doctor says they don't consider anything abnormal until the level is 50 or higher. My wife's nursing textbook actually gives the normal level up to 55. But should i care about this anyways? I have read that Hep C positive people can have normal ALT levels anyways.

2. I have tried to find the band intensity meanings and can't. Can anyone provide some info on what they mean and what my results mean if there is anything important in terms of band intensity?

3. For the anti-HCV results. What does 0.9 and 1.2 represent? Units of something? Googling numbers is a disaster and all i ever see is positive, negative and indeterminate results for this test. But do the values go from 0-4 which seems like it in the RIBA test? Maybe someone with experience can give me an idea what the numbers mean.

4. I was quite surprised with getting a negative PCR-RNA result as supposedly RIBA is quite accurate but of course this is for antibodies ONLY and the PCR-RNA test tells you if you have the VIRUS ITSELF. There are a few websites (maybe 1 or 2) that i have found that a single negative RNA test doesn't necessarily tell you that you don't have this virus. I know that the test is something like 99.5% accurate and i could fall in the 0.5% but i am surprised about these websites interpretations. Can a lab actually screw up somehow (besides switching my samples) to create a false negative?

5. How quickly would a PCR-RNA test detect the virus? From what i've read it is usually 3 weeks. If i had the positive RIBA test in late December 2010 would the PCR-RNA test pickup the virus 2 months later in my late February test?

6. I have read an answer on here about cross-reaction with other antibidies in your immune system. Is this a distinct possibility in my case?

Any information would be greatly appreciated. It's great sites like this and the responses especially from first hand experience that goes along way in calming me down in this time.

Thanks again fro any responses.

[Bill1954]

1.  My ALT level is 47 but my doctor says they don't consider anything abnormal until the level is 50 or higher. My wife's nursing textbook actually gives the normal level up to 55. But should i care about this anyways? I have read that Hep C positive people can have normal ALT levels anyways.


Different labs report with different reference ranges. Additionally, it’s quite possible to have mildly elevated (less than 100) results from other reasons; muscle strain, fatty liver (steatosis), etc.

2. I have tried to find the band intensity meanings and can't. Can anyone provide some info on what they mean and what my results mean if there is anything important in terms of band intensity?

I can’t comment on this with any authority or reliability

3. For the anti-HCV results. What does 0.9 and 1.2 represent? Units of something? Googling numbers is a disaster and all i ever see is positive, negative and indeterminate results for this test. But do the values go from 0-4 which seems like it in the RIBA test? Maybe someone with experience can give me an idea what the numbers mean.

These numeric results are referencing ‘signal to cut off ratios’. Each HCV anibody test manufacturer reports with different reference ranges; this is explained in the U.S. CDC in some detail here:

http://www.cdc.gov/hepatitis/HCV/LabTesting.htm


4. I was quite surprised with getting a negative PCR-RNA result as supposedly RIBA is quite accurate but of course this is for antibodies ONLY and the PCR-RNA test tells you if you have the VIRUS ITSELF. There are a few websites (maybe 1 or 2) that i have found that a single negative RNA test doesn't necessarily tell you that you don't have this virus. I know that the test is something like 99.5% accurate and i could fall in the 0.5% but i am surprised about these websites interpretations. Can a lab actually screw up somehow (besides switching my samples) to create a false negative?

Of course, repetitive (serial) PCR testing offers better statistical power than a single sample, but the methodology is considered quite specific for infection. Mistakes can occur, but we’re told they’re *very* unlikely.

5. How quickly would a PCR-RNA test detect the virus? From what i've read it is usually 3 weeks. If i had the positive RIBA test in late December 2010 would the PCR-RNA test pickup the virus 2 months later in my late February test?

My understanding is that PCR testing is specific for presence of virus at around 3 weeks; we have similar impressions.

6. I have read an answer on here about cross-reaction with other antibodies in your immune system. Is this a distinct possibility in my case?

This is a moot point, I believe. Setting antibody results aside, your HCV RNA results are negative; this is the clinically relevant point anyway, yes?

Bottom line; you’re HCV RNA by PCR test is negative. This is the clinically relevant issue at hand, despite the path you took to discover this.

Congratulations, and take care-

-Bill

[cdnab]

Hey Bill,

Thanks for all the comments. I would hope that the HCV RNA results would be most conclusive. I'm just curious of what type of mistakes could be made on a test like this that would skew the result. Can one say that the test is more prone to false negatives or false positives?

I will also probably try and find out what type of 'signal to cut off ratios’ they use up here in the lab in the anti-HCV test. Following the link you provided, there doesn't seem to be a test listed there that would correspond to the low negative/positive borderline of 1.0 that i was told was used. As well the 'Reference for Interpretation of Hepatitis C Virus (HCV) Test Results' pdf attached in the link you provided doesn't show an 'indeterminate' result or a 'negative anti-HCV / positive RIBA' result which is why i question how RIBA results are shown including the Band Intensity question.

[cdnab]

Bill or anyone else i have another question. Is it a fair assumption that if i did in fact have the virus, it would show up in the current (February 2011) PCR RNA test because the RIBA test was positive 2 months prior in December 2010?