Info about HCV RNA lab report

[mama4888]

I'm writing on behalf of my dad. This forum has been so helpful in providing me with information during his triple therapy. My question has to with his RNA tests. His doctors switched to Solstas Lab Partners and the report came back as

HCV RNA Quant <43
No detectable level of HCV RNA

I assume it means he is UND. However, the report provides no additional information about lower limit of detectability below the 43 quantification level. Is anyone familiar with the test used by Solstas Labs and know if they test for the prescence of the virus below 43 and if so, what that lower level is? His doctor assumed they can't detect anything less than 43 and the lab will not talk to me.

Many thanks!!

[hcvJames]

Sorry didn't see the other thread. Thank you for the explanation .. of course in a month I'll be confused again!

[working dog]

i still don't get it all the way...i must have been <43 detectable at 4 weeks ..and thats why they wanted me to do 48 weeks

[willbb]

mama  &hcv james:
I believe flycyclist gave a good explanation in your other thread. It is sometimes a bit confusing ,however basically........
the limit of quantitation on that test is 43 IU/mL or above.  If HCV RNA is deteced the test can give a numeric number (viral load) if the IU/mL is 43 or above.  The level of dectection goes down to 7.1 IU/mL.  The assay will detect HCV RNA down to 7.1 IU/mL which is fairly sensitive but it can't quantify or give a numeric value for any HCV RNA detected between 7.1 IU/mL and 42 IU/mL.  The patient is still detected, but no numeric value can be assigned.  
HCV RNA detected but under the quatifiable range should not be considered undetected.  This is particularly important for patients treating with Incivek at the 4 week mark.

The test will read either:

<43 HCV RNA DETECTED
                 or
<43 HCV RNA NOT DETECTED

So because your dads lab report stated "Not Detected".he has no virus detectable under the limit of Detection,so he is eligable for doing 24 weeks of treatment (if this result holds at week 12).

Best to you and your dad..
Will

[hcvJames]

Yes. As with many things, I'm confused about this. For instance, my 4 wk test said <43 and the 12 wk UND. The difference as explained by the doc and this forum was <43 is the limit of the test but there is still something there. This is why if <43 at 4 wks instead of 24 wk tx you have to go 48.

PS. I've never figured out how the second test is triggered. That is, if you are <43 the test must also indicate an unquantifiable presence and they leave it at that but it also must be able to indicate a lack of presence, thereby triggering the qualitative(?) test to confirm an UND status. This is a question not a statement... Plz correct any erroneous thinking on my part.

[mama4888]

Will - Thanks for your quick reply. Does this mean the test can only quantify levels to 43 IU/mL and not detect the presence of virus (that is not quantifiable) below 43? We are so happy he is UND, but unsure for treatment length purposes (he is on Incivek triple therapy) if he is UND for purposes of 24 wk treatment. I think on the Vertex studies, they use a lower limit of 10 IU/mL as a detection limit and 25 as a quantification limit.

Just to give you more information, he received this result on both his 4 wk and most recently 12 wk tests.

[willbb]

assume it means he is UND.
---------------------
Hi.
Thats correct ..he has no Detectable virus.. Congrats to your dad.

He has had this test below:

43 IU/ml. The HCV Quant Real-Time (RT) PCR and the COBAS® AmpliPrep/COBAS® TaqMan® HCV assay detects the virus down to 43 IU/mL.

Will