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Medical Forum / Diseases and Disorders / Hepatitis / January 2006

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kjoh - 01 Jan 2006 03:22 GMT
Grey?  Gordo?  Translation? What does it all mean!!!???SCREAM!
Hot off the press from Pubmed.gov

Assessment of early virological response to antiviral therapy by comparing
four
assays for HCV RNA quantitation using the international unit standard:
Implications for clinical management of patients with chronic hepatitis C
virus
infection.

WHO International Standards for nucleic acid tests are used widely to
compare
the different assays used in HCV RNA quantitation. The aim of the study
was to
assess the impact of the international unit standard for measuring HCV RNA
in
the management of patients with chronic hepatitis C virus (HCV)
infection.
Twenty-seven naive patients infected chronically by HCV were treated with
ribavirin plus PEG-interferon-alfa-2b for 48 weeks. SVR was obtained for
16
patients (the other were non-responders). For HCV RNA quantitation, four
assays
were undertaken: Versant HCV RNA 3.0 (Bayer), Real time PCR (TaqMan,
Roche), LCx
HCV RNA (Abbott), and Cobas Amplicor-Monitor v2 (Roche). Considering a
2-log
decline at Week 12 after the beginning of therapy, discordant results were
found
with the four HCV RNA methods in predicting SVR or non-response. At Week 4
and
Week 12, significant differences were observed between Versant HCV RNA
3.0
versus PCR HCV Taqman, Versant HCV RNA 3.0 versus LCx HCV RNA, Cobas
Monitor
Amplicor HCV 2.0 versus LCx HCV RNA, and Cobas Monitor Amplicor HCV 2.0
versus
PCR HCV Taqman (P < 0.001). The HCV RNA cutoff, given a 100% negative
predictive
value at Week 4 and Week 12, differed with the assays used to quantify HCV
RNA,
despite the use of the IU/ml units. Eighty-nine percent of serum values
for HCV
RNA were concordant by the IU standard. All assays, however, failed to
detect
HCV RNA in some cases. Despite the use of the IU standard HCV-infected
patients
might be monitored with only one assay. J. Med. Virol. 78:208-215, 2006.
(c)
2005 Wiley-Liss, Inc.
greyhackles - 01 Jan 2006 17:01 GMT
>Grey?  Gordo?  Translation? What does it all mean!!!???SCREAM!
>Hot off the press from Pubmed.gov
[quoted text clipped - 3 lines]
>Implications for clinical management of patients with chronic hepatitis C
>virus infection.
[snipped]

Geeze, this one's hard to decipher, and the abstract didn't offer an
conclusion.

I'll try to dig up the whole report, but in the mean time, about all I can
take from this is:

- tests are imprecise within the dynamic range they are being used to
construct predictions of treatment results

- it is difficult to correlate the results from different VL tests (but we
already knew that, didn't we?)

- false negatives happen. Yuck...

/greyhackles
greyhackles - 01 Jan 2006 17:13 GMT
>>Grey?  Gordo?  Translation? What does it all mean!!!???SCREAM!
>>Hot off the press from Pubmed.gov
[quoted text clipped - 20 lines]
>
>/greyhackles

fwiw, checked out some related articles linked from the original, there's been
a lot of similar work with varying results. The ones that bother me the most
relate to false-negatives at  EOTx, some tests clearly aren't sensitive enough
to reliably manage the task.

But we already knew that, too.

Can't find the full original article without anteing up...

/greyhackles
Firestar - 04 Jan 2006 04:44 GMT
> >>Grey?  Gordo?  Translation? What does it all mean!!!???SCREAM!
> >>Hot off the press from Pubmed.gov
[quoted text clipped - 31 lines]
>
> /greyhackles

Conclusion:  Different test methodologies yield different results.  OK if
they are repeatable and variance between tests is constant, then some
comparisons could be made.  Unfortunately, they are not always repeatable
and vary considerably.  Best to use one lab and stick with it.
thom
 
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