Corrections to the AASLD Practice Guideline
Article first published online: 30 JUN 2004
Copyright © 2004 American Association for the Study of Liver Diseases
Volume 40, Issue 1, page 268, July 2004
How to Cite
Hendricks, D. A. (2004), Corrections to the AASLD Practice Guideline. Hepatology, 40: 268. doi: 10.1002/hep.20325
- Issue published online: 30 JUN 2004
- Article first published online: 30 JUN 2004
To the Editor:
With this letter, I wish to correct inaccuracies reported in the recent American Association for the Study of Liver Diseases (AASLD) Practice Guideline,1 with regard to qualitative and quantitative hepatitis C virus (HCV) RNA tests.
Concerning qualitative HCV RNA tests, the authors report on page 1149 that “The Food and Drug Administration (FDA) has approved 2 PCR-based tests for qualitative detection of HCV RNA: (1) Amplicor Hepatitis C Virus Test, version 2.0, and (2) Cobas Amplicor Hepatitis C Virus Test, version 2.0 (Roche Molecular Systems, Branchburg, NJ), which have lower limits of detection of approximately 50 IU/mL.” In fact, the FDA has approved three assays for qualitative detection of HCV RNA. In addition to the two tests cited in the article, the Versant HCV RNA Qualitative Assay (Bayer HealthCare LLC, Tarrytown, NY), which uses transcription-mediated-amplification technology, was approved by the FDA in November, 2002, and has a limit of detection of 9.6 IU/mL.2, 3
Concerning quantitative HCV RNA tests, Table 4 of the article (also on page 1149) incorrectly lists the dynamic range of the Versant HCV RNA 3.0 Assay, which is based on branched DNA technology, as “615–700,000 IU/mL.” The correct dynamic range for this assay is 615–7,700,000 IU/mL.4
Given the significance of the FDA approval status and performance characteristics of HCV RNA tests to individuals and organizations involved in caring for hepatitis C patients, it is important that this information be reported accurately. I appreciate the opportunity to clarify this information for the AASLD Practice Guideline.
David A. Hendricks Ph.D. Director and Senior Research Fellow*, * Scientific and Medical Affairs, Molecular Testing Segment, Bayer Diagnostics, Berkeley, CA.