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Pathology and Laboratory Medicine Service, Veterans Affairs Medical Center, Washington, DC 20422, and Department of Pathology, George Washington University School of Medicine, Washington, DC 20037.
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Department of Pathology, The Ohio State University
College of Medicine, Columbus, OH 43210.
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Departments of Pathology and Laboratory Medicine, Emory
University School of Medicine, Atlanta, GA 30322.
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Department of Laboratory Medicine, University of
Washington School of Medicine, Seattle, WA 98104-2499.
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Department of Medicine, University of Massachusetts
Medical Center, Worchester, MA 06155.
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Hepatitis C Programs, National Institute of Diabetes,
Digestive, and Kidney Diseases, National Institutes of Health,
Bethesda, MD 20892, and Georgetown University School of Medicine,
Washington, DC 20037.
a Address correspondence to this author at: Pathology and Laboratory Medicine Service–113, VA Medical Center, 50 Irving Street NW, Washington, DC 20422. Fax 202-745-8284; e-mail
d.robert.dufour{at}med.va.gov
Purpose: To review information on performance characteristics for tests that are commonly used to identify acute and chronic hepatic injury.
Data Sources and Study Selection: A MEDLINE search was performed
for key words related to hepatic tests, including quality
specifications, aminotransferases, alkaline phosphatase,
-glutamyltransferase, bilirubin, albumin, ammonia, and viral
markers. Abstracts were reviewed, and articles discussing performance
of laboratory tests were selected for review. Additional articles were
selected from the references.
Guideline Preparation and Review: Drafts of the guidelines were posted on the Internet, presented at the AACC Annual Meeting in 1999, and reviewed by experts. Areas requiring further amplification or literature review were identified for further analysis. Specific recommendations were made based on analysis of published data and evaluated for strength of evidence and clinical impact. The drafts were also reviewed by the Practice Guidelines Committee of the American Association for the Study of Liver Diseases and approved by the committee and the Association’s Council.
Recommendations: Although many specific recommendations are made
in the guidelines, some summary recommendations are discussed here.
Alanine aminotransferase is the most important test for recognition of
acute and chronic hepatic injury. Performance goals should aim for
total error of <10% at the upper reference limit to meet clinical
needs in monitoring patients with chronic hepatic injury. Laboratories
should have age-adjusted reference limits for enzymes in children, and
gender-adjusted reference limits for aminotransferases,
-glutamyltransferase, and total bilirubin in adults. The
international normalized ratio should not be the sole method for
reporting results of prothrombin time in liver disease; additional
research is needed to determine the reporting mechanism that best
correlates with functional impairment. Harmonization is needed for
alanine aminotransferase activity, and improved standardization for
hepatitis C viral RNA measurements.
The following articles in journals at HighWire Press have cited this article:
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  H. J. Kim, S. W. Oh, D. J. Kim, and E. Y. Choi Abundance of Immunologically Active Alanine Aminotransferase in Sera of Liver Cirrhosis and Hepatocellular Carcinoma Patients Clin. Chem., May 1, 2009; 55(5): 1022 - 1025. [Abstract] [Full Text] [PDF]
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 C A Bevan, C S Palmer, J R Sutcliffe, P Rao, S Gibikote, and J Crameri Blunt abdominal trauma in children: how predictive is ALT for liver injury? Emerg. Med. J., April 1, 2009; 26(4): 283 - 288. [Abstract] [Full Text] [PDF]
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 J. R. Ticehurst, F. M. Hamzeh, and D. L. Thomas Factors Affecting Serum Concentrations of Hepatitis C Virus (HCV) RNA in HCV Genotype 1-Infected Patients with Chronic Hepatitis J. Clin. Microbiol., August 1, 2007; 45(8): 2426 - 2433. [Abstract] [Full Text] [PDF]
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 P. B. Watkins, N. Kaplowitz, S. V. Colucci, P. W. Stewart, and S. C. Harris Acetaminophen and Aminotransferase Elevations--Reply JAMA, December 20, 2006; 296(23): 2798 - 2799. [Full Text] [PDF]
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 J. J. Saukkonen, D. L. Cohn, R. M. Jasmer, S. Schenker, J. A. Jereb, C. M. Nolan, C. A. Peloquin, F. M. Gordin, D. Nunes, D. B. Strader, et al. An Official ATS Statement: Hepatotoxicity of Antituberculosis Therapy. Am. J. Respir. Crit. Care Med., October 15, 2006; 174(8): 935 - 952. [Abstract] [Full Text] [PDF]
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E. Q. Konnick, S. M. Williams, E. R. Ashwood, and D. R. Hillyard Evaluation of the COBAS Hepatitis C Virus (HCV) TaqMan Analyte-Specific Reagent Assay and Comparison to the COBAS Amplicor HCV Monitor V2.0 and Versant HCV bDNA 3.0 Assays J. Clin. Microbiol., May 1, 2005; 43(5): 2133 - 2140. [Abstract] [Full Text] [PDF]
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 E. G. Giannini, R. Testa, and V. Savarino Liver enzyme alteration: a guide for clinicians Can. Med. Assoc. J., February 1, 2005; 172(3): 367 - 379. [Abstract] [Full Text] [PDF]
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R. Rej Clinical Chemistry through Clinical Chemistry: A Journal Timeline Clin. Chem., December 1, 2004; 50(12): 2415 - 2458. [Abstract] [Full Text] [PDF]
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 D. Liu, C. Li, Y. Chen, C. Burnett, X. Y. Liu, S. Downs, R. D. Collins, and J. Hawiger Nuclear Import of Proinflammatory Transcription Factors Is Required for Massive Liver Apoptosis Induced by Bacterial Lipopolysaccharide J. Biol. Chem., November 12, 2004; 279(46): 48434 - 48442. [Abstract] [Full Text] [PDF]
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S. Y. Jeong, K. J. Kim, D. J. Kim, S. W. Oh, and E. Y. Choi Sandwich ELISA for Measurement of Cytosolic Aspartate Aminotransferase in Sera from Patients with Liver Diseases Clin. Chem., May 1, 2003; 49(5): 826 - 829. [Full Text] [PDF]
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D. R. Dufour, M. Talastas, M. D.A. Fernandez, B. Harris, D. B. Strader, and L. B. Seeff Low-Positive Anti-Hepatitis C Virus Enzyme Immunoassay Results: An Important Predictor of Low Likelihood of Hepatitis C Infection Clin. Chem., March 1, 2003; 49(3): 479 - 486. [Abstract] [Full Text] [PDF]
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M. M.A.L. Pelsers, A. Morovat, G. J.M. Alexander, W. T. Hermens, A. K. Trull, and J. F.C. Glatz Liver Fatty Acid-binding Protein as a Sensitive Serum Marker of Acute Hepatocellular Damage in Liver Transplant Recipients Clin. Chem., November 1, 2002; 48(11): 2055 - 2057. [Full Text] [PDF]
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A. H.B. Wu, R. Valdes Jr, and C. D. Hawker Guidelines and Recommendations in Laboratory Medicine Clin. Chem., July 1, 2002; 48(7): 1135 - 1136. [Full Text] [PDF]
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M. J. McQueen Overview of Evidence-based Medicine: Challenges for Evidence-based Laboratory Medicine Clin. Chem., August 1, 2001; 47(8): 1536 - 1546. [Abstract] [Full Text] [PDF]
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A. Larsson, N. Tryding, and D. R. Dufour Is It Necessary to Order Aspartate Aminotransferase with Alanine Aminotransferase in Clinical Practice? Dr. Dufour responds: Clin. Chem., June 1, 2001; 47(6): 1133 - 1135. [Full Text] [PDF]
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D. R. Dufour, J. A. Lott, F. S. Nolte, D. R. Gretch, R. S. Koff, and L. B. Seeff Diagnosis and Monitoring of Hepatic Injury. II. Recommendations for Use of Laboratory Tests in Screening, Diagnosis, and Monitoring Clin. Chem., December 1, 2000; 46(12): 2050 - 2068. [Abstract] [Full Text] [PDF]
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