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Updated Definitions of Healthy Ranges for Serum Alanine Aminotransferase Levels

Daniele Prati, MD; Emanuela Taioli, MD, PhD; Alberto Zanella, MD; Emanuela Della Torre, DSc; Sonia Butelli, DSc; Emanuela Del Vecchio, DSc; Luciana Vianello, MD; Francesco Zanuso, MD; Fulvio Mozzi, DSc; Silvano Milani, PhD; Dario Conte, MD; Massimo Colombo, MD; and Girolamo Sirchia, MD, FRCPath (Edin)
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From Centro Transfusionale e di Immunologia dei Trapianti, Laboratorio di Epidemiologia, Divisione di Ematologia, Istituto di Statistica Medica e Biometria, Cattedra di Gastroenterologia, and Istituto di Medicina Interna, IRCCS Ospedale Maggiore and Università degli Studi di Milano, Milan, Italy.


Grant Support: By a grant from IRCCS Ospedale Maggiore Policlinico, Milan, Italy (51501—Ricerca Corrente 1998).

Requests for Single Reprints: Daniele Prati, MD, Centro Trasfusionale e di Immunologia dei Trapianti IRCCS Ospedale Maggiore Via Francesco Sforza, 35 20122 Milano, Italy; e-mail, dprati@yahoo.com.

Current Author Addresses: Drs. Prati, Della Torre, Butelli, Del Vecchio, Vianello, Zanuso, Mozzi, and Sirchia: Centro Trasfusionale e di Immunologia dei Trapianti, IRCCS Ospedale Maggiore di Milano, via F.Sforza, 35, 20122 Milano, Italy.

Dr. Taioli: Laboratorio di Epidemiologia, IRCCS Ospedale Maggiore di Milano, via F.Sforza, 28, 20122 Milano, Italy.

Dr. Zanella: Divisione di Ematologia, IRCCS Ospedale Maggiore di Milano, Via F.Sforza, 35, 20122 Milano, Italy.

Dr. Milani: Istituto di Statistica Medica e Biometria, Università degli Studi, Via Venezian 1, 20133 Milano, Italy.

Dr. Conte: Cattedra di Gastroenterologia, Università degli Studi and IRCCS Ospedale Maggiore di Milano, via F.Sforza, 35, 20122 Milano, Italy.

Dr. Colombo: Istituto di Medicina Interna, Università degli Studi and IRCCS Ospedale Maggiore di Milano, via F.Sforza, 35, 20122 Milano, Italy.

Author Contributions: Conception and design: D. Prati, E. Taioli, A. Zanella.

Analysis and interpretation of the data: D. Prati, E. Taioli, L. Vianello, F. Mozzi, S. Milani, D. Conte, M. Colombo.

Drafting of the article: D. Prati, E. Taioli, A. Zanella, D. Conte.

Critical revision of the article for important intellectual content: D. Prati, E. Taioli, A. Zanella, F. Mozzi, S. Milani, D. Conte, M. Colombo, G. Sirchia.

Final approval of the article: D. Prati, E. Taioli, A. Zanella, E. Della Torre, S. Butelli, E. Del Vecchio, L. Vianello, F. Zanuso, F. Mozzi, S. Milani, D. Conte, M. Colombo, G. Sirchia.

Provision of study materials or patients: D. Prati, E. Della Torre, S. Butelli, E. Del Vecchio, L. Vianello, F. Zanuso, F. Mozzi, D. Conte, M. Colombo, G. Sirchia.

Statistical expertise: E. Taioli, S. Milani.

Obtaining of funding: D. Prati.

Administrative, technical, or logistic support: E. Della Torre, S. Butelli, E. Del Vecchio, F. Zanuso.

Collection and assembly of data: E. Della Torre, S. Butelli, E. Del Vecchio, L. Vianello, F. Zanuso, F. Mozzi.


Ann Intern Med. 2002;137(1):1-10. doi:10.7326/0003-4819-137-1-200207020-00006
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Our data suggest that it may be prudent to abandon the traditional approach of defining a universal “normal” ALT range that is supposed to be valid for all clinical situations. However, creating an equation to individualize normal limits on the basis of our multivariate analysis does not seem to be an optimal solution either because it is unlikely to be widely adopted (1). To balance these issues, we attempted to define updated “normal” guidelines or “healthy” ranges. These revised values are superior to the previously established limits for identification of persons at risk for liver disease, but must be used flexibly. In deciding whether to further investigate for liver disease in a given patient, clinicians should consider the patient's age, medical history, and preferences.

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Figure 1.
Procedures for selection of the study participants.

*Donor candidates were not suitable for the following reasons: previous blood transfusion (2%); use of major illicit drugs (1.5%); at-risk sexual exposures (9%); history of hepatitis or other blood borne infections (4%); recent exposure in a malaria-endemic area (5%); low hemoglobin level (15%); use of medication not compatible with blood donation (4%); seizure or central nervous system disorders (12%); hypertension, arrhythmias, or cardiac disease (8%); hypotension (9%); recent surgery (2%) or other medical or behavioral risks (26%); serologic reactivity on screening assays (anti–HIV 1, anti–HIV 2, hepatitis B surface antigen, anti–hepatitis C virus [HCV], or syphilis) on the sample collected at blood donation (2.5%). †Standard upper limits were 667 nkat/L (40 U/L) in men, and 500 nkat/L (30 U/L) in women. ‡Two trained hepatologists used a recently proposed algorithm (2) to re-evaluate medical history and physical examination. Participants also underwent additional blood testing, including measurement of the following values: aspartate aminotransferase, alanine aminotransferase (ALT), alkaline phosphatase, γ-glutamyl transpeptidase, total proteins, bilirubin, iron, total iron-binding capacity, serum ferritin, serum protein electrophoresis, creatine kinase, ceruloplasmin, α1-antitrypsin, antibodies to cytomegalovirus and Epstein–Barr virus, and autoantibodies. Participants also underwent ultrasonography of the liver.

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Figure 2.
Receiver-operating characteristic curves of sensitivity (true-positive fraction) plotted against 1 − specificity (false-positive fraction) in blood donors who were positive for anti–hepatitis C virus.

Newly calculated healthy limits are indicated in each panel. A. Male participants. B. Female participants. To convert the alanine aminotransferase thresholds to nkat/L, multiply by 16.667.

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Summary for Patients

New Definitions for Healthy Ranges of Alanine Aminotransferase, a Blood Test of Liver Function

The summary below is from the full report titled “Updated Definitions of Healthy Ranges for Serum Alanine Aminotransferase Levels.” It is in the 2 July 2002 issue of Annals of Internal Medicine (volume 137, pages 1-9). The authors are D Prati, E Taioli, A Zanella, E Della Torre, S Butelli, E Del Vecchio, L Vianello, F Zanuso, F Mozzi, S Milani, D Conte, M Colombo, and G Sirchia.

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