LeHavreV1, Main, Exploration, bibRecord, 001564

A prospective assessment of the inter-laboratory variability of biochemical markers of fibrosis (FibroTest) and activity (ActiTest) in patients with chronic liver disease

Identifieur interne : 001564 ( Main/Exploration ); précédent : 001563; suivant : 001565

A prospective assessment of the inter-laboratory variability of biochemical markers of fibrosis (FibroTest) and activity (ActiTest) in patients with chronic liver disease

Auteurs : Philippe Halfon [France] ; Françoise Imbert-Bismut [France] ; Djamila Messous [France] ; Gilles Antoniotti [France] ; Didier Benchetrit [France] ; Philippe Cart-Lamy [France] ; Gilles Delaporte [France] ; Danièle Doutheau [France] ; Théo Klump [France] ; Michel Sala [France] ; Didier Thibaud [France] ; Elisabeth Trepo [France] ; Dominique Thabut [France] ; Robert P. Myers [France] ; Thierry Poynard [France]

Source :

Comparative Hepatology [ 1476-5926 ] ; 2002.

RBID : PMC:149429

Abstract

Background

Biochemical markers for liver fibrosis (FibroTest) and necroinflammatory features (ActiTest) are an alternative to liver biopsy in patients with chronic hepatitis C. Our aim was to assess the inter-laboratory variability of these tests, and their 6 components (γ-glutamyl transpeptidase, alanine aminotransferase, α₂-macroglobulin, haptoglobin, apolipoprotein A1, and total bilirubin) and to identify factors associated with this variability.

Results

Serum of 24 patients with chronic hepatitis C or severe alcoholic liver disease were prospectively recorded and analyzed in one reference center and in 8 additional laboratories. When γ-glutamyl transpeptidase and alanine aminotransferase were expressed in international units, there was no significant difference between laboratories in the results of FibroTest or ActiTest; kappa statistics were greater than 0.50 with only 0.8% of cases (3/384) with a discordance of more than one stage. The main factor significantly associated with variability was the expression of γ-glutamyl transpeptidase and alanine aminotransferase, as multiples of upper limit of reference values. The use of standardized method with pyridoxal phosphate reduced the variability of alanine aminotransferase expression, and standardized original Szasz method reduced the variability of γ-glutamyl transpeptidase expression.

Conclusions

The variability of FibroTest and ActiTest was acceptable without clinical consequences for the prediction of the stage of liver fibrosis and grade of activity. Standardized methods and assay calibration should be used and expression of alanine aminotransferase and γ-glutamyl transpeptidase in multiples of the upper limit of reference values should not be employed.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC149429

DOI: 10.1186/1476-5926-1-3
PubMed: 12537583
PubMed Central: 149429

Affiliations:

Le document en format XML

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<author><name sortKey="Myers, Robert P" sort="Myers, Robert P" uniqKey="Myers R" first="Robert P" last="Myers">Robert P. Myers</name>
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<author><name sortKey="Poynard, Thierry" sort="Poynard, Thierry" uniqKey="Poynard T" first="Thierry" last="Poynard">Thierry Poynard</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A prospective assessment of the inter-laboratory variability of biochemical markers of fibrosis (FibroTest) and activity (ActiTest) in patients with chronic liver disease</title>
<author><name sortKey="Halfon, Philippe" sort="Halfon, Philippe" uniqKey="Halfon P" first="Philippe" last="Halfon">Philippe Halfon</name>
<affiliation wicri:level="3"><nlm:aff id="I1">Laboratoire Alphabio, 23 Rue de Friedland 13006 Marseille, France</nlm:aff>
<country xml:lang="fr">France</country>
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<author><name sortKey="Imbert Bismut, Francoise" sort="Imbert Bismut, Francoise" uniqKey="Imbert Bismut F" first="Françoise" last="Imbert-Bismut">Françoise Imbert-Bismut</name>
<affiliation wicri:level="3"><nlm:aff id="I2">Laboratoire de Biochimie, Groupe Hospitalier Pitié-Salpêtrière, 75651 Paris, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Laboratoire de Biochimie, Groupe Hospitalier Pitié-Salpêtrière, 75651 Paris</wicri:regionArea>
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<author><name sortKey="Messous, Djamila" sort="Messous, Djamila" uniqKey="Messous D" first="Djamila" last="Messous">Djamila Messous</name>
<affiliation wicri:level="3"><nlm:aff id="I2">Laboratoire de Biochimie, Groupe Hospitalier Pitié-Salpêtrière, 75651 Paris, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Laboratoire de Biochimie, Groupe Hospitalier Pitié-Salpêtrière, 75651 Paris</wicri:regionArea>
<placeName><region type="region" nuts="2">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
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<author><name sortKey="Antoniotti, Gilles" sort="Antoniotti, Gilles" uniqKey="Antoniotti G" first="Gilles" last="Antoniotti">Gilles Antoniotti</name>
<affiliation wicri:level="3"><nlm:aff id="I3">Laboratoire Biomedica, 7 Rue Davat, 73100 Aix les Bains, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Laboratoire Biomedica, 7 Rue Davat, 73100 Aix les Bains</wicri:regionArea>
<placeName><region type="region" nuts="2">Auvergne-Rhône-Alpes</region>
<region type="old region" nuts="2">Rhône-Alpes</region>
<settlement type="city">Aix les Bains</settlement>
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<author><name sortKey="Benchetrit, Didier" sort="Benchetrit, Didier" uniqKey="Benchetrit D" first="Didier" last="Benchetrit">Didier Benchetrit</name>
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<country xml:lang="fr">France</country>
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<author><name sortKey="Cart Lamy, Philippe" sort="Cart Lamy, Philippe" uniqKey="Cart Lamy P" first="Philippe" last="Cart-Lamy">Philippe Cart-Lamy</name>
<affiliation wicri:level="3"><nlm:aff id="I5">Laboratoire Clinilab, 42 Avenue de la Plaine Fleurie, 38240 Meylan, France</nlm:aff>
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<author><name sortKey="Delaporte, Gilles" sort="Delaporte, Gilles" uniqKey="Delaporte G" first="Gilles" last="Delaporte">Gilles Delaporte</name>
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<country xml:lang="fr">France</country>
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<region type="old region" nuts="2">Région Centre</region>
<settlement type="city">Gien</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Doutheau, Daniele" sort="Doutheau, Daniele" uniqKey="Doutheau D" first="Danièle" last="Doutheau">Danièle Doutheau</name>
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<author><name sortKey="Klump, Theo" sort="Klump, Theo" uniqKey="Klump T" first="Théo" last="Klump">Théo Klump</name>
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<author><name sortKey="Sala, Michel" sort="Sala, Michel" uniqKey="Sala M" first="Michel" last="Sala">Michel Sala</name>
<affiliation wicri:level="3"><nlm:aff id="I9">Laboratoire Claude Levy, 78 Avenue de Verdun, 94200 Ivry-sur-Seine, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Laboratoire Claude Levy, 78 Avenue de Verdun, 94200 Ivry-sur-Seine</wicri:regionArea>
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<author><name sortKey="Thibaud, Didier" sort="Thibaud, Didier" uniqKey="Thibaud D" first="Didier" last="Thibaud">Didier Thibaud</name>
<affiliation wicri:level="3"><nlm:aff id="I10">Laboratoire Sery, 4 Rue Gustave Cazavan, 76600 Le Havre, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Laboratoire Sery, 4 Rue Gustave Cazavan, 76600 Le Havre</wicri:regionArea>
<placeName><region type="region" nuts="2">Région Normandie</region>
<region type="old region" nuts="2">Haute-Normandie</region>
<settlement type="city">Le Havre</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Trepo, Elisabeth" sort="Trepo, Elisabeth" uniqKey="Trepo E" first="Elisabeth" last="Trepo">Elisabeth Trepo</name>
<affiliation wicri:level="3"><nlm:aff id="I11">Centre de Biologie République, Centre de Biologie République, 42 Place de la République, 69002 Lyon, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Centre de Biologie République, Centre de Biologie République, 42 Place de la République, 69002 Lyon</wicri:regionArea>
<placeName><region type="region" nuts="2">Auvergne-Rhône-Alpes</region>
<region type="old region" nuts="2">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Thabut, Dominique" sort="Thabut, Dominique" uniqKey="Thabut D" first="Dominique" last="Thabut">Dominique Thabut</name>
<affiliation wicri:level="3"><nlm:aff id="I12">Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, AP-HP, Université Paris 6 et UPRESA 8067 CNRS Paris, 47 Boulevard de l'Hôpital, 75651 Paris Cedex 13, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, AP-HP, Université Paris 6 et UPRESA 8067 CNRS Paris, 47 Boulevard de l'Hôpital, 75651 Paris Cedex 13</wicri:regionArea>
<placeName><region type="region" nuts="2">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Myers, Robert P" sort="Myers, Robert P" uniqKey="Myers R" first="Robert P" last="Myers">Robert P. Myers</name>
<affiliation wicri:level="3"><nlm:aff id="I12">Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, AP-HP, Université Paris 6 et UPRESA 8067 CNRS Paris, 47 Boulevard de l'Hôpital, 75651 Paris Cedex 13, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, AP-HP, Université Paris 6 et UPRESA 8067 CNRS Paris, 47 Boulevard de l'Hôpital, 75651 Paris Cedex 13</wicri:regionArea>
<placeName><region type="region" nuts="2">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Poynard, Thierry" sort="Poynard, Thierry" uniqKey="Poynard T" first="Thierry" last="Poynard">Thierry Poynard</name>
<affiliation wicri:level="3"><nlm:aff id="I12">Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, AP-HP, Université Paris 6 et UPRESA 8067 CNRS Paris, 47 Boulevard de l'Hôpital, 75651 Paris Cedex 13, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, AP-HP, Université Paris 6 et UPRESA 8067 CNRS Paris, 47 Boulevard de l'Hôpital, 75651 Paris Cedex 13</wicri:regionArea>
<placeName><region type="region" nuts="2">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">Comparative Hepatology</title>
<idno type="eISSN">1476-5926</idno>
<imprint><date when="2002">2002</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Biochemical markers for liver fibrosis (FibroTest) and necroinflammatory features (ActiTest) are an alternative to liver biopsy in patients with chronic hepatitis C. Our aim was to assess the inter-laboratory variability of these tests, and their 6 components (γ-glutamyl transpeptidase, alanine aminotransferase, α<sub>2</sub>
-macroglobulin, haptoglobin, apolipoprotein A1, and total bilirubin) and to identify factors associated with this variability.</p>
</sec>
<sec><title>Results</title>
<p>Serum of 24 patients with chronic hepatitis C or severe alcoholic liver disease were prospectively recorded and analyzed in one reference center and in 8 additional laboratories. When γ-glutamyl transpeptidase and alanine aminotransferase were expressed in international units, there was no significant difference between laboratories in the results of FibroTest or ActiTest; kappa statistics were greater than 0.50 with only 0.8% of cases (3/384) with a discordance of more than one stage. The main factor significantly associated with variability was the expression of γ-glutamyl transpeptidase and alanine aminotransferase, as multiples of upper limit of reference values. The use of standardized method with pyridoxal phosphate reduced the variability of alanine aminotransferase expression, and standardized original Szasz method reduced the variability of γ-glutamyl transpeptidase expression.</p>
</sec>
<sec><title>Conclusions</title>
<p>The variability of FibroTest and ActiTest was acceptable without clinical consequences for the prediction of the stage of liver fibrosis and grade of activity. Standardized methods and assay calibration should be used and expression of alanine aminotransferase and γ-glutamyl transpeptidase in multiples of the upper limit of reference values should not be employed.</p>
</sec>
</div>
</front>
<back><div1 type="bibliography"><listBibl><biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
<biblStruct></biblStruct>
</listBibl>
</div1>
</back>
</TEI>
<affiliations><list><country><li>France</li>
</country>
<region><li>Alsace (région administrative)</li>
<li>Auvergne-Rhône-Alpes</li>
<li>Centre-Val de Loire</li>
<li>Grand Est</li>
<li>Haute-Normandie</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Rhône-Alpes</li>
<li>Région Centre</li>
<li>Région Normandie</li>
<li>Île-de-France</li>
</region>
<settlement><li>Aix les Bains</li>
<li>Gien</li>
<li>Ivry-sur-Seine</li>
<li>Le Havre</li>
<li>Lyon</li>
<li>Marseille</li>
<li>Meylan</li>
<li>Paris</li>
<li>Strasbourg</li>
</settlement>
</list>
<tree><country name="France"><region name="Provence-Alpes-Côte d'Azur"><name sortKey="Halfon, Philippe" sort="Halfon, Philippe" uniqKey="Halfon P" first="Philippe" last="Halfon">Philippe Halfon</name>
</region>
<name sortKey="Antoniotti, Gilles" sort="Antoniotti, Gilles" uniqKey="Antoniotti G" first="Gilles" last="Antoniotti">Gilles Antoniotti</name>
<name sortKey="Benchetrit, Didier" sort="Benchetrit, Didier" uniqKey="Benchetrit D" first="Didier" last="Benchetrit">Didier Benchetrit</name>
<name sortKey="Cart Lamy, Philippe" sort="Cart Lamy, Philippe" uniqKey="Cart Lamy P" first="Philippe" last="Cart-Lamy">Philippe Cart-Lamy</name>
<name sortKey="Delaporte, Gilles" sort="Delaporte, Gilles" uniqKey="Delaporte G" first="Gilles" last="Delaporte">Gilles Delaporte</name>
<name sortKey="Doutheau, Daniele" sort="Doutheau, Daniele" uniqKey="Doutheau D" first="Danièle" last="Doutheau">Danièle Doutheau</name>
<name sortKey="Imbert Bismut, Francoise" sort="Imbert Bismut, Francoise" uniqKey="Imbert Bismut F" first="Françoise" last="Imbert-Bismut">Françoise Imbert-Bismut</name>
<name sortKey="Klump, Theo" sort="Klump, Theo" uniqKey="Klump T" first="Théo" last="Klump">Théo Klump</name>
<name sortKey="Messous, Djamila" sort="Messous, Djamila" uniqKey="Messous D" first="Djamila" last="Messous">Djamila Messous</name>
<name sortKey="Myers, Robert P" sort="Myers, Robert P" uniqKey="Myers R" first="Robert P" last="Myers">Robert P. Myers</name>
<name sortKey="Poynard, Thierry" sort="Poynard, Thierry" uniqKey="Poynard T" first="Thierry" last="Poynard">Thierry Poynard</name>
<name sortKey="Sala, Michel" sort="Sala, Michel" uniqKey="Sala M" first="Michel" last="Sala">Michel Sala</name>
<name sortKey="Thabut, Dominique" sort="Thabut, Dominique" uniqKey="Thabut D" first="Dominique" last="Thabut">Dominique Thabut</name>
<name sortKey="Thibaud, Didier" sort="Thibaud, Didier" uniqKey="Thibaud D" first="Didier" last="Thibaud">Didier Thibaud</name>
<name sortKey="Trepo, Elisabeth" sort="Trepo, Elisabeth" uniqKey="Trepo E" first="Elisabeth" last="Trepo">Elisabeth Trepo</name>
</country>
</tree>
</affiliations>
</record>

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A prospective assessment of the inter-laboratory variability of biochemical markers of fibrosis (FibroTest) and activity (ActiTest) in patients with chronic liver disease

A prospective assessment of the inter-laboratory variability of biochemical markers of fibrosis (FibroTest) and activity (ActiTest) in patients with chronic liver disease

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