[ Acides biliaires: validation de la méthode et intérêt diagnostique en cas de cholestase gravidique ]
Volume 29, Issue 4, July 2020, Pages 842–847
W. Masri1, E. Plouvier2, L. Sedrati3, M. Bendaoud4, and Y. Costa5
1 Laboratoire de Biochimie, Le Grand Hôpital de L'Est Francilien, France
2 Laboratoire de Biochimie, Le Grand Hôpital de L'Est Francilien, France
3 Laboratoire de Biochimie, Le Grand Hôpital de L'Est Francilien, France
4 Laboratoire de Biochimie, Le Grand Hôpital de L'Est Francilien, France
5 Laboratoire de Biochimie, Le Grand Hôpital de L'Est Francilien, France
Original language: French
Copyright © 2020 ISSR Journals. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
The intrahepatic cholestasis is the most common of hepatopathies specific to pregnancy. Serum total bile acids concentration (ACIBI) is the most sensitive and specific diagnostic marker of this disease. The objective of this study is to validate the enzymatic quantification method of ACIBI of Randox on Cobas 6000 c501® Roche Diagnostics ™. A retrospective study of 6 months on all patients in the gynecology-obstetric department of the hospital completes the method validation.The repeatability study on ACIBI concentrations at 20 and 40 μmol / L shows coefficients of variation respectively at 1.1% and 0.9%, that of reproducibility at 2.4% and 1.8%. The linearity is 230 μmol / L and the limit of quantification is 3 μmol / L. The measurement uncertainty is 0.52 μmol / L for a concentration of 12 μmol / L.The statistical analysis of 150 folders shows 9 cases of cholestasis of pregnancy without any other associated anomaly; 5 severe cases at a mean level of ACIBI at 56 ± 10 μmol / L with premature delivery and 4 cases of moderate CG with ACIBI at 26 ± 8 μmol / L accompanied by a regression of symptoms following treatment with ursodeoxycholic acid.The enzymatic assay method of bile acids of Randox validated in our laboratory showed good performances. In addition to its diagnostic value, the determination of bile acids has a prognostic and therapeutic value. Elevated fasting level > 40 μmol / L is considered as a risk factor for fetal complications and it is considered in the decision to to premature inducing of labour.
Author Keywords: Bile acid, method validation, cholestasis of pregnancy.
Volume 29, Issue 4, July 2020, Pages 842–847
W. Masri1, E. Plouvier2, L. Sedrati3, M. Bendaoud4, and Y. Costa5
1 Laboratoire de Biochimie, Le Grand Hôpital de L'Est Francilien, France
2 Laboratoire de Biochimie, Le Grand Hôpital de L'Est Francilien, France
3 Laboratoire de Biochimie, Le Grand Hôpital de L'Est Francilien, France
4 Laboratoire de Biochimie, Le Grand Hôpital de L'Est Francilien, France
5 Laboratoire de Biochimie, Le Grand Hôpital de L'Est Francilien, France
Original language: French
Copyright © 2020 ISSR Journals. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
The intrahepatic cholestasis is the most common of hepatopathies specific to pregnancy. Serum total bile acids concentration (ACIBI) is the most sensitive and specific diagnostic marker of this disease. The objective of this study is to validate the enzymatic quantification method of ACIBI of Randox on Cobas 6000 c501® Roche Diagnostics ™. A retrospective study of 6 months on all patients in the gynecology-obstetric department of the hospital completes the method validation.The repeatability study on ACIBI concentrations at 20 and 40 μmol / L shows coefficients of variation respectively at 1.1% and 0.9%, that of reproducibility at 2.4% and 1.8%. The linearity is 230 μmol / L and the limit of quantification is 3 μmol / L. The measurement uncertainty is 0.52 μmol / L for a concentration of 12 μmol / L.The statistical analysis of 150 folders shows 9 cases of cholestasis of pregnancy without any other associated anomaly; 5 severe cases at a mean level of ACIBI at 56 ± 10 μmol / L with premature delivery and 4 cases of moderate CG with ACIBI at 26 ± 8 μmol / L accompanied by a regression of symptoms following treatment with ursodeoxycholic acid.The enzymatic assay method of bile acids of Randox validated in our laboratory showed good performances. In addition to its diagnostic value, the determination of bile acids has a prognostic and therapeutic value. Elevated fasting level > 40 μmol / L is considered as a risk factor for fetal complications and it is considered in the decision to to premature inducing of labour.
Author Keywords: Bile acid, method validation, cholestasis of pregnancy.
Abstract: (french)
La cholestase gravidique est la plus fréquente des hépatopathies spécifiques de la grossesse. La concentration sérique des acides biliaires totaux (ACIBI) constitue le marqueur diagnostique le plus sensible et le plus spécifique de cette maladie. L’objectif de cette étude est de valider la méthode enzymatique de quantification des ACIBI de Randox sur Cobas 6000 c501® Roche Diagnostics™. Une étude rétrospective de 6 mois sur l’ensemble des patientes dans le service de gynécologie-obstétrique du centre hospitalier complète la validation de méthode.L’étude de la répétabilité sur des concentrations d’ACIBI à 20 et à 40 μmol/L montre des coefficients de variation respectivement à 1.1% et 0.9%, celle de la reproductibilité à 2.4 % et 1.8%. La linéarité est de 230 μmol/L et la limite de quantification est de 3 μmol /L. L’incertitude de mesure est de 0.52 μmol/L pour une concentration de 12 μmol/L.L’analyse statistique des 150 dossiers montre 9 cas de cholestase gravidique sans autre anomalie associée; 5 cas graves à un taux moyen des ACIBI à 56 ± 10 μmol /L avec un déclenchement prématuré d’accouchement et 4 cas de CG modérée avec des ACIBI à 26 ± 8 μmol /L accompagnées d’une régression des symptômes suite au traitement par l’acide ursodésoxycholique.La méthode enzymatique de dosage des acides biliaires de Randox validée dans notre laboratoire a montré de bonnes performances. Outre son intérêt diagnostique, le dosage des acides biliaires a un intérêt pronostique et thérapeutique. Un taux à jeun > 40 µmol/L est considéré comme un facteur de risque de complications fœtales et pris en compte dans la décision de déclenchement prématuré de l’accouchement.
Author Keywords: Acides biliaires, validation méthode, cholestase gravidique.
How to Cite this Article
W. Masri, E. Plouvier, L. Sedrati, M. Bendaoud, and Y. Costa, “Bile acids: Method validation and diagnosis of intrahepatic cholestasis of pregnancy,” International Journal of Innovation and Applied Studies, vol. 29, no. 4, pp. 842–847, July 2020.
