TEST FOR FATTY LIVER DISEASE

OWLiver®

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OWLiver How it works Example of the evaluation result Additional Information Sample extraction, conservation, and transport scheme for the OWLiver® test Non-invasive test References

OWLiver

The OWLiver® test is a non-invasive diagnostic method based on a blood test to determine a panel of biomarkers (metabolites) through metabolomics

How it works

All metabolites are measured by high performance liquid chromatography and mass spectrometry (UHPLC-MS) 1,2.  The analysis and determination of these metabolites reflect the amount of fat, inflammation and fiber deposits in the liver3-6. In this regard, OWLiver® makes possible to accurately establish the degree of development of non-alcoholic fatty liver disease (NAFLD *, or MALFD *, 7). NAFLD is the most common cause of chronic liver disease in our setting. In fact, an increase in its incidence is expected in the coming years, besides it is associated with the increase in obesity and the metabolic syndrome8.

The relative concentrations of biomarkers are analyzed together in three algorithms that generate a final OWLiver® score. The value of the determination indicates the probability of approximation of the patient’s liver status to a healthy liver, steatotic stage, a non-alcoholic steatohepatitis (NASH *) stage, or NASH and significant-advanced fibrosis (≥F2) stage 3-6.

 

Example of the evaluation result

*NAFLD: Non-Alcoholic Fatty Liver Disease.
*MAFLD: Metabolic dysfunction-Associated Fatty Liver Disease, new definition upon an international expert consensus statement.7
*NASH: Non-Alcoholic Steatohepatitis.
*NASH F2-F3: Non-Alcoholic Steatohepatitis and significant to advance Fibrosis (F2-F3).

Additional Information

Allows a reliable diagnosis of the patient in any harmful phase of NAFLD.3-6

Allows monitoring the follow-up of the patient, seeking surveillance in the regression or progression of NASH and liver fibrosis.3-6

Sample extraction, conservation, and transport scheme for the OWLiver® test

  • The necessary amount of sample to perform the OWLiver® test is 0.2ml (200µl) of serum.
  • Blood must be collected under fasting conditions ( 8 hours) and extracted into vacutainer SST II Advance tubes or similar, without anticoagulant and with a separating gel (Vacutainer System Blood Set needles, or similar), being these tubes transparent glass plastic with silicone-coated inside and clot activator or similar.
  • Blood sample is centrifuged according to the extraction tube manufacturer’s instructions. Once the phases have separated, the serum is collected and stored in an Eppendorf-type tube.
  • The sample should be frozen for storage at -80ºC before 24hours. In case it is not possible, it will be frozen at -20ºC for a maximum period of 6 weeks.
  • Shipment of the samples is performed on dry ice to keep them frozen.

Non-invasive test

OWLiver is an easy, fast, reproducible, and reliable non-invasive test. It becomes the most important alternative to biopsy for identifying the early stages of NAFLD*, as well as NASH* and treatable fibrosis, 4-7.

Click here, to download an example of the Results Report

For more information: owliver@labrubio.com

References

  1. Barr J, Caballería J, Martínez-Arranz I, Domínguez-Díez A, Alonso C, Muntané J, et al. Obesity-dependent metabolic signatures associated with nonalcoholic fatty liver disease progression. J Proteome Res. 2012;11(4):2521 -32.2.
  2. Barr J, Vázquez-Chantada M, Alonso C, Pérez-Cormenzana M, Mayo R, Galán A, et al. Liquid chromatography-mass spectrometry-based parallel metabolic profiling of human and mouse model serum reveals putative biomarkers associated. J Proteome Res. 2010;9(9):4501 -12.
  3. Mayo R, Crespo J, Martínez‐Arranz I, Banales JM, Arias M, Mincholé I, et al. Metabolomic‐based noninvasive serum test to diagnose nonalcoholic steatohepatitis: Results from discovery and validation cohorts. Hepatol Commun. 2018;2(7):807 -20.
  4. Bril F, Millán L, Kalavalapalli S, McPhaul MJ, Caulfield MP, Martinez-Arranz I, et al. Use of a metabolomic approach to non-invasively diagnose non-alcoholic fatty liver disease in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018;20(7):1702 -9.
  5. Martínez‐Arranz I, Mayo R, Banales J, Mincholé I, Ortiz P, Bril F, et al. Non‐invasive serum lipidomic approach to discriminate non‐alcoholic steatohepatitis in multiethnic patients with type 2 diabetes mellitus. Hepatol. 2019; 70(1):1030A.
  6. Noureddin M, Mayo R, Martínez-Arranz I, Mincholé I, Cusi K, Bril F, et al. Serum-based Metabolomics Advanced StEatohepatitis Fibrosis Score (MASEF) for the non- invasive identification of patients with non-alcoholic steatohepatitis with significant fibrosis. J Hepatol. 2020; 73(1): S136.
  7. Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, et al. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020;73(1):202-209
  8. Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, et al. Global burden of NAFLD and NASH: trends, predictions,risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018;15(1):11–20.
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