FibroMeter is a blood test used to aid in the evaluation and management of liver fibrosis. This test was specifically designed for patients with chronic viral hepatitis (with or without HIV co-infection). This non-invasive blood analysis is from the creators of the FibroScan instrument.

Features and benefits

  • Non-invasive diagnostic test that evaluates the level of fibrosis in the liver from blood biomarkers and patient demographic information
  • High diagnostic accuracy confirmed by a rules-based system
  • No interference from patients with Gilbert disease or hemolysis
    (e.g., induced by ribavirin)
  • An economic alternative to FibroSURE
  • Enhanced graphical reports available

Education Resource

Test Details

Scores are algorithmically calculated from values of blood biomarkers, platelet count, demographic information.

Measurements Performed by ARUP Alpha-2-macroglobulin, ALT, AST, GGT, prothrombin index, urea
Information Provided by Client Patient's platelet count, age, gender
Calculated Scores Score ranges from 0 to 1, 1 being the most severe stage:
  • Fibrosis score (FibroMeter)
  • Cirrhosis score (CirrhoMeter)
  • Necroinflammatory activity score (InflaMeter)
Metavir Classifications Corresponding classifications are reported together with the scores:
  • F0–F4 for fibrosis/cirrhosis
  • A0–A3 for activity grade

Method Comparison

Comparison between FibroMeter and other non-invasive tests:

  Echosens FibroMeter FibroSURE (FibroTest) FibroSpect II
Markers used
  • age, gender
  • ALT
  • alpha-2-macroglobulin
  • gamma-glutamyl transpeptidase (GGT)
  • AST
  • platelet count
  • prothrombin index
  • urea
  • age, gender
  • ALT
  • alpha-2-macroglobulin
  • gamma-glutamyl transpeptidase (GGT)
  • apolipoprotein A1
  • bilirubin
  • haptoglobin
  • alpha-2-macroglobulin
  • Hyaluronic acid
  • Tissue inhibitor of metalloproteinase
Conditions that may affect test¹
  • Non-hepatic inflammation
    • Increased alpha 2-macroglobulin
  • To reduce misclassification, test scores are evaluated by a rule-based algorithm to detect anomalous profile results, which may modify test scores as needed.
  • Non-hepatic inflammation
    • Increased alpha 2-macroglobulin
    • Increased haptoglobin
  • Increased bilirubin
    • Gilbert syndrome
    • Extrahepatic cholestasis
  • Decreased haptoglobin
    • Hemolysis (Side effect of Ribavirin treatment)
  • Severe malnutrition
  • Provides a binary distinction between no/mild and advanced fibrosis; not able to differentiate among each Metavir stage
Turnaround Time 1–5 days 2–5 days 2–5 days
FDA Approval No No No
NY Approval Yes Yes Yes

¹ Stebastiani G et al, 2011

Metavir
Classification
Echosens FibroMeter² FibroSURE (FibroTest)³
≥F2 F4 ≥F2 F4
AUROC 0.85–0.89 0.91 0.74–0.87 0.71–0.87
Sensitivity % 80.5–89.0 94.1 65.0–77.0 50.0–87.0
Specificity % 84.1–89.9 87.6 72.0–91.0 70.0–92.9
PPV % 82.0–86.3 68.0 76.0–80.0 57.9–93.0
NPV % 77.6–82.5 94.7 66.7–81.0 44.0–90.5

² Leroy V et al, 2007 and Cales P et al 2005
³ Leroy V et al, 2007, Sebastiani G et al, 2006, Cales P et al 2005, Imbert-Bismut F et al 2001, and Shaheen AA et al 2007.

Comparison between liver biopsy and the non-invasive FibroMeter test:

  FibroMeter Liver Biopsy
Nature of Test Non-invasive Invasive
Advantages Measurement of global fibrosis, suitable for serial observations Direct, evaluation of co-exisiting pathologies
Limitations Indirect measurement of functional changes of the liver Sampling error, inter-observer variability, possible hospitalization
Risks Very little risk Pain, bleeding, pneumothorax, hemothorax, infection
Cost Less expensive than biopsy Expensive
Contradictions None known Uncooperative patient, severe coagulopathy, extrahepatic biliary obstruction, ascites, morbid obesity

Ordering Information

How to Order

Please contact your hospital or reference laboratory to inquire about pricing, test-request forms, and billing for this test.

Test Information

Virus
Test Name Liver Fibrosis, Chronic Viral Hepatitis (Echosens FibroMeter)
Test Code 2005661
Mnemonic FIBRO V
Method Quantitative nephelometry, enzymatic, spectrophotometric, and electromagnetic mechanical clot detection
Specimen Information 3 mL serum AND 1 mL citrated plasma. Must supply patient platelet count performed on EDTA whole blood (ordered separately through client institution)
 

Specimen Collection Requirements

Collection Lavender (EDTA) or pink (K2EDTA) tube, serum separator tube, and light blue (sodium citrate) tube
Preparation Separate serum and citrated plasma from cells as soon as possible or within two hours of collection. Transfer 3 mL serum to an ARUP standard transport tube (min: 1.2 mL). Transfer 1 mL platelet-poor citrated plasma to the ARUP standard transport tube (min: 0.5 mL).
Transport Temperature Serum and citrated plasma should be shipped frozen; do not send the EDTA whole blood to ARUP.
Remarks Separately arrange for on-site automated platelet count on the EDTA whole blood sample. Include patient platelet count with test submission information.
Specimen Stability From time of collection to initiation of testing:
Serum: refrigerated: unacceptable; frozen: two weeks
Plasma: refrigerated: unacceptable; frozen: two weeks

Frequently Asked Questions

Does it matter which instrument is used to generate the platelet count?

  • No. Many hematology analyzers are available and are suitable for the FibroMeter test. Please contact us at fibrometer@aruplab.com if you have questions regarding a specific analyzer.

Why is urea used in FibroMeter?

  • Each of the individual analytes in the algorithm have been shown to be a marker for liver function. This includes urea, which decreases with impaired liver function and advanced liver disease. However, the accuracy of using the FibroMeter test to assess fibrosis is based on a proprietary algorithm that evaluates and weighs the concentration of each analyte along with demographic data to provide a score.

Test Interpretation and Strategy

The result states that "FibroMeter and CirrhoMeter scores are modified by the rules-based algorithm." What does this mean?

  • To reduce misclassification, test scores are evaluated by a rule-based algorithm to detect anomalous profile results, which may modify test scores as needed.

Can this test be used if a patient has a co-infection of HCV/HIV or HBV/HIV?

  • Yes.

Performance and Limitations

Can this test be used on patients receiving ribavirin therapy?

  • Yes.

What is the clinical performance of this test?

Metavir
Classification
FibroMeter
≥F2 F4
AUROC 0.85–0.89 0.91
Sensitivity % 80.5–89.0 94.1
Specificity % 84.1–89.9 87.6
PPV % 82.0–86.3 68.0
NPV % 77.6–82.5 94.7

Can this test be run without the platelet count?

  • No. The platelet count is necessary for the score calculation. If necessary, platelet count values from an earlier or later draw can be used. However, the date of platelet count must be within three days from the collection of the other blood samples submitted to ARUP for the FibroMeter test.

Can this test be used on a pediatric patient?

  • The FibroMeter test was validated on patients age 18 or older. Pediatric specimens will not be rejected, but results should be interpreted with caution.

References

Sebastiani G et al. Non-invasive assessment of liver fibrosis: it is time for laboratory medicine. Clin Chem Lab Med 2011 49:13-32. doi: 10.1515/CCLM.2011.001.

Calés P et al. Evaluating the accuracy and increasing the reliable diagnosis rate of blood tests for liver fibrosis in chronic hepatitis C. Liver Int 2008;28(10):1352–62. doi:10.1111/j.1478–3231.2008.01789.x.

Boursier J et al. Comparison of accuracy of fibrosis degree classifications by liver biopsy and non-invasive tests in chronic hepatitis C. BMC Gastroenterol 2011;11:132. doi:10.1186/1471–230X–11–132.

Leroy V et al. Prospective evaluation of FibroTest®, FibroMeter®, and HepaScore® for staging liver fibrosis in chronic hepatitis B: comparison with hepatitis C. J Hepatol 2014;pii:S0168–8278(14)00137–8. doi:10.1016/j.jhep.2014.02.029.

Calés P et al. Improved fibrosis staging by elastometry and blood test in chronic hepatitis C. Liver Int 2013;doi:10.1111/liv.12327.

Calés P et al. Comparison of liver fibrosis blood tests developed for HCV with new specific tests in HIV/HCV co-infection. J Hepatol 2010;53(2):238–44. doi:10.1016/j.jhep.2010.03.007.