Liver fibrosis diagnosis by blood test and elastography in chronic hepatitis C: agreement or combination?
P Calès1,2, J Boursier1,2, J Lebigot2
1Liver-Gastroenterology Department, University Hospital, Angers, France.
Insights
A combined blood and elastography test accurately diagnoses liver fibrosis in hepatitis C patients, improving upon individual tests and potentially reducing the need for biopsies. This approach offers precise staging for better patient management.
Area of Science:
- Hepatology
- Diagnostic Accuracy
- Fibrosis Staging
Background:
- Current guidelines recommend transient elastography plus blood tests for significant fibrosis diagnosis in chronic hepatitis C.
- Test concordance is crucial for confirming the diagnosis.
Purpose of the Study:
- To validate and improve the diagnostic rule by combining FibroMeter blood test and transient elastography into a single test.
- To assess the accuracy of this combined approach for diagnosing liver fibrosis.
Main Methods:
- A total of 1199 patients were included in exploratory and validation sets.
- Accuracy was evaluated by correct diagnosis rate for severe fibrosis (Metavir F ≥ 3).
- Analysis considered classical test scores and fibrosis classification based on test concordance.
Main Results:
- Combined test classification accuracy (91.7%) significantly improved compared to individual blood tests (84.1%) and elastography (88.2%).
- Individual test accuracy decreased significantly in discordant cases, but the combined test maintained high accuracy.
- Non-invasive tests were unreliable in rare cases of full discordance and severe fibrosis.
Conclusions:
- The recommendation for test concordance is validated.
- A combined test, using classification rather than scores, enhances diagnostic accuracy and precise staging.
- This combined approach avoids 99% of liver biopsies and validates the use of combined non-invasive testing.
Background:
In chronic hepatitis C, the European Association for the Study of the Liver and the Asociacion Latinoamericana para el Estudio del Higado recommend performing transient elastography plus a blood test to diagnose significant fibrosis; test concordance confirms the diagnosis.
Aim:
To validate this rule and improve it by combining a blood test, FibroMeter (virus second generation, Echosens, Paris, France) and transient elastography (constitutive tests) into a single combined test, as suggested by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.
Methods:
A total of 1199 patients were included in an exploratory set (HCV, n = 679) or in two validation sets (HCV ± HIV, HBV, n = 520). Accuracy was mainly evaluated by correct diagnosis rate for severe fibrosis (pathological Metavir F ≥ 3, primary outcome) by classical test scores or a fibrosis classification, reflecting Metavir staging, as a function of test concordance.
Results:
Score accuracy: there were no significant differences between the blood test (75.7%), elastography (79.1%) and the combined test (79.4%) (P = 0.066); the score accuracy of each test was significantly (P < 0.001) decreased in discordant vs. concordant tests. Classification accuracy: combined test accuracy (91.7%) was significantly (P < 0.001) increased vs. the blood test (84.1%) and elastography (88.2%); accuracy of each constitutive test was significantly (P < 0.001) decreased in discordant vs. concordant tests but not with combined test: 89.0 vs. 92.7% (P = 0.118). Multivariate analysis for accuracy showed an interaction between concordance and fibrosis level: in the 1% of patients with full classification discordance and severe fibrosis, non-invasive tests were unreliable. The advantage of combined test classification was confirmed in the validation sets.
Conclusions:
The concordance recommendation is validated. A combined test, expressed in classification instead of score, improves this rule and validates the recommendation of a combined test, avoiding 99% of biopsies, and offering precise staging.
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