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Safety of the BioPredictive tests
Up one levelPrecautions for use, safety
An expert system analyzes each FibroTest and its parameters in order to ensure their proper applicability. Over 95% of tests are interpretable and enable an effective diagnosis of fibrosis and activity. In less than 5% of cases, the expert system detects the profiles that are at risk of false positives or false negatives and clearly indicates them on the result sheet.
Applicability and safety integrated in the tests
FibroTest : 95-99%
FibroTest is applicable in 95 to 99% of cases. It has been validated for the following diseases : (available scientific publications)
- Chronic hepatitis C
- Chronic hepatitis B
- Chronic hepatitis C or B with HIV co-infection
- Alcoholic liver diseases (steatosis and steatohepatitis)
- Steatosis and non-alcoholic steatohepatitis (diabetes, overweight, hypertriglyceridemia, hypercholesterolemia, hypertension)
The test is robust and validated, including for the following specific populations:
- Subjects over the age of 65 years
- Children
- Patients with renal insufficiency and patients with renal transplanation
- Hemophiliac
- Patients with chronic inflammatory disease
- General population
The tests are not applicable in only 1 to 5% of cases:
- Acute hepatitises, e.g., acute viral hepatitis A, B, C, D, E; drug-induced hepatitis
- Extrahepatic cholestasis, e.g., pancreatic cancer, gallstones
- Severe hemolysis, e.g., some cardiac valves
- Gilbert's syndrome with high unconjugated hyperbilirubinemia
- Acute inflammatory syndrome (the blood test just needs to be postponed)
These cases are detected by our safety mechanisms and are clearly indicated on the results sheet.
Reproducibility
Only the analyses performed in pre-analytical and analytical conditions and using the automated analyzers and reagents validated by our reference center are authorized by BioPredictive.
Tracibility
Our systems are declared with the French Committee on Technologies and Freedom (CNIL) and guarantee the anonymity of the provided information. The BioPredictive information system implements a tracibility device on all of its processes, thus assuring its quality management.
Key figures of FibroTest
| 95 % | Applicability |
|---|---|
| 87,5 % | Diagnostic accuracy (percentage of true positives and true negatives compared to histology) |
| 0 % | False positives within a population of 1,000 blood donors |
| 0.84 | Diagnostic value for advanced fibrosis, estimated by the area under the curve (AUROC) |
| 0.90 | Diagnostic value for cirrhosis, estimated by the area under the curve (AUROC) |
| 0.96 | Prognostic value (death related to HCV) of FibroTest, estimated by the area under the curve (AUROC) |