WHAT YOU NEED TO KNOW ABOUT FIBROTEST & FIBROMAX
THE INNOVATIVE DIAGNOSTIC AND STAGING TOOLS FOR THE MOST COMMON LIVER DISEASES
The tests consist of a simple blood test then the analysis of specific blood markers, using a patented algorithm to provide a precise diagnosis for the 5 most
common liver injuries. (Hepatitis B, Hepatitis C, HIV-HCV co-infected, metabolic disorders and alcohol abuse).
These algorithms have been scientifically validated and quality-monitored to ensure that the results delivered are of the highest analytical standards.
The validation and analytical standardization of FibroTest-ActiTest® and FibroMax® have been established in over 50 clinical studies.
All these studies support the scientific rationale that FibroTest® is a universal marker of fibrosis and as such the new method for liver fibrosis diagnostic.
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PRESENTATION
AND SLIDE DECK
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Tests provided by a biotech company: Biopredictive ( www.biopredictive.com).
See Results Sheet
or Download PDF
Process: 4 easy steps !
1. The doctor writes a prescription for FibroTest or FibroMax
2. With this prescription, the patient presents to an approved laboratory (list available at www.biopredictive.com),
where a blood sample is taken from the patient.
3. A Biologist / lab technician enters the value for each found biomarkers directly on our secure web site.
4. The algorithm is automatically performed and diagnostic results immediately generated.
WHICH LIVER BIOMARKERS ARE USED?
* FibroTest: alpha-2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT and ALT (for ActiTest).
* FibroMax: alpha-2 macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, ALT, AST, GGT, fasting glucose, triglycerides, and total cholesterol.
See In Situ
or Download PDF
PROCESS FOR LABORATORIES (DISTRIBUTORS/ AGENTS) INTERESTED IN PERFORMING FIBROTEST AND FIBROMAX
- The laboratory should register on www.biopredictive.com in the customer area
- It will receive a service agreement and technical recommendation, which the laboratory should return signed to confirm that they have the required equipment and accept the service conditions
- The laboratory will then receive a login and password granting them the access to the secure website.
- When a patient comes to the lab with a FibroTest/FibroMax prescription, the biologist/lab technician logs in-on the BioPredictive website with his/hers login and password
- The biologist/lab technician enters the patient�s data (serum marker value), and process a preferred payment method.
- The diagnostic results immediately appear and can be downloaded as pdf. (colored graphics)
See Quick Process
TECHNICAL REQUIREMENT
Technical recommendations are based on several published studies co-ordinated by the Biochemistry Department of
Piti�-Salp�tri�re Hospital Group in Paris. These studies assessed the intra-laboratory and inter-laboratory variabilities and sera
storage. Test result reliability depends on the rigorous usage of the technical recommendations. Conversely, failing to follow these technical
recommendations could significantly impair the diagnostic value (results) of the tests.
THE FOLLOWING RECOMMENDATIONS ARE SPECIFICALLY RELATED TO :
1. Process for blood draw and sample handling.
2. The equipment and the reagents.
3. Calibration, and controls.
4. And the criteria for reliability of the assays
Wouldn't an interested laboratory have the required machine, it is also possible to validate the equipment the laboratory
has for the testing of biomarkers. It suggests a comparison study between the results of the "in-validation equipment" and those from FibroTest's
and FibroMax's reference laboratory: La Piti� Salp�tri�re, Paris, France.
Download technical recommendations PDF
SPECIFICATIONS
A. PRE-ANALYTICAL PHASE: ESSENTIAL CONDITIONS REQUIRED
Blood sample
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Blood is obtained by venipuncture (the classical requested 12 hour patient fasting is necessary for FibroMax® but is not required
for Fibro Test-ActitTest®)
• Blood samples are collected in 5-ml or 7-ml tubes, without anticoagulant
• Blood samples are collected in 5-ml or 7-ml tubes, without anticoagulant
• Blood sample is centrifugated within 2 hours of the blood collection
• The centrifugation conditions (speed and time) must be in conformity with recommendations of tube manufacturer
STORAGE AND TRANSPORT CONDITIONS, PRETREATMENT BEFORE ANALYSIS
• Biochemical assays are usually performed on fresh serum
• Serum can be decanted and stored for no more than 72 hours at + 2®C/
+ 4®C, • while protected from light to avoid bilirubin degradation
• The assays of the specific proteins can be carried out on serum stored at +2®C / +4®C for no more than 5 days
• If you intend to defer analysis beyond the recommended time, serum must be frozen at – 80®C from the start
• Freezing and thawing can be done only once
INTERFERENCE
Lipids and hemolysis interfere with measurements. It is always possible to dilute a lightly lipemic serum
according to the recommendations of the standardized methods. Hemolysed and/or hyperlipemic serum must be rejected.
B. BIOPREDICTIVE TEST PARAMETER ASSAYS
The performances of the assay methods of the FibroTest and ActiTest have been verified on analyzers and under the conditions specified in the Tecnical Recommendations document.
They are a guarantee of the quality of the results of the BioPredictive tests.
The materials of assessment (including the reagents and analyzers), as well as the various assay methods (ie immunonephelemetric and nephlometry for protein assays) are also
covered in detail in the Technical Recommendations document.
Download technical recommendations PDF
For more information
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