Test ID: FHFIB
Hepatitis C Virus (HCV) FibroSURE
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Assessment of Liver status following a diagnosis of HCV. Baseline
determination of liver status before initiating HCV therapy. Post-
treatment assessment of liver status six months after completion of
therapy. Non-invasive assessment of liver status in patient
who are at increased risk of complications from a liver biopsy.
Method Name A short description of the method used to perform the test
Immunologic
Colorimetric
Kinetic – colorimetric
Nephelometry
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
FibroTest FORWARD
HCV FibroSURE FORWARD
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Draw blood in a plain red-top tube(s) or serum gel tube(s). Separate
serum from cells within 1 hour and send 2 tubes of serum,
2.5 mL in first tube and 0.5 mL in second tube frozen in plastic
screw-capped tubes. Ship frozen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Specimens other than | Serum |
| Anticoagulants other than | NA |
| Hemolysis | Mild OK; Gross reject |
| Thawing | NA |
| Lipemia | Mild OK; Gross reject |
| Icteric | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Frozen (preferred) | |
| Refrigerated | 72 hours | |
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
TESTS REFERENCE INTERVAL
HCV FibroSURE Results:
Fibrosis Score 0.00 - 0.21
Fibrosis Stage
Necroinflammat Activity Score 0.00 - 0.17
Necroinflammat Activity Grade
Analysis:
Alpha-2-Macroglobulins, Qn 110 - 276 mg/dL
Haptoglobin 34 – 200 mg/dL
Apolipoprotein A-1 Females: 110 – 205 mg/dL
Males: 110 – 180 mg/dL
Bilirubin, Total
Newborns, term and near term:
24 hours old: 0.0 – 8.0 mg/dL
48 hours old: 0.0 – 12.2 mg/dL
72 hours old: 0.0 – 15.6 mg/dL
96 hours to 1 month old: 0.0 – 1.2 mg/dL
Children 1 month and older and
Adults: 0.0 – 1.2 mg/dL
GGT Females: 0 – 60 IU/L
Males: 0 – 65 IU/L
ALT (SGPT) Females: 0 - 40 IU/L
Males: 0 – 55 IU/L
Interpretations:
Quantitative results of 6 biochemical tests are analyzed using a
computational algorithm to provide a quantitative surrogate marker
(0.0-1.0) for liver fibrosis (METAVIR F0-F4) and for
necroinflammatory activity (METAVIR A0-A3).
Fibrosis Scoring:
<0.21 = Stage F0 – No fibrosis
0.21 – 0.27 = Stage F0 – F1
0.27 – 0.31 = Stage F1 – Portal fibrosis
0.31 – 0.48 = Stage F1 – F2
0.48 – 0.58 = Stage F2 – Bridging fibrosis with few septa
0.58 – 0.72 = Stage F3 – Bridging fibrosis with many septa
0.72 – 0.74 = Stage F3 – F4
>0.74 = Stage F4 – Cirrhosis
Macroinflamm Activity Scoring:
<0.17 = Grade A0 – No Activity
0.17 – 0.29 = Grade A0 – A1
0.29 – 0.36 = Grade A1 – Minimal activity
0.36 – 0.52 = Grade A1 – A2
0.52 – 0.60 = Grade A2 – Moderate activity
0.60 – 0.62 = Grade A2 – A3
>0.62 = Grade A3 – Severe activity
Limitations:
The negative predictive value of a Fibrotest score <0.31 (absence
of clinically significant fibrosis) was 85% when compared to liver
biopsy in 1,270 HCV infected patients with a 38% prevalence of
significant liver fibrosis (F2, 3 or 4). The positive predictive value of
a Fibrotest score >0.48 (F2, 3, 4) was 61% in that same patient
cohort. HCV FibroSURE is not recommended in patients with
Gilbert Disease, acute hemolysis (e.g. HCV ribavirin therapy
mediated hemolysis), acute hepatitis of the liver, extra-hepatic
cholestasis, transplant patients, and/or renal insufficiency patients.
Any of these clinical situations may lead to inaccurate quantitative
predictions of fibrosis and necroinflammatory activity in the liver.
Comment:
The performance characteristics of this test have been
determined by LabCorp. This test has not been cleared or
approved by the U.S. Food and Drug Administration (FDA).
The FDA has determined that such clearance or approval is not
currently required. LabCorp is regulated under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) and is
certified to perform high complexity testing.
Results and Interpretation Provided By:
Lab-Corp RTP
1912 Alexander Drive
Research Triangle Park, NC 27709
Test Performed By: Lab-Corp Burlington
1447 York Court
Burlington, NC 27215-2230
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Varies, Monday through Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
82172/Apolipoprotein
82247/Bilirubin; total
82977/Glutamyltransferase, gamma (GGT)
83010/Haptoglobin;quantitative
83883/Nephelometry;each analyte not elsewhere specified
84460/alanine amino (ALT)(SGPT)
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| Z0981 | HCV FibroSURE Results: | N/A |
| Z0971 | Fibrosis Score | 48795-9 |
| Z0972 | Fibrosis Stage | 48794-2 |
| Z0973 | Necroinflammat Activity Score | 48792-6 |
| Z0974 | Necroinflammat Activity Grade | 48793-4 |
| Z0982 | Analysis: | N/A |
| Z0975 | Alpha 2 Macroglobulins, Qn | 1835-8 |
| Z0976 | Haptoglobin | 4542-7 |
| Z0977 | Apolipoprotein A-1 | 1869-7 |
| Z0978 | Bilirubin, Total | 1975-2 |
| Z0979 | GGT | 2324-2 |
| Z0980 | ALT (SGPT) | 1743-4 |
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