Test Details
Result Turnaround Time
3 - 6 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This test is intended for noninvasive assessment of liver status in patients with alcoholic liver disease. Quantitative results of 10 biochemicals in combination with age, gender, height, and weight are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and alcoholic steatohepatitis (ASH) (0.0-1.0, H0-H3).
Special Instructions
The patient's age, gender, height, and weight at the time of collection must be submitted for FibroSure® testing.
Limitations
ASH FibroSure® is recommended for patients with suspected alcoholic liver disease. It is not recommended for patients with other liver diseases. It is also not recommended in patients with Gilbert disease, acute hemolysis, acute hepatitis, acute inflammation of the liver, extrahepatic cholestasis, transplant patients, and/or renal insufficiency patients. Any of these clinical situations may lead to inaccurate quantitative predictions of fibrosis.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
References
Specimen Requirements
Specimen
Serum
Volume
3.5 mL
Minimum Volume
2 mL
Container
Red-top tube or gel-barrier tube
Collection Instructions
Separate serum from cells within two hours of collection, and transfer serum to a transfer tube.
Stability Requirements
Temperature | Period |
---|---|
Room temperature | 72 hours (stability provided by manufacturer or literature reference) |
Refrigerated | 72 hours (stability provided by manufacturer or literature reference) |
Frozen | 7 days (stability provided by manufacturer or literature reference) |
Freeze/thaw cycles | Stable x1 (stability provided by manufacturer or literature reference) |
Storage Instructions
Specimen can be stored refrigerated at 2°C to 8°C for 72 hours and frozen at -70°C for seven days. Frozen samples are stable for one freeze/thaw cycle.
Patient Preparation
Patient should be fasting for at least eight hours.
Causes for Rejection
Gross hemolysis; gross lipemia; improper labeling; nonfasting specimen; patient younger than 14 years of age
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
550180 | ASH FibroSure | 550191 | Fibrosis Score | 48795-9 | ||
550180 | ASH FibroSure | 550192 | Fibrosis Stage | 48794-2 | ||
550180 | ASH FibroSure | 550181 | Steatosis Score | N/A | ||
550180 | ASH FibroSure | 550183 | Steatosis Grade | N/A | ||
550180 | ASH FibroSure | 550184 | ASH Score | 48792-6 | ||
550180 | ASH FibroSure | 550185 | ASH Grade | 48793-4 | ||
550180 | ASH FibroSure | 550398 | Methodology: | 62364-5 | ||
550180 | ASH FibroSure | 550199 | Height: | in | 3137-7 | |
550180 | ASH FibroSure | 550201 | Weight: | LBS | 3141-9 | |
550180 | ASH FibroSure | 122137 | Alpha 2-Macroglobulins, Qn | mg/dL | 1835-8 | |
550180 | ASH FibroSure | 001629 | Haptoglobin | mg/dL | 4542-7 | |
550180 | ASH FibroSure | 016874 | Apolipoprotein A-1 | mg/dL | 1869-7 | |
550180 | ASH FibroSure | 001100 | Bilirubin, Total | mg/dL | 1975-2 | |
550180 | ASH FibroSure | 001960 | GGT | IU/L | 2324-2 | |
550180 | ASH FibroSure | 001547 | ALT (SGPT) P5P | IU/L | 1743-4 | |
550180 | ASH FibroSure | 001125 | AST (SGOT) P5P | IU/L | 30239-8 | |
550180 | ASH FibroSure | 001067 | Cholesterol, Total | mg/dL | 2093-3 | |
550180 | ASH FibroSure | 001036 | Glucose, Serum | mg/dL | 2345-7 | |
550180 | ASH FibroSure | 001175 | Triglycerides | mg/dL | 2571-8 | |
550180 | ASH FibroSure | 550188 | Interpretation: | N/A | ||
550180 | ASH FibroSure | 550107 | Fibrosis Scoring: | N/A | ||
550180 | ASH FibroSure | 550189 | Steatosis Grading | N/A | ||
550180 | ASH FibroSure | 550190 | ASH Scoring | N/A | ||
550180 | ASH FibroSure | 550135 | Limitations: | 8251-1 | ||
550180 | ASH FibroSure | 550193 | Comment: | 77202-0 | ||
550180 | ASH FibroSure | 123098 | Comment: | 77202-0 | ||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550191 | |||||
Result Code Name | Fibrosis Score | |||||
UofM | ||||||
Result LOINC | 48795-9 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550192 | |||||
Result Code Name | Fibrosis Stage | |||||
UofM | ||||||
Result LOINC | 48794-2 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550181 | |||||
Result Code Name | Steatosis Score | |||||
UofM | ||||||
Result LOINC | N/A | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550183 | |||||
Result Code Name | Steatosis Grade | |||||
UofM | ||||||
Result LOINC | N/A | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550184 | |||||
Result Code Name | ASH Score | |||||
UofM | ||||||
Result LOINC | 48792-6 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550185 | |||||
Result Code Name | ASH Grade | |||||
UofM | ||||||
Result LOINC | 48793-4 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550398 | |||||
Result Code Name | Methodology: | |||||
UofM | ||||||
Result LOINC | 62364-5 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550199 | |||||
Result Code Name | Height: | |||||
UofM | in | |||||
Result LOINC | 3137-7 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550201 | |||||
Result Code Name | Weight: | |||||
UofM | LBS | |||||
Result LOINC | 3141-9 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 122137 | |||||
Result Code Name | Alpha 2-Macroglobulins, Qn | |||||
UofM | mg/dL | |||||
Result LOINC | 1835-8 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 001629 | |||||
Result Code Name | Haptoglobin | |||||
UofM | mg/dL | |||||
Result LOINC | 4542-7 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 016874 | |||||
Result Code Name | Apolipoprotein A-1 | |||||
UofM | mg/dL | |||||
Result LOINC | 1869-7 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 001100 | |||||
Result Code Name | Bilirubin, Total | |||||
UofM | mg/dL | |||||
Result LOINC | 1975-2 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 001960 | |||||
Result Code Name | GGT | |||||
UofM | IU/L | |||||
Result LOINC | 2324-2 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 001547 | |||||
Result Code Name | ALT (SGPT) P5P | |||||
UofM | IU/L | |||||
Result LOINC | 1743-4 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 001125 | |||||
Result Code Name | AST (SGOT) P5P | |||||
UofM | IU/L | |||||
Result LOINC | 30239-8 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 001067 | |||||
Result Code Name | Cholesterol, Total | |||||
UofM | mg/dL | |||||
Result LOINC | 2093-3 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 001036 | |||||
Result Code Name | Glucose, Serum | |||||
UofM | mg/dL | |||||
Result LOINC | 2345-7 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 001175 | |||||
Result Code Name | Triglycerides | |||||
UofM | mg/dL | |||||
Result LOINC | 2571-8 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550188 | |||||
Result Code Name | Interpretation: | |||||
UofM | ||||||
Result LOINC | N/A | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550107 | |||||
Result Code Name | Fibrosis Scoring: | |||||
UofM | ||||||
Result LOINC | N/A | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550189 | |||||
Result Code Name | Steatosis Grading | |||||
UofM | ||||||
Result LOINC | N/A | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550190 | |||||
Result Code Name | ASH Scoring | |||||
UofM | ||||||
Result LOINC | N/A | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550135 | |||||
Result Code Name | Limitations: | |||||
UofM | ||||||
Result LOINC | 8251-1 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 550193 | |||||
Result Code Name | Comment: | |||||
UofM | ||||||
Result LOINC | 77202-0 | |||||
Order Code | 550180 | |||||
Order Code Name | ASH FibroSure | |||||
Order Loinc | ||||||
Result Code | 123098 | |||||
Result Code Name | Comment: | |||||
UofM | ||||||
Result LOINC | 77202-0 |