Test Details
Methodology
See individual test components.
Result Turnaround Time
3 - 5 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
Assessment of liver status following a diagnosis of HBV; baseline determination of liver status before initiating HBV therapy; posttreatment assessment of liver status six months after completion of therapy; noninvasive assessment of liver status in patients who are at increased risk of complications from a liver biopsy
Special Instructions
The patient's age and gender must be included on the test request form.
Limitations
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Specimen Requirements
Specimen
Serum
Volume
3.5 mL
Minimum Volume
2 mL
Container
Gel-barrier tube is preferred. Red top tube is acceptable.
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 |
|---|---|---|---|---|---|---|
| 550605 | HBV FibroSure | 550609 | Fibrosis Score | 48795-9 | ||
| 550605 | HBV FibroSure | 550611 | Fibrosis Stage | 48794-2 | ||
| 550605 | HBV FibroSure | 550612 | Necroinflammat Activity Score | 48792-6 | ||
| 550605 | HBV FibroSure | 550613 | Necroinflammat Activity Grade | 48793-4 | ||
| 550605 | HBV FibroSure | 550398 | Methodology: | 62364-5 | ||
| 550605 | HBV FibroSure | 122137 | Alpha 2-Macroglobulins, Qn | mg/dL | 1835-8 | |
| 550605 | HBV FibroSure | 001629 | Haptoglobin | mg/dL | 4542-7 | |
| 550605 | HBV FibroSure | 016874 | Apolipoprotein A-1 | mg/dL | 1869-7 | |
| 550605 | HBV FibroSure | 001100 | Bilirubin, Total | mg/dL | 1975-2 | |
| 550605 | HBV FibroSure | 001960 | GGT | IU/L | 2324-2 | |
| 550605 | HBV FibroSure | 001547 | ALT (SGPT) P5P | IU/L | 1743-4 | |
| 550605 | HBV FibroSure | 550637 | Interpretations: | N/A | ||
| 550605 | HBV FibroSure | 550638 | Fibrosis Scoring: | N/A | ||
| 550605 | HBV FibroSure | 550639 | Necroinflamm Activity Scoring: | N/A | ||
| 550605 | HBV FibroSure | 550607 | Limitations: | N/A | ||
| 550605 | HBV FibroSure | 550642 | Comment: | 77202-0 | ||
| 550605 | HBV FibroSure | 123095 | Comment: | 77202-0 | ||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 550609 | |||||
| Result Code Name | Fibrosis Score | |||||
| UofM | ||||||
| Result LOINC | 48795-9 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 550611 | |||||
| Result Code Name | Fibrosis Stage | |||||
| UofM | ||||||
| Result LOINC | 48794-2 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 550612 | |||||
| Result Code Name | Necroinflammat Activity Score | |||||
| UofM | ||||||
| Result LOINC | 48792-6 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 550613 | |||||
| Result Code Name | Necroinflammat Activity Grade | |||||
| UofM | ||||||
| Result LOINC | 48793-4 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 550398 | |||||
| Result Code Name | Methodology: | |||||
| UofM | ||||||
| Result LOINC | 62364-5 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 122137 | |||||
| Result Code Name | Alpha 2-Macroglobulins, Qn | |||||
| UofM | mg/dL | |||||
| Result LOINC | 1835-8 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 001629 | |||||
| Result Code Name | Haptoglobin | |||||
| UofM | mg/dL | |||||
| Result LOINC | 4542-7 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 016874 | |||||
| Result Code Name | Apolipoprotein A-1 | |||||
| UofM | mg/dL | |||||
| Result LOINC | 1869-7 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 001100 | |||||
| Result Code Name | Bilirubin, Total | |||||
| UofM | mg/dL | |||||
| Result LOINC | 1975-2 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 001960 | |||||
| Result Code Name | GGT | |||||
| UofM | IU/L | |||||
| Result LOINC | 2324-2 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 001547 | |||||
| Result Code Name | ALT (SGPT) P5P | |||||
| UofM | IU/L | |||||
| Result LOINC | 1743-4 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 550637 | |||||
| Result Code Name | Interpretations: | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 550638 | |||||
| Result Code Name | Fibrosis Scoring: | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 550639 | |||||
| Result Code Name | Necroinflamm Activity Scoring: | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 550607 | |||||
| Result Code Name | Limitations: | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 550642 | |||||
| Result Code Name | Comment: | |||||
| UofM | ||||||
| Result LOINC | 77202-0 | |||||
| Order Code | 550605 | |||||
| Order Code Name | HBV FibroSure | |||||
| Order Loinc | ||||||
| Result Code | 123095 | |||||
| Result Code Name | Comment: | |||||
| UofM | ||||||
| Result LOINC | 77202-0 |