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ASH FibroSure®

CPT

[MAAA: 0002M] or 82172; 82247; 82465; 82947; 82977; 83010; 83883; 84450; 84460; 84478

Synonyms
  • Alcoholic Liver Disease
  • Noninvasive Liver Biopsy
  • Steatohepatitis

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.

Related Documents

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

Naveau S, Raynard B, Ratziu V, et al. Biomarkers for the prediction of liver fibrosis in patients with chronic alcoholic liver disease. Clin Gastroenterol Hepatol. 2005 Feb; 3(2):167-174. 15704051
Poynard T, Ratziu V, Naveau S, et al. The diagnostic value of biomarkers (SteatoTest) for the prediction of liver steatosis. Comp Hepatol. 2005 Dec 23; 4:10. 16375767
Thabut D, Naveau S, Charlotte F, et al. The diagnostic value of biomarkers (AshTest) for the prediction of alcoholic steatohepatitis in patients with chronic alcoholic liver disease. J Hepatol. 2006 Jun; 44(6):1175-1185. 16580087

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

TemperaturePeriod
Room temperature72 hours (stability provided by manufacturer or literature reference)
Refrigerated72 hours (stability provided by manufacturer or literature reference)
Frozen7 days (stability provided by manufacturer or literature reference)
Freeze/thaw cyclesStable 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 Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550191
Result Code NameFibrosis Score
UofM
Result LOINC48795-9
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550192
Result Code NameFibrosis Stage
UofM
Result LOINC48794-2
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550181
Result Code NameSteatosis Score
UofM
Result LOINCN/A
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550183
Result Code NameSteatosis Grade
UofM
Result LOINCN/A
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550184
Result Code NameASH Score
UofM
Result LOINC48792-6
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550185
Result Code NameASH Grade
UofM
Result LOINC48793-4
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550398
Result Code NameMethodology:
UofM
Result LOINC62364-5
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550199
Result Code NameHeight:
UofMin
Result LOINC3137-7
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550201
Result Code NameWeight:
UofMLBS
Result LOINC3141-9
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code122137
Result Code NameAlpha 2-Macroglobulins, Qn
UofMmg/dL
Result LOINC1835-8
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code001629
Result Code NameHaptoglobin
UofMmg/dL
Result LOINC4542-7
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code016874
Result Code NameApolipoprotein A-1
UofMmg/dL
Result LOINC1869-7
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code001100
Result Code NameBilirubin, Total
UofMmg/dL
Result LOINC1975-2
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code001960
Result Code NameGGT
UofMIU/L
Result LOINC2324-2
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code001547
Result Code NameALT (SGPT) P5P
UofMIU/L
Result LOINC1743-4
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code001125
Result Code NameAST (SGOT) P5P
UofMIU/L
Result LOINC30239-8
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code001067
Result Code NameCholesterol, Total
UofMmg/dL
Result LOINC2093-3
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code001036
Result Code NameGlucose, Serum
UofMmg/dL
Result LOINC2345-7
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code001175
Result Code NameTriglycerides
UofMmg/dL
Result LOINC2571-8
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550188
Result Code NameInterpretation:
UofM
Result LOINCN/A
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550107
Result Code NameFibrosis Scoring:
UofM
Result LOINCN/A
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550189
Result Code NameSteatosis Grading
UofM
Result LOINCN/A
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550190
Result Code NameASH Scoring
UofM
Result LOINCN/A
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550135
Result Code NameLimitations:
UofM
Result LOINC8251-1
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code550193
Result Code NameComment:
UofM
Result LOINC77202-0
Order Code550180
Order Code NameASH FibroSure
Order Loinc
Result Code123098
Result Code NameComment:
UofM
Result LOINC77202-0