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NASH FibroSure® Plus

Test Number 550960
Test number copied
CPT

[MAAA: 0003M] or 82172; 82247; 82465; 82947; 82977; 83010; 83883; 84450; 84460; 84478
Synonyms
  • Fatty Liver Disease
  • Liver Fibrosis
  • MASH
  • MASLD
  • Metabolic Dysfunction-Associated Steatohepatitis
  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Nonalcoholic Steatohepatitis
  • Noninvasive Liver Biopsy

Test Details

Methodology

See individual test components.

Result Turnaround Time

4 - 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 Information

Related Documents

For more information, please view the literature below.

NASH FibroSure® Plus: Non-invasive testing for assessing NASH

NAFLD-NASH Capabilities Brochure

Use

This test is a noninvasive assessment of liver status in patients with nonalcoholic fatty liver disease (NAFLD), now known as metabolic dysfunction-associated steatotic liver disease (MASLD). Quantitative results of 10 biochemicals in combination with age and gender 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 nonalcoholic steatohepatitis (NASH) (0.0-0.75, N0-N2). The absence of steatosis (S<0.41) precludes the diagnosis of NASH, now known as metabolic dysfunction-associated steatohepatitis (MASH).

Special Instructions

The patient's age and gender must be submitted, but the patient's height and weight are not required for NASH FibroSure® Plus testing.

Limitations

NASH FibroSure® Plus is recommended for patients with suspected NAFLD, now known as metabolic dysfunction-associated steatotic liver disease (MASLD). It is not recommended for patients with other liver diseases. It is also not recommended in patients with Gilbert disease, acute hemolysis, acute viral hepatitis, drug induced hepatitis, genetic liver disease, autoimmune hepatitis and/or extra- hepatic cholestasis. 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 Food and Drug Administration.

References

Poynard T, Peta V, Munteanu M, et al. The diagnostic performance of a simplified blood test (SteatoTest-2) for the prediction of liver steatosis. Eur J Gastroenterol Hepatol. 2019 Mar;31(3):393-402.30516570
Poynard T, Munteanu M, Charlotte F, et al. Diagnostic performance of a new noninvasive test for nonalcoholic steatohepatitis using a simplified histological reference. Eur J Gastroenterol Hepatol. 2018 May;30(5):569-577.29406435
Ratziu V, Massard J, Charlotte F, et al. Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease. BMC Gastroenterol. 2006 Feb 14;6:6.16503961

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

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
550960 NASH FibroSure(R) Plus 93691-4 550963 Fibrosis Score 48795-9
550960 NASH FibroSure(R) Plus 93691-4 550964 Fibrosis Stage 48794-2
550960 NASH FibroSure(R) Plus 93691-4 550965 Steatosis Score 93695-5
550960 NASH FibroSure(R) Plus 93691-4 550966 Steatosis Grade 93696-3
550960 NASH FibroSure(R) Plus 93691-4 550967 NASH Score 93692-2
550960 NASH FibroSure(R) Plus 93691-4 550968 NASH Grade 93693-0
550960 NASH FibroSure(R) Plus 93691-4 550398 Methodology: 62364-5
550960 NASH FibroSure(R) Plus 93691-4 122137 Alpha 2-Macroglobulins, Qn mg/dL 1835-8
550960 NASH FibroSure(R) Plus 93691-4 001629 Haptoglobin mg/dL 4542-7
550960 NASH FibroSure(R) Plus 93691-4 016874 Apolipoprotein A-1 mg/dL 1869-7
550960 NASH FibroSure(R) Plus 93691-4 001100 Bilirubin, Total mg/dL 1975-2
550960 NASH FibroSure(R) Plus 93691-4 001960 GGT IU/L 2324-2
550960 NASH FibroSure(R) Plus 93691-4 001547 ALT (SGPT) P5P IU/L 1743-4
550960 NASH FibroSure(R) Plus 93691-4 001125 AST (SGOT) P5P IU/L 30239-8
550960 NASH FibroSure(R) Plus 93691-4 001067 Cholesterol, Total mg/dL 2093-3
550960 NASH FibroSure(R) Plus 93691-4 001036 Glucose, Serum mg/dL 2345-7
550960 NASH FibroSure(R) Plus 93691-4 001175 Triglycerides mg/dL 2571-8
550960 NASH FibroSure(R) Plus 93691-4 550969 Interpretations: 93694-8
550960 NASH FibroSure(R) Plus 93691-4 550107 Fibrosis Scoring: N/A
550960 NASH FibroSure(R) Plus 93691-4 550971 Steatosis Scoring N/A
550960 NASH FibroSure(R) Plus 93691-4 550972 NASH Scoring N/A
550960 NASH FibroSure(R) Plus 93691-4 550973 Limitations: 62364-5
550960 NASH FibroSure(R) Plus 93691-4 550974 Comment: 8251-1
550960 NASH FibroSure(R) Plus 93691-4 123099 Comment: 77202-0
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550963
Result Code NameFibrosis Score
UofM
Result LOINC48795-9
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550964
Result Code NameFibrosis Stage
UofM
Result LOINC48794-2
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550965
Result Code NameSteatosis Score
UofM
Result LOINC93695-5
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550966
Result Code NameSteatosis Grade
UofM
Result LOINC93696-3
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550967
Result Code NameNASH Score
UofM
Result LOINC93692-2
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550968
Result Code NameNASH Grade
UofM
Result LOINC93693-0
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550398
Result Code NameMethodology:
UofM
Result LOINC62364-5
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code122137
Result Code NameAlpha 2-Macroglobulins, Qn
UofMmg/dL
Result LOINC1835-8
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code001629
Result Code NameHaptoglobin
UofMmg/dL
Result LOINC4542-7
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code016874
Result Code NameApolipoprotein A-1
UofMmg/dL
Result LOINC1869-7
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code001100
Result Code NameBilirubin, Total
UofMmg/dL
Result LOINC1975-2
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code001960
Result Code NameGGT
UofMIU/L
Result LOINC2324-2
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code001547
Result Code NameALT (SGPT) P5P
UofMIU/L
Result LOINC1743-4
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code001125
Result Code NameAST (SGOT) P5P
UofMIU/L
Result LOINC30239-8
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code001067
Result Code NameCholesterol, Total
UofMmg/dL
Result LOINC2093-3
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code001036
Result Code NameGlucose, Serum
UofMmg/dL
Result LOINC2345-7
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code001175
Result Code NameTriglycerides
UofMmg/dL
Result LOINC2571-8
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550969
Result Code NameInterpretations:
UofM
Result LOINC93694-8
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550107
Result Code NameFibrosis Scoring:
UofM
Result LOINCN/A
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550971
Result Code NameSteatosis Scoring
UofM
Result LOINCN/A
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550972
Result Code NameNASH Scoring
UofM
Result LOINCN/A
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550973
Result Code NameLimitations:
UofM
Result LOINC62364-5
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code550974
Result Code NameComment:
UofM
Result LOINC8251-1
Order Code550960
Order Code NameNASH FibroSure(R) Plus
Order Loinc93691-4
Result Code123099
Result Code NameComment:
UofM
Result LOINC77202-0