NASH FibroSure® Plus

CPT: [MAAA: 0003M] or 82172; 82247; 82465; 82947; 82977; 83010; 83883; 84450; 84460; 84478
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Synonyms

  • Fatty Liver Disease
  • NAFLD
  • Nonalcoholic Fatty Liver Disease
  • Noninvasive Liver Biopsy
  • Steatohepatitis

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.


Related Documents


Specimen Requirements


Specimen

Serum


Volume

3.5 mL


Minimum Volume

2 mL


Container

Gel-barrier tube is preferred. Red-top tube is acceptable.


Collection

Separate serum from cells within two hours of collection.


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.


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)


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


Test Details


Use

This test is a noninvasive assessment of liver status in patients with nonalcoholic fatty liver disease (NAFLD). 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.


Limitations

NASH FibroSure® Plus is recommended for patients with suspected nonalcoholic fatty 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 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.


Methodology

See individual test components.


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 steatohepatis 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

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

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