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NASH FibroSure® Plus

CPT: 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

This test is not approved for New York state clients.

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

For more information, please view the literature below.

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


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

Refrigerated

72 hours

Frozen

7 days

Freeze/thaw cycles

Stable x1


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 000000 2 48795-9
550960 NASH FibroSure(R) Plus 93691-4 000000 A 48794-2
550960 NASH FibroSure(R) Plus 93691-4 000000 2 93695-5
550960 NASH FibroSure(R) Plus 93691-4 000000 A 93696-3
550960 NASH FibroSure(R) Plus 93691-4 000000 2 93692-2
550960 NASH FibroSure(R) Plus 93691-4 000000 A 93693-0
550960 NASH FibroSure(R) Plus 93691-4 000000 1835-8
550960 NASH FibroSure(R) Plus 93691-4 000000 4542-7
550960 NASH FibroSure(R) Plus 93691-4 000000 1869-7
550960 NASH FibroSure(R) Plus 93691-4 000000 1 1975-2
550960 NASH FibroSure(R) Plus 93691-4 000000 2324-2
550960 NASH FibroSure(R) Plus 93691-4 000000 1743-4
550960 NASH FibroSure(R) Plus 93691-4 000000 30239-8
550960 NASH FibroSure(R) Plus 93691-4 000000 2093-3
550960 NASH FibroSure(R) Plus 93691-4 000000 2345-7
550960 NASH FibroSure(R) Plus 93691-4 000000 2571-8
550960 NASH FibroSure(R) Plus 93691-4 000000 S 93694-8
550960 NASH FibroSure(R) Plus 93691-4 000000 S N/A
550960 NASH FibroSure(R) Plus 93691-4 000000 S 62364-5
550960 NASH FibroSure(R) Plus 93691-4 000000 A 8251-1
550960 NASH FibroSure(R) Plus 93691-4 000000 S 77202-0

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