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NASH FibroSure®

CPT: [MAAA: 0003M] or 82172; 82247; 82465; 82947; 82977; 83010; 83883; 84450; 84460; 84478
Updated on 01/14/2022
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Synonyms

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

Special Instructions

The patient's age, gender, height, and weight at the time of collection must be submitted for FibroSure® testing.

The patient's age, gender, height, and weight at the time of collection must be submitted for FibroSure® testing.

The patient's age, gender, height, and weight at the time of collection must be submitted for FibroSure® testing.


Expected Turnaround Time

3 - 6 days



Related Documents

For more information, please review the literature below.

NAFLD-NASH Capabilities Brochure

For more information, please review the literature below.

NAFLD-NASH Capabilities Brochure

For more information, please review the literature below.

NAFLD-NASH Capabilities Brochure

For more information, please review the literature below.

NAFLD-NASH Capabilities Brochure

For more information, please review the literature below.

NAFLD-NASH Capabilities Brochure


Specimen Requirements


Specimen

Serum


Volume

3.5 mL


Minimum Volume

2 mL


Container

Red-top tube or gel-barrier tube


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.


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, 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 nonalcoholic steatohepatitis (NASH) (0.0-0.75, N0-N2). The absence of steatosis (S<0.38) precludes the diagnosis of NASH.


Limitations

NASH FibroSure® is recommended for patients with suspected nonalcoholic fatty liver disease. It is not recommended for patient with other liver diseases. It is also not recommended in patients with Gilbert disease, acute hemolysis, acute hepatitis, acute inflammation of the liver, autoimmune hepatitis, 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

Poynard T, Ratziu V, Charlotte F, et al. Diagnostic value of biochemical markers (NashTest) for the prediction of non-alcoholo steato hepatitis in patients with non-alcoholic fatty liver disease. BMC Gastroenterol. 2006 Nov 10, 6:34. 17096854
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
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; 6:6. 16503961

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
550140 NASH FibroSure 4877-4 000000 2 48795-9
550140 NASH FibroSure 4877-4 000000 A 48794-2
550140 NASH FibroSure 000000 2 N/A
550140 NASH FibroSure 000000 A N/A
550140 NASH FibroSure 4877-4 000000 2 48792-6
550140 NASH FibroSure 4877-4 000000 A 48793-4
550140 NASH FibroSure 3137-4 000000 3137-7
550140 NASH FibroSure 3147-4 000000 3141-9
550140 NASH FibroSure 1837-4 000000 1835-8
550140 NASH FibroSure 4547-4 000000 4542-7
550140 NASH FibroSure 1867-4 000000 1869-7
550140 NASH FibroSure 1977-4 000000 1 1975-2
550140 NASH FibroSure 2327-4 000000 2324-2
550140 NASH FibroSure 1747-4 000000 1743-4
550140 NASH FibroSure 3027-4 000000 30239-8
550140 NASH FibroSure 2097-4 000000 2093-3
550140 NASH FibroSure 2347-4 000000 2345-7
550140 NASH FibroSure 2577-4 000000 2571-8
550140 NASH FibroSure 000000 S N/A
550140 NASH FibroSure 8257-4 000000 S 8251-1
550140 NASH FibroSure 7727-4 000000 A 77202-0
550140 NASH FibroSure 7727-4 000000 S 77202-0

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