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Non-Alcoholic Fatty Liver Disease Advanced Fibrosis Rule-Out Cascade

CPT: 84450; 85049

Synonyms

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

Test Includes

AST (SGOT) and Platelet Count; reflex to NASH FibroSure® that includes age, gender, height, weight; Alpha 2-Macroglobulins, Qn; Haptoglobin; Apolipoprotein A-1; Bilirubin, Total; GGT; ALT (SGPT) P5P; AST (SGOT) P5P; Cholesterol, Total; Glucose; Triglycerides


Special Instructions

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


Expected Turnaround Time

1 - 5 days




Specimen Requirements


Specimen

Serum and whole blood


Volume

Serum: 4.0 mL divided into two tubes, 0.5 for initial testing and 3.5 for possible reflex

Whole blood: tube filled to capacity


Minimum Volume

Serum: 3.0 mL divided into two tubes, 0.5 for initial testing and 2.5 for possible reflex

Whole blood: tube filled to capacity


Container

Gel-barrier tube or red-top tube and lavender-top (EDTA) tube


Collection

Serum: Separate from cells within 45 minutes of collection.

Whole blood: Invert EDTA tube immediately 8 to 10 times once tube is filled at the time of collection.


Storage Instructions

Serum sample for initial testing and whole blood can be stored room temperature. Serum sample for possible reflex can be stored refrigerated a 2°C to 8°C for 72 hours.


Patient Preparation

Patient should be fasting for at least eight hours.


Causes for Rejection

Serum: Gross hemolysis; gross lipemia; improper labeling; nonfasting specimen; patient younger than 14 years of age.

Whole blood: Frozen specimen; hemolysis; clotted specimen; tube not filled with minimum volume; improper labeling; transfer tubes with whole blood; specimen diluted or contaminated with IV fluid; specimen received with plasma removed; specimen collected in any anticoagulant other than EDTA.


Test Details


Use

The cascade is intended for use in patients with non-alcoholic fatty liver disease (NAFLD) and suspected non-alcoholic steatohepatitis (NASH) with advanced fibrosis that include subjects with no alcohol-related disorders and any of the following: elevated liver function tests, obesity, type 2 diabetes, metabolic syndrome, imaging evidence of fat accumulation, dyslipidemia, polycystic ovary syndrome. These patients may be at high risk for progression to advanced liver fibrosis that can cause a fast progression to end-stage liver disease, hepatocellular carcinoma, and liver transplantation. Non-invasive blood biomarkers can help identifying those patients using rule-out approach. Liver biopsy is still required to definitively diagnose patients with NASH and NASH fibrosis.


Limitations

Clumping may cause false low platelet count. Platelet satellitism around neutrophils will cause a pseudothrombocytopenia. RBC or WBC fragments including fragmented fragile leucemic cells and neutrophil pseudoplatelets may cause falsely elevated counts. NASH FibroSure® is recommended for patients with suspected non-alcoholic 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 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 predictons 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.


Additional Information

The cascade starts with AST to Platelet Ratio Index (APRI). APRI is reported to be a simple, non-invasive, and readily available laboratory test index that can stratify patients with NAFLD who are at high or low risk for significant fibrosis and cirrhosis with high degree of accuracy. If the APRI result stratifies the patient to be at low risk, the testing will stop and the result will be reported with the following comment: "Low risk for liver fibrosis, consider monitoring APRI every 2 years."

If the APRI result stratifies the patient to be at high risk, the testing will stop and the result will be reported with the following comment: "High risk for liver fibrosis, consider liver biopsy."

If the APRI result stratifies the patient to be at intermediate risk, the testing cascade will reflex to NASH FibroSure®. This test is a non-invasive assessment of liver status in patients with 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, hepatic steatosis, and non-alcoholic steatohepatitis (NASH). The absence of steatosis precludes the diagnosis of NASH.

If NASH FibroSure® result stratifies the patient to be at low risk, the testing will stop and the result will be reported with the following comment: "Low risk for liver fibrosis, consider monitoring APRI every 2 years." If NASH FibroSure® result stratifies the patient to be at high risk, the testing will stop and the result will be reported with the following comment: "High risk for liver fibrosis, consider liver biopsy."


References

Angulo P, Bugianesi E, Bjornsson ES, et al. Simple noninvasive systems predict long-term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology. 2013 Oct;145(4):782-789.e4.23860502
Boursier J, Vergniol J, Guillet A, et al. Diagnostic accuracy and prognostic significance of blood fibrosis tests and liver stiffness measurement by FibroScan in non-alcoholic fatty liver disease. J Hepatol. 2016 Sep;65(3):570-578.27151181
Chou R, Wasson N. Blood tests to diagnose fibrosis or cirrhosis in patients with chronic hepatitis C virus infection: a systematic review. Ann Intern Med. 2013 Jun 4;158(11):807-820.23732714
Lin ZH, Xin YN, Dong QJ, et al. Performance of the aspartate aminotransferase-to-platelet ratio index for the staging of hepatitis C-related fibrosis: an updated meta-analysis. Hepatology. 2011 Mar;53(3):726-736.21319189
Poynard T, Ratziu V, Charlotte F, et al. Diagnostic value of biochemical markers (NashTest) for the prediction of non-alcoholic steatohepatitis 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 Feb 14;6:6.16503961
Rinella ME, Sanyal AJ. Management of NAFLD: a stage-based approach. Nat Rev Gastroenterol Hepatol. 2016 Apr;13(4):196-205.26907882
Sanyal A, Ratziu V, Goodman Z, et al. 507 APRI and FIB-4 index scores can enrich for subjects with fibrotic nonalcoholic steatohepatitis (NASH) in Clinical Trials - The CENTAUR trial data. Gastroenterology. 2016 Apr;150(4)Supp1:S1037-S1038.10.1016/S0016-5085(16)33508-9
Shaheen AA, Myers RP. Diagnostic accuracy of the aspartate aminotransferase-to-platelet ratio index for the prediction of hepatitis C-related fibrosis: a systematic review. Hepatology. 2007 Sep;46(3):912-921.17705266
Tapper EB, Krajewski K, Lai M, et al. Simple non-invasive biomarkers of advanced fibrosis in the evaluation of nonalcoholic fatty liver disease. Gastroenterol Rep (Oxf). 2014 Nov;2(4):276-280.25002154
Vilar-Gomez E, Chalasani N. Non-invasive assessment of non-alcoholic fatty liver disease: Clinical prediction rules and blood-based biomarkers. J Hepatol. 2018 Feb;68(2):305-315.29154965

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