APRI With Reflex to NASH FibroSure® Plus

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.

AST to Platelet Ratio Index (APRI) is reported to be a simple, noninvasive and readily available laboratory test index that can stratify patients with HCV and nonalcoholic steatohepatitis (NASH), now known as metabolic dysfunction-associated steatohepatitis (MASH), who are at high or low risk for significant fibrosis and cirrhosis with high degree of accuracy.

NASH FibroSure® Plus 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 NASH/MASH (0.0-0.75, N0-N2). The absence of steatosis (S<0.41) precludes the diagnosis of NASH/MASH.

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 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. The FDA has determined that such clearance or approval is not necessary.

Clumping may cause false low platelet count. Platelet satellitism around neutrophils will cause a pseudothrombocytopenia. RBC or WBC fragments including fragmented fragile leukemic cells and neutrophil pseudoplatelets may cause falsely elevated counts. NASH FibroSure® Plus is recommended for patients with suspected non-alcoholic fatty liver disease, now called 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 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 Food and Drug Administration.