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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
The patient's age, gender, height, and weight at the time of collection must be submitted for FibroSure® testing.
1 - 5 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
For more information, please view the literature below.
Serum and whole blood
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
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
Gel-barrier tube or red-top tube and lavender-top (EDTA) tube
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.
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 should be fasting for at least eight hours.
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.
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.
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.
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."
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