Venient Fx Hepatic Function Basic
Test Description
Venient Fx Hepatic Function Basic is a disruptive, non-invasive test that provides primary information on liver and bile-pancreatic exocrine function.
It is based on a routine blood test and powered by both proprietary machine learning and public algorithms, and provides highly accurate primary diagnostic information, including the likelihood of having a liver function disorder. As a first line test, the results of the parameters included in it are useful in guiding through different diagnostic, prognostic and therapeutic options. Although the results are usually preliminary in decision making, in some cases, they can be definitive.
It is based on the measurement of hepatic enzymes and total and direct bilirubin. In addition, it also incorporates other determinations such as insulin, glucose, creatinine, and glycosylated hemoglobin (HbA1c).
In case of a positive result, the diagnostic report may suggest the performance of a specific second line test, in order to deepen the diagnostic information, confirm therapies, establish prognoses or follow up the disease.
If liver disease is suggested, other tests will be recommended as appropriate.
Screening recommendations
The United States Preventative Services Task Force (USPSTF) recommends screening for hepatitis C virus (HCV) infection in adults aged 18 to 79 years.
However, Kience Inc. recommends the Venient Fx Hepatic Function Basic test as a first approach to treat patients with symptoms, signs, or suspected disease: hepatitis A, hepatitis B, hepatitis C, hepatitis D, secondary hepatitis due to CMV/EBV infection, autoimmune hepatitis, drug-induced hepatitis, drug-induced liver injury (DILI), metabolic dysfunction associated with fatty liver disease (MAFLD), nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), cholestasis in patients with porto-pulmonary hypertension, hepatic cholestasis due to severe heart failure or acute pancreatitis (alcohol-related, drug-induced, gallstones or hypertriglyceridemia).
Intended Use
The target population for Venient Fx Hepatic Function Basic is patients with clinically suspected hepatitis A, hepatitis B, hepatitis C, hepatitis D, secondary hepatitis due to CMV/EBV infection, autoimmune hepatitis, drug-induced hepatitis, drug-induced liver injury (DILI), non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), or hepatic cholestasis.
Sample Clinical Vignette
A 60-year-old-male with history of hypertension, Type 2 Diabetes Mellitus on insulin treatment and a BMI of 30.3, visits his healthcare provider for persistent edema in his lower limbs. The alcohol consumption in the past 10 years is persistent (>10 g ethanol/day). On physical exam he also shows abdominal distension, caput medusae, splenomegaly and flank dullness on percussion. A blood sample was sent to establish the liver function.
Required Laboratory Determinations
Serum Hepatic Enzymes ―Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH)―; Serum Hormones —Insulin—; Other Serum Analytes —Bilirubin Total, Bilirubin Direct, Bilirubin Indirect, Serum Creatinine, Glucose, Glycated Hemoglobin (HbA1c)—.