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Palladino, Agostino; Gee, Matthew; Shalhoub, Victoria; Kiaei, David
Clinica chimica acta, 08/2023, Volume: 548Journal Article
•ELFTM aids prognostic evaluation in patients with advanced liver fibrosis in NASH.•The ELF score comprises results of 3 fibrosis markers, HA, PIIINP, and TIMP-1.•The Atellica IM Analyzer was used for analytical performance of 3 analytes and ELF.•Detection capability, precision, interference, linearity, hook effect, were studied.•All predetermined requirements were met making the assay fit for clinical use. The Enhanced Liver Fibrosis (ELFTM) Test comprises 3 direct serum markers of fibrosis—hyaluronic acid (HA), amino-terminal pro-peptide of type III procollagen (PIIINP), and tissue inhibitor of matrix metalloproteinase 1 (TIMP-1)—whose results are combined in an algorithm to generate the ELF score. Outside the U.S., the ELF Test and score are CE marked for assessment of liver fibrosis severity in patients with signs, symptoms, or risk factors of chronic liver disease to support diagnosis of fibrosis staging or prognosis for likelihood of progression to cirrhosis and liver-related clinical events. In the U.S., the FDA granted de novo marketing authorization to aid prognostic evaluation of disease progression (to cirrhosis and liver-related clinical events) in nonalcoholic steatohepatitis patients with advanced liver fibrosis. We describe the analytical performance of the ELF analytes and score on the Atellica® IM Analyzer. Clinical and Laboratory Standards Institute protocols were followed for detection capability (limits of blank LoB, detection LoD, and quantitation LoQ), precision, interference, linearity, hook effect, and ELF reference interval. All parameters met predetermined requirements: HA (LoB 1.00 ng/mL, LoD 2.00 ng/mL, LoQ 3.00 ng/mL); PIIINP (LoB 0.50 ng/mL, LoD 0.75 ng/mL, LoQ 1.00 ng/mL); TIMP-1 (LoB 3.0 ng/mL, LoD 4.0 ng/mL, LoQ 5.0 ng/mL). Across the 3 assays, repeatability was ≤5.4% CV; within-lab precision was ≤8.5% CV. ELF score repeatability was ≤0.6% CV, within-lab precision ≤1.3% CV, and reproducibility ≤1.1% CV. Good correlation was obtained between the Atellica IM ELF and ADVIA Centaur ELF Tests (y = 1.01x − 0.22, r = 0.997). Assays were linear across analytical measuring ranges. Analytical performance validation results for the ELF Test and ELF score were excellent making the test acceptable for routine clinical use.
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