Alessandra Dellavance1, Flávia Fernandes2, Natália Shimabokuro3, Flavia Latini4, Danielle Baldo1, José Augusto Barreto4, Valdecir Marvulle5, Luis Eduardo Andrade6, Maria Lucia Ferraz7. 1. Research and Development Division, Fleury Group, São Paulo, Brazil. 2. University of the State of Rio de Janeiro, Gastroenterology and Hepatology Department, Rio de Janeiro, Brazil; Bonsucesso Federal Hospital, Gastroenterology and Hepatology Department, Rio de Janeiro, Brazil. Electronic address: ffernandes.flavia@gmail.com. 3. Federal University of São Paulo, Rheumatology Division, UNIFESP, São Paulo, Brazil. 4. Benevolent Association of Blood Collection, Colsan, São Paulo, Brazil. 5. Federal University of São Paulo, Statistics Department, UNIFESP, São Paulo, Brazil. 6. Federal University of São Paulo, Rheumatology Department, São Paulo, Brazil. 7. Federal University of São Paulo, Gastroenterology Department, São Paulo, Brazil; D'Or Institute for Research and Education, Rio de Janeiro, Brazil.
Abstract
BACKGROUND: The Enhanced Liver Fibrosis (ELF) is a serological score that includes hyaluronic acid (HA), tissue inhibitor of matrix metalloproteinases-1(TIMP-1), and aminoterminal propeptide of type III procollagen (PIIINP) and shows good performance for detecting liver fibrosis. There are few studies evaluating ELF's intra and inter-assay variation and stability of the samples. The influence of host variables, such as age, gender and body mass index (BMI) is also not well known. We determined ELF's analytical performance and possible influences of gender, age and BMI. METHODS: The study included 958 healthy blood donors evaluated for age, gender, and BMI. RESULTS: Mean ELF scores were significantly different between female (8.53±0.75) and male groups (8.76±0.76) and also according to age strata (p<0.001). For both genders, ELF significantly varied in individuals with BMI under 25 (p<0.001). Analytes remained stable after freezing/thawing cycles and intra- and inter-assay coefficients of variation were low. CONCLUSIONS: ELF has appropriate precision and is quite robust, due to the high stability of the analytes in fresh and frozen samples. ELF's results are influenced by gender, age and BMI which should be taken into account when analyzing its results.
BACKGROUND: The Enhanced Liver Fibrosis (ELF) is a serological score that includes hyaluronic acid (HA), tissue inhibitor of matrix metalloproteinases-1(TIMP-1), and aminoterminal propeptide of type III procollagen (PIIINP) and shows good performance for detecting liver fibrosis. There are few studies evaluating ELF's intra and inter-assay variation and stability of the samples. The influence of host variables, such as age, gender and body mass index (BMI) is also not well known. We determined ELF's analytical performance and possible influences of gender, age and BMI. METHODS: The study included 958 healthy blood donors evaluated for age, gender, and BMI. RESULTS: Mean ELF scores were significantly different between female (8.53±0.75) and male groups (8.76±0.76) and also according to age strata (p<0.001). For both genders, ELF significantly varied in individuals with BMI under 25 (p<0.001). Analytes remained stable after freezing/thawing cycles and intra- and inter-assay coefficients of variation were low. CONCLUSIONS: ELF has appropriate precision and is quite robust, due to the high stability of the analytes in fresh and frozen samples. ELF's results are influenced by gender, age and BMI which should be taken into account when analyzing its results.