title: Validation of fecal elastase-1 determination using immunoenzymatic assay in HIV-infected patients.
abstract: Pancreatic elastase-1 is a proteolytic enzyme exclusively produced in the pancreas, is stable when passing through the bowel, and its determination is associated with chronic pancreatitis. The clinical diagnosis of pancreatitis is based on anamnesis, physical examination, radiological, sonographic, endoscopic, and laboratory findings. Nowadays, there is a test for the determination of fecal elastase-1, by enzymatic reaction (enzyme-linked immunosorbent assay, ELISA), which specifically determines human elastase-1, promoting the pancreatic function evaluation. Parameters such as linearity, calibration curve, sensitivity, specificity, precision, accuracy, recovery, and receiver operator characteristic (ROC) curve are used to evaluate the test. The aim of this study was the validation of the immunoenzymatic assay (ELISA) and the use of its results in patients with HIV, alcoholics, and under antiretroviral therapy. The study involved 157 patients, 95 of them were HIV-infected, and 62 were completely healthy. The elastase-1 ELISA kit from Bioserv was used, and we noted that the obtained results were linear, sensitive, precise, and accurate. Moreover, our results suggest that this test can be a laboratory evaluation to determine the relationship of pancreatitis with alcohol use, but not its association with antiretroviral use in HIV patients (P=0.424). This test is useful to diagnose pathologies related to pancreatic insufficiency.
authors.affiliation: Faculdade de Medicina do ABC, São Paulo, Brazil. claudia.giorgia@ibest.com.br
authors.forename: Claudia Giorgia Bronzatti
authors.initials: CG
authors.lastname: de Oliveira
authors.forename: Fernando Luiz
authors.initials: FL
authors.lastname: Affonso Fonseca
authors.forename: Nicolle
authors.initials: N
authors.lastname: Stackunas Salotto
authors.forename: Felipe
authors.initials: F
authors.lastname: Ambrosio Chicoli
authors.forename: Pedro
authors.initials: P
authors.lastname: Leopoldo Dória
authors.forename: Rudá
authors.initials: R
authors.lastname: Alessi
authors.forename: Ethel
authors.initials: E
authors.lastname: Zimberg Chehter
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D002908:Chronic Disease; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005243:Feces / Q000737:chemistry / Q000201:enzymology*; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000201:enzymology*; D006801:Humans; D008297:Male; D010196:Pancreatic Elastase / Q000378:metabolism*; D010195:Pancreatitis / Q000175:diagnosis / Q000201:enzymology* / Q000209:etiology; D019512:Pancreatitis, Alcoholic / Q000175:diagnosis / Q000201:enzymology; D011237:Predictive Value of Tests; D012372:ROC Curve; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results
chemical_list: D011933:Reagent Kits, Diagnostic; D010196:Pancreatic Elastase