Validação de um sistema imunocromatográfico de fluxo lateral para a detecção de anticorpos contra o vírus da Hepatite C

Abstract

The hepatitis C virus is one of the major causes of chronic liver disease and is considered one of the biggest public health problems in the world. In general, it can be said that in the last decade there have been great advances in the diagnosis of hepatitis C. During this period there was a progressive improvement in the sensitivity and specificity of the immunoenzymatic tests used to detect antibodies against HCV. Since 1993, lateral flow immunoassays, commonly called point-of-care tests, have been used in Brazil as a diagnostic alternative for various diseases. With the advancement of development and production technologies, point-of-care tests proved to be efficient in the investigation of infectious-contagious diseases. Since 2005, the use of point-of-care tests has been able to meet the growing demand for the diagnosis of diseases that are relevant to public health, since their use increases the agility of response to individuals and allows them to be quickly referred for medical care and treatment. The present study aims at evaluating the performance of a lateral flow immunochromatographic test for the detection of anti-HCV antibodies with the aim of increasing the number of test options available in the national territory and guaranteeing the reliability of these tests used as diagnosis in Brazil. At the end of the study, the immunoassay presented diagnostic sensitivity of 95.4% and specificity of 99.6%, being considered satisfactory for an initial test, but requiring adjustments and later validations.