Validação de um teste rápido imunocromatográfico para semi-quantificação de antígeno prostático específico em soro humano

Abstract

Around 1.1 million cases of prostate cancer are estimated worldwide every year, accounting for more than 250,000 deaths. It is widely known that the improvement on patients' prognosis is due to an early diagnosis of this neoplasm. Although the Prostate Specific Antigen (PSA) has some limitations concerning sensitivity and specificity for the pathology in question, its serum dosage is used in many countries as a tool for screening and early detection of prostate cancer, which makes it one of the most used devices since its discovery. In 2014, the Brazilian public health system authorized more than 4.8million tests of this kind. Considering the territorial and economic heterogeneity of the Brazilian population, it is necessary to the develop tests with low cost and easy application, which will assist the diagnosis of prostate cancer, without sacrificing sensitivity and specificity. Thus, this study means to validate a rapid test for semi-quantification of PSA in human serum, developed by the Brazilian company FK Biotechnology. At the end of the study, the product showed diagnostic sensitivity of 100% and specificity of 85.71%, being considered satisfactory for a preliminary test, but requiring subsequent adjustments.