ОЦЕНКА ИНФОРМАТИВНОСТИ НОВОГО ДИАГНОСТИЧЕСКОГО МЕТОДА «ФП ТЕСТ» ДЛЯ ОПРЕДЕЛЕНИЯ СТЕПЕНИ АКТИВНОСТИ ГЕПАТИТА У ПАЦИЕНТОВ С ХРОНИЧЕСКОЙ HCV-ИНФЕКЦИЕЙ

Aim. To evaluate the informativeness indicators of the new diagnostic method «ФП Тест» version 1.0 to determine the moderate/severe degree of hepatitis activity in patients with chronic HCV infection. Materials and methods . The study included 304 patients with chronic HCV infection. 184 patients were randomly selected into the training sample, 120 patients into the test sample. As a standard method for diagnosing hepatitis activity, a puncture biopsy of the liver was performed in all patients with the calculation of the histological activity index according to the Knodell scale. Minimal/mild degree of hepatitis activity (HAI 0–8 score) was detected in 46,38% of patients, moderate/severe hepatitis activity (HAI 9–18 score) in 53,62% of patients. Results. The accuracy of the method «ФП Тест» version 1.0 for the diagnosis of moderate/severe hepatitis activity was 79,17%, sensitivity — 78,46%, specificity — 80,00%. The values of the area under the ROC — curve for classifying patients depending on the presence or absence of moderate/severe hepatitis activity were: «ФП Тест» version 1.0 (AUC=0,84, cut-off value=0,52), determination of ALT level (AUC=0,74, cut-off value=61,40 U/L), determination of AST level (AUC=0,76, cut-off value=39,00 U/L). Conclusion . The new diagnostic method «ФП Тест» is a simple, affordable and informative test to determine the moderate/severe degree of hepatitis activity in patients with chronic HCV infection.