Validation of a rapid screening diagnostic kit for field investigations of hepatitis C viral infection

Abstract

Background: Hepatitis C virus (HCV) screening, case finding and treatment is an urgent public health issue and a national priority on health, social and economic levels. However, the high cost of the gold standard diagnostic test, polymerase chain reaction (PCR), and the inaccessibility of trustful laboratories in many areas pushed the epidemiologists to search for easier, cheaper and field-applicable screening tools to detect infected individuals and then to confirm only the positive cases by the expensive PCR testing. Methodology: A total of 558 blood samples were confirmed for diagnosis of HCV by qualitative and quantitative PCR as a reference test. Those samples, 178 positive cases of HCV and 380 negative samples were further, examined by the enzyme-linked immunosorbant assay (ELISA) and the InTec rapid diagnostic testing kit to detect and compare their sensitivity, specificity, accuracy and efficiency as mass screening tests. Results: Compared with the reference PCR test, the InTec rapid diagnostic test showed a sensitivity of 99.4%, a specificity of 98.7%, a positive predictive value of 97.3%, a negative predictive value of 99.7%, an accuracy percent of 98.9% and an error percent of 1.1%. These results were comparable to that of ELISA. Conclusions: The InTec rapid diagnostic testing kit is a simple, cheap, sensitive, specific and efficient test that can be used in the field for simple and rapid diagnosis of HCV infection. The accuracy of the InTec kits has implications for its use in clinical and outreach settings Such field diagnosis of HCV infection is essential for case finding, screening and surveillance of HCV and for all the efforts that are exerted to treat, control and combat the disease.