Document Type : Original Article
Authors
1
1Department of Public Health and Occupational Medicine, Faculty of Medicine, Minia University, Minia, Egypt. 2Department of Public Health, Faculty of Health Sciences-AlQunfudah, Umm Al-Quraa University, Kingdom of Saudi Arabia.
2
Department of Public Health and Community Medicine, Faculty of Medicine, Beni Suef University, Beni Suef, Egypt.
3
3Department of Public Health and Community Medicine, Faculty of Medicine, Beni Suef University, Beni Suef, Egypt.
4
Department of Cancer and Molecular Biology, NCI Cairo University, Cairo, Egypt. 5Department of Medical Genetics, Faculty of Medicine, Umm Al-Quraa University, Al-Qunfudah, Kingdom of Saudi Arabia.
5
Department of Public Health and Community Medicine, Faculty of Medicine, Zagazig University, Al-Sharqia, Egypt.
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 fieldapplicable 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.
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