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221931

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

Article

Last updated: 28 Dec 2024

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Tags

Healthcare research

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.

DOI

10.21608/mjmr.2022.221931

Keywords

HCV, Screening, Case finding, InTec test, Rapid Detection, Validity 

Authors

First Name

Ashraf

Last Name

Ewis

MiddleName

A.

Affiliation

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.

Email

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City

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Orcid

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First Name

Doaa

Last Name

Khalil

MiddleName

M.

Affiliation

Department of Public Health and Community Medicine, Faculty of Medicine, Beni Suef University, Beni Suef, Egypt.

Email

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City

-

Orcid

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First Name

Ahmed

Last Name

Arafa

MiddleName

E.

Affiliation

Department of Public Health and Community Medicine, Faculty of Medicine, Beni Suef University, Beni Suef, Egypt.

Email

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City

-

Orcid

-

First Name

Zynab

Last Name

Abdel Salam

MiddleName

M.

Affiliation

3Department of Public Health and Community Medicine, Faculty of Medicine, Beni Suef University, Beni Suef, Egypt.

Email

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City

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Orcid

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First Name

Mohamed

Last Name

Elhefny

MiddleName

A.

Affiliation

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.

Email

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City

-

Orcid

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First Name

Amal

Last Name

El-Badawy

MiddleName

-

Affiliation

Department of Public Health and Community Medicine, Faculty of Medicine, Zagazig University, Al-Sharqia, Egypt.

Email

-

City

-

Orcid

-

Volume

30

Article Issue

3

Related Issue

31754

Issue Date

2019-07-01

Receive Date

2022-02-26

Publish Date

2019-07-01

Page Start

214

Page End

219

Online ISSN

2682-4558

Link

https://mjmr.journals.ekb.eg/article_221931.html

Detail API

https://mjmr.journals.ekb.eg/service?article_code=221931

Order

44

Type

Original Article

Type Code

2,212

Publication Type

Journal

Publication Title

Minia Journal of Medical Research

Publication Link

https://mjmr.journals.ekb.eg/

MainTitle

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

Details

Type

Article

Created At

23 Jan 2023