October 2018 Vol. 6 No.10

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Original Research Article

Indeterminate HCV ELISA and RIBA results versus HCV RNA; A comparative study in premarital couples in Makkah, Saudi Arabia

Talat A. M. Albukhari^1*, Aiysha Q. Alanazi², Meaad Q. Alanazi², Fahd Alanzi³, Abdulmajeed Q. Alanazi⁴, Abdulrahman Q. Alanazi⁴,
Dalal AlShaya⁵, Hayat Alafarai⁵, Adel Alanazi⁴, Abdulaziz S. Alenazi², Yousef A. Khalifa³, Hanaa Nafady-Hego¹,Majed M. Almoqati⁴, Muslih A. Alotaibi⁴, Arif Alrawaili⁵ and Badi Alenazi⁴

¹Haematology and Immunology department, Faculty of Medicine, Umm AL-Qura University, Saudi Arabia
²KAMC, Riyadh, Saudi Arabia
³KSMC, Riyadh, Saudi Arabia
⁴MOH, Riyadh, Saudi Arabia
⁵College of Science, PNU, Riyadh, Saudi Arabia

*Corresponding Author’s E-mail: fqalenzi@ksu.edu.sa

Accepted October 11, 2018

Abstract

Hepatitis C virus (HCV) infection is diagnosed by the presence of antibodies and is supplemented by confirmatory testing methods, such as recombinant immunoblot assay (RIBA) and HCV RNA detection. It is mandatory to go for HCV virus screening before marriage in Saudi Arabia, the diagnosis is based on serology and confirmation by RIBA testing. This study aimed to evaluate the efficacy of RIBA testing in diagnosis of HCV infection in pre-marital screening couples positive or indeterminate for anti-HCV antibodies. A total 15.342 subjects were screened for HCV, out of which 98 samples with positive and indeterminate anti-HCV enzyme-linked immunosorbent assay (ELIZA) results were further assessed using RIBA 3 and quantitative HCV RNA Abbott real-time polymerase chain reaction (PCR) assay. A total 98 blood samples with positive and indeterminate results for anti-HCV were further assessed for anti-HCV antibodies using a RIBA 3.0 Strip Immunoblot Assay. The positivity rates for HCV infection by ELISA among premarital screening couples were 0.63 % (98 out of 15342). Using RIBA, 28 out of ELISA +ve cases were RIBA indeterminate, 43 were RIBA +ve and the remaining 27 were RIBA negative. All RIBA indeterminate cases were negative using qualitative HCV-RNA analysis. In this study, individuals with indeterminate RIBA results had no detectable HCV-RNA suggesting that real-time PCR may be unnecessary, particularly in low-risk populations.

Keywords: Hepatitis C virus. ELISA. RIBA. HCV-RNA. Indeterminate