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CC BY-NC-ND 4.0 · J Lab Physicians 2019; 11(04): 369-372
DOI: 10.4103/JLP.JLP_172_19
Original Article

Evaluation of screening effectiveness of hepatitis B surface antigen and anti-HCV rapid test kits in Pakistan

Usman Waheed
Safe Blood Transfusion Programme, Ministry of National Health Services, Government of Pakistan, Islamabad, Pakistan
Department of Pathology and Blood Transfusion Services, Shaheed Zulfiqar Ali Bhutto Medical University, PIMS, Islamabad, Pakistan
,
Yetmgeta Eyayou Abdella
World Health Organization's Regional Office for Eastern Mediterranean, Cairo, Egypt
,
Noor e Saba
Peshawar Regional Blood Centre, Department of Health, Khyber Pakhtunkhwa, Pakistan
,
Muhammad Arshad
Department of Biological Sciences, International Islamic University, Islamabad, Pakistan
,
Akhlaaq Wazeer
Department of Biological Sciences, International Islamic University, Islamabad, Pakistan
,
Ahmad Farooq
Department of Biological Sciences, International Islamic University, Islamabad, Pakistan
,
Javaid Usman
Department of Pathology, Army Medical College, Rawalpindi, Pakistan
,
Abida Arshad
Department of Biology, PMAS Arid Agriculture University, Rawalpindi, Pakistan
,
Hasan Abbas Zaheer
Safe Blood Transfusion Programme, Ministry of National Health Services, Government of Pakistan, Islamabad, Pakistan
Department of Pathology and Blood Transfusion Services, Shaheed Zulfiqar Ali Bhutto Medical University, PIMS, Islamabad, Pakistan
› Author Affiliations Financial support and sponsorship Nil.
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Abstract

OBJECTIVE: The current study was conducted to evaluate the performance and screening effectiveness of commercially available rapid screening kits in comparison with chemiluminescence immunoassay (CLIA) and polymerase chain reaction (PCR).

MATERIALS AND METHODS: This single-center, cross-sectional study was conducted at the Department of Pathology and Blood Transfusion Services, Shaheed Zulfiqar Ali Bhutto Medical University, PIMS, Islamabad, from January to April 2019. A total of 10 commercially available immunochromatographic test (ICT) devices and one CLIA kit (LIAISON XL) were tested for their sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy using 100 positive and 100 negative samples each for HBV and HCV, respectively.

RESULTS: The sensitivities and specificities of ICT kits for hepatitis B surface antigen were 65% and 70% (Hightop), 67% and 85% (RightSign), 62% and 73% (Wondfo), 70% and 80% (Accu-Chek), 68% and 77% (Fastep), 73% and 85% (Abon), 77% and 83% (ImmuMed), 80% and 90% (Insta-Answer), 67% and 81% (BioCheck), and 72% and 83% CTK Biotech, respectively. Similarly, the sensitivities and specificities of different ICT kits for HCV were 69% and 80% (Hightop), 76% and 83% (RightSign), 69% and 81% (Wondfo), 78% and 79% (Accu-Check), 68% and 68% (Fastep), 63% and 73% (Abon), 71% and 70% (ImmuMed), 79% and 68% (Insta-Answer), 62% and 66% (BioChek), and 69% and 78% CTK Biotech, respectively. The sensitivity and specificity of Diasorin Liaison Murex assay for both HBV and HCV were found to be 100% when compared with PCR. The PPV, NPV and Accuracy were determined accordingly.

CONCLUSION: Rapid testing ICT devices for both HBV and HCV available in Pakistan were found to have a variable degree of sensitivity and specificity when compared with CLIA and PCR. Comparatively expensive but quality methods are more reliable as compared to rapid devices.

Key words

Blood banks - HBV - HCV - Pakistan - Screening


Publication History

Received: 07 November 2019

Accepted: 16 November 2019

Article published online:
19 April 2020

© 2019.

Thieme Medical and Scientific Publishers Private Ltd.
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