Performance Evaluation of In Vitro Screening Kits for Hepatitis B in Resource-Limited Settings

Authors

  • Noore Saba Peshawar Regional Blood Centre, Department of Health, Khyber Pakhtunkhwa, Pakistan
  • Muhammad Nisar Peshawar Regional Blood Centre, Department of Health, Khyber Pakhtunkhwa, Pakistan
  • Iqbal Muhammad Peshawar Regional Blood Centre, Department of Health, Khyber Pakhtunkhwa, Pakistan
  • Muhammad Saeed Department of Biological Sciences, International Islamic University, Islamabad, Pakistan
  • Akhlaaq Wazeer Department of Biological Sciences, International Islamic University, Islamabad, Pakistan
  • Zohra Shaheen Field Epidemiology and Laboratory Training Program, National Institute of Health, Islamabad, Pakistan
  • Taimoor Haider Shah Faculty of Allied Health Sciences, University of Sialkot, Sialkot, Pakistan
  • Saeed Ahmed Department of Blood Bank, Prince Mohammad bin Abdulaziz Hospital, Riyadh, Saudi Arabia
  • Yasar Mehmood Yousafzai Institute of Basic Medical Sciences, Khyber Medical University, Peshawar, Pakistan

Keywords:

Hepatitis B virus, chemiluminescence immunoassay, PCR, antigen.

Abstract

Objective: The aim of this study was to assess the performance of different screening assays for the detection of hepatitis B virus surface antigen (HBsAg).

Methodology: This single-centre, cross-sectional prospective study was conducted at the Peshawar Regional Blood Centre. A total of 210 blood donor samples were tested including 70 positive and 140 negative samples for HBsAg. Six rapid screening devices, two ELISA and one CLIA were assessed in comparison with Polymerase Chain Reaction for the detection of HBsAg. The specificity, sensitivity, positive predictive value (PPV), negative predictive value (NPV), Positive Likelihood Ratio (PLR), Positive Likelihood Ratio (NLR), and efficiency were calculated using the PCR results as the gold standard.

Results: The results showed that CLIA showed 100% sensitivity and 100% specificity. The ELISA ChiL showed 98.57% sensitivity and 99.29% specificity while the other ELISA AiD had 97.14% sensitivity and 100% specificity. The rapid devices showed variable results.   

Conclusion: The chemiluminescence immunoassay (Liaison Murex assay) showed results similar to PCR. Screening in blood banks should be performed by ELISA or other higher technology.

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Published

2023-03-07