Volume 31, Issue 3 (Summer 2025)
Intern Med Today 2025, 31(3): 0-0 |
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Sadeghi tabar A, Armand M, Sehat Z, Talebi N, Moradi R, Razi S et al . Comparative Performance of Laboratory Methods for Detecting Hepatitis B Surface Antigen in More Than 1,000 Iranian Laboratories: A National External Quality Assessment Study (2008–2021). , Intern Med Today. 2025; 31 (3)
URL: http://imtj.gmu.ac.ir/article-1-4118-en.html
URL: http://imtj.gmu.ac.ir/article-1-4118-en.html
Ali Sadeghi tabar1 
, Maryam Armand *2 , Zahra Sehat3 , Negin Talebi3 , R Moradi3 , Saeed Razi3 , Azadeh Haji Parvaneh3
, Maryam Armand *2 , Zahra Sehat3 , Negin Talebi3 , R Moradi3 , Saeed Razi3 , Azadeh Haji Parvaneh3
1- Monoclonal Antibody Research Center, Avicenna Research Institute, ACECR, Tehran, Iran.
2- Avicenna Fertility Center, Avicenna Research Institute, Academic Center for Education, Culture and Research (ACECR), Tehran, Iran. ,sehat.zahra@gmail.com
3- Avicenna Fertility Center, Avicenna Research Institute, Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
2- Avicenna Fertility Center, Avicenna Research Institute, Academic Center for Education, Culture and Research (ACECR), Tehran, Iran. ,
3- Avicenna Fertility Center, Avicenna Research Institute, Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.
Abstract: (33 Views)
Aims: Hepatitis B virus (HBV) infection remains a major global public health challenge, highlighting the importance of accurate and timely laboratory diagnosis. This study aimed to evaluate the predictive performance of different laboratory methods used for detecting hepatitis B surface antigen (HBsAg) in medical diagnostic laboratories across Iran.
Materials and Methods: This descriptive cross-sectional study analyzed data from the External Quality Assessment Program (EQAP), which involved more than 1,000 medical diagnostic laboratories across Iran. HBsAg test results collected between 2008 and 2021 were evaluated. The performance of different laboratory methods and commercial kits was assessed based on false-positive and false-negative results. Data were analyzed using SPSS software (version 21).
Results: The findings demonstrated variability in the performance of different laboratory methods and commercial kits across EQAP periods. Among enzyme-linked immunosorbent assay (ELISA)-based methods, a considerable number of false-positive results were observed in negative-control samples, potentially due to cross-reactivity among assay components. Significant differences were also identified among ELISA kit brands, which may reflect variations in manufacturing technology, antigen specificity, and epitope selection. Although false-negative results were less frequent, assay sensitivity and specificity differed across methods and manufacturers.
Conclusion: Despite limitations related to specificity and occasional false-positive reactions, ELISA remains one of the most practical and widely accessible methods for HBsAg detection because of its affordability, availability, and operational advantages. Continuous external quality assessment and the selection of high-performance diagnostic kits with lower error rates are essential to improve the accuracy and reliability of HBV laboratory diagnosis.
Materials and Methods: This descriptive cross-sectional study analyzed data from the External Quality Assessment Program (EQAP), which involved more than 1,000 medical diagnostic laboratories across Iran. HBsAg test results collected between 2008 and 2021 were evaluated. The performance of different laboratory methods and commercial kits was assessed based on false-positive and false-negative results. Data were analyzed using SPSS software (version 21).
Results: The findings demonstrated variability in the performance of different laboratory methods and commercial kits across EQAP periods. Among enzyme-linked immunosorbent assay (ELISA)-based methods, a considerable number of false-positive results were observed in negative-control samples, potentially due to cross-reactivity among assay components. Significant differences were also identified among ELISA kit brands, which may reflect variations in manufacturing technology, antigen specificity, and epitope selection. Although false-negative results were less frequent, assay sensitivity and specificity differed across methods and manufacturers.
Conclusion: Despite limitations related to specificity and occasional false-positive reactions, ELISA remains one of the most practical and widely accessible methods for HBsAg detection because of its affordability, availability, and operational advantages. Continuous external quality assessment and the selection of high-performance diagnostic kits with lower error rates are essential to improve the accuracy and reliability of HBV laboratory diagnosis.
Keywords: Diagnostic accuracy, ELISA, External quality assessment, HBsAg, Hepatitis B virus, Laboratory methods
Type of Study: Original |
Subject:
Laboratory Medicine
Received: 2025/01/11 | Accepted: 2025/04/5 | Published: 2025/05/30
Received: 2025/01/11 | Accepted: 2025/04/5 | Published: 2025/05/30
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