Validity Testing of the HbsAg Immunochromatographic Test Method in Donor Blood at the Indonesian Red Cross

Marisha Alsahda; Mulat Muliasih; Zulhafis Mandala; Hidayat Hidayat

doi:10.30872/

Authors

Marisha Alsahda Universitas Malahayati Author
Mulat Muliasih Universitas Malahayati Author https://orcid.org/0000-0003-2120-8153 (unauthenticated)
Zulhafis Mandala Universitas Malahayati Author
Hidayat Hidayat Universitas Malahayati Author

DOI:

https://doi.org/10.30872/

Keywords:

HBsAg, Chemiluminescence Immunoassay, Immunochromatographic Test, diagnostic validity, blood donor.

Abstract

Hepatitis B is one of the major transfusion-transmitted infections that may compromise blood transfusion safety. The Immunochromatographic Test (ICT) is still used in several blood transfusion units; however, its diagnostic validity compared with Chemiluminescence Immunoassay (CLIA) requires further evaluation. This study aimed to determine the diagnostic validity of ICT for detecting Hepatitis B Surface Antigen (HBsAg) using CLIA as the reference method. This analytical observational study with a cross-sectional design involved 100 donor blood samples collected at the Indonesian Red Cross Blood Transfusion Unit of Lampung Province. HBsAg test results obtained by ICT were compared with those obtained by CLIA as the gold standard. Diagnostic performance was evaluated by calculating sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV). The results showed that CLIA identified 53 samples (53%) as reactive and 47 samples (47%) as nonreactive, whereas ICT identified 39 samples (39%) as reactive and 61 samples (61%) as nonreactive. ICT demonstrated a sensitivity of 73.58%, specificity of 100%, PPV of 100%, and NPV of 77.05%. In conclusion, ICT showed excellent specificity and PPV but lower sensitivity and NPV than CLIA. Therefore, CLIA is recommended for HBsAg screening in blood donors to improve transfusion safety.

Author Biographies

Marisha Alsahda, Universitas Malahayati

Department of Medicine, Faculty of Medicine, Universitas Malahayati, Bandar Lampung, Indonesia
Mulat Muliasih, Universitas Malahayati

Department of Clinical Pathology, Faculty of Medicine, Universitas Malahayati, Bandar Lampung, Indonesia
Zulhafis Mandala, Universitas Malahayati

Department of Biochemistry, Faculty of Medicine, Universitas Malahayati, Bandar Lampung, Indonesia
Hidayat Hidayat, Universitas Malahayati

Department of Clinical Pathology, Faculty of Medicine, Universitas Malahayati, Bandar Lampung, Indonesia

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