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Comparative Diagnostic Yield of Rapid Immunoassay-Based Tests and Nucleic Acid Testing for Transfusion-Transmissible
D K Singh1, Ranvijay Singh1, Anju Singh2
1Department of Transfusion Medicine, Rajarshi Dashrath Autonomous State Medical College (RDASMC), Ayodhya, IND.
Background:
Transfusion-transmissible infections (TTIs), particularly human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), continue to compromise blood safety, especially in high-burden and resource-limited settings. Variability in diagnostic performance across screening modalities contributes to residual risk, particularly during the immunological window period.
Objective:
To comparatively evaluate the diagnostic performance and incremental yield of Rapid tests, enzyme-linked immunosorbent assay (ELISA), chemiluminescent immunoassay (CLIA), and nucleic acid testing (NAT) in detecting HIV, HBV, and HCV among blood donors in a tertiary care setting and to identify an optimal screening strategy.
Methods:
A cross-sectional analytical study was conducted on 2,153 blood donor samples collected over 12 months from September 2024 to September 2025. Eligible donors were aged 18-60 years. Each sample was tested using rapid card tests, ELISA, CLIA, and NAT. Inclusion required sufficient sample volume and complete testing by all four modalities. Data were analysed using descriptive statistics, focusing on detection rates and inter-modality discrepancies.
Results:
Rapid tests showed the lowest detection rates for HIV, hepatitis B surface antigen (HBsAg), and HCV at 0.05%, 0.93%, and 0.19%, respectively. ELISA and CLIA demonstrated higher detection rates, with CLIA showing slightly increased detection for HCV. NAT confirmed fewer positive cases for HIV, HBsAg, and HCV at 0.05%, 1.25%, and 0.14%, respectively, suggesting exclusion of likely false-positive serological results. Incremental analysis showed that ELISA and CLIA detected additional reactive donor samples missed by Rapid tests, while NAT refined diagnostic interpretation by confirming active infection.
Conclusion:
Significant variation exists among diagnostic modalities for TTI screening among blood donors. Rapid tests alone are insufficient for reliable screening. ELISA and CLIA improve serological detection, while NAT provides confirmatory accuracy. A tiered screening approach combining serological methods with NAT may enhance transfusion safety in tertiary care blood bank settings.
