Published in PLOS One on 2026-04-08, this study is presented as an attributed evidence briefing. The excerpts below are the original researchers’ words, reproduced under their Creative Commons Attribution licence. Health Signal has selected the abstract and, where needed, opening background paragraphs; the complete methods, results, limitations and references remain in the linked paper.
Original study title: Diagnostic performance of four hepatitis-B surface antigen conformité Européenne (CE) marked and one WHO prequalified rapid diagnostic tests in Uganda
Original authors: Leah Naluwagga Baliruno, Charles Drago Kato, Harriet Nakigozi, Huzaima Mujuzi, Emmanuel Seremba
Source: PLOS One • DOI 10.1371/journal.pone.0346259
Read the complete primary study ↗ · Creative Commons Attribution licence
From the researchers
Abstract
Globally, over 254 million people are infected with chronic Hepatitis B (HBV). Eighty million of these reside in sub-Saharan Africa (SSA). HBV claims an estimated one million lives annually. Efforts to eradicate it from SSA have been slow, partly due to a lack of affordable, accurate screening tools. The diagnostic accuracy of the commonly used rapid diagnostic tests (RDTs) in SSA is poorly understood; hence a need to characterize the validity of five RDTs being used for HBV diagnosis using the Hepatitis B surface antigen (HBsAg) serologic marker.
In this case-control study with 1:1 case: control matching, and a prevalence of 50%, 200 samples of residual donor blood were tested using RDTs against the reference test Fortress Diagnostic, 2016 Enzyme-Linked Immunosorbent Assay (ELISA). They were subsequently subjected to five RDT kits: the SD Bioline (Abbott Diagnostics Korea Inc.), a World Health Organization (WHO) pre-qualified test kit, and four Conformité Européenne (CE) Marked RDTs: One-Step, NOVA (Atlas Link Technology), Astracare (Astra Biotech GmbH), and Accurate (Pharmagen Uganda Ltd). Sensitivity and specificity were computed using ELISA as the reference test. The Statistical Program for Social Sciences (SPSS) was used for statistical analysis.
All five RDT brands demonstrated a sensitivity of 93% (95% CI 93%− 93%). Their specificity, however, ranged from 95% (95% CI 94.9%− 97.8%) for Astracare to 98% (95% CI 94.9%− 98.0%) for SD Bioline.
All the RDTs demonstrated good specificity and good performance characteristics. CE-marked RDTs thus present an opportunity for massive screening of the at-risk populations in the WHO-led campaign to eliminate HBV as a public health threat in Uganda and other low-resource settings by 2030.
1. Introduction
Hepatitis B virus (HBV) is a common cause of viral hepatitis infection with possible complications of liver failure, cirrhosis, and hepatocellular carcinoma that are responsible for an estimated mortality of 500,000–1.2 million worldwide every year [1]. Currently, the global mortality from viral hepatitis exceeds that of HIV, TB, or malaria, and is likely to exceed the toll from those three diseases combined by 2040 [2]. An estimated 1.3 million people died from viral hepatitis in 2022, from data obtained from 187 countries, and viral hepatitis is one of the communicable diseases for which mortality is increasing. Out of the 1.3 million deaths caused by hepatitis, hepatitis B caused 1.1 million deaths. The WHO African Region accounts for 63% of new hepatitis B infections. Additionally, the diagnosis coverage and end treatment coverage among all people with hepatitis B was 4% and 0.2% by the end of 2022 [3].
In its bid to eliminate HBV as a public health threat by 2030, the WHO has identified the shortage of screening tools as one of the key challenges that must be addressed for the success of the campaign [4]. This challenge is undoubtedly huge in low-resource settings, including sub-Saharan Africa. Screening and diagnosis of HBV infections is usually achieved through testing for the hepatitis B surface antigen (HBsAg). This is the first serological marker to appear in blood following infection and it becomes detectable during the incubation period [5]. Its presence signifies current infection. Several serological methods are available to detect HBsAg, including Enzyme Immuno Assays (EIA), and lateral flow or rapid diagnostic tests [6].
Reading this evidence
Use the full paper to check the study design, participant selection, comparator and outcome definitions before drawing a practical conclusion. An association does not by itself show cause and effect. A reported performance measure needs its denominator and uncertainty. A finding from a particular facility, sample or time period should retain that scope when it is discussed elsewhere.
This briefing makes the source accessible within the wider technology & industry desk. It does not assess an individual patient or certify a product. When considering relevance to another health system, examine the original authors’ account of context and limitations, then seek local implementation evidence. The related reporting below provides other studies to read alongside this one; it is a topic connection, rather than a claim that their results are directly comparable.
© 2026 Leah Naluwagga Baliruno, Charles Drago Kato, Harriet Nakigozi, Huzaima Mujuzi, Emmanuel Seremba. Excerpts reproduced under CC BY. Selection, formatting and contextual notes by Health Signal. The researchers are the authors of the source study, not members of Health Signal’s staff.
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