The authors declare that they have no competing interests.
Hepatitis B virus (HBV) infection remains a major global public health challenge. According to the World Health Organization (WHO), an estimated 254 million people were living with chronic HBV infection in 2022, and approximately 1.1 million deaths each year are attributable to HBV-related complications, mainly cirrhosis and hepatocellular carcinoma [
Burkina Faso is among the countries with a high HBV burden. Previous studies have reported hepatitis B surface antigen (HBsAg) prevalence rates ranging from 8% to 12% in the general population [
Detection of HBsAg is the cornerstone of chronic HBV diagnosis. Automated immunoassays, such as the Architect® system (Abbott), are considered the reference standard because of their excellent diagnostic performance. However, their implementation requires well-equipped laboratories, trained personnel, and substantial financial resources, limiting their availability in rural and peripheral healthcare facilities [
Rapid diagnostic tests (RDTs) offer a practical alternative in resource-limited settings. They are easy to use, affordable, and do not require sophisticated laboratory equipment, thereby expanding access to HBV screening in underserved populations. Among these, the DetermineTM HBsAg rapid test (Abbott) has been widely used in several African countries. Nevertheless, the diagnostic performance of RDTs may vary according to the study population, field conditions, and epidemiological context. Consequently, international guidelines recommend local validation before large-scale implementation [
In the Cascades region of Burkina Faso, data on the field performance of the DetermineTM HBsAg rapid test remain scarce. This study, therefore, aimed to evaluate the diagnostic performance of the DetermineTM HBsAg rapid test for detecting HBsAg, using the Architect® system as the reference standard, in a rural population from Moussodougou, Burkina Faso.
A cross-sectional diagnostic accuracy study was conducted from April to June 2021 in the rural municipality of Moussodougou, located in the Comoé Province of the Cascades Region, southwestern Burkina Faso. Community sensitization, participant recruitment, and blood sample collection were carried out at the primary healthcare centers (Centres de Santé et de Promotion Sociale, CSPS) of the four main villages: Moussodougou, Mondon, Kolokolo, and Diamon. Laboratory analyses were performed at the Immunology Laboratory of the National Centre for Malaria Research and Training (CNRFP) in Banfora for DetermineTM HBsAg rapid test and the Hematology and Immunology Laboratory of Souro Sanou University Teaching Hospital (CHUSS) in Bobo-Dioulasso for Architect® Ci4100 analysis.
The study population consisted of residents of Moussodougou who voluntarily participated in a community-based hepatitis B screening campaign. Community awareness sessions on HBV infection were organized before participant recruitment. Individuals who agreed to participate received individual pre-test counselling before enrollment.
Eligible participants were residents of the study area who provided informed consent. For participants younger than 18 years, consent was obtained from a parent or legal guardian. Participants were consecutively enrolled throughout the study period. No prior sample size calculation was performed, and all eligible volunteers were included, resulting in a final sample of 770 participants.
Approximately 4 mL of venous blood was collected from each participant into dry tubes. Blood samples were transported from the collection sites to the laboratory of the National Centre for Malaria Research and Training (CNRFP), Banfora, under a controlled temperature of +4˚C to +8˚C. Following centrifugation at 5,000 rpm for 10 minutes, serum was aliquoted into two cryovials (a primary and a backup aliquot) for each participant. The primary aliquots were stored at −80˚C at the CNRFP laboratory and were used for the DetermineTM HBsAg analyses. The backup aliquots were transported under refrigerated conditions (+4˚C to +8˚C) to the laboratory of the Souro Sanou University Hospital (CHUSS), where they were stored at −80˚C until quantitative HBsAg testing was performed using the Abbott ARCHITECT immunoassay system.
HBsAg was qualitatively detected using the DetermineTM HBsAg rapid test (Abbott, Japan), an immunochromatographic lateral-flow sandwich assay. Briefly, 50 µL of serum was applied to the sample pad, and results were interpreted within the manufacturer’s recommended reading time. A test was considered positive when both the control and test lines were visible, negative when only the control line appeared, and invalid when the control line was absent.
All serum samples were also analyzed using the Architect® HBsAg assay (Abbott Diagnostics), which served as the reference standard. HBsAg was quantified using a chemiluminescent microparticle immunoassay (CMIA). In this assay, HBsAg binds to anti-HBs-coated paramagnetic microparticles and is subsequently detected using an acridinium-labeled conjugate. The emitted chemiluminescent signal is proportional to the HBsAg concentration and is automatically measured by the analyzer. For internal quality control, one negative control and one positive control were analyzed with each analytical run on the Abbott ARCHITECT Ci4100 system. The analytical run was considered valid only when the control results fell within the acceptable ranges specified by the manufacturer. The unit of measurement was the International Unit per milliliter (IU/mL). The analytical measuring range was 0.05 - 250 IU/mL (50 - 250,000 mIU/mL). An automatic dilution system was used to analyze samples with concentrations exceeding the analytical measuring range. Samples with HBsAg concentrations ≥ 0.05 IU/mL were classified as positive, whereas those with HBsAg concentrations < 0.05 IU/mL were classified as negative. All analyses were performed according to the manufacturer’s instructions and the laboratory’s standard operating procedures.
Data were entered into Microsoft Excel, and statistical analyses were performed using R software version 4.5.1 (R Foundation for Statistical Computing, Vienna, Austria). Quantitative variables were summarized as means ± standard deviations, medians, and ranges, whereas qualitative variables were presented as frequencies and percentages.
The diagnostic performance of the DetermineTM HBsAg rapid test was assessed using the Architect® assay as the reference standard. Sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy were calculated with their corresponding 95% confidence intervals (95% CI). Agreement between the two methods was evaluated using Cohen’s kappa coefficient and interpreted according to the Landis and Koch classification as poor (
The community screening activities carried out in 2021 were conducted under administrative authorizations issued by the competent health authorities. For the subsequent scientific use of the collected data, authorization to use the data was requested from and granted by the Ethics Committee of the Souro Sanou University Hospital prior to the conduct of this study (Approval No. CEI/CHUSS-2025/2026, issued on April 10, 2026).
Participation was entirely voluntary and was subject to the provision of informed consent. For participants younger than 18 years, informed consent was obtained from a parent or legal guardian.
To ensure confidentiality, each participant was assigned a unique, anonymous identification code. All collected data were used exclusively for scientific research purposes.
Individual test results were communicated confidentially to each participant. Participants who tested negative received counselling on hepatitis B prevention and were referred for hepatitis B vaccination. Those who tested positive for HBsAg were referred to appropriate healthcare facilities for further clinical evaluation and management.
A total of 770 participants were enrolled in the study. The mean age was 33.6 years ± 19.6 years (range: 1 - 85 years), with a median age of 33 years. Females accounted for 60.9% (469/770) of the study population, yielding a male-to-female ratio of 0.64. More than half of the participants (53.8%) were recruited from Moussodougou village, and housewives represented the largest occupational group (45.8%) (
Table 1. Sociodemographic characteristics of the study participants.
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| <15 | 176 | 22.86 |
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| 51 - 70 | 139 | 18.05 |
| >70 | 27 | 3.51 |
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| Male | 301 | 39.09 |
| Female |
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| Diamon | 147 | 19.09 |
| Kolokolo | 111 | 14.42 |
| Mondon | 98 | 12.73 |
| Moussodougou |
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| Housewife |
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| Farmer | 197 | 25.58 |
| Student | 163 | 21.17 |
| Other | 57 | 7.40 |
Mean age (years): 33.59221; Age range (years): 1 - 85; Median age (years): 33; Standard deviation (years): 19.58789.
The DetermineTM HBsAg rapid test detected HBsAg in 67 of the 770 participants, corresponding to a prevalence of 8.70% (95% CI: 6.81 - 10.92). Using the Architect® assay as the reference standard, 74 participants tested positive, giving an HBsAg prevalence of 9.61% (95% CI: 7.62 - 11.91) (
Table 2. Prevalence of HBsAg positivity according to the diagnostic method.
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| Negative | 703 | 91.29 | 89.08 - 93.19 |
| Positive | 67 |
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6.81 - 10.92 |
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100 | |
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| Negative | 696 | 90.39 | 88.09 - 92.38 |
| Positive | 74 |
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7.62 - 11.91 |
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100 |
Among the 770 samples analyzed, 67 tested positive, and 696 tested negative with both methods. Seven samples that were positive with the Architect® assay were not detected by the DetermineTM HBsAg rapid test, corresponding to false-negative results. No false-positive results were observed (
Table 3. Agreement between the DetermineTM HBsAg rapid test and the Architect® assay.
| Determine TM HBsAg Rapid Test | |||
| Architect® Assay (Reference Method) | Positive | Negative | Total |
| Positive | 67 | 7 | 74 |
| Negative | 0 | 696 | 696 |
| Total | 67 | 703 | 770 |
Using the Architect® assay as the reference standard, the DetermineTM HBsAg rapid test showed a sensitivity of 90.54% (95% CI: 81.48 - 96.11) and a specificity of 100% (95% CI: 99.47 - 100). The positive predictive value was 100%% (95% CI: 94.64 - 100), the negative predictive value was 99.00% (95% CI: 97.96 - 99.60), and the overall diagnostic accuracy was 99.09% (95% CI: 98.14 - 99.63). Agreement between the two methods was almost perfect, with a Cohen’s kappa coefficient of 0. 9454 (95% CI: 0.8748 - 1.0000) according to the Landis and Koch classification (
Table 4. Diagnostic performance of the DetermineTM HBsAg rapid test compared with the Architect® assay.
| Performance Measure | Determine TM HBsAg % (95% CI) |
| Sensitivity | 90.54 (81.48 - 96.11) |
| Specificity | 100 (99.47 - 100) |
| Positive Predictive Value (PPV) | 100 (94.64 - 100) |
| Negative Predictive Value (NPV) | 99.00 (97.96 - 99.60) |
| Overall Diagnostic Accuracy | 99.09 (98.14 - 99.63) |
| Cohen’s Kappa Coefficient | 0. 9454 (95% CI: 0.8748 - 1.0000) |
Among the 74 HBsAg-positive participants identified by the Architect® assay, most (53/74; 71.6%) had HBsAg concentrations ≥ 1,001 units, whereas seven participants (9.5%) were classified in each of the following categories: [0.01 - 5.99], [6.00 - 100.99], and [101.00 - 1000.99] units. Overall, most infected participants had relatively high HBsAg concentrations. We also observed that the seven discordant subjects had antibody levels within the 0.01 - 5.99 IU/mL range.
This study evaluated the diagnostic performance of the DetermineTM HBsAg rapid test for detecting hepatitis B surface antigen (HBsAg) in a rural population in Burkina Faso, using the Architect® assay as the reference standard. Overall, the DetermineTM HBsAg rapid test demonstrated excellent diagnostic performance, with high sensitivity (90.54%), perfect specificity (100%), high predictive values, an overall diagnostic accuracy of 99.09%, and near-perfect agreement with the reference assay (
The sensitivity observed in this study indicates that the DetermineTM HBsAg rapid test correctly identified more than nine out of ten HBsAg-positive individuals. Although slightly lower than the manufacturer’s reported performance, this value remains consistent with WHO recommendations and with findings from previous evaluations reporting sensitivities ranging from 85% to 100% and specificities above 98% for HBsAg rapid diagnostic tests [
One of the main strengths of the DetermineTM HBsAg rapid test was its perfect specificity. No false-positive results were identified among the 770 participants, indicating that every positive rapid test result was confirmed by the reference assay. This finding is consistent with previous studies conducted in highly endemic settings, which also reported excellent specificity for immunochromatographic HBsAg assays [
The positive predictive value of 100% further confirms the reliability of positive DetermineTM HBsAg results, while the negative predictive value of 99.00% demonstrates the test’s excellent ability to exclude HBV infection among individuals with negative results. These findings support the use of the DetermineTM HBsAg rapid test in decentralized screening programs, particularly in rural and resource-constrained settings where access to automated laboratory platforms remains limited [
Agreement between the DetermineTM HBsAg rapid test and the Architect® assay was almost perfect (
Beyond its diagnostic performance, the DetermineTM HBsAg rapid test offers several practical advantages, including ease of use, rapid turnaround time, affordability, and the absence of sophisticated laboratory requirements. These characteristics make it particularly suitable for peripheral health facilities and community-based screening campaigns in rural Burkina Faso. Expanding access to reliable HBV screening is one of the key pillars of the WHO strategy for eliminating viral hepatitis as a public health threat by 2030, especially in low-resource settings where automated diagnostic platforms remain scarce [
This study has some limitations. First, the study was conducted in a single rural municipality, and participants self-selected for community screening following awareness campaigns, which could limit the generalizability of the results. Second, only HBsAg detection was evaluated, without additional serological or molecular markers that could have provided a more comprehensive assessment of HBV infection. Finally, factors associated with the discordant results between the two assays were not investigated. Nevertheless, this study provides valuable evidence on the field performance of the DetermineTM HBsAg rapid test in a rural African setting, where data remain limited [
Overall, our findings demonstrate that the DetermineTM HBsAg rapid test is a reliable tool for HBV screening in rural settings. Its excellent specificity, high sensitivity, outstanding predictive values, and almost perfect agreement with the Architect® assay support its integration into HBV screening and surveillance programs in Burkina Faso and other resource-limited countries.
This study demonstrated that the DetermineTM HBsAg rapid test has excellent diagnostic performance for the detection of hepatitis B surface antigen (HBsAg) in a rural population of Burkina Faso. Compared with the Architect® assay, used as the reference standard, the DetermineTM HBsAg rapid test achieved a sensitivity of 90.54%, a specificity of 100%, a positive predictive value of 100%, a negative predictive value of 99.00%, and an almost perfect diagnostic agreement (
These diagnostic performances, combined with the simplicity, affordability, and rapid turnaround time of the DetermineTM HBsAg rapid test, support its use in community-based screening programs and peripheral healthcare facilities where access to automated diagnostic platforms remains limited.
Expanding decentralized HBV screening through the use of reliable rapid diagnostic tests could improve the early identification of infected individuals and accelerate progress toward the World Health Organization’s 2030 hepatitis elimination targets. Nevertheless, multicentre studies incorporating molecular confirmatory methods are warranted to further assess the diagnostic performance of the DetermineTM HBsAg rapid test across different epidemiological settings in Burkina Faso.
Hepatitis B virus infection remains highly endemic in sub-Saharan Africa.
Rapid diagnostic tests are recommended by the World Health Organization to improve access to hepatitis B screening in resource-limited settings.
The diagnostic performance of HBsAg rapid tests may vary according to epidemiological and field conditions.
This study provides evidence of the excellent diagnostic performance of the DetermineTM HBsAg rapid test in a rural community in Burkina Faso.
The DetermineTM HBsAg rapid test demonstrated perfect specificity and almost perfect agreement with the Architect® reference assay.
These findings support the use of the DetermineTM HBsAg rapid test for decentralized HBV screening in resource-limited settings.
The authors sincerely thank all study participants and the healthcare staff of the Moussodougou primary healthcare centers for their cooperation during participant recruitment and sample collection. They are also grateful to the staff of the National Centre for Malaria Research and Training (CNRFP) in Banfora and Souro Sanou University Teaching Hospital (CHUSS) in Bobo-Dioulasso for their technical support.