Multidisciplinary, General Biochemistry, Genetics and Molecular Biology, Immunology and Microbiology, Infectious Diseases
14
Scopus Publications
Scopus Publications
Assessing user experience with the Bioline™ HCV point-of-care test in primary healthcare settings: a mixed-methods study Evans Duah, Evans Mantiri Mathebula, Kuhlula Maluleke, Tinyiko Violet Baloyi, Richard Kobina Dadzie Ephraim, et al. BMC Health Services Research, 2025 Background Hepatitis C Virus (HCV) is a major public health challenge, particularly in resource-limited settings with inadequate diagnostic services. The Bioline™ HCV Point-of-Care (POC) test provides a promising solution for improving diagnosis in Primary Healthcare (PHC) clinics without laboratory infrastructure. This study evaluated the test’s usability, acceptability, and deliverability in Ghana using user-oriented REASSURED criteria. Methods A convergent parallel mixed-methods design was adopted. Quantitative data was collected through direct observation of Healthcare Workers (HCWs) using audit checklists and analyzed with Stata 16. The analysis included descriptive statistics, inter-rater concordance assessment, and the application of the System Usability Scale (SUS). Qualitative data, analyzed using Atlas.ti 24.2.0, explored user experiences, confidence, storage infrastructure, and suggestions for test design improvement through in-depth interviews. Results The quantitative audit included 81 non-laboratory HCWs, with 22 participating in in-depth interviews. The test scored 88.7 on the SUS (95% CI: 86.40-90.88), with 88% of HCWs rating it as easy or very easy to use. Most HCWs (81.5%) successfully completed all testing steps independently, achieving 100% inter-rater concordance, but 83% made errors in at least one step, primarily during pre-testing. Qualitative findings revealed widespread acceptance, confidence, and adaptability despite challenges with storage infrastructure. Discussion The Bioline™ HCV POC test demonstrated high usability and acceptance among HCWs in resource-limited settings. Enhancements such as improved packaging, simplified information sheets, refined droppers, and additional components like gloves could further optimize usability. These findings support the Sustainable Development Goal (SDG) 3 by enhancing access to timely HCV diagnosis, contributing to Universal Health Coverage, and strengthening health systems in underserved areas. Trial registration This study is part of a diagnostic trial registered in the Pan African Clinical Trial Registry (https://pactr.samrc.ac.za) on 24th October 2024 with trial registration number: PACTR202410837698664.
Evaluating performance of the Bioline™ HCV point-of-care test in Ghana Evans Duah, Evans Mantiri Mathebula, Kuhlula Maluleke, Daniel Edem Azumah, Richard Kobina Dadzie Ephraim, et al. BMC Infectious Diseases, 2025 Background Hepatitis C Virus (HCV) causes liver diseases including chronic hepatitis, cirrhosis, and hepatocellular carcinoma. In low- and middle-income countries (LMICs), particularly sub-Saharan Africa (SSA), HCV diagnostic resources are limited. Moreover, most evaluations of point-of-care (POC) invitro diagnostics (IVDs) are conducted outside the region using non-African populations, which may not reflect their performance in local settings where they are mostly used. This study assessed the diagnostic performance of the Bioline™ HCV POC test in Ghanaian HCV target populations. Methods A cross-sectional field evaluation was conducted among HCV priority populations including incarcerated individuals, patients requiring HCV testing, and voluntary blood donors undergoing pre-donation screening. Venous blood samples were tested using the Bioline™ HCV POC test, and the results were compared with the Enzyme-Linked Immunosorbent Assay (ELISA) reference standard. The sensitivity, specificity, test efficiency, Youden index, predictive values, likelihood ratios, and receiver operating characteristic (ROC) indicators were calculated. Results The Bioline™ HCV POC test demonstrated a sensitivity of 96.7% (95% CI: 82.8–99.9%), specificity of 99.8% (95% CI: 98.9–100%), and positive and negative predictive values of 96.7% (95% CI: 82.8–99.9%) and 99.8% (95% CI: 98.9–100%), respectively. The test efficiency was 99.6% (98.6–99.9%), Youden index 0.97 (0.82–0.99) with a ROC area of 0.98 and highly favorable likelihood ratios (LR + 483.5, LR − 0.03). Conclusion This study highlights the high diagnostic performance of the Bioline™ HCV POC test in Ghanaian populations. The test’s reliability underscores its potential as a valuable tool for HCV screening and early detection in resource-limited settings, contributing to efforts to reduce the global HCV burden. Trial registration This study is part of a diagnostic trial registered in the Pan African Clinical Trial Registry (https://pactr.samrc.ac.za) on 24th October 2024 with trial registration number: PACTR202410837698664.
Usability of a blood-based HIV self-test kit in Lusaka province, Zambia: A cross-sectional analysis Fales Z. Mwamba, Mwansa Mwape, Brenda C. Simfukwe, Nowella M. Musunga, Evans M Mathebula, et al. African Journal of Laboratory Medicine, 2025 Background: Despite progress toward the Joint United Nations Programme on HIV/AIDS (UNAIDS) 95-95-95 targets, Zambia faces persistent gaps in HIV testing coverage. The Ministry of Health implemented blood-based HIV self-testing (HIVST) to improve accessibility. This study evaluated the CheckNOW™ HIVST kit’s usability in Lusaka province health facilities. Objective: To determine usability, awareness and user-friendliness of the CheckNOW™ HIVST among Zambian adults. Methods: We conducted a cross-sectional study from 04 September 2023 – 22 September 2023 across four high-volume healthcare facilities. A total of 323 CheckNOW™ HIVST kits were distributed, with 316 consenting adults successfully enrolled in the study. Data were collected through structured questionnaires administered via face-to-face interviews following test completion, capturing information on socio-demographics, HIV testing history and user perception of the self-testing process. Descriptive statistics were employed for data analysis. Results: Among 316 participants, 56.3% (178/316) were female, and 41.5% (131/316) were aged 25–34 years. The majority (95.0%, 300/316; p < 0.001) found the CheckNOW™ kit easy to use, while 65.0% (206/316) had prior awareness of HIVST. Additionally, 83.6% (264/316; p < 0.001) followed the test instructions correctly and independently. A high proportion (98.7%, 312/316; p < 0.001) expressed willingness to test again, and 99.7% (315/316; p < 0.001) would recommend it to others. Conclusion: The CheckNOW™ blood-based HIVST kit demonstrated high usability and ease of use, supporting its potential to expand HIV testing coverage in Zambia. However, increased awareness efforts are necessary to maximise uptake and ensure broader accessibility. What this study adds: This study provides the first evidence that blood-based HIV self-testing is feasible and acceptable within Zambian clinical settings. It offers a critical new strategy to expand testing coverage and reach key populations by integrating self-testing into routine health services.
Barriers and enablers for implementation of digital-linked diagnostics models at point-of-care in South Africa: stakeholder engagement Boitumelo Moetlhoa, Siphesihle R. Nxele, Kuhlula Maluleke, Evans Mathebula, Musa Marange, et al. BMC Health Services Research, 2024 The integration of digital technologies holds significant promise in enhancing accessibility to disease diagnosis and treatment at point-of-care (POC) settings. Effective implementation of such interventions necessitates comprehensive stakeholder engagements. This study presents the outcomes of a workshop conducted with key stakeholders, aiming to discern barriers and enablers in implementing digital-connected POC diagnostic models in South Africa. The workshop, a component of the 2022 REASSURED Diagnostics symposium, employed the nominal group technique (NGT) and comprised two phases: Phase 1 focused on identifying barriers, while Phase 2 centered on enablers for the implementation of digital-linked POC diagnostic models. Stakeholders identified limited connectivity, restricted offline functionality, and challenges related to load shedding or rolling electricity blackouts as primary barriers. Conversely, ease of use, subsidies provided by the National Health Insurance, and 24-h assistance emerged as crucial enablers for the implementation of digital-linked POC diagnostic models. The NGT workshop proved to be an effective platform for elucidating key barriers and enablers in implementing digital-linked POC diagnostic models. Subsequent research endeavors should concentrate on identifying optimal strategies for implementing these advanced diagnostic models in underserved populations.
REASSURED evaluation of the Bioline HCV point-of-care testing for diagnosing hepatitis C virus infection in primary healthcare settings of Ghana: a study protocol Evans Duah, Richard Kobina Dadzie Ephraim, Evans Mantiri Mathebula, Tivani Phosa Mashamba-Thompson BMJ Open, 2024 IntroductionHepatitis C virus (HCV) infection is a silent epidemic that needs a comprehensive and contextualised approach to manage. Access to readily available, affordable and acceptable HCV point-of-care (POC) in vitro diagnostics (IVDs) is equally required to meet the global HCV goals. However, most guidelines for evaluating these IVDs such as the WHO prequalification process and country-specific standards disproportionately focus on diagnostic performance. The real-time connectivity, ease of specimen collection, affordability, sensitivity, specificity, user-friendliness, rapidity and robustness, equipment-free or simplicity and deliverability to end-users (REASSURED) criteria provide a holistic and user-oriented evaluation of the IVDs in the populations they are meant to be used. Therefore, as part of a multinational study in sub-Saharan Africa, we will conduct an evaluation of the Bioline HCV POC test for diagnosing HCV infection in primary healthcare settings of Ghana using the REASSURED criteria.Methods and analysisThis field evaluation will be conducted in three phases. The first phase will use a cross-sectional field evaluation study design to evaluate the diagnostic performance of the Bioline HCV POC test. The second phase will use mixed methods to ascertain operational characteristics and users’ perceptions. In the third phase, a cross-sectional survey will be used to estimate the costs of accessing HCV diagnostics services using three proposed HCV testing models to inform the affordability of the testing pathways and linkage to care in the primary healthcare clinics. This phase will run concurrently with the second phase of the study. Thematic content analysis and quantitative data analysis will be performed using ATLAS.ti V.23.0.6 and StataCorp LLC’s Stata statistical software V.16.0, respectively.Ethics and disseminationThe study protocol has been reviewed and fully approved by the Faculty of Health Sciences Research Ethics Committee, University of Pretoria (281/2023) and the Ghana Health Service Ethics Review Committee (GHS-ERC013/08/23). This diagnostic trial has also been registered in the Pan African Clinical Trial Registry (PACTR202410837698664). The findings of the study will be presented in relevant peer-reviewed journals, at local and international conferences, and to all stakeholders involved.
The feasibility and impact of deploying a four-tests panel at antenatal care in primary health care facilities of a developing country, Kenya Missiani Ochwoto, Micah Matiang’i, Noah Machuki Onchieku, Simon Ndoria, Lydia Matoke, et al. Frontiers in Public Health, 2024 IntroductionContracting HIV, syphilis, hepatitis B virus (HBV), and malaria during pregnancy significantly affects the health of the woman, the pregnancy, and the unborn child. The World Health Organization (WHO) recommends testing pregnant women for these infections to achieve triple elimination of mother-to-child transmissions. However, this goal has not been fully realized in low- to medium-income countries, primarily due to segmented testing practices. This study aimed to investigate the effect of introducing a four-tests panel on the quality of antenatal care (ANC) among pregnant women attending selected Primary Health Care facilities in Kenya.MethodsUsing a multi-design approach, we analyzed ANC medical records from 577 pregnant women attending eight facilities across four different counties. Blood from the women fingerpick was tested for HIV, Syphilis Hepatitis B Virus and Malaria using the four-tests panel and the results compared to those in the medical records.ResultsOut of 577 ANC women, only 8.3% had test results for all four infections available. The majority of the mothers had been tested for syphilis (93.7%), HIV (78.5%), and malaria (62.6%), only 19.5% had been tested for HBV. Testing the women using the 4-tests panel yielded positivity rates of 6.9% for HIV, 0.9% for syphilis, 1.9% for malaria, and 1.1% for HBV. Among those without previous test results, the positivity rate was 2.8% for syphilis, 13.8% for HIV (with 10.6% testing positive for recent p24 infections, F = 24.876, p &lt; 0.001), 2.3% for malaria, and 4.5% for HBV, with 83.3% of these individuals having no prior test results. The mean positivity rate of those tested using the 4-tests panel compared to segmented single tests was significantly different. The panel was cost-effective and user-friendly for healthcare workers, and in facilities facing staff shortages, it reduced turnaround time and workloads by half. The use of the panel also improved the profiling of ANC mothers and enhanced data management for the four infections by 91.7%.ConclusionAdopting the 4-tests panel has the potential to improve test result outputs, enhance the quality-of-service delivery, and contribute significantly to the achievement of triple elimination goals.
Diagnostic performance of NxTek™ Eliminate Malaria-Pf test for the detection of Plasmodium falciparum in school children with asymptomatic malaria Abdissa Biruksew, Ashenafi Demeke, Zewdie Birhanu, Estifanos Kebede, Lemu Golassa, et al. Malaria Journal, 2023 Background One of the major roadblocks to the falciparum malaria elimination programme is the presence of a portion of the population, such as school children, with asymptomatic malaria infection. Targeting such reservoirs of infections is critical to interrupting transmission and enhancing elimination efforts. The NxTek™ Eliminate Malaria Pf test is a highly sensitive rapid diagnostic test (hsRDT) for the detection of HRP-2. However, knowledge gaps exist in Ethiopia on the diagnostic performance of hsRDT for the detection of Plasmodium falciparum in school children with asymptomatic malaria. Methods A school-based cross-sectional study was conducted from September 2021 to January 2022 on 994 healthy school children (aged 6–15 years). Finger-pricked whole blood samples were collected for microscopy, hsRDT, conventional RDT (cRDT or SD Bioline Malaria Ag Pf/P.v), and QuantStudio™ 3 Real—Time PCR system (qPCR). The hsRDT was compared to cRDT and microscopy. qPCR and microscopy were used as reference methods. Results The prevalence of Plasmodium falciparum was 1.51%, 2.2%. 2.2% and 4.52%, by microscopy, hsRDT, cRDT and qPCR, respectively. Using qPCR as reference, the sensitivity of hsRDT was higher (48.89%) than the microscopy (33.3%), and showed 100% specificity and a positive predictive value (PPV). Microscopy showed similar specificity and PPV as hsRDT. Using microscopy as a reference, the diagnostic perforrmances of both hsRDT and cRDT were similar. Both RDTs demonstrated identical diagnostic performances in both comparison methods. Conclusions hsRDT has the same diagnostic performance as cRDT but improved diagnostic characteristics than microscopy for detection of P. falciparum in school children with asymptomatic malaria. It can be a useful tool for the national malaria elimination plan of Ethiopia.
