Co-creation of a novel approach for improving supply chain management for SARS-CoV-2 point of care diagnostic services in Mopani District, Limpopo Province: nominal group technique.

Introduction: Effective supply chain management (SCM) of point-of-care (POC) tests for diseases like severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) requires active participation from diverse stakeholders, government entities, and regulatory bodies. The responsibility for overseeing various aspects of POC tests, including procurement, quality assurance, storage, inventory management, distribution, and human resource capacity, lies with national, provincial, and local levels of government. This study aimed to collaboratively develop an innovative approach to enhance SCM for SARS-CoV-2 POC diagnostic services in resource-limited settings, using the Mopani District in Limpopo province, South Africa, as a case study. Methods: Key stakeholders were invited to participate in an online workshop using purposive sampling. The study employed the nominal group technique (NGT) for data collection, which consisted of two phases. Phase 1 focused on identifying barriers in the supply chain of COVID-19 rapid tests, while phase 2 aimed to devise strategies to overcome the priority barriers identified in phase 1. Participants used a Likert scale of 1-5 to rank barriers and strategies, and an overall ranking score was calculated for each. The participants were provided with the results of the ranking exercise for their feedback. Results: Eleven key stakeholders from national (n = 1), provincial (n = 4), and local government (n = 2) levels, research entities (n = 3), and non-governmental organizations (n = 1) took part in the study. Participants identified significant barriers in the supply chain, such as the availability of testing kits, unknown demand, information on SCM during a pandemic, methods of controlling stock, and procurement processes. Strategies suggested by key stakeholders included monitoring stock levels and optimizing stock visibility systems to improve test availability, enhancing information visibility and consistent data updates to address unknown demand and improve SCM during a pandemic, employing data capturing and digitization for effective stock control, and implementing demand planning and standardized procurement processes at the national level to enhance stock procurement. Discussion: The successful collaboration with key stakeholders, facilitated by the NGT, resulted in the co-creation of a novel approach to enhance SCM for COVID-19 diagnostic services in resource-limited settings. This study holds the potential to support the provision of COVID-19 diagnostic services in such settings. A recommended follow-up study would assess the feasibility of implementing this approach.

Barriers and enablers for implementation of digital-linked diagnostics models at point-of-care in South Africa: stakeholder engagement.

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 diagnostics at point-of-care in sub-Saharan Africa: A scoping review.

Point-of-care (POC) diagnostics that meet the REASSURED criteria are essential in combating the rapid increase and severity of global health emergencies caused by infectious diseases. However, little is known about whether the REASSURED criteria are implemented in regions known to have a high burden of infectious diseases such as sub-Saharan Africa (SSA). This scoping review maps evidence of the use of REASSURED POC diagnostic tests in SSA. The scoping review was guided by the advanced methodological framework of Arksey and O'Malley, and Levac et al. We searched the following electronic databases for relevant literature: Scopus, Dimensions, ProQuest Central, Google Scholar, and EBSCOhost (MEDLINE, CINAHL, as well as AFRICA-WIDE). Two reviewers independently screened abstracts and full-text articles using the inclusion criteria as reference. We appraised the quality of the included studies using the mixed-method appraisal tool (MMAT) version 2018. We retrieved 138 publications, comprising 134 articles and four grey literature articles. Of these, only five articles were included following abstract and full-text screening. The five included studies were all conducted in SSA. The following themes emerged from the eligible articles: quality assurance on accuracy of REASSURED POC diagnostic tests, sustainability of REASSURED POC diagnostic tests, and local infrastructure capability for delivering REASSURED POC diagnostic tests to end users. All five articles had MMAT scores between 90% and 100%. In conclusion, our scoping review revealed limited published research on REASSURED diagnostics at POC in SSA. We recommend primary studies aimed at investigating the implementation of REASSURED POC diagnostic tests in SSA.

A scoping review protocol on integration of mobile-linked POC diagnostics in community-based healthcare: User experience.

BACKGROUND: Mobile-linked point-of-care diagnostics forms an integral part of diagnostic health services for efficient communication between patients and healthcare professionals despite geographical location and time of diagnosis. The efficiency of this technology lies in the user experience which means that the interaction of the user with the implemented technology needs to be simple, convenient, and consistent. Having a well-structured user experience of these devices in community-based healthcare will aid in sustainable implementation. Herein, we propose to conduct a literature search to systematically map out evidence based on mobile-linked POC diagnostics user experience at a community level in resource-limited settings. METHODOLOGY: The proposed scoping review will be guided by the advanced Arksey and O'Malley methodological framework and further advanced by Levac et al. A comprehensive search will be conducted to find relevant published literature from the following electronic databases: Scopus, Web of Science, EBSCOhost (Medline, CINAHL, Africa-wide, Academic Search Complete). Grey literature will also be searched, including reports from government and international organizations such as World Health Organization (WHO), Foundation for Innovative New Diagnostics (FIND), and the Food and Drug Administration (FDA). Two independent reviewers will screen the relevant studies and the degree of the agreement will be determined by calculating Cohen's kappa statistic. The quality of eligible data will also be appraised using the mixed method appraisal tool version 2018. DISCUSSION: We anticipate that the planned scoping review will present useful evidence to inform stakeholders on the integration of mobile-linked diagnostic devices in community-based healthcare which will guide further research on the subject.

The synergistic effects of coupling Au nanoparticles with an alkynyl Co(II) phthalocyanine on the detection of prostate specific antigen.

Prostate specific antigen (PSA) aptasensors are fabricated using a novel asymmetrically substituted Co phthalocyanine (CoPc), gold nanoparticles (AuNPs) and PSA-specific antigen. The fabricated aptasensors are: GCE-AuNPs-Aptamer, GCE@CoPc-Aptamer and GCE-AuNPs@CoPc-Aptamer (GCE = glassy carbon electrode). The fabricated sensors are characterized at each modification step to monitor the changes occurring at the sensor surface. Concentration studies were carried out using differential pulse voltammetry (DPV) and electrochemical impedance spectroscopy (EIS) to determine detection limits. All the fabricated aptasensors were found to be highly specific and selective but the GCE-AuNPs@CoPc-Aptamer nanoconjugate performed the best. The aptasensors were also tested in spiked serum samples and detection limits, as well as % recoveries were determined. The results obtained showed that the GCE-AuNPs@CoPc-Aptamer has the potential to be used for clinical studies as the results agree with those obtained for detection of PSA in buffer.

The electrochemical detection of prostate specific antigen on glassy carbon electrode modified with combinations of graphene quantum dots, cobalt phthalocyanine and an aptamer.

Herein, a novel aptasensor is developed for the electrochemical detection of prostate specific antigen (PSA) on electrode surfaces modified using various combinations of a Cobalt phthalocyanine (CoPc), an aptamer and graphene quantum dots (GQDs). Electrochemical impedance spectroscopy (EIS) as well as differential pulse voltammetry (DPV) are employed for the detection of PSA. In both analytical techniques, linear calibration curves were observed at a concentration range of 1.2-2.0 pM. The glassy carbon electrode where CoPc and GQDs are placed on the electrode when non-covalently linked followed by addition of the aptamer (GQDs-CoPc(ππ)-aptamer (sequential)) showed the best performance with a limit of detection (LoD) as low as 0.66 pM when using DPV. The detection limits were much lower than the dangerous levels reported for PSA in males tested for prostate cancer. This electrode showed selectivity for PSA in the presence of bovine serum albumin, glucose and L-cysteine. The aptasensor showed good stability, reproducibility and repeatability, deeming it a promising early detection device for prostate cancer.

Characterization of phthalocyanine functionalized quantum dots by dynamic light scattering, laser Doppler, and capillary electrophoresis.

In this work, we characterized different phtalocyanine-capped core/shell/shell quantum dots (QDs) in terms of stability, ζ-potential, and size at various pH and ionic strengths, by means of capillary electrophoresis (CE), and compared these results to the ones obtained by laser Doppler electrophoresis (LDE) and dynamic light scattering (DLS). The effect of the phthalocyanine metallic center (Zn, Al, or In), the number (one or four), and nature of substituents (carboxyphenoxy- or sulfonated-) of functionalization on the phthalocyanine physicochemical properties were evaluated. Whereas QDs capped with zinc mono-carboxyphenoxy-phtalocyanine (ZnMCPPc-QDs) remained aggregated in the whole analyzed pH range, even at low ionic strength, QDs capped with zinc tetracarboxyphenoxy phtalocyanine (ZnTPPc-QDs) were easily dispersed in buffers at pH equal to or higher than 7.4. QDs capped with aluminum tetrasulfonated phthalocyanine (AlTSPPc-QDs) and indium tetracarboxyphenoxy phthalocyanines (InTCPPc-QDs) were stable in aqueous suspension only at pH higher than 9.0 due to the presence of functional groups bound to the metallic center of the phthalocyanine. The ζ-potential values determined by CE for all the samples decreased when ionic strength increased, being well correlated with the aggregation of the nanoconjugates at elevated salt concentrations. The use of electrokinetic methodologies has provided insights into the colloidal stability of the photosensitizer-functionalized QDs in physiological relevant solutions and thereby, its usefulness for improving their design and applications for photodynamic therapy. Graphical Abstract Schematic illustration of the phthalocyanine capped QDs nanoconjugates and the capillary electrophoresis methods applied for size and ζ-potential characterization.