Accuracy of self-collected versus healthcare worker collected specimens for diagnosing sexually transmitted infections in females: an updated systematic review and meta-analysis.

The use of self-collected specimens as an alternative to healthcare worker-collected specimens for diagnostic testing has gained increasing attention in recent years. This systematic review aimed to assess the diagnostic accuracy of self-collected specimens compared to healthcare worker-collected specimens across different sexually transmitted infections (STIs) including Chlamydia trachomatis (CT), human papillomavirus (HPV), Mycoplasma genitalium (MG), Neisseria gonorrhoea (NG), Treponema pallidum and Trichomonas vaginalis (TV) in females. A rigorous process was followed to screen for studies in various electronic databases. The quality of included studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. There were no studies on syphilis that met the criteria for inclusion in the review. A total of six studies for chlamydia, five studies for HPV, four studies for MG, and seven studies for gonorrhoea and trichomoniasis were included in the review. However, not all studies were included in the sub-group meta-analysis. The analysis revealed that self-collected specimens demonstrated comparable diagnostic accuracy to healthcare worker-collected specimens across most STIs. This indicates that the diagnostic accuracy of self-collected specimens can provide accurate results and enhance access to diagnostic testing, potentially improving healthcare service delivery. Future research should further explore the diagnostic accuracy of self-collected specimens in larger and more diverse populations.

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.

Impact of COVID-19 on TB diagnostic services at primary healthcare clinics in eThekwini district, South Africa.

We assessed the impact of the pandemic on TB diagnostics at primary healthcare clinics (PHCs) during the different stages of COVID-19 in eThekwini district, South Africa. Data from the District Health Information System (DHIS) were used to conduct an interrupted time series analysis that assessed the changes in TB investigations and confirmed TB cases during four pandemic periods: lockdown and the subsequent three peaks of infection compared to the two years prior (2018-2022). The initial lockdown resulted in - 45% (95% CI - 55 to - 31) and - 40% (95% CI - 59 to - 28) immediate declines in TB investigations and confirmed cases, respectively. Both indicators showed substantial recovery in the months after the first wave (p < 0.05). However, while TB investigations sustained smaller declines throughout the pandemic, they rebounded and surpassed pre-COVID-19 levels by the end of the investigation period. On the other hand, confirmed cases experienced reductions that persisted until the end of the investigation period. TB diagnostic services at PHCs were considerably disrupted by COVID-19, with the confirmation of cases being the most adversely affected throughout the pandemic. The reasons for these persistent declines in TB detection must be determined to inform the development of sustainable diagnostic systems that are capable of withstanding future pandemics.

Towards development of a novel approach for enhancement of TB diagnostic services during the pandemic: A case of primary health care clinics in eThekwini district KwaZulu-Natal: A study protocol.

INTRODUCTION: The COVID-19 pandemic has greatly impacted TB diagnostic services in high TB burden settings. This has caused cases to go undetected and increased the number of TB deaths in 2020. Renewed efforts to improve the resilience of TB services during pandemics are required. Therefore, the current study aims to propose a novel approach for conducting TB diagnostic services in high burden settings during the pandemic. METHODS/DESIGN: The proposed study will be conducted in three phases. During the first phase, a geospatial analysis to assess the geographic accessibility of TB diagnostic services will be conducted. In the second phase, the effect of COVID-19 on TB diagnostic services will be determined using an interrupted time series analysis. During the third phase, the barriers and enablers of TB diagnostic services will be explored using patient interviews and a vertical audit. The fourth phase of the study will be guided by the outcomes of the previous three phases where a nominal group technique with key stakeholders will be conducted to propose a novel means for conducting TB diagnostic services during the pandemic. The data of the study will be analyzed using the latest version of ArcGIS, Stata software. DISCUSSION: The study has received full ethical approval from ethics committees. The results together with input from relevant TB stakeholders will be used to develop a new approach to conducting TB diagnostic services at Primary healthcare clinics.

Mapping Evidence of Self-Sampling to Diagnose Sexually Transmitted Infections in Women: A Scoping Review.

BACKGROUND: Sexually transmitted infections (STIs) are a major global healthcare burden, disproportionately affecting women. Self-sampling interventions for diagnostic purposes have the potential to improve STI healthcare management and expand STI services. However, there is currently no published evidence of the global use of self-sampling interventions to diagnose STIs in women. The main aim of this scoping review was to map evidence on the use of self-sampling interventions to diagnose STIs in women. METHODOLOGY: The methodology of this scoping review was guided by Arksey and O'Malley and Levac. A comprehensive literature search was conducted in PubMed, Scopus, Web of Science, Medline (EBSCO), ProQuest, and Cochrane. For grey literature, a search was conducted in Open Grey, World Health Organization, Google, and conference proceedings and dissertations. All search results were screened and assessed for eligibility. Thereafter data from eligible studies was extracted and analysed. The quality of these studies was appraised using the Mixed Methods Appraisal Tool 2018 version. RESULTS: A total of 770 articles were retrieved from databases and grey literature sources. A total of 44 studies were eligible for data extraction following title, abstract and full-text screening. Of the included studies, 63% presented evidence of research conducted in high-income countries and 37% presented evidence in low- and middle-income countries. Studies presented evidence on the following: feasibility of self-sampling in remote areas; acceptance and ease of use of self-sampling interventions; types of self-sampled specimens; pooled samples for diagnosing STIs; laboratory diagnostic assays for STI using self-sampled specimens; and self-testing of self-sampled specimens. CONCLUSIONS: Self-sampling interventions are feasible and easy to use and, therefore, can improve STI management and treatment in women across various age groups and various access levels to good-quality healthcare. Despite this, there is a lack of evidence of self-sampling interventions designed according to user preferences. We recommend studies to collaborate with women to co-develop user-friendly self-sampling interventions to diagnose STIs in women.

Evidence of TB Services at Primary Healthcare Level during COVID-19: A Scoping Review.

Tuberculosis (TB) is still a major public health concern, despite the availability of preventative and curative therapies. Significant progress has been made in the past decade towards its control. However, the emergence of the novel coronavirus disease 2019 (COVID-19) has disrupted numerous essential health services, including those for TB. This scoping review maps the available evidence on TB services at the primary healthcare (PHC) level during the COVID-19 period. A comprehensive literature search was conducted in PubMed, Web of Science, Medline OVID, Medline EBSCO, and Scopus. A total of 820 articles were retrieved from the databases and 21 met the eligibility criteria and were used for data extraction. The emerging themes were the effect of the COVID-19 pandemic on TB services, patient and provider experiences, recommendations for TB services during the COVID-19 period, and the implementation of the recommendations. The review found that the mitigation strategies, as well as fear and stigma experienced at the start of the COVID-19 pandemic may have led to TB cases potentially going undetected, which may threaten TB treatment outcomes. Therefore, efforts must be directed at finding these missing cases and ensuring that PHC facilities are equipped to adequately diagnose and treat them.

A Scoping Review of Supply Chain Management Systems for Point of Care Diagnostic Services: Optimising COVID-19 Testing Capacity in Resource-Limited Settings.

BACKGROUND: Point of care (POC) testing has enabled rapid coronavirus disease 2019 (COVID-19) diagnosis in resource-limited settings with limited laboratory infrastructure and high disease burden. However, the accessibility of the tests is not optimal in these settings. This scoping review mapped evidence on supply chain management (SCM) systems for POC diagnostic services to reveal evidence that can help guide future research and inform the improved implementation of SARS-CoV-2 POC diagnostics in resource-limited settings. METHODOLOGY: This scoping review was guided by an adapted version of the Arksey and O'Malley methodological framework. We searched the following electronic databases: Medline Ovid, Medline EBSCO, Scopus, PubMed, PsychInfo, Web of Science and EBSCOHost. We also searched grey literature in the form of dissertations/theses, conference proceedings, websites of international organisations such as the World Health Organisation and government reports. A search summary table was used to test the efficacy of the search strategy. The quality of the included studies was appraised using the mixed method appraisal tool (MMAT) version 2018. RESULTS: We retrieved 1206 articles (databases n = 1192, grey literature n = 14). Of these, 31 articles were included following abstract and full-text screening. Fifteen were primary studies conducted in LMICs, and 16 were reviews. The following themes emerged from the included articles: availability and accessibility of POC diagnostic services; reasons for stockouts of POC diagnostic tests (procurement, storage, distribution, inventory management and quality assurance) and human resources capacity in POC diagnostic services. Of the 31 eligible articles, 15 underwent methodological quality appraisal with scores between 90% and 100%. CONCLUSIONS: Our findings revealed limited published research on SCM systems for POC diagnostic services globally. We recommend primary studies aimed at investigating the barriers and enablers of SCM systems for POC diagnostic services for highly infectious pathogens such SARS-CoV-2 in high disease-burdened settings with limited laboratory infrastructures.