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| Tests included in the WHO essential diagnostics list at the primary care level. HbA1c, glycated hemoglobin; HBeAg, hepatitis B e-antigen; HBsAg, hepatitis B surface antigen; HIV, human immunodeficiency virus; LAMP, loop-mediated isothermal amplification; RDT, rapid diagnostic test.
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Good primary care is an essential precondition for a decent healthcare system. In fact, primary health care is at the heart of Universal Health Coverage (UHC). UHC, in turn, is critical to achieve the sustainable development goals. While access to essential medicines is explicit in UHC, access to essential diagnostics has received little attention....
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Citations
... .. . ..", [52] since diagnostic services are an essential ingredient of the UHC target [53]. Research from developing countries has shown a strong association between the scope of services provided in PHC facilities and the acceptability of the services offered [13,54]. ...
Accurate disease diagnosis relies on a well-organized and reliable laboratory system. This study assesses the quality of laboratory services in Tanzania based on the nationwide Star Rating Assessment (SRA) of Primary Healthcare (PHC) facilities conducted in 2017/18. This cross-sectional study utilized secondary data from all the country’s PHC facilities stored in the SRA database. Laboratory service quality was assessed by aggregating scores as percentages of the maximum achievable score across various indicators: dedicated laboratory department/room, adequate equipment, staffing levels, adherence to testing protocols, establishment of turnaround times, internal and external quality controls, and safety and supplies management. Scores equal to or exceeding 80% were deemed compliant. Multiple linear regression was used to determine the influence of facility characteristics (level, ownership, location, staffing) on quality scores, with statistical significance set at p < 0.05. The study included 6,663 PHC facilities (85.9% dispensaries, 11% health centers, 3.2% hospital-level-1), with the majority being public (82.3% vs. 17.7%) and located in rural areas (77.1% vs. 22.9%). On average, facilities scored 30.8% (SD = 35.7), and only 26.6% met staffing requirements. Compliance with quality standards was higher in private (63% vs. 19%, p<0.001) and urban facilities (62% vs. 16%, p<0.001). More than half of the facilities did not meet either of the eight quality indicators. Quality was positively linked to staffing compliance (Beta = 5.770) but negatively impacted by dispensaries (Beta = -6.342), rural locations (Beta = -0.945), and public ownership (Beta = -1.459). A score of 30% falls significantly short of the national target of 80%. Improving laboratory staffing levels at PHC facilities could improve the quality of laboratory services, especially in public facilities that are based in rural areas. There is a need to further strengthen laboratory services in PHC facilities to ensure the quality of laboratory services and clients’ satisfaction.
... The presence of a prevention doctor in the company involved the occupational health and safety of employees that can be regularly monitored and addressed. Doctors and psychologists should ensure both managers and staff that are aware of their mission and services, as well as the problems associated with occupational health (stress, psychosocial risks, exposure to noise, etc.) by hosting conferences and specific training [20][21][22][23]. With regard to employees' attitudes toward consulting doctors, 30% of employees in this company did not have regular consultations with the doctor, while 70% visited the doctor on a daily basis. ...
... One sign of progress was the publication of the first Essential Diagnostic List (EDL) by the WHO in 2018, nearly 45 years after the first essential medicines list was released. The EDL identifies the basic in vitro diagnostics that should be available at the point of care and in laboratories, with the aim of assisting governments to develop their own national lists and providing guidance to developers on diagnostic demand [5,6]. ...
This article assesses the availability of essential diagnostic tests in primary health care facilities in two districts in Sierra Leone. In addition to evaluating whether a test is physically present at a facility, it extends the concept of availability to include whether equipment is functional and whether infrastructure, systems, personnel and resources are in place to allow a particular test to be “ready to hand”, that is, available for immediate use when needed. Between February 2019 and September 2019, a cross-sectional mixed-methods survey was conducted in all 40 Community Health Centres (CHCs) in Western Area, one of five principal divisions in Sierra Leone. The number of rapid diagnostic tests (RDTs) available ranged from 1–12, with 75% of facilities having 9 or less RDTs available out of a possible 17. While RDTs were overall more widely present than manual assays, there was wide variation between tests. The presence of RDTs at individual facilities was associated with having a permanent laboratory technician on staff. Despite CHCs being formally designated as providing laboratory services, no CHC fulfilled standard World Health Organisation (WHO) criteria for a laboratory. Only 9/40 (22.5%) CHCs had a designated laboratory space and a permanently employed laboratory technician. There was low availability of essential equipment and infrastructure. Supply chains were fragmented and unreliable, including a high dependency (>50%) on informal private sources for the majority of the available RDTs, consumables, and reagents. We conclude that the readiness of diagnostic services, including RDTs, depends on the presence and functionality of essential infrastructure, human resources, equipment and systems and that RDTs are not on their own a solution to infrastructural failings. Efforts to strengthen laboratory systems at the primary care level should take a holistic approach and focus on whether tests are “ready-to-hand” in addition to whether they are physically present.
... It paves the way toward improved healthcare delivery and ultimately better patient outcomes by promoting greater equitable access to quality and affordable diagnostics at all levels of the healthcare delivery system [16]. Countries need to adopt and develop national lists that suit their national or regional needs, disease burdens, and health system capacities to ensure their impact on healthcare practice and patient outcomes [2,5,17]. To date, the WHO has published three EDL model lists [14,18,19]. ...
The World Health Organization (WHO) model list of Essential In vitro Diagnostic (EDL) introduced in 2018 complements the established Essential Medicines List (EML) and improves its impact on advancing universal health coverage and better health outcomes. We conducted a scoping review of the literature on implementing the WHO essential lists in Africa to inform the implementation of the recently introduced EDL. We searched eight electronic databases for studies reporting on implementing the WHO EDL and EML in Africa. Two authors independently conducted study selection and data extraction, with disagreements resolved through discussion. We used the Supporting the Use of Research Evidence (SURE) framework to extract themes and synthesised findings using thematic content analysis. We used the Mixed Method Appraisal Tool (MMAT) version 2018 to assess the quality of included studies. We included 172 studies reporting on EDL and EML after screening 3,813 articles titles and abstracts and 1,545 full-text papers. Most (75%, n = 129) studies were purely quantitative in design, comprising descriptive cross-sectional designs (60%, n = 104), 15% (n = 26) were purely qualitative, and 10% (n = 17) had mixed-methods approaches. There were no qualitative or randomised experimental studies about EDL. The main barrier facing the EML and EDL was poorly equipped health facilities—including unavailability or stock-outs of essential in vitro diagnostics and medicines. Financial and non-financial incentives to health facilities and workers were key enablers in implementing the EML; however, their impact differed from one context to another. Only fifty-six (33%) of the included studies were of high quality. Poorly equipped and stocked health facilities remain an implementation barrier to essential diagnostics and medicines. Health system interventions such as financial and non-financial incentives to improve their availability can be applied in different contexts. More implementation study designs, such as experimental and qualitative studies, are required to evaluate the effectiveness of essential lists.
... A major component in achieving this goal is to consider access to diagnostic services. Indeed, essential diagnostics are the first step towards accessing appropriate care, influencing 70% of health decisions [2]. By prescribing the appropriate treatment, diagnostics help reduce excessive drug use, thereby reducing the emergence of antimicrobial resistance and also minimizing financial losses. ...
... By prescribing the appropriate treatment, diagnostics help reduce excessive drug use, thereby reducing the emergence of antimicrobial resistance and also minimizing financial losses. In addition, they are essential for the early detection of diseases, enabling the monitoring and control of the spread and emergence of infectious diseases [2,3]. A recent study [4] on 10 low-and middle-income countries (LMICs) showed that major gaps in diagnostic availability exist in some of these countries, particularly at the primary care level. ...
Diagnostic networks are complex systems that include both laboratory-tested and community-based diagnostics, as well as a specimen referral system that links health tiers. Since diagnostics are the first step before accessing appropriate care, diagnostic network optimization (DNO) is crucial to improving the overall healthcare system. The aim of our review was to understand whether the field of DNO, and especially route optimization, has benefited from the recent advances in geospatial modeling, and notably physical accessibility modeling, that have been used in numerous health systems assessment and strengthening studies. All publications published in English between the journal’s inception and 12 August 2021 that dealt with DNO, geographical accessibility and optimization, were systematically searched for in Web of Science and PubMed, this search was complemented by a snowball search. Studies from any country were considered. Seven relevant publications were selected and charted, with a variety of geospatial approaches used for optimization. This paucity of publications calls for exploring the linkage of DNO procedures with realistic accessibility modeling framework. The potential benefits could be notably better-informed travel times of either the specimens or population, better estimates of the demand for diagnostics through realistic population catchments, and innovative ways of considering disease epidemiology to inform DNO.
... 73,74 The EDL will translate to real access to the tests contained only when country governments adopt it, adapt it to the prevailing local disease prevalence, and implement it. 75 To date, only India has developed a national EDL, while a few other countries such as Nigeria, Bangladesh, and Pakistan have begun work with WHO to develop their national EDLs. 76 It is imperative that more African countries follow suit. ...
Invasive fungal infections (IFIs) such as cryptococcosis, disseminated histoplasmosis, and chronic pulmonary aspergillosis are significant causes of morbidity and mortality in Africa. Lack of laboratory infrastructure and laboratory personnel trained in diagnostic mycology hamper prompt detection and management of IFIs on the continent. Point-of-care tests (POCT) obviate the need for complex infrastructure, skilled technicians, and stable electricity and have had major impacts on the diagnosis of bacterial, viral, and parasitic infections in low- and middle-income countries. Over the last 10 years, POCTs for IFIs have become increasingly available and they have the potential to revolutionize the management of these infections if scaled up in Africa. At the beginning of 2021, the World Health Organization (WHO) Essential Diagnostic List (EDL) included a cryptococcal antigen test for the diagnosis of cryptococcosis, Histoplasma antigen test for the diagnosis of disseminated histoplasmosis, and Aspergillus-specific test for the diagnosis of chronic pulmonary aspergillosis. All of these are available in formats that may be used as POCTs and it is hoped that this will improve the diagnosis of these life-threatening IFIs, especially in low- and middle-income countries. This perspective review discusses commercially available POCTs and outlines strategies of a blueprint to achieve their roll-out in Africa. The strategies include raising awareness, conducting research that uncovers the exact burden of IFIs, increasing advocacy, integrating diagnosis of IFIs into existing public health programs, adoption of the WHO EDL at country levels, and improving logistics and supply chains.
... Another study was a pilot in India, which focused on the availability, in primary health centers, of tests on the first version of the WHO EDL (30). Overall, the availability of EDL tests in India was quite variable across 3 districts. ...
Background
We determined the availability and pricing of laboratory testing in the Northern Region of Ghana to identify current gaps with respect to the WHO's Essential Diagnostics List (EDL).
Methods
A representative sample of facilities offering diagnostic testing within the Northern Region was geographically mapped and evaluated, with random sampling stratified by population density. Data were collected on testing menus, volumes, turn-around times, and out-of-pocket test prices. A total of 27 health centers and 39 clinical laboratories were surveyed between June and August 2019.
Results
Health centers offered a median of 2 of 20 tests recommended by the WHO for facilities without laboratories. The most common tests offered included point-of-care tests for malaria, HIV, and pregnancy. Clinical laboratories offered a median of 11 of 72 tests on the EDL. These facilities most commonly provided testing for malaria, HIV, pregnancy, HBsAg, urinalysis, HCV Ab, syphilis, glucose, and CBC. Urban laboratories had a total of 36 EDL tests available while rural laboratories had 12. Test prices were higher in private compared to public laboratories. National Health Insurance reimbursements were lower than out-of-pocket prices (38%), and when controlling for test price, test availability was negatively associated with this gap in reimbursement.
Conclusions
Availability of diagnostic testing in Ghana’s Northern Region is severely limited compared to the WHO's EDL. The disparity is pronounced in rural facilities. Reimbursement rates should be reset to more closely match out-of-pocket test prices in order to achieve the Universal Health Coverage target of the Sustainable Development Goals.
... Diagnosis is the first critical step to offer quality healthcare and to contain emergencies. Although the WHO essential diagnostic lists (EDL) is a critical step in the right direction, the impact of the EDL will be enhanced when countries adopt the EDL to their own national needs and put in place mechanisms to implement the EDL [26]. WHO published the first EDL in May 2018 [27], it defines essential diagnostics as those that satisfy the priority health care needs of the population and are selected with due regard to disease prevalence and public health relevance. ...
Introduction:
Laboratory services are crucial parts of the health system having a great contribution to disease prevention and management. The importance of accurate and reliable laboratory test results is less recognized in developing countries like Ethiopia where most medical decisions are based on clinical judgment. It is time for countries like Ethiopia to not only increase health care coverage but also improve access to essential diagnostic tests. Hence, this proposed study aims to assess essential in-vitro laboratory service provision in accordance with the WHO standards in Guragae Zone primary health care unit level, South Ethiopia.
Methods:
Health institution-based cross-sectional study was carried out. 30% randomly selected primary health care units were recruited. Each facility was visited with a WHO checklist by a trained data collector to assess the availability of essential diagnostics service provision. The proportion of available in-vitro diagnostics services was calculated. Results were presented as percentages in tables and figures.
Result:
Twenty-one primary health care facilities located in Guragae Zone were assessed between May and July 2019. All surveyed facilities had major gaps in essential test availability. Among essential diagnostic tests listed with WHO like C-reactive protein, lipid profile, Amylase and Lipase, TroponinT/I, hepatitis B e-antigen, IgM-specific antibodies to hepatitis B core antigen, Glucose-6-phosphate dehydrogenase activity, and anti-HIV/p24 rapid test were not provided in any facilities. However, essential diagnostic services like urine dipstick testing, random blood sugar, smear microscopy, and few serological tests were provided at all primary health care units. All surveyed facilities had limited major laboratory equipment and consumables.
Conclusion and recommendation:
The present study shows limited access to essential laboratory tests at the primary health care level. Hence, the responsible body should invest to make essential tests accessible at the primary care unit level within the framework of universal health coverage in the study area. The fact that access to essential diagnostic tests is the first key step in improving quality of care; such study has its own efforts to enable the implementation of essential diagnostic lists, and improve access to diagnostics in the country.
... A heavy reliance on outdated diagnostic technologies also contributes to misdiagnoses: many countries continue to rely on often inaccurate smear microscopy [20,21]. In turn, health systems must ensure patient safety, appropriate prevention and detection, case notification, timely treatment, and continuous and integrated of care. ...
In this article, we describe the framework of the Lancet Global Health Commission on High Quality Health Systems, propose new and undermeasured indicators of TB care quality, and discuss implications of the Commission's key conclusions for measuring and improving the quality of TB care services. The Commission contends that measurement of quality should focus on the processes of care and their impacts. In addition to monitoring treatment coverage and the availability of tools, governments should consider indicators of clinical competence (for e.g. ability of providers to correctly diagnose TB and adhere to treatment guidelines), of timely, continuous and integrated care and of respectful and patient-centered care. Indicators of impact include TB mortality and treatment success rates, but also quality of life and daily functioning among TB patients, public trust in TB services, and bypassing of the formal health system for TB care. Cascades of care, from initial care seeking to recurrence-free survival, should be built in every high-burden country to monitor quality longitudinally. In turn, improvement efforts should target the foundations of health systems and consider the Commission's four universal actions: governing for quality, redesigning service delivery, transforming the health workforce and igniting demand for quality TB services. Important work remains to validate new indicators of TB care quality, develop data collection systems for new measures, and to test new strategies for improving the delivery of competent and respectful TB care. Keywords: Developing countries, Health systems, Quality, Measurement, Monitoring, Improvement
Objective To assess material usage in commercial lateral flow assay kits and determine baselines for quantitative material requirements in target product profiles for new tests.
Methods We collected and weighted the components of 21 different commercial COVID-19 lateral flow test kits, with emergency use authorisations from the UK MHRA, EU, the US FDA, and the WHO EUL. We took test kits apart manually, classified components and weighted them individually.
Findings Large variations in the total average weights of COVID-19 LFA cassette test kits were observed from 13 g per test to 84 g. The average weight of standard LFA housing in the sample is 4.1 g per casing (range 2.47 g - 6.54 g) whilst the outer packaging makes up between 25% and over 88% of the whole kit and was found to be a large source of weight variations, followed by instructions and LFA housing types.
Conclusion The contribution of LFA tests to global plastic pollution is set to grow year-on-year due to increasingly decentralised testing. Wide variation in the weight of components included in existing COVID-19 test kits suggests there is scope for manufacturers to reduce the amount of materials, including plastic, in test products. We propose that a quantitative baseline of material usage is introduced in future target product profiles for LFA format test kits. This would limit the number of products with a large volume of plastic from reaching the market and reduce the burden of plastic waste from diagnostic testing on local waste management systems.
