RESUMO
Dating to the discovery of the Lupus Erythematosus (LE) cell in 1948, there has been a dramatic growth in the discovery of unique autoantibodies and their cognate targets, all of which has led to the availability and use of autoantibody testing for a broad spectrum of autoimmune diseases. Most studies of the sensitivity, specificity, commutability, and harmonization of autoantibody testing have focused on widely available, commercially developed and agency-certified autoantibody kits. However, this is only a small part of the spectrum of autoantibody tests that are provided through laboratories world-wide. This manuscript will review the wider spectrum of testing by exploring the innovation pathway that begins with autoantibody discovery followed by assessment of clinical relevance, accuracy, validation, and then consideration of regulatory requirements as an approved diagnostic test. Some tests are offered as "Research Use Only (RUO)", some as "Laboratory Developed Tests (LDT)", some enter Health Technology Assessment (HTA) pathways, while others are relegated to a "death valley" of autoantibody discovery and become "orphan" autoantibodies. Those that achieve regulatory approval are further threatened by the business world's "Darwinian Sea of Survival". As one example of the trappings of autoantibody progression or failure, it is reported that more than 200 different autoantibodies have been described in systemic lupus erythematosus (SLE), a small handful (~10%) of these have achieved regulatory approval and are widely available as commercial diagnostic kits, while a few others may be available as RUO or LDT assays. However, the vast majority (90%) are orphaned and languish in an autoantibody 'death valley'. This review proposes that it is important to keep an inventory of these "orphan autoantibodies" in 'death valley' because, with the increasing availability of multi-analyte arrays and artificial intelligence (MAAI), some can be rescued to achieve a useful role in clinical diagnostic especially in light of patient stratification and precision medicine.
Assuntos
Autoanticorpos/imunologia , Biomarcadores , Testes Diagnósticos de Rotina , Imunoensaio , Doenças Autoimunes/diagnóstico , Doenças Autoimunes/etiologia , Aprovação de Teste para Diagnóstico , Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Testes Diagnósticos de Rotina/tendências , Humanos , Imunoensaio/métodos , Imunoensaio/normas , Imunoensaio/tendências , Pesquisa Translacional BiomédicaRESUMO
While genetics evaluation is increasingly utilized in adult neurology patients, its usage and efficacy are not well characterized. Here, we report our experience with 1461 consecutive patients evaluated in an adult neurogenetics clinic at a large academic medical center between January 2015 and March 2020. Of the 1461 patients evaluated, 1215 patients were referred for the purposes of identifying a genetic diagnosis for an undiagnosed condition, 90.5% of whom underwent genetic testing. The modalities of genetic testing utilized varied across referral diagnostic categories, including a range of utilization of whole exome sequencing (WES) as an initial test in 13.9% of neuromuscular patients to 52.9% in white matter disorder patients. The usage of WES increased over time, from 7.7% of initial testing in 2015 to a peak of 27.3% in 2019. Overall, genetic testing yielded a causal genetic diagnosis in 30.7% of patients. This yield was higher in certain referring diagnosis categories, such as neuromuscular (39.0%) and epilepsy (29.8%). Our study demonstrates that evaluation at an adult neurogenetics referral center can yield diagnoses in a substantial fraction of patients. Additional research will be needed to determine optimal genetic testing strategies and cost effectiveness of adult neurogenetics evaluation.
Assuntos
Testes Genéticos/tendências , Doenças do Sistema Nervoso/diagnóstico , Adulto , Análise Custo-Benefício , Testes Diagnósticos de Rotina/tendências , Exoma/genética , Feminino , Humanos , Masculino , Doenças do Sistema Nervoso/genética , Doenças do Sistema Nervoso/patologia , Sequenciamento do ExomaRESUMO
CONTEXT.: Coronavirus disease 2019 (COVID-19) changed the dynamics of health care delivery, shifting patient priorities and deferring care perceived as less urgent. Delayed or eliminated care may place patients at risk for adverse outcomes. OBJECTIVE.: To identify opportunities for laboratory test stewardship to close potential gaps in care created by the COVID-19 pandemic. DESIGN.: The study was a retrospective time series design examining laboratory services received before and during the COVID-19 pandemic at a large metropolitan health system serving women and children. RESULTS.: Laboratory test volumes displayed 3 distinct patterns: (1) a decrease during state lockdown, followed by near-complete or complete recovery; (2) no change; and (3) a persistent decrease. Tests that diagnose or monitor chronic illness recovered only partially. For example, hemoglobin A1c initially declined 80% (from 2232 for April 2019 to 452 for April 2020), and there was a sustained 16% drop (28-day daily average 117 at August 30, 2019, to 98 at August 30, 2020) 4 months later. Blood lead dropped 39% (from 2158 for April 2019 to 1314 for April 2020) and remained 23% lower after 4 months. CONCLUSIONS.: The pandemic has taken a toll on patients, practitioners, and health systems. Laboratory professionals have access to data that can provide insight into clinical practice and identify pandemic-related gaps in care. During the pandemic, the biggest patient threat is underuse, particularly among tests to manage chronic diseases and for traditionally underserved communities and people of color. A laboratory stewardship program, focused on peri-pandemic care, positions pathologists and other laboratory professionals as health care leaders with a commitment to appropriate, equitable, and efficient care.
Assuntos
COVID-19/prevenção & controle , Serviços de Laboratório Clínico/tendências , Testes Diagnósticos de Rotina/tendências , Alocação de Recursos para a Atenção à Saúde/tendências , Acessibilidade aos Serviços de Saúde/tendências , COVID-19/diagnóstico , Serviços de Laboratório Clínico/organização & administração , Alocação de Recursos para a Atenção à Saúde/organização & administração , Política de Saúde , Acessibilidade aos Serviços de Saúde/organização & administração , Humanos , Estudos Retrospectivos , TexasRESUMO
Importance: Low-value care, defined as care offering no net benefit in specific clinical scenarios, is associated with harmful outcomes in patients and wasteful spending. Despite a national education campaign and increasing attention on reducing health care waste, recent trends in low-value care delivery remain unknown. Objective: To assess national trends in low-value care use and spending. Design, Setting, and Participants: In this cross-sectional study, analyses of low-value care use and spending from 2014 to 2018 were conducted using 100% Medicare fee-for-service enrollment and claims data. Included individuals were aged 65 years or older and continuously enrolled in Medicare parts A, B, and D during each measurement year and the previous year. Data were analyzed from September 2019 through December 2020. Exposure: Being enrolled in fee-for-service Medicare for a period of time, in years. Main Outcomes and Measures: The Milliman MedInsight Health Waste Calculator was used to assess 32 claims-based measures of low-value care associated with Choosing Wisely recommendations and other professional guidelines. The calculator designates services as wasteful, likely wasteful, or not wasteful based on an absence of indication of appropriate use in the claims history; calculator-designated wasteful services were defined as low-value care. Spending was calculated as claim-line level (ie, spending on the low-value service) and claim level (ie, spending on the low-value service plus associated services), adjusting for inflation. Results: Among 21â¯045â¯759 individuals with fee-for-service Medicare (mean [SD] age, 77.4 [7.9] years; 12â¯515â¯915 [59.5%] women), the percentage receiving any of 32 low-value services decreased from 36.3% (95% CI, 36.3%-36.4%) to 33.6% (95% CI, 33.6%-33.6%) from 2014 to 2018. Uses of low-value services per 1000 individuals decreased from 677.8 (95% CI, 676.2-679.5) to 632.7 (95% CI, 632.6-632.8) from 2014 to 2018. Three services comprised approximately two-thirds of uses among 32 low-value services per 1000 individuals: preoperative laboratory testing decreased from 213.8 (95% CI, 213.4-214.2) to 166.2 (95% CI, 166.2-166.2), while opioids for back pain increased from 154.4 (95% CI, 153.6-155.2) to 182.1 (95% CI, 182.1-182.1) and antibiotics for upper respiratory infections increased from 75.0 (95% CI, 75.0-75.1) to 82 (95% CI, 82.0-82.0). Spending per 1000 individuals on low-value care also decreased, from $52 765.5 (95% CI, $51â¯952.3-$53â¯578.6) to $46â¯921.7 (95% CI, $46â¯593.7-$47â¯249.7) at the claim-line level and from $160â¯070.4 (95% CI, $158â¯999.8-$161â¯141.0) to $144â¯741.1 (95% CI, $144â¯287.5-$145â¯194.7) at the claim level. Conclusions and Relevance: This cross-sectional study found that among individuals with fee-for-service Medicare receiving any of 32 measured services, low-value care use and spending decreased marginally from 2014 to 2018, despite a national education campaign in collaboration with clinician specialty societies and increased attention on low-value care. While most use of low-value care came from 3 services, 1 of these was opioid prescriptions, which increased over time despite the harms associated with their use. These findings may represent several opportunities to prevent patient harm and lower spending.
Assuntos
Planos de Pagamento por Serviço Prestado , Gastos em Saúde/tendências , Serviços de Saúde/tendências , Medicare , Idoso , Idoso de 80 Anos ou mais , Analgésicos Opioides/uso terapêutico , Antibacterianos/uso terapêutico , Dor nas Costas/tratamento farmacológico , Testes Diagnósticos de Rotina/tendências , Feminino , Humanos , Masculino , Cuidados Pré-Operatórios/tendências , Infecções Respiratórias/tratamento farmacológico , Estados UnidosRESUMO
Soil-transmitted helminths (STHs) affect more than 1.5 billion people. The global strategy to control STH infections requires periodic mass drug administration (MDA) based on prevalence among populations at risk determined by diagnostic testing. Widely used copromicroscopy methods to detect infection, however, have low sensitivity as the prevalence and intensity of STH infections decline with repeated MDA. More sensitive diagnostic tools are needed to inform program decision-making. Using an integrated product development process, PATH conducted qualitative and quantitative formative research to inform the design and development of a more sensitive test for STH infections. The research, grounded in a conceptual framework for ensuring access to health products, involved stakeholder analysis, key opinion leader interviews, observational site visits of ongoing STH surveillance programs, and market research including market sizing, costing and willingness-to-pay analyses. Stakeholder analysis identified key groups and proposed strategic engagement of stakeholders during product development. Interviews highlighted features, motivations and concerns that are important for guiding design and implementation of new STH diagnostics. Process mapping outlined current STH surveillance workflows in Kenya and the Philippines. Market sizing in 2016 was estimated around half a million tests for lower STH burden countries, and 1-2 million tests for higher STH burden countries. The cost of commodities per patient for a molecular STH diagnostic may be around $10, 3-4 times higher than copromicroscopy methods, though savings may be possible in time and staffing requirements. The market is highly price sensitive as even at $5 per test, only 27% of respondents thought the test would be used by surveillance programs. A largely subsidized STH control strategy and a semi-functional Kato-Katz test may have created few incentives for manufacturers to innovate in STH diagnostics. Diverse partnerships, as well as balancing needs and expectations for new STH diagnostics are necessary to ensure access to needed products.
Assuntos
Testes Diagnósticos de Rotina/tendências , Helmintíase/diagnóstico , Animais , Pesquisa Biomédica/economia , Pesquisa Biomédica/tendências , Testes Diagnósticos de Rotina/economia , Testes Diagnósticos de Rotina/métodos , Fezes/parasitologia , Helmintíase/economia , Helmintíase/parasitologia , Helmintos/fisiologia , Humanos , Quênia , Laboratórios/economia , Laboratórios/tendências , Filipinas , Solo/parasitologiaRESUMO
BACKGROUND: Parasitic diseases are one of the world's most devastating and prevalent infections, causing millions of morbidities and mortalities annually. In the past, many of these infections have been linked predominantly to tropical or subtropical areas. Nowadays, however, climatic and vector ecology changes, a significant increase in international travel, armed conflicts, and migration of humans and animals have influenced the transmission of some parasitic diseases from 'book pages' to reality in developed countries. It has also been noted that many patients who have never travelled to endemic areas suffer from blood-borne infections caused by protozoa. In the light of existing knowledge, this new trend can be explained by the fact that in the process of migration a large number of asymptomatic carriers become a part of the blood bank donor and transplant donor populations. Accurate and rapid diagnosis represents the crucial weapon in the fight against parasitic infections. AIMS: To review old and new approaches for rapid diagnosis of parasitic infections. SOURCES: Data for this review were obtained through searches of PubMed using combinations of the following terms: parasitological diagnostics, microscopy, lateral flow assays, immunochromatographic assays, multiplex-PCR, and transplantation. CONTENT: In this review, we provide a brief account of the advantages and limitations of rapid methods for diagnosis of parasitic diseases and focus our attention on current and future research in this area. The approximate costs associated with the use of different techniques and their applicability in endemic and non-endemic areas are also discussed. IMPLICATIONS: Microscopy remains the cornerstone of parasitological diagnostics, especially in the field and low-resource settings, and provides epidemiological assessment of parasite burden. However, increased use and availability of point-of-care tests and molecular assays in modern era allow more rapid and accurate diagnoses and increased sensitivity in the identification of parasitic infections.
Assuntos
Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/tendências , Doenças Parasitárias/diagnóstico , Parasitologia/métodos , Parasitologia/tendências , Animais , Testes Diagnósticos de Rotina/economia , Humanos , Microscopia , Técnicas de Diagnóstico Molecular , Parasitos , Doenças Parasitárias/epidemiologia , Testes ImediatosRESUMO
Recent advances in molecular and mass screening technologies have paved the way for discovery of novel diagnostic tests and/or biomarkers for accurate identification of specific diseases and organ injuries. However, new diagnostic tests/biomarkers should be subjected to thorough evaluation before introduction into routine clinical practice. This review focuses on the up-to-date methodology in designing and evaluating diagnostic tests/biomarkers, and assessing their clinical utilities for improving health care efficiency, cost-effectiveness and outcomes. In addition to improved diagnostic utilities, future diagnostic tests should be developed in collaboration with our industrial partners and be applicable at the bedside for disease surveillance.
Assuntos
Biomarcadores/análise , Testes Diagnósticos de Rotina/normas , Testes Diagnósticos de Rotina/tendências , Comportamento Cooperativo , Análise Custo-Benefício , Humanos , Projetos de PesquisaRESUMO
BACKGROUND: Limited English proficiency (LEP) patients may be particularly vulnerable in the high acuity and fast-paced setting of the emergency department (ED). OBJECTIVE: To compare the care processes of LEP patients in the ED. DESIGN: Retrospective cohort study. SETTING: ED in a large tertiary care academic medical center. PATIENTS: Adult LEP and English Proficient (EP) patients during their index presentation to the ED from September 1, 2013, to August 31, 2015. LEP patients were identified as those who selected a preferred language other than English when registering for care. MAIN MEASURES: Rates of diagnostic studies, admission, and return visits for those originally discharged from the ED. KEY RESULTS: We studied 57,435 visits of which 5241 (9.1%) were for patients with LEP. In adjusted analyses, LEP patients were more likely to receive an X-ray/ultrasound (OR 1.11, CI 1.03-1.19) and be admitted to the hospital (OR 1.09, CI 1.01-1.19). There was no difference in 72-h return visits (OR 0.98, CI 0.73-1.33). LEP patients presenting with complaints related to the cardiovascular system were more likely to receive a stress test (OR 1.51, CI 1.22-1.86), and those with gastrointestinal diagnoses were more likely to have an X-ray/ultrasound (OR 1.31, CI 1.02-1.68). In stratified analyses, Spanish speakers were less likely to be admitted (OR 0.8, CI 0.70-0.91), but those preferring "other" languages, which were all languages with < 500 patients, had a statistically significant higher adjusted rate of admission (OR 1.35, CI 1.17-1.57). CONCLUSIONS: ED patients with LEP experienced both increased rates of diagnostic testing and of hospital admission. Research is needed to examine why these differences occurred and if they represent inefficiencies in care.
Assuntos
Barreiras de Comunicação , Serviços Médicos de Emergência/tendências , Serviço Hospitalar de Emergência/tendências , Idioma , Adolescente , Adulto , Idoso , Estudos de Coortes , Testes Diagnósticos de Rotina/tendências , Serviços Médicos de Emergência/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Admissão do Paciente/tendências , Estudos Retrospectivos , Centros de Atenção Terciária/tendências , Adulto JovemRESUMO
BACKGROUND: Many clinical practice guidelines encourage diagnosis and empiric treatment of lower urinary tract infection without laboratory investigation; however, urine culture testing remains one of the largest volume tests in the clinical microbiology laboratory. In this study, we sought to determine if there were specific patient groups to which increased testing was directed. To do so, we combined laboratory data on testing rates with Census Canada sociodemographic data. METHODS: Urine culture testing data was obtained from the Calgary Laboratory Services information system for 2011. We examined all census dissemination areas within the city of Calgary and, for each area, testing rates were determined for age and gender cohorts. We then compared these testing rates to sociodemographic factors obtained from Census Canada and used Poisson regression and generalized estimating equations to test associations between testing rates and sociodemographic variables. RESULTS: Per capita urine culture testing is increasing in Calgary. For 2011, 100,901 individuals (9.2% of all people) received urine cultures and were included in this analysis. The majority of cultures were received from the community (67.9%). Substantial differences in rate of testing were observed across the city. Most notably, urine culture testing was drastically lower in areas of high (≥ $100000) household income (RR = 0.07, p < 0.0001) and higher employment rate (RR = 0.36, p < 0.0001). Aboriginal - First Nations status (RR = 0.29, p = 0.0008) and Chinese visible minority (RR = 0.67, p = 0.0005) were also associated with decreased testing. Recent immigration and visible minority status of South Asian, Filipino or Black were not significant predictors of urine culture testing. Females were more likely to be tested than males (RR = 2.58, p < 0.0001) and individuals aged 15-39 were the most likely to be tested (RR = 1.69, p < 0.0001). CONCLUSIONS: Considerable differences exist in urine culture testing across Calgary and these are associated with a number of sociodemographic factors. In particular, areas of lower socioeconomic standing had significantly increased rates of testing. These observations highlight specific groups that should be targeted to improve healthcare delivery and, in turn, enhance laboratory utilization.
Assuntos
Testes Diagnósticos de Rotina/economia , Testes Diagnósticos de Rotina/estatística & dados numéricos , Classe Social , Urinálise/economia , Urinálise/estatística & dados numéricos , Adolescente , Adulto , Idoso , Alberta/epidemiologia , Testes Diagnósticos de Rotina/tendências , Emprego/economia , Emprego/tendências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Urinálise/tendências , Adulto JovemRESUMO
INTRODUCTION: Previous work has shown poisoning-related emergency department (ED) visits are increasing, and these visits are resource-intensive. Little is known, however, about how resource utilization for patients with known or suspected poisoning differs from that of general ED patients. METHODS: We reviewed 4 years of operational data at a single ED. We identified visits due to known or suspected poisoning (index cases), and paired them with time-matched controls. In the primary analysis, we compared the groups with respect to a broad array of resource utilization characteristics. In a secondary analysis, we performed the same comparison after excluding patients ultimately transferred to a psychiatric facility. RESULTS: There were 405 index cases and 802 controls in the primary analysis, and 374 index cases and 741 controls in the secondary analysis. In the primary/secondary analyses, patients with known or suspected poisoning had longer ED lengths of stay in minutes (370 vs. 232/295 vs. 234), higher rates of laboratory results per patient (40.4 vs. 26.8/39.6 vs. 26.8), greater administration of intravenous medications and fluids per patient (2.0 vs. 1.6/2.1 vs. 1.6), higher rates of transfer to a psychiatric facility (7.7 vs. 0.2%/not applicable), and higher rates of both admission (40.2 vs. 32.8/43.6 vs. 33.1%) and admission to an advanced care bed (21.5 vs. 7.6/23.3 vs. 7.8%). Patients with known or suspected poisoning had lower rates of imaging per patient, for both plain radiographs (0.4 vs. 0.5/0.4 vs. 0.5) and advanced imaging studies (0.3 vs. 0.5/0.4 vs. 0.5). CONCLUSIONS: ED patients with known or suspected poisoning are more resource intensive than general ED patients. These results may have implications for both resource allocation (particularly for departments that might see a high volume of such patients) and ED operations management.
Assuntos
Serviço Hospitalar de Emergência , Recursos em Saúde/tendências , Necessidades e Demandas de Serviços de Saúde/tendências , Avaliação das Necessidades/tendências , Intoxicação/terapia , Administração Intravenosa , Adulto , Idoso , Arizona , Testes Diagnósticos de Rotina/tendências , Feminino , Hidratação/tendências , Humanos , Tempo de Internação/tendências , Masculino , Pessoa de Meia-Idade , Admissão do Paciente/tendências , Transferência de Pacientes/tendências , Intoxicação/diagnóstico , Intoxicação/etiologia , Estudos Retrospectivos , Adulto JovemRESUMO
BACKGROUND: The World Health Organization guidelines have recommended that all cases of suspected malaria should receive a confirmatory test with microscopy or a malaria rapid diagnostic test (RDT), however evidence from sub-Saharan Africa (SSA) illustrates that only one-third of children under five with a recent fever received a test. The aim of this study was to evaluate availability, price and market share of microscopy and RDT from 2009/11 to 2014/15 in 8 SSA countries, to better understand barriers to improving access to malaria confirmatory testing in the public and private health sectors. RESULTS: Repeated national cross-sectional quantitative surveys were conducted among a sample of outlets stocking anti-malarial medicines and/or diagnostics. In total, 169,655 outlets were screened. Availability of malaria blood testing among all screened public health facilities increased significantly between the first survey wave in 2009/11 and the most recent in 2014/15 in Benin (36.2, 85.4%, p < 0.001), Kenya (53.8, 93.0%, p < 0.001), mainland Tanzania (46.9, 89.9%, p < 0.001), Nigeria (28.5, 86.2%, p < 0.001), Katanga, the Democratic Republic of the Congo (DRC) (76.0, 88.2%, p < 0.05), and Uganda (38.9, 95.6%, p < 0.001). These findings were attributed to an increase in availability of RDTs. Diagnostic availability remained high in Kinshasa (the DRC) (87.6, 97.6%) and Zambia (87.9, 91.6%). Testing availability in public health facilities significantly decreased in Madagascar (88.1, 73.1%, p < 0.01). In the most recent survey round, the majority of malaria testing was performed in the public sector in Zambia (90.9%), Benin (90.3%), Madagascar (84.5%), Katanga (74.3%), mainland Tanzania (73.5%), Uganda (71.8%), Nigeria (68.4%), Kenya (53.2%) and Kinshasa (51.9%). In the anti-malarial stocking private sector, significant increases in availability of diagnostic tests among private for-profit facilities were observed between the first and final survey rounds in Kinshasa (82.1, 94.0%, p < 0.05), Nigeria (37.0, 66.0%, p < 0.05), Kenya (52.8, 74.3%, p < 0.001), mainland Tanzania (66.8, 93.5%, p < 0.01), Uganda (47.1, 70.1%, p < 0.001), and Madagascar (14.5, 45.0%, p < 0.01). Blood testing availability remained low over time among anti-malarial stocking private health facilities in Benin (33.1, 20.7%), and high over time in Zambia (94.4, 87.5%), with evidence of falls in availability in Katanga (72.7, 55.6%, p < 0.05). Availability among anti-malarial stocking pharmacies and drug stores-which are the most common source of anti-malarial medicines-was rare in all settings, and highest in Uganda in 2015 (21.5%). Median private sector price of RDT for a child was equal to the price of pre-packaged quality-assured artemisinin-based combination therapy (QAACT) treatment for a two-year old child in some countries, and 1.5-2.5 times higher in others. Median private sector QAACT price for an adult varied from having parity with an RDT for an adult to being up to 2 times more expensive. The exception was in both Kinshasa and Katanga, where the median price of QAACT was less expensive than RDTs. CONCLUSIONS: Significant strides have been made in the availability of testing, mainly through the widespread distribution of RDT, and especially in public health facilities. Significant barriers to universal coverage of diagnostic testing can be attributed to very low availability in the private sector, particularly among pharmacies and drug stores, which are responsible for most anti-malarial distribution. Where tests are available, price may serve as a barrier to uptake, particularly for young children. Several initiatives that have introduced RDT into the private sector can be modified and expanded as a means to close this gap in malaria testing availability and promote universal diagnosis.
Assuntos
Comércio/economia , Testes Diagnósticos de Rotina/tendências , Setor de Assistência à Saúde/tendências , Setor Privado/tendências , Setor Público/tendências , África Subsaariana , Comércio/tendências , Estudos Transversais , Testes Diagnósticos de Rotina/economia , Testes Diagnósticos de Rotina/estatística & dados numéricos , Setor de Assistência à Saúde/economia , Setor de Assistência à Saúde/estatística & dados numéricos , Humanos , Malária , Setor Privado/economia , Setor Público/economiaRESUMO
Global efforts to address schistosomiasis and soil-transmitted helminthiases (STH) include deworming programs for school-aged children that are made possible by large-scale drug donations. Decisions on these mass drug administration (MDA) programs currently rely on microscopic examination of clinical specimens to determine the presence of parasite eggs. However, microscopy-based methods are not sensitive to the low-intensity infections that characterize populations that have undergone MDA. Thus, there has been increasing recognition within the schistosomiasis and STH communities of the need for improved diagnostic tools to support late-stage control program decisions, such as when to stop or reduce MDA. Failure to adequately address the need for new diagnostics could jeopardize achievement of the 2020 London Declaration goals. In this report, we assess diagnostic needs and landscape potential solutions and determine appropriate strategies to improve diagnostic testing to support control and elimination programs. Based upon literature reviews and previous input from experts in the schistosomiasis and STH communities, we prioritized two diagnostic use cases for further exploration: to inform MDA-stopping decisions and post-MDA surveillance. To this end, PATH has refined target product profiles (TPPs) for schistosomiasis and STH diagnostics that are applicable to these use cases. We evaluated the limitations of current diagnostic methods with regards to these use cases and identified candidate biomarkers and diagnostics with potential application as new tools. Based on this analysis, there is a need to develop antigen-detecting rapid diagnostic tests (RDTs) with simplified, field-deployable sample preparation for schistosomiasis. Additionally, there is a need for diagnostic tests that are more sensitive than the current methods for STH, which may include either a field-deployable molecular test or a simple, low-cost, rapid antigen-detecting test.
Assuntos
Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Helmintíase/diagnóstico , Helmintíase/parasitologia , Pessoal de Laboratório Médico , Esquistossomose/diagnóstico , Esquistossomose/parasitologia , Solo/parasitologia , Biomarcadores , Criança , Testes Diagnósticos de Rotina/economia , Testes Diagnósticos de Rotina/tendências , Fezes , Feminino , Helmintíase/epidemiologia , Helmintíase/transmissão , Humanos , Controle de Infecções/economia , Controle de Infecções/métodos , Controle de Infecções/normas , Controle de Infecções/estatística & dados numéricos , Londres , Masculino , Carga Parasitária , Prevalência , Serviços Preventivos de Saúde/métodos , Serviços Preventivos de Saúde/estatística & dados numéricos , Esquistossomose/epidemiologia , Esquistossomose/prevenção & controleRESUMO
The idea of a private sector subsidy programme of artemisinin-based combination therapies (ACTs) was first proposed in 2004. Since then, several countries around the world have hosted pilot projects or programmes on subsidized ACTs and/or the Affordable Medicines Facility-malaria programme (AMFm). Overall the private sector subsidy programmes of ACTs have been effective in increasing availability of ACTs in the private sector and driving down average prices but struggled to crowd out antimalarial monotherapies. The results obtained from this ambitious strategy should inform policy makers in the designing of future interventions aimed to control malaria morbidity and mortality. Among the interventions recently proposed, a subsidy of rapid diagnostic tests (RDTs) in the private sector has been recommended by governments and international donors to cope with over-treatment with ACTs and to delay the emergence of resistance to artemisinin. In order to improve the cost-effectiveness of co-paid RDTs, we should build on the lessons we learned from almost 10 years of private sector subsidy programmes of ACTs in malaria-endemic countries.
Assuntos
Antimaláricos/uso terapêutico , Artemisininas/uso terapêutico , Testes Diagnósticos de Rotina/estatística & dados numéricos , Prescrição Inadequada/prevenção & controle , Malária/tratamento farmacológico , Setor Privado , Antimaláricos/provisão & distribuição , Artemisininas/provisão & distribuição , Testes Diagnósticos de Rotina/economia , Testes Diagnósticos de Rotina/tendências , HumanosAssuntos
Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Reforma dos Serviços de Saúde/legislação & jurisprudência , Reforma dos Serviços de Saúde/métodos , Política de Saúde/legislação & jurisprudência , Testes Diagnósticos de Rotina/tendências , Reforma dos Serviços de Saúde/tendências , Política de Saúde/tendências , Humanos , Estados Unidos , United States Food and Drug AdministrationRESUMO
In 2015, tuberculosis remains a major global health problem, and drug-resistant tuberculosis is a growing threat. Although tuberculosis diagnosis in many countries is still reliant on older tools, new diagnostics are changing the landscape. Stimulated, in part, by the success and roll out of Xpert MTB/RIF, there is now considerable interest in new technologies. The landscape looks promising, with a robust pipeline of new tools, particularly molecular diagnostics, and well over 50 companies actively engaged in product development. However, new diagnostics are yet to reach scale, and there needs to be greater convergence between diagnostics development and development of shorter-duration tuberculosis drug regimens. Another concern is the relative absence of non-sputum-based diagnostics in the pipeline for children and of biomarker tests for triage, cure, and progression of latent Mycobacterium tuberculosis infection. Several initiatives, described in this supplement, have been launched to further stimulate product development and policy, including assessment of needs and priorities, development of target product profiles, compilation of data on resistance-associated mutations, and assessment of market size and potential for new diagnostics. Advocacy is needed to increase funding for tuberculosis research and development, and governments in high-burden countries must invest more in tuberculosis control to meet post-2015 targets for care, control, and prevention.
Assuntos
Testes Diagnósticos de Rotina/métodos , Técnicas de Diagnóstico Molecular/métodos , Tuberculose/diagnóstico , Pesquisa Biomédica/economia , Pesquisa Biomédica/tendências , Testes Diagnósticos de Rotina/tendências , Humanos , Técnicas de Diagnóstico Molecular/tendências , Tuberculose/tratamento farmacológico , Tuberculose/epidemiologia , Tuberculose/prevenção & controleRESUMO
To accelerate the fight against tuberculosis, major diagnostic challenges need to be addressed urgently. Post-2015 targets are unlikely to be met without the use of novel diagnostics that are more accurate and can be used closer to where patients first seek care in affordable diagnostic algorithms. This article describes the efforts by the stakeholder community that led to the identification of the high-priority diagnostic needs in tuberculosis. Subsequently target product profiles for the high-priority diagnostic needs were developed and reviewed in a World Health Organization (WHO)-led consensus meeting. The high-priority diagnostic needs included (1) a sputum-based replacement test for smear-microscopy; (2) a non-sputum-based biomarker test for all forms of tuberculosis, ideally suitable for use at levels below microscopy centers; (3) a simple, low cost triage test for use by first-contact care providers as a rule-out test, ideally suitable for use by community health workers; and (4) a rapid drug susceptibility test for use at the microscopy center level. The developed target product profiles, along with complimentary work presented in this supplement, will help to facilitate the interaction between the tuberculosis community and the diagnostics industry with the goal to lead the way toward the post-2015 global tuberculosis targets.
Assuntos
Testes Diagnósticos de Rotina/métodos , Prioridades em Saúde , Técnicas de Diagnóstico Molecular/métodos , Tuberculose/diagnóstico , Biomarcadores/análise , Pesquisa Biomédica/economia , Pesquisa Biomédica/tendências , Testes Diagnósticos de Rotina/tendências , Humanos , Testes de Sensibilidade Microbiana/métodos , Técnicas de Diagnóstico Molecular/tendências , Escarro/microbiologiaRESUMO
On July 1st, 2013, about two years after the FDA's drafting of the guidance for companion diagnostics (CoDx), the Ministry of Health, Labour, and Welfare in Japan issued an official notification regarding the co-development of CoDx with a drug which requires dedicated diagnostic tests or medical devices to predict the efficacy of or adverse reactions to the drug. Both recommend to co-develop CoDx and drugs as well as indicate the approved tests and devices on the package insert of the drug. However, since many useful predictive biomarkers may be discovered after the commercial launch of a drug, the more effective use of laboratory developed tests (LDT) should be considered in order to avoid a biomarker test lag. Due to an increase of clinical needs for multiple biomarker assays using sequence and/or microarray technologies, on November 19th, 2013, the FDA approved 510K clearance for the next-generation sequencer and its universal kit. This strategically new regulatory framework may allow clinical laboratories certified under the CLIA Act to more easily perform LDT for genetic markers. Unfortunately, no act like the CLIA exits in Japan to promote LDT well validated for clinical practice, and it may be necessary to reform the regulatory classification and requirements and also quality management system for in-vitro diagnostics tests and devices for reimbursement in the future.
Assuntos
Testes Diagnósticos de Rotina/tendências , Guias como Assunto , Patologia Molecular , Humanos , Hibridização in Situ Fluorescente , Seguro Saúde/tendências , Japão , Patologia Molecular/economia , Medicina de Precisão/economiaRESUMO
Societal demand for faster and more accurate assignment of treatments is based in both patient care needs and in health economics. From a patient care standpoint, there needs to be a transformation from the empiric method of therapeutic decision making to avoid unwanted side effects from inefficacious treatments. For health economics, the delay in effective therapy and expenditures for ineffective therapies add to the burden of care. To accomplish this transformation, we need to modify our current method of classifying disease from a phenotypic description to one that incorporates the different molecular drivers that created the observed phenotype. To do so, a deeper, systems-based understanding of these disease drivers is required, which will yield a new generation of diagnostic tests, or systems diagnostics.