Abstract:
BACKGROUND:Rapid diagnostic tests (RDTs) largely account for the scale-up of malaria diagnosis in endemic settings. However, diversity in labelling including the instructions for use (IFU) limits their interchangeability and user-friendliness. Uniform, easy to follow and consistent labelling, aligned with international standards and appropriate for the level of the end user's education and training, is crucial but a consolidated resource of information regarding best practices for IFU and labelling of RDT devices, packaging and accessories is not available. METHODS:The Roll Back Malaria Partnership (RBM) commissioned the compilation of international standards and regulatory documents and published literature containing specifications and/or recommendations for RDT design, packaging and labelling of in vitro diagnostics (IVD) (which includes RDTs), complemented with a questionnaire based survey of RDT manufacturers and implementers. A summary of desirable RDT labelling characteristics was compiled, which was reviewed and discussed during a RBM Stakeholder consultation meeting and subsequently amended and refined by a dedicated task force consisting of country programme implementers, experts in RDT implementation, IVD regulatory experts and manufacturers. RESULTS:This process led to the development of consensus documents with a list of suggested terms and abbreviations as well as specifications for labelling of box, device packaging, cassettes, buffer bottle and accessories (lancets, alcohol swabs, transfer devices, desiccants). Emphasis was placed on durability (permanent printing or water-resistant labels), legibility (font size, letter type), comprehension (use of symbols) and ease of reference (e.g. place of labelling on the box or cassette packaging allowing quick oversight). A generic IFU template was developed, comprising background information, a template for procedure and reading/interpretation, a selection of appropriate references and a symbol key of internationally recognized symbols together with suggestions about appropriate lay-out, style and readability. CONCLUSIONS:The present document together with its additional files compiled proposes best practices in labelling and IFU for malaria RDTs. It is expected that compliance with these best practices will increase harmonization among the different malaria RDT products available on the market and improve their user-friendliness.
journal_name
Malar Jjournal_title
Malaria journalauthors
Jacobs J,Barbé B,Gillet P,Aidoo M,Serra-Casas E,Van Erps J,Daviaud J,Incardona S,Cunningham J,Visser Tdoi
10.1186/1475-2875-13-505subject
Has Abstractpub_date
2014-12-17 00:00:00pages
505issn
1475-2875pii
1475-2875-13-505journal_volume
13pub_type
杂志文章相关文献
MALARIA JOURNAL文献大全abstract:BACKGROUND:Malaria is a widespread infectious disease that threatens a large proportion of the population in tropical and subtropical areas. Given the emerging resistance against the current standard anti-malaria chemotherapeutics, the development of alternative drugs is urgently needed. New anti-malarials representing...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-017-1839-3
更新日期:2017-05-15 00:00:00
abstract:BACKGROUND:Malaria rapid diagnostic tests (RDTs) are assumed to be simple-to-use and mobile technologies that have the capacity to standardize parasitological diagnosis for malaria across a variety of clinical settings. In order to evaluate these tests, it is important to consider how such assumptions play out in pract...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-016-1083-2
更新日期:2016-02-05 00:00:00
abstract:BACKGROUND:Sulphadoxine-pyrimethamine (SP) has been in use for the treatment of uncomplicated falciparum malaria in Malaysia since the 1970s and is still widely employed in spite of widespread clinical resistance. Resistance to SP is known to be mediated by mutations in the pfdhfr and pfdhps genes. The aim of the prese...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-12-198
更新日期:2013-06-12 00:00:00
abstract:BACKGROUND:Relatively few programmes have attempted to actively engage the private sector in national malaria control efforts. This paper evaluates the health impact of a large-scale distribution of insecticide-treated nets (ITNs) conducted in partnership with a Zambian agribusiness, and its cost-effectiveness from the...
journal_title:Malaria journal
pub_type: 杂志文章,随机对照试验
doi:10.1186/1475-2875-12-102
更新日期:2013-03-18 00:00:00
abstract:BACKGROUND:Polymorphisms within the PfATP6 gene have been indicated as potential molecular markers for artemisinin efficacy. Since 2004, the use of artemisinin combination therapy (ACT) was introduced as first-line treatment of the uncomplicated malaria cases in Suriname. The aim of this research was to determine chang...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-11-322
更新日期:2012-09-11 00:00:00
abstract:BACKGROUND:The use of rapid diagnostic tests (RDTs) to diagnose malaria is common in sub-Saharan African laboratories, remote primary health facilities and in the community. Currently, there is a lack of reliable methods to ascertain health worker competency to accurately use RDTs in the testing and diagnosis of malari...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-020-03569-y
更新日期:2021-01-20 00:00:00
abstract:BACKGROUND:Although chemoprophylaxis remains an important strategy for preventing malaria in travellers, its effectiveness may be compromised by lack of adherence. Inappropriate use of chemoprophylaxis is likely to increase the risk of acquiring malaria, but may probably also worsen the severity of imported cases. The ...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-12-265
更新日期:2013-07-31 00:00:00
abstract:BACKGROUND:While sub-microscopic malarial infections are frequent and potentially deleterious during pregnancy, routine molecular detection is still not feasible. This study aimed to assess the performance of a Histidine Rich Protein 2 (HRP2)-based ultrasensitive rapid diagnostic test (uRDT, Alere Malaria Ag Pf) for th...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-020-03261-1
更新日期:2020-05-24 00:00:00
abstract:BACKGROUND:Due to the development of resistance to synthetic insecticides, adverse effects to human health, non-target organisms and the environment, there is an urgent need to develop new insecticides, which are effective, safe, biodegrable and target-specific. This study was undertaken to evaluate the adulticidal act...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-13-173
更新日期:2014-05-06 00:00:00
abstract:BACKGROUND:In Togo, the National Malaria Control Programme, in collaboration with the Global Fund to Fight AIDS, Tuberculosis and Malaria, has implemented a pilot study for malaria sentinel surveillance since 2017, which consists of collecting information in real time and analysing this information for decision-making....
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-020-03399-y
更新日期:2020-09-09 00:00:00
abstract:BACKGROUND:Mosquito transgenesis offers new promises for the genetic control of vector-borne infectious diseases such as malaria and dengue fever. Genetic control strategies require the release of large number of male mosquitoes into field populations, whether they are based on the use of sterile males (sterile insect ...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-11-302
更新日期:2012-08-28 00:00:00
abstract:BACKGROUND:The effects that artemether-lumefantrine (AL) has on gametocyte dynamics in the short-term have recently been described. However there is limited long-term longitudinal data on the effect of AL on gametocyte dynamics in asymptomatic children. METHODS:An epidemiological study was conducted in Kombewa, Wester...
journal_title:Malaria journal
pub_type: 杂志文章,随机对照试验
doi:10.1186/1475-2875-13-265
更新日期:2014-07-09 00:00:00
abstract:BACKGROUND:The development of insecticide resistance and the increased outdoor-biting behaviour of malaria vectors reduce the efficiency of indoor vector control methods. Attractive toxic sugar baits (ATSBs), a method targeting the sugar-feeding behaviours of vectors both indoors and outdoors, is a promising supplement...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-015-1012-9
更新日期:2015-12-08 00:00:00
abstract::While significant advances have been made in the prevention and treatment of malaria in recent years, these successes continue to fall short of the World Health Organization (WHO) goals for malaria control and elimination. For elimination strategies to be effective, limited disease transmission, achieved through rapid...
journal_title:Malaria journal
pub_type: 杂志文章,评审
doi:10.1186/1475-2875-13-291
更新日期:2014-07-28 00:00:00
abstract:BACKGROUND:Intermittent preventive treatment with sulphadoxine-pyrimethamine (SP) is recommended for reducing the risk of malaria in pregnancy and its consequences on mothers and babies (IPTp-SP). Indicators of implementation and effects of IPTp-SP were collected in a rural clinic in Southern Senegal. METHODS:Women se...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-7-234
更新日期:2008-11-07 00:00:00
abstract:BACKGROUND:To date, human peripheral blood mononuclear cells (PBMCs) have been used mainly in immune stimulation assays and the interpretation of data can be influenced by the previous immunological history of donors and cross reactivity with other infectious agents. Resolving these limitations requires an alternative ...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-017-1781-4
更新日期:2017-03-27 00:00:00
abstract::This opinion article deals with the diagnostic clinical challenges faced by clinicians or health care workers in malaria-endemic areas when a severely sick child presents to the clinic with fever, coma or respiratory distress. Indeed, the coexistence of malaria with other severe infections like meningitis, invasive ba...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-018-2533-9
更新日期:2018-10-22 00:00:00
abstract:BACKGROUND:In many low-income countries, the private commercial sector plays an important role in the provision of malaria treatment. However, the quality of care it provides is often poor, with artemisinin combination therapy (ACT) generally being too costly for consumers. Decreasing ACT prices is critical for improvi...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-015-0737-9
更新日期:2015-05-30 00:00:00
abstract:BACKGROUND:Appropriate case management of suspected malaria in Cambodia is critical given anti-malarial drug resistance in the region. Improving diagnosis and the use of recommended malarial treatments is a challenge in Cambodia where self-treatment and usage of drug cocktails is widespread, a notable difference from m...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-11-335
更新日期:2012-10-05 00:00:00
abstract:BACKGROUND:Acute kidney injury (AKI) is a common complication of malaria. In low resource settings, a lack of diagnostic tools and delayed treatment of malaria associated AKI lead to significant morbidity and mortality. The aim of this study was to assess the diagnostic performance of salivary urea nitrogen (SUN) dipst...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-018-2627-4
更新日期:2018-12-18 00:00:00
abstract:BACKGROUND:Species of anopheline mosquitoes are largely distributed over emerged lands around the world and, within the tropics, few areas are without these insects, which are vectors of malaria parasites. Among the exceptions is the Seychelles archipelago in the western Indian Ocean. However, in the Aldabra island gro...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-10-31
更新日期:2011-02-08 00:00:00
abstract:BACKGROUND:In Plasmodium, the high level of genetic diversity and the interactions established by co-infecting parasite populations within the same host may be a source of selection on pathogen virulence and drug resistance. As different patterns have already been described in humans and mosquitoes, parasite diversity ...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-12-114
更新日期:2013-03-27 00:00:00
abstract:BACKGROUND:The importance of the submicroscopic reservoir of Plasmodium infections for malaria elimination depends on its size, which is generally considered small in low transmission settings. The precise estimation of this reservoir requires more sensitive parasite detection methods. The prevalence of asymptomatic, s...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-015-0906-x
更新日期:2015-09-30 00:00:00
abstract:BACKGROUND:Primaquine (PQ) prevents relapses of vivax malaria but may induce severe haemolysis in glucose-6-phosphate dehydrogenase (G6PD) deficient patients. Data on the safety of primaquine in infants are limited. METHODS:A retrospective, hospital-based cohort study of infants aged 1-12 months with vivax malaria was...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-019-2745-7
更新日期:2019-04-02 00:00:00
abstract:BACKGROUND:Malaria remains the most important public health problem in tropical and subtropical areas. Mothers' or caregivers' ability to recognize childhood malaria-related morbidity is crucial as knowledge, attitudes and health seeking behavior of caregivers towards childhood malaria could influence response to signs...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-9-47
更新日期:2010-02-11 00:00:00
abstract::Genetic manipulation of malaria parasites remains an inefficient, time-consuming and resource-intensive process. Presented here is a set of methods for 96-well plate-based transfection and culture that improve the efficiency of genetic manipulation of Plasmodium falciparum. Compared to standard protocols plate-based t...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-11-22
更新日期:2012-01-18 00:00:00
abstract:BACKGROUND:Single nucleotide polymorphism (SNP) genotyping provides the means to develop a practical, rapid, inexpensive assay that will uniquely identify any Plasmodium falciparum parasite using a small amount of DNA. Such an assay could be used to distinguish recrudescence from re-infection in drug trials, to monitor...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-7-223
更新日期:2008-10-29 00:00:00
abstract:BACKGROUND:Marking mosquitoes is vital for mark-release-recapture and many laboratory studies, but their small size precludes the use of methods that are available for larger animals such as unique identifier tags and radio devices. Fluorescent dust is the most commonly used method to distinguish released individuals f...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-020-03306-5
更新日期:2020-07-06 00:00:00
abstract:BACKGROUND:Agro-ecological systems have been associated with increased malaria intensity. This study determined association between different agro-ecological systems, prevalence of malaria parasitaemia and anaemia in Mvomero district, Tanzania. METHODS:The study was carried out in three agro-ecosystems namely, savanna...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/s12936-019-2859-y
更新日期:2019-07-09 00:00:00
abstract:BACKGROUND:The WHO has reported that RDT and microscopy-confirmed malaria cases have declined in recent years. However, it is still unclear if this reflects a real decrease in incidence in Bangladesh, as particularly the hilly and forested areas of the Chittagong Hill Tract (CHT) Districts report more than 80% of all c...
journal_title:Malaria journal
pub_type: 杂志文章
doi:10.1186/1475-2875-13-16
更新日期:2014-01-09 00:00:00