Introduction Of Rapid Diagnostic Tests Research Articles

Evolution of pfhrp2 and pfhrp3 deletions in Equatorial Guinea between the pre– and post–RDT introduction

BackgroundPfhrp2 and pfhrp3 deletions are threatening Plasmodium falciparum malaria diagnosis by rapid diagnostic tests (RDT) due to false negatives. This study assesses the changes in the frequencies of pfhrp2 and pfhrp3 deletions (pfhrp2Del and pfhrp3Del, respectively) and the genes in their flaking regions, before and after RDT introduction in Equatorial Guinea.MethodsA total of 566 P. falciparum samples were genotyped to assess the presence of pfhrp2 and pfhrp3 deletions and their flanking genes. The specimens were collected 18 years apart from two provinces of Equatorial Guinea, North Bioko (Insular Region) and Litoral Province (Continental Region). Orthologs of pfhrp2 and pfhrp3 genes from other closely related species were used to compare sequencing data to assess pfhrp2 and pfhrp3 evolution. Additionally, population structure was studied using seven neutral microsatellites.ResultsThis study found that pfhrp2Del and pfhrp3Del were present before the introduction of RDT; however, they increased in frequency after their use, reaching more than 15%. Haplotype networks suggested that pfhrp2Del and pfhrp3Del emerged multiple times. Exon 2 of pfhrp2 and pfhrp3 genes had high variability, but there were no significant changes in amino acid sequences.ConclusionsBaseline sampling before deploying interventions provides a valuable context to interpret changes in genetic markers linked to their efficacy, such as the dynamic of deletions affecting RDT efficacy.

Involvement of Private Pharmacies in the Biological Diagnosis of Malaria Cases: The Case of Côte d’Ivoire

Introduction. In Côte d’Ivoire, current policy recommends the introduction of rapid diagnostic tests (RDTs) for malaria, including in the private sector, to facilitate effective case management. The main objective of the study was to examine the impact of introducing RDTs in private pharmacies with regard to national recommendations. Patients and methods. In order to assess knowledge, attitudes and practices after a few years of practice, a cross-sectional study was carried out from August to December 2015 among 300 professionals from private pharmacies (PPs) in the northern zone of the city of Abidjan. Results. Overall, PPs performing RDTs accounted for 25.1%. Fever (63.3%), headache (17.7%) and body aches (16.1%) were the main signs that led pharmacists to perform the test. The main criteria determining the choice of RDT are good sensitivity and specificity (45.6%), easy handling (42.6%) and lowest cost (11.8%). In 57.4% of cases, pharmacists performing RDTs said that the cost of the test (CFA 2000 or EUR 3 on average) is the main reason for non-acceptance by customers. In 97.1% of cases, the measures taken in the event of negative results were symptomatic treatment counselling followed by a medical consultation. In 2.9% of cases, some pharmacists recommended an antimalarial. On the other hand, in 92.6% of cases, the measures taken in the event of a positive result were antimalarial treatment with artemisinin-based combination therapies (ACTs). For pharmacies that did not carry out RDTs (74.9%), low customer demand was cited in 56.1% of cases. Conclusion. It would be appropriate for private pharmacy outlets to comply with the legislation by not carrying out RDTs within their pharmacies. Pending the implementation of these texts, it is imperative to improve on the shortcomings revealed.

Diagnostic accuracy of DPP Fever Panel II Asia tests for tropical fever diagnosis.

Fever is the most frequent symptom in patients seeking care in South and Southeast Asia. The introduction of rapid diagnostic tests (RDTs) for malaria continues to drive patient management and care. Malaria-negative cases are commonly treated with antibiotics without confirmation of bacteraemia. Conventional laboratory tests for differential diagnosis require skilled staff and appropriate access to healthcare facilities. In addition, introducing single-disease RDTs instead of conventional laboratory tests remains costly. To overcome some of the delivery challenges of multiple separate tests, a multiplexed RDT with the capacity to diagnose a diverse range of tropical fevers would be a cost-effective solution. In this study, a multiplex lateral flow immunoassay (DPP Fever Panel II Assay) that can detect serum immunoglobulin M (IgM) and specific microbial antigens of common fever agents in Asia (Orientia tsutsugamushi, Rickettsia typhi, Leptospira spp., Burkholderia pseudomallei, Dengue virus, Chikungunya virus, and Zika virus), was evaluated. Whole blood (WB) and serum samples from 300 patients with undefined febrile illness (UFI) recruited in Vientiane, Laos PDR were tested using the DPP Fever Panel II, which consists of an Antibody panel and Antigen panel. To compare reader performance, results were recorded using two DPP readers, DPP Micro Reader (Micro Reader 1) and DPP Micro Reader Next Generation (Micro Reader 2). WB and serum samples were run on the same fever panel and read on both micro readers in order to compare results. ROC analysis and equal variance analysis were performed to inform the diagnostic validity of the test compared against the respective reference standards of each fever agent (S1 Table). Overall better AUC values were observed in whole blood results. No significant difference in AUC performance was observed when comparing whole blood and serum sample testing, except for when testing for R. typhi IgM (p = 0.04), Leptospira IgM (p = 0.02), and Dengue IgG (p = 0.03). Linear regression depicted R2 values had ~70% agreement across WB and serum samples, except when testing for leptospirosis and Zika, where the R2 values were 0.37 and 0.47, respectively. No significant difference was observed between the performance of Micro Reader 1 and Micro Reader 2, except when testing for the following pathogens: Zika IgM, Zika IgG, and B pseudomallei CPS Ag. These results demonstrate that the diagnostic accuracy of the DPP Fever Panel II is comparable to that of commonly used RDTs. The optimal cut-off would depend on the use of the test and the desired sensitivity and specificity. Further studies are required to authenticate the use of these cut-offs in other endemic regions. This multiplex RDT offers diagnostic benefits in areas with limited access to healthcare and has the potential to improve field testing capacities. This could improve tropical fever management and reduce the public health burden in endemic low-resource areas.

Evaluation of the performance of advantage P.f. malaria Card® and advantage malaria Pan + Pf Card®, two rapid diagnostic tests for parasitological confirmation of malaria cases in field situation in Togo

BackgroundIn Togo, malaria remains a major public health problem, and the management of suspected cases requires confirmation with appropriate biological methods. Malaria diagnosis has been improved by the introduction of rapid diagnostic tests (RDTs), recommended by the World Health Organization (WHO) for areas where microscopy is not available. To be used, these RDTs must meet performance criteria defined by the WHO. This study was conducted to evaluate the diagnostic performance of two RDTs: Advantage P.f. Malaria Card® detecting HRP2 antigen and Advantage Malaria Pan + Pf Card® detecting both HRP2 and pLDH antigens.MethodsThis was a cross-sectional analytical study conducted from December 2019 to February 2020 on malaria-suspected cases received in three sentinel sites in Togo and from whom capillary blood was collected to perform the two RDTs according to the manufacturer's instructions. Sensitivity and specificity were estimated by comparing to thick/thin blood smear, the gold standard, and to PCR, which is a more sensitive.ResultsA total of 390 participants (54.9% female) with a median age of 18 (± 0.8) years were included in the study. The sensitivity of both Advantage P.f. Malaria Card® and Advantage Malaria Pan + Pf Card® compared to thick/thin blood smear was 91.8% and 91.3%, respectively, and for both the specificity was 94.7%. Compared to PCR, the sensitivity was 84.2% and 83.8%, respectively, and the specificity 96.5%.ConclusionsThe performances of the Advantage P.f. Malaria Card® and Advantage Malaria PAN + Pf Card® compared to microscopy, considered the gold standard, were acceptable under the field conditions found in Togo. They can therefore be used for the biological diagnosis of malaria.Graphical

Solving the enigma of acute febrile illness

The diagnosis of patients presenting with acute febrile illness is one of the most challenging in clinical medicine. For many years in Africa and other tropical regions, fever has been presumptively treated as malaria. 1 Macarayan E Papanicolas I Jha A The quality of malaria care in 25 low-income and middle-income countries. BMJ Glob Health. 2020; 5e002023 Crossref PubMed Scopus (8) Google Scholar The development and widespread use of malaria rapid tests markedly improved the specificity of the diagnosis of fever caused by malarial parasites but led to unacceptable levels of presumptive use of antibiotics for patients with negative malaria rapid test results. 2 Hopkins H Bruxvoort KJ Cairns ME et al. Impact of introduction of rapid diagnostic tests for malaria on antibiotic prescribing: analysis of observational and randomised studies in public and private healthcare settings. BMJ. 2017; 356j1054 PubMed Google Scholar , 3 D'Acremont V Kilowoko M Kyungu E et al. Beyond malaria—causes of fever in outpatient Tanzanian children. N Engl J Med. 2014; 370: 809-817 Crossref PubMed Scopus (288) Google Scholar , 4 WHOIntegrated management of childhood illness. https://www.who.int/teams/maternal-newborn-child-adolescent-health-and-ageing/child-health/integrated-management-of-childhood-illnessDate accessed: May 1, 2022 Google Scholar This unintended consequence is serious as it contributes to antimicrobial resistance and affects our ability to conserve antibiotics for future generations. 5 Murray CJL Ikuta KS Sharara F et al. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399: 629-655 Summary Full Text Full Text PDF PubMed Scopus (651) Google Scholar In their Article in The Lancet Infectious Diseases, Yukari C Manabe and colleagues showed that highly accurate multiplex molecular tests for determining some of the causes of fever are now available outside of laboratory settings with only 2–3 min of hands-on time and providing results within 1 h. 6 Manabe YC Betz J Jackson O Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy study. Lancet Infect Dis. 2022; (published online June 15.)https://doi.org/10.1016/S1473-3099(22)00290-0 Summary Full Text Full Text PDF PubMed Scopus (1) Google Scholar These multiplex molecular tests that can be performed at the point of need represent another major advance towards solving the enigma of differential diagnosis of acute febrile illness, and have added utility as a public health tool for surveillance and outbreak investigations. Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy studyThis 1 h sample-to-answer, molecular device can detect common causative agents of acute febrile illness with excellent positive percent agreement and negative percent agreement directly in whole blood. The targets of the assay are prevalent in tropical and subtropical regions globally, and the assay could help to provide both public health surveillance and individual diagnoses. Full-Text PDF

Evaluation of the combination of rapid diagnostic tests and microscopy for imported malaria surveillance in Anhui Province, China

Background: In the Anhui Province, China, efforts to interrupt the local malaria transmission were successful, with no endemic cases reported since 2014. Contrastingly, imported malaria cases are still being reported, indicating a disease reintroduction risk after years of elimination. A good surveillance system is key for avoiding the risk, detecting imported cases and possible cases associated with local transmission early. Therefore, rapid diagnostic tests (RDTs) were combined with microscopy to strengthen malaria surveillance in the province. Herein, we aimed to evaluate the efficacy of this surveillance strategy.Methods: We conducted a retrospective study using malaria surveillance data from January 2016 to June 2020. Epidemiological characteristics and diagnostic information were analysed using descriptive and comparative statistics. The diagnostic performance of the combined toolbox (Wondfo RDTs plus microscopy) was evaluated based on its sensitivity, specificity, positive and negative predictive values, and Cohen's kappa coefficient, using real-time polymerase chain reaction as the gold standard.Results: The combined toolbox displayed a higher overall sensitivity for malaria cases than that of microscopy alone (93.74% vs 89.37%; padj <0.05), which could detect 94.65%, 88.16%, 95.00%, and 100.00% of Plasmodium falciparum, P. ovale, P. vivax, and P. malariae infections, respectively. In clinical practice, Wondfo RDTs ability to detect P. falciparum infections was better than that of microscopy (97.55% vs 89.67%, padj < 0.05). In contrast, microscopy displayed a higher specificity than that of Wondfo RDTs (81.82% vs 63.28%, p adj <0.05). Moreover, the consistency between microscopy and the gold standard results was also better than that of RDTs (Kappa value:0.669 vs 0.596).Conclusions: The combination of microscopy and RDTs is an effective strategy for malaria surveillance because it possibly detected more P. falciparum infections due to the introduction of RDTs. In contrast, microscopy is complementary to some limitations related to the use of RDTs in field practice. Thus, monitoring malaria cases in non-endemic areas may require employing more than one diagnostic tool in surveillance strategies. Moreover, further understanding of the advantages and disadvantages of different detection methods is necessary for applying optimum combinations in field settings.

Management of Gram-Negative Bloodstream Infections in the Era of Rapid Diagnostic Testing: Impact With and Without Antibiotic Stewardship.

BackgroundVerigene Blood-Culture Gram-Negative is a rapid diagnostic test (RDT) that detects gram-negatives (GNs) and resistance within hours from gram stain. The majority of the data support the use of RDTs with antimicrobial stewardship (AMS) intervention in gram-positive bloodstream infection (BSI). Less is known about GN BSI.MethodsThis was a retrospective quasi-experimental (nonrandomized) study of adult patients with RDT-target GN BSI comparing patients pre-RDT/AMS vs post-RDT/pre-AMS vs post-RDT/AMS. Optimal therapy was defined as appropriate coverage with the narrowest spectrum, accounting for source and co-infecting organisms. Time to optimal therapy was analyzed using Kaplan-Meier and multivariable Cox proportional hazards regression.ResultsEight-hundred thirty-two patients were included; 237 pre-RDT/AMS vs 308 post-RDT/pre-AMS vs 237 post-RDT/AMS, respectively. The proportion of patients on optimal antibiotic therapy increased with each intervention (66.5% vs 78.9% vs 83.2%; P < .0001). Time to optimal therapy (interquartile range) decreased with introduction of RDT: 47 (7.9–67.7) hours vs 24.9 (12.4–55.2) hours vs 26.5 (10.3–66.5) hours (P = .09). Using multivariable modeling, infectious diseases (ID) consult was an effect modifier. Within the ID consult stratum, controlling for source and ICU stay, compared with the pre-RDT/AMS group, both post-RDT/pre-AMS (adjusted hazard ratio [aHR], 1.34; 95% CI, 1.04–1.72) and post-RDT/AMS (aHR, 1.28; 95% CI, 1.01–1.64), improved time to optimal therapy. This effect was not seen in the stratum without ID consult.ConclusionsWith the introduction of RDT and AMS, both proportion and time to optimal antibiotic therapy improved, especially among those with an existing ID consult. This study highlights the beneficial role of RDTs in GN BSI.

SAT353 - The head-start project: introduction of rapid diagnostic tests for hepatitis C screening in primary healthcare sites as a first step towards decentralizing hepatitis C care in Malaysia

SAT353 - The head-start project: introduction of rapid diagnostic tests for hepatitis C screening in primary healthcare sites as a first step towards decentralizing hepatitis C care in Malaysia

Trends in reported malaria cases and the effects of malaria control in the Democratic Republic of the Congo.

BackgroundConsiderable upscaling of malaria control efforts have taken place over the last 15 years in the Democratic Republic of Congo, the country with the second highest malaria case load after Nigeria. Malaria control interventions have been strengthened in line with the Millenium Development Goals. We analysed the effects of these interventions on malaria cases at health facility level, using a retrospective trend analysis of malaria cases between 2005 and 2014. Data were collected from outpatient and laboratory registers based on a sample of 175 health facilities that represents all eco-epidemiological malaria settings across the country.MethodsWe applied a time series analysis to assess trends of suspected and confirmed malaria cases, by health province and for different age groups. A linear panel regression model controlled for non-malaria outpatient cases, rain fall, nightlight intensity, health province and time fixed effects, was used to examine the relationship between the interventions and malaria case occurrences, as well as test positivity rates.ResultsOverall, recorded suspected and confirmed malaria cases in the DRC have increased. The sharp increase in confirmed cases from 2010 coincides with the introduction of the new treatment policy and the resulting scale-up of diagnostic testing. Controlling for confounding factors, the introduction of rapid diagnostic tests (RDTs) was significantly associated with the number of tested and confirmed cases. The test positivity rate fluctuated around 40% without showing any trend.ConclusionThe sharp increase in confirmed malaria cases from 2010 is unlikely to be due to a resurgence of malaria, but is clearly associated with improved diagnostic availability, mainly the introduction of RDTs. Before that, a great part of malaria cases were treated based on clinical suspicion. This finding points to a better detection of cases that potentially contributed to improved case management. Furthermore, the expansion of diagnostic testing along with the increase in confirmed cases implies that before 2010, cases were underreported, and that the accuracy of routine data to describe malaria incidence has improved.

Fever case management at private health facilities and private pharmacies on the Kenyan coast: analysis of data from two rounds of client exit interviews and mystery client visits

BackgroundPrivate sector availability and use of malaria rapid diagnostic tests (RDTs) lags behind the public sector in Kenya. Increasing channels through which quality malaria diagnostic services are available can improve access to testing and help meet the target of universal diagnostic testing. Registered pharmacies are currently not permitted to perform blood tests, and evidence of whether malaria RDTs can be used by non-laboratory private providers in line with the national malaria control guidelines is required to inform ongoing policy discussions in Kenya.MethodsTwo rounds of descriptive cross-sectional exit interviews and mystery client surveys were conducted at private health facilities and registered pharmacies in 2014 and 2015, 6 and 18 months into a multi-country project to prime the private sector market for the introduction of RDTs. Data were collected on reported RDT use, medicines received and prescribed, and case management of malaria test-negative mystery clients. Analysis compared outcomes at facilities and pharmacies independently for the two survey rounds.ResultsAcross two rounds, 534 and 633 clients (including patients) from 130 and 120 outlets were interviewed, and 214 and 250 mystery client visits were completed. Reported testing by any malaria diagnostic test was higher in private health facilities than registered pharmacies in both rounds (2014: 85.6% vs. 60.8%, p < 0.001; 2015: 85.3% vs. 56.3%, p < 0.001). In registered pharmacies, testing by RDT was 52.1% in 2014 and 56.3% in 2015. At least 75% of test-positive patients received artemisinin-based combination therapy (ACT) in both rounds, with no significant difference between outlet types in either round. Provision of any anti-malarial for test-negative patients ranged from 0 to 13.9% across outlet types and rounds. In 2015, mystery clients received the correct (negative) diagnosis and did not receive an anti-malarial in 75.5% of visits to private health facilities and in 78.4% of visits to registered pharmacies.ConclusionsNon-laboratory staff working in registered pharmacies in Kenya can follow national guidelines for diagnosis with RDTs when provided with the same level of training and supervision as private health facility staff. Performance and compliance to treatment recommendations are comparable to diagnostic testing outcomes recorded in private health facilities.

Decreased endemic malaria in Suriname: moving towards elimination

BackgroundSuriname has moved from being the country with the highest annual parasite index in the Americas to one on the threshold of elimination. The progress toward elimination in the stable populations of Suriname between 2000 and 2015 is reviewed.MethodsData was obtained from the Medical Mission and the Ministry of Health Malaria Programme case-reporting systems, and analysed with a focus on disease burden and differentiation of the disease geographically, by malaria species, age, gender, ethnicity, incidence and gametocytaemia.ResultsBetween 2000 and 2015 there were 57,811 locally acquired cases of malaria in the stable populations of Suriname. A significant reduction in indigenous malaria cases was observed from 2006 to 2015. The number of imported malaria cases saw a relative increase compared to the number of autochthonous cases. In 2015 over 95% of the cases reported in stable communities are imported, mainly from neighbouring French Guiana, a department of France. The overall decline in malaria case incidence followed the mass-distribution of free long-lasting insecticide-impregnated mosquito nets and increased awareness building efforts, improved access to malaria services as a result of the introduction of Rapid Diagnostic Tests and the implementation of active case detection in high risk areas. In addition, improved management of Plasmodium falciparum infections was achieved with the introduction of artemisinin combination therapy.ConclusionsThe existence of a network of policlinics in the interior ran by Medical Mission, for the indigenous population, allowed the rapid implementation of the strategy in stable communities. The success of malaria control in Suriname indicates that the availability at local level, of prompt and adequate prevention, diagnosis and treatment is a key requirement for the elimination of malaria.

Evaluation of GENEDIA® malaria pf/pan antigen test relative to blood smear microscopy in a malaria diagnosis in Ethiopia.

Background: Early and accurate diagnosis of malaria followed by prompt treatment is crucial to reduce morbidity and mortality in endemic regions. Presumptive treatment of malaria is widely practiced where microscopy or rapid diagnostic tests are not readily available. Introduction of rapid diagnostic tests (RDTs) for the treatment of malaria needs prior evaluation of their performance relative to reference methods. Hence, this study evaluated the diagnostic capacity of GENEDIA® Malaria Pf/pan Ag Rapid Test relative to blood smear for P. falciparum and P. vivax malaria in Ethiopia. Methods: This was a cross-sectional study conducted from November to December 2014 on malaria blood samples collected from symptomatic patients who visited malaria control center in Adama, Oromia Region, Ethiopia. Thick and thin malaria blood films stained by 10% Giemsa working solution were examined microscopically under 100x magnifications for Plasmodium detection, species identification and determination of parasitaemia. The RDT was performed as per the manufacturer’s instruction. Results: A total of 417 febrile malaria suspected outpatients were diagnosed in the study center. Of which, 149(35.7%) by light microscopy (Pf =47; Pv =93; mixed Pf/Pv =9), and 151 (36.2%) by Genedia® RDT (Pf=20; Pv=87; Pf/pan=44) were positive for malaria. RDT detected 0.6% (n=27) mixed Pf/pv cases on samples that were P. falciparum conformed by microscopy. The general sensitivity, specificity, positive and negative predictive value of GENEDIA® test relative to microscopy were respectively 95.3%, 96.6%, 94.0% and 97.4%. Conclusion: The GENEDIA® Malaria Pf/pan Ag test showed good sensitivity and specificity to diagnose malaria in Ethiopia, with respect to the blood film microscopy.

Modelling the drivers of the spread of Plasmodium falciparum hrp2 gene deletions in sub-Saharan Africa.

Rapid diagnostic tests (RDTs) have transformed malaria diagnosis. The most prevalent P. falciparum RDTs detect histidine-rich protein 2 (PfHRP2). However, pfhrp2 gene deletions yielding false-negative RDTs, first reported in South America in 2010, have been confirmed in Africa and Asia. We developed a mathematical model to explore the potential for RDT-led diagnosis to drive selection of pfhrp2-deleted parasites. Low malaria prevalence and high frequencies of people seeking treatment resulted in the greatest selection pressure. Calibrating our model against confirmed pfhrp2-deletions in the Democratic Republic of Congo, we estimate a starting frequency of 6% pfhrp2-deletion prior to RDT introduction. Furthermore, the patterns observed necessitate a degree of selection driven by the introduction of PfHRP2-based RDT-guided treatment. Combining this with parasite prevalence and treatment coverage estimates, we map the model-predicted spread of pfhrp2-deletion, and identify the geographic regions in which surveillance for pfhrp2-deletion should be prioritised.

Impact of introduction of rapid diagnostic tests for malaria on antibiotic prescribing: analysis of observational and randomised studies in public and private healthcare settings

Objectives To examine the impact of use of rapid diagnostic tests for malaria on prescribing of antimicrobials, specifically antibiotics, for acute febrile illness in Africa and Asia.Design Analysisof nine preselected...

Introducing malaria rapid diagnostic tests in private medicine retail outlets: A systematic literature review.

BackgroundMany patients with malaria-like symptoms seek treatment in private medicine retail outlets (PMR) that distribute malaria medicines but do not traditionally provide diagnostic services, potentially leading to overtreatment with antimalarial drugs. To achieve universal access to prompt parasite-based diagnosis, many malaria-endemic countries are considering scaling up malaria rapid diagnostic tests (RDTs) in these outlets, an intervention that may require legislative changes and major investments in supporting programs and infrastructures. This review identifies studies that introduced malaria RDTs in PMRs and examines study outcomes and success factors to inform scale up decisions.MethodsPublished and unpublished studies that introduced malaria RDTs in PMRs were systematically identified and reviewed. Literature published before November 2016 was searched in six electronic databases, and unpublished studies were identified through personal contacts and stakeholder meetings. Outcomes were extracted from publications or provided by principal investigators.ResultsSix published and six unpublished studies were found. Most studies took place in sub-Saharan Africa and were small-scale pilots of RDT introduction in drug shops or pharmacies. None of the studies assessed large-scale implementation in PMRs. RDT uptake varied widely from 8%-100%. Provision of artemisinin-based combination therapy (ACT) for patients testing positive ranged from 30%-99%, and was more than 85% in five studies. Of those testing negative, provision of antimalarials varied from 2%-83% and was less than 20% in eight studies. Longer provider training, lower RDT retail prices and frequent supervision appeared to have a positive effect on RDT uptake and provider adherence to test results. Performance of RDTs by PMR vendors was generally good, but disposal of medical waste and referral of patients to public facilities were common challenges.ConclusionsExpanding services of PMRs to include malaria diagnostic services may hold great promise to improve malaria case management and curb overtreatment with antimalarials. However, doing so will require careful planning, investment and additional research to develop and sustain effective training, supervision, waste-management, referral and surveillance programs beyond the public sector.

Expanding access to parasite-based malaria diagnosis through retail drug shops in Tanzania: evidence from a randomized trial and implications for treatment

BackgroundTanzania has seen a reduction in the fraction of fevers caused by malaria, likely due in part to scale-up of control measures. While national guidelines require parasite-based diagnosis prior to treatment, it is estimated that more than half of suspected malaria treatment-seeking in Tanzania initiates in the private retail sector, where diagnosis by malaria rapid diagnostic test (RDT) or microscopy is illegal. This pilot study investigated whether the introduction of RDTs into Accredited Drug Dispensing Outlets (ADDOs) under realistic market conditions would improve case management practices.MethodsDispensers from ADDOs in two intervention districts in Tanzania were trained to stock and perform RDTs and monitored quarterly. Each district was assigned a different recommended retail price to evaluate the need for a subsidy. Malaria RDT and artemisinin-based combination therapy (ACT) uptake and availability were measured pre-intervention and 1 year post-intervention through structured surveys of ADDO owners and exiting customers in both intervention districts and one contiguous control district. Descriptive analysis and logistic regression were used to compare the three districts and identify predictive variables for testing.Results and discussionA total of 310 dispensers from 262 ADDOs were trained to stock and perform RDTs. RDT availability in intervention ADDOs increased from 1% (n = 172) to 73% (n = 163) during the study; ACT medicines were available in 75% of 260 pre-intervention and 68% of 254 post-intervention ADDOs. Pre-treatment testing performed within the ADDO increased from 0 to 65% of suspected malaria patients who visited a shop (95% CI 60.8–69.6%) with no difference between intervention districts. Overall parasite-based diagnosis increased from 19 to 74% in intervention districts and from 3 to 18% in the control district. Prior knowledge of RDT availability (aOR = 1.9, p = 0.03) and RDT experience (aOR = 1.9, p = 0.01) were predictors for testing. Adherence data indicated that 75% of malaria positives received ACT, while 3% of negatives received ACT.ConclusionsTrained and supervised ADDO dispensers in rural Tanzania performed and sold RDTs under real market conditions to two-thirds of suspected malaria patients during this one-year pilot. These results support the hypothesis that introducing RDTs into regulated private retail sector settings can improve malaria testing and treatment practices without an RDT subsidy.Trial registration ISRCTN ISRCTN14115509

Introducing rapid tests for malaria into the retail sector: what are the unintended consequences?

The observation that many people in Africa seek care for febrile illness in the retail sector has led to a number of public health initiatives to try to improve the...

How Do Patients and Health Workers Interact around Malaria Rapid Diagnostic Testing, and How Are the Tests Experienced by Patients in Practice? A Qualitative Study in Western Uganda.

BackgroundSuccessful scale-up in the use of malaria rapid diagnostic tests (RDTs) requires that patients accept testing and treatment based on RDT results and that healthcare providers treat according to test results. Patient-provider communication is a key component of quality care, and leads to improved patient satisfaction, higher adherence to treatment and better health outcomes. Voiced or perceived patient expectations are also known to influence treatment decision-making among healthcare providers. While there has been a growth in literature on provider practices around rapid testing for malaria, there has been little analysis of inter-personal communication around the testing process. We investigated how healthcare providers and patients interact and engage throughout the diagnostic and treatment process, and how the testing service is experienced by patients in practice.MethodsThis research was conducted alongside a larger study which explored determinants of provider treatment decision-making following negative RDT results in a rural district (Kibaale) in mid-western Uganda, ten months after RDT introduction. Fifty-five patients presenting with fever were observed during routine outpatient visits at 12 low-level public health facilities. Observation captured communication practices relating to test purpose, results, diagnosis and treatment. All observed patients or caregivers were immediately followed up with in-depth interview. Analysis followed the ‘framework’ approach. A summative approach was also used to analyse observation data.ResultsProviders failed to consistently communicate the reasons for carrying out the test, and particularly to RDT-negative patients, a diagnostic outcome or the meaning of test results, also leading to confusion over what the test can detect. Patients appeared to value testing, but were frustrated by the lack of communication on outcomes. RDT-negative patients were dissatisfied by the absence of information on an alternative diagnosis and expressed uncertainty around adequacy of proposed treatment.ConclusionsPoor provider communication practices around the testing process, as well as limited inter-personal exchange between providers and patients, impacted on patients’ perceptions of their proposed treatment. Patients have a right to health information and may be more likely to accept and adhere to treatment when they understand their diagnosis and treatment rationale in relation to their perceived health needs and visit expectations.

A qualitative study of health professionals' uptake and perceptions of malaria rapid diagnostic tests in Burkina Faso.

BackgroundSince 2012, rapid diagnostic tests (RDT) for malaria have been in use nationwide in Burkina Faso. The objective is to strengthen health professionals’ diagnostic capabilities and promote good therapeutic practices. A qualitative study was conducted to learn about the adoption of this tool in the natural context of a national scale-up policy.MethodsThis study involved five health centres in two health districts. Twenty-eight individual interviews were conducted in 2013 with health professionals and members of the health district management teams. Health professionals’ RDT use and drug prescription practices were observed during 278 curative care consultations over 5 weeks.ResultsHealth professionals assessed the use of RDT positively as it allowed them to reach clear and accurate diagnoses and above all to deliver appropriate, rational care. However, the introduction of RDTs did not really change their diagnostic practices or prescribing practices for artemisinin-based combination therapy (ACT). They continued to rely predominantly on symptoms in establishing their diagnoses because of doubts regarding the reliability of the tests and the occasional stockouts of RDTs experienced by the health centres. Patients with negative RDT results continued to receive anti-malarial treatments. However, the situation remains quite heterogeneous.ConclusionThe use of RDTs points to the co-existence of official standards and different standards applied in practice. Setting up regular supervision activities provided an opportunity to observe and understand the various obstacles encountered by health professionals and to monitor how official directives are put into practice. For efficient use of RDTs and their results, health professionals need information and directives that are up-to-date and standardized.

Why do health workers give anti-malarials to patients with negative rapid test results? A qualitative study at rural health facilities in western Uganda.

BackgroundThe large-scale introduction of malaria rapid diagnostic tests (RDTs) promises to improve management of fever patients and the rational use of valuable anti-malarials. However, evidence on the impact of RDT introduction on the overprescription of anti-malarials has been mixed. This study explored determinants of provider decision-making to prescribe anti-malarials following a negative RDT result.MethodsA qualitative study was conducted in a rural district in mid-western Uganda in 2011, ten months after RDT introduction. Prescriptions for all patients with negative RDT results were first audited from outpatient registers for a two month period at all facilities using RDTs (n = 30). Facilities were then ranked according to overall prescribing performance, defined as the proportion of patients with a negative RDT result prescribed any anti-malarial. Positive and negative deviant facilities were sampled for qualitative investigation; positive deviants (n = 5) were defined ex post facto as <0.75 % and negative deviants (n = 7) as >5 %. All prescribing clinicians were targeted for qualitative observation and in-depth interview; 55 fever cases were observed and 22 providers interviewed. Thematic analysis followed the ‘framework’ approach.Results8344 RDT-negative patients were recorded at the 30 facilities (prescription audit); 339 (4.06 %) were prescribed an anti-malarial. Of the 55 observed patients, 38 tested negative; one of these was prescribed an anti-malarial. Treatment decision-making was influenced by providers’ clinical beliefs, capacity constraints, and perception of patient demands. Although providers generally trusted the accuracy of RDTs, anti-malarial prescription was driven by perceptions of treatment failure or undetectable malaria in patients who had already taken artemisinin-based combination therapy prior to facility arrival. Patient assessment and other diagnostic practices were minimal and providers demonstrated limited ability to identify alternative causes of fever. Provider perceptions of patient expectations sometimes appeared to influence treatment decisions.ConclusionsThe study found high provider adherence to RDT results, but that providers believed in certain clinical exceptions and felt they lacked alternative options. Guidance on how the RDT works and testing following partial treatment, better methods for assisting providers in diagnostic decision-making, and a context-appropriate provider behaviour change intervention package are needed.