scholarly journals Usability of a point-of-care diagnostic to identify glucose-6-phosphate dehydrogenase deficiency: a multi-country assessment of test label comprehension and results interpretation

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Emily Gerth-Guyette ◽  
Wondimagegn Adissu ◽  
Marcelo Brito ◽  
Eduardo Garbin ◽  
Marcela Macedo ◽  
...  

Abstract Background Point-of-care glucose-6-phosphate dehydrogenase (G6PD) testing has the potential to make the use of radical treatment for vivax malaria safer and more effective. Widespread use of G6PD tests as part of malaria case management has been limited, in part due to due concerns regarding product usability, user training, and supervision. This study seeks to assess how well end users can understand the Standard™ G6PD Test (SD Biosensor, Suwon, South Korea) workflow, result output, and label after training. This will ultimately help inform test registration and introduction. Methods Potential G6PD test users who provide malaria case management at three sites in Brazil, Ethiopia, and India were trained on the use of the SD Biosensor Standard G6PD Test and assessed based on their ability to understand the test workflow and interpret results. The assessment was done through a questionnaire, designed to assess product usability against key technical product specifications and fulfill regulatory evidence requirements. Any participant who obtained 85% or above correct responses to the questionnaire was considered to adequately comprehend how to use and interpret the test. Results Forty-five participants, including malaria microscopists, laboratory staff, nurses, and community health workers took part in the study. Seventy-eight percent of all participants in the study (35/45) obtained passing scores on the assessment with minimal training. Responses to the multiple-choice questions indicate that most participants understood well the test intended use, safety claims, and warnings. The greatest source of error regarding the test was around the correct operating temperature. Most test results were also read and interpreted correctly, with the haemoglobin measurement being a more problematic output to interpret than the G6PD measurement. Conclusions These data results show how a standardized tool can be used to assess a user’s ability to run a point-of-care diagnostic and interpret results. When applied to the SD Biosensor Standard G6PD Test, this tool demonstrates that a range of users across multiple contexts can use the test and suggests improvements to the test instructions and training that can improve product usability, increase user comprehension, and ultimately contribute to more widespread effective use of point-of-care G6PD tests. Trial registration: NCT04033640

Author(s):  
Michael Aidoo ◽  
Sandra Incardona

In 2010, the World Health Organization changed its guidance on malaria case management, recommending parasitological confirmation of all suspected cases before treatment with an antimalarial. This recommendation was in large part as a result of the availability of quality assured malaria rapid diagnostic tests (RDTs) that made it possible for malaria diagnosis to be performed by laboratory staff in all health facilities irrespective of the facility’s place in the tiered health system. Community health workers and other non-laboratory health workers who traditionally did not perform malaria testing due to the technical and logistic demands of smear microscopy were now able to test for malaria. The use of RDTs has led to substantial increases in testing rates, improved quality of case management, as well as more accurate reporting of malaria cases. Although current RDTs have limitations, they remain one of the most important tools in contemporary malaria control. Further improvements to existing products, such as increased sensitivity for non-falciparum tests, diversification of Plasmodium falciparum antigen targets, along with strengthened health system support for current RDTs will further enhance their utility in malaria control and prevention.


2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Beatrice Amboko ◽  
Kasia Stepniewska ◽  
Peter M. Macharia ◽  
Beatrice Machini ◽  
Philip Bejon ◽  
...  

Abstract Background Health workers' compliance with outpatient malaria case-management guidelines has been improving, specifically regarding the universal testing of suspected cases and the use of artemisinin-based combination therapy (ACT) only for positive results (i.e., ‘test and treat’). Whether the improvements in compliance with ‘test and treat’ guidelines are consistent across different malaria endemicity areas has not been examined. Methods Data from 11 national, cross-sectional, outpatient malaria case-management surveys undertaken in Kenya from 2010 to 2016 were analysed. Four primary indicators (i.e., ‘test and treat’) and eight secondary indicators of artemether-lumefantrine (AL) dosing, dispensing, and counselling were measured. Mixed logistic regression models were used to analyse the annual trends in compliance with the indicators across the different malaria endemicity areas (i.e., from highest to lowest risk being lake endemic, coast endemic, highland epidemic, semi-arid seasonal transmission, and low risk). Results Compliance with all four ‘test and treat’ indicators significantly increased in the area with the highest malaria risk (i.e., lake endemic) as follows: testing of febrile patients (OR = 1.71 annually; 95% CI = 1.51–1.93), AL treatment for test-positive patients (OR = 1.56; 95% CI = 1.26–1.92), no anti-malarial for test-negative patients (OR = 2.04; 95% CI = 1.65–2.54), and composite ‘test and treat’ compliance (OR = 1.80; 95% CI = 1.61–2.01). In the low risk areas, only compliance with test-negative results significantly increased (OR = 2.27; 95% CI = 1.61–3.19) while testing of febrile patients showed declining trends (OR = 0.89; 95% CI = 0.79–1.01). Administration of the first AL dose at the facility significantly increased in the areas of lake endemic (OR = 2.33; 95% CI = 1.76–3.10), coast endemic (OR = 5.02; 95% CI = 2.77–9.09) and semi-arid seasonal transmission (OR = 1.44; 95% CI = 1.02–2.04). In areas of the lowest risk of transmission and highland epidemic zone, none of the AL dosing, dispensing, and counselling tasks significantly changed over time. Conclusions There is variability in health workers' compliance with outpatient malaria case-management guidelines across different malaria-risk areas in Kenya. Major improvements in areas of the highest risk have not been seen in low-risk areas. Interventions to improve practices should be targeted geographically.


2018 ◽  
Vol 4 (4) ◽  
pp. 34 ◽  
Author(s):  
Athena Anderle ◽  
Germana Bancone ◽  
Gonzalo Domingo ◽  
Emily Gerth-Guyette ◽  
Sampa Pal ◽  
...  

Glucose-6-phosphate dehydrogenase (G6PD) deficiency, an X-linked genetic disorder, is associated with increased risk of jaundice and kernicterus at birth. G6PD deficiency can manifest later in life as severe hemolysis, when the individual is exposed to oxidative agents that range from foods such as fava beans, to diseases such as typhoid, to medications such as dapsone, to the curative drugs for Plasmodium (P.) vivax malaria, primaquine and tafenoquine. While routine testing at birth for G6PD deficiency is recommended by the World Health Organization for populations with greater than 5% prevalence of G6PD deficiency and to inform P. vivax case management using primaquine, testing coverage is extremely low. Test coverage is low due to the need to prioritize newborn interventions and the complexity of currently available G6PD tests, especially those used to inform malaria case management. More affordable, accurate, point-of-care (POC) tests for G6PD deficiency are emerging that create an opportunity to extend testing to populations that do not have access to high throughput screening services. Some of these tests are quantitative, which provides an opportunity to address the gender disparity created by the currently available POC qualitative tests that misclassify females with intermediate G6PD activity as normal. In populations where the epidemiology for G6PD deficiency and P. vivax overlap, screening for G6PD deficiency at birth to inform care of the newborn can also be used to inform malaria case management over their lifetime.


2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Elizabeth Davlantes ◽  
Cristolde Salomao ◽  
Flavio Wate ◽  
Deonilde Sarmento ◽  
Humberto Rodrigues ◽  
...  

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Abiodun A. Ojo ◽  
Kolawole Maxwell ◽  
Olusola Oresanya ◽  
Justice Adaji ◽  
Prudence Hamade ◽  
...  

Abstract Background Nigeria was among the first African countries to adopt and implement change of treatment policy for severe malaria from quinine to artesunate. Seven years after the policy change health systems readiness and quality of inpatient malaria case-management practices were evaluated in Kano State of Nigeria. Methods A cross-sectional survey was undertaken in May 2019 at all public hospitals. Data collection comprised hospital assessments, interviews with inpatient health workers and data extraction from medical files for all suspected malaria patients admitted to the paediatric and medical wards in April 2019. Descriptive analyses included 22 hospitals, 154 health workers and 1,807 suspected malaria admissions analysed from malaria test and treat case-management perspective. Results 73% of hospitals provided malaria microscopy, 27% had rapid diagnostic tests and 23% were unable to perform any parasitological malaria diagnosis. Artemisinin-based combination therapy (ACT) was available at 96% of hospitals, artemether vials at 68% while injectable quinine and artesunate were equally stocked at 59% of hospitals. 32%, 21% and 15% of health workers had been exposed to relevant trainings, guidelines and supervision respectively. 47% of suspected malaria patients were tested while repeat testing was rare (7%). 60% of confirmed severe malaria patients were prescribed artesunate. Only 4% of admitted non-severe test positive cases were treated with ACT, while 76% of test negative patients were prescribed an anti-malarial. Artemether was the most common anti-malarial treatment for non-severe test positive (55%), test negative (43%) and patients not tested for malaria (45%). In all categories of the patients, except for confirmed severe cases, artemether was more commonly prescribed for adults compared to children. 44% of artesunate-treated patients were prescribed ACT follow-on treatment. Overall compliance with test and treat policy for malaria was 13%. Conclusions Translation of new treatment policy for severe malaria into inpatient practice is compromised by lack of malaria diagnostics, stock-outs of artesunate and suboptimal health workers’ practices. Establishment of the effective supply chain and on-going supportive interventions for health workers accompanied with regular monitoring of the systems readiness and clinical practices are urgently needed.


PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259020
Author(s):  
Beatrice Amboko ◽  
Kasia Stepniewska ◽  
Lucas Malla ◽  
Beatrice Machini ◽  
Philip Bejon ◽  
...  

Background Health workers’ compliance with outpatient malaria case-management guidelines has been improving in Africa. This study examined the factors associated with the improvements. Methods Data from 11 national, cross-sectional health facility surveys undertaken from 2010–2016 were analysed. Association between 31 determinants and improvement trends in five outpatient compliance outcomes were examined using interactions between each determinant and time in multilevel logistic regression models and reported as an adjusted odds ratio of annual trends (T-aOR). Results Among 9,173 febrile patients seen at 1,208 health facilities and by 1,538 health workers, a higher annual improvement trend in composite “test and treat” performance was associated with malaria endemicity-lake endemic (T-aOR = 1.67 annually; p<0.001) and highland epidemic (T-aOR = 1.35; p<0.001) zones compared to low-risk zone; with facilities stocking rapid diagnostic tests only (T-aOR = 1.49; p<0.001) compared to microscopy only services; with faith-based/non-governmental facilities compared to government-owned (T-aOR = 1.15; p = 0.036); with a daily caseload of >25 febrile patients (T-aOR = 1.46; p = 0.003); and with under-five children compared to older patients (T-aOR = 1.07; p = 0.013). Other factors associated with the improvement trends in the “test and treat” policy components and artemether-lumefantrine administration at the facility included the absence of previous RDT stock-outs, community health workers dispensing drugs, access to malaria case-management and Integrated Management of Childhood Illness (IMCI) guidelines, health workers’ gender, correct health workers’ knowledge about the targeted malaria treatment policy, and patients’ main complaint of fever. The odds of compliance at the baseline were variable for some of the factors. Conclusions Targeting of low malaria risk areas, low caseload facilities, male and government health workers, continuous availability of RDTs, improving health workers’ knowledge about the policy considering age and fever, and dissemination of guidelines might improve compliance with malaria guidelines. For prompt treatment and administration of the first artemether-lumefantrine dose at the facility, task-shifting duties to community health workers can be considered.


2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Hosein Azizi ◽  
Reza Majdzadeh ◽  
Ayat Ahmadi ◽  
Elham Davtalab Esmaeili ◽  
Behrouz Naghili ◽  
...  

Abstract Background Health workers (HWs) appropriate malaria case management includes early detection and prompt treatment with appropriate anti-malarial drugs. Subsequently, HWs readiness and practice are considered authentic evidence to measure the health system performance regarding malaria control programme milestones and to issue malaria elimination certification. There is no comprehensive evidence based on meta-analysis, to measure the performance of HWs in case management of malaria. This study aimed to evaluate HWs performance in early malaria case detection (testing) and the appropriate treatment. Methods The published literature in English was systematically searched from Medline, Scopus, Embase, and Malaria Journal up to 30th December 2020. The inclusion criteria were any studies that assessed HWs practice in early case detection by malaria testing and appropriate treatment. Eligibility assessment of records was performed independently in a blinded, standardized way by two reviewers. Pooled prevalence estimates were stratified by HWs cadre type. Meta-regression analysis was performed to explore the impact of the appropriateness of the method and risk of bias as potential sources of the heterogeneity in the presence of effective factors. Results The study pooled data of 9245 HWs obtained from 15 included studies. No study has been found in eliminating settings. The pooled estimate for appropriate malaria treatment and malaria testing were 60%; 95% CI: 53–67% and 57%; 95% CI: 49–65%, respectively. In the final multivariable meta-regression, HWs cadre and numbers, appropriateness of study methods, malaria morbidity and mortality, total admissions of malaria suspected cases, gross domestic product, availability of anti-malarial drugs, and year of the publication were explained 85 and 83% of the total variance between studies and potential sources of the heterogeneity for malaria testing and treating, respectively. Conclusion HWs adherence to appropriate malaria case management guidelines were generally low while no study has been found in eliminating countries. Studies with the inappropriateness methods and risk of bias could be overestimating the actual proportion of malaria appropriate testing and treating. Strategies that focus on improving readiness and early identification of acute febrile diseases especially in the countries that progress to malaria elimination should be highly promoted.


2014 ◽  
Vol 21 ◽  
pp. 172
Author(s):  
E.N. Wesangula ◽  
D. Memusi ◽  
J. Mbului ◽  
R. Kolute

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