Category Archives: Diagnosis

Performance assessment of laboratory technicians on Malaria Microscopy in 5 high endemic districts of Rwanda

Parasitological diagnosis plays an increasing role in malaria control and elimination. Noella Umulisa, Angelique Mugirente, Tharcisse Munyaneza, Aniceth Rucogoza, Aline Uwimana, Beata Mukarugwiro, Stephen Mutwiwa, Aimable and Mbituyumuremyi of the
Maternal and Child Survival Program, Jhpiego, the National Reference Laboratory, Rwanda Biomedical Centre (RBC), and the Malaria and Other Parasitic Diseases Division (Mal & OPDD) in Rwanda will present their experiences building the capacity of lab technicians during Session 47 at the American Society of Tropical Medicine and Hygiene Annual Meeting on 6 November 2017.  Their abstract is found below.

Accurate malaria diagnostics help to establish the true prevalence of each Plasmodium species and can ensure appropriate treatment. Light microscopy is the gold standard for malaria diagnosis and sufficient training of laboratory staff is paramount for the correct microscopy diagnosis of malaria. In Rwanda each of about 400 health centers has a laboratory able to perform malaria microscopy, at least 2 trained lab technicians and 1 to 2 functioning microscopes.

The objective of the study is to evaluate the performance of laboratory technicians in detecting and quantifying malaria parasites in 81 health centers from 5 highly endemic districts (Huye, Nyanza, Ngoma, Kirehe, Kayonza, Gatsibo). In October 2015 the Rwanda Biomedical Center and partners trained 1 lab technician per health center from these districts in malaria microscopy.

The training emphasized determining parasite density and detection of malaria species. From August to September 2016 a follow-up assessment was conducted. Of the 81 technicians trained, 30 were randomly chosen and assessed at their health facilities.

A standardized pre-validated slide panel of 5 slides was distributed, a comprehensive checklist used to collect information and conduct visual inspection and maneuvers used in routine malaria diagnosis. During the training a significant increase was found between pre and post tests with median scores improving from 47% to 85%.

As part of the assessment 150 lab tech-prepared slides were analyzed to evaluate the quality of thick and thin blood smears. There was a significant increase in quality of both blood smear types. The sensitivity and specificity of participants in detection of malaria parasites were 100% and 86% respectively, while species identification and parasite quantification accuracy were 79% and 75% respectively.

The findings of this assessment support the need for continuous capacity building for laboratory staff to ensure accurate malaria diagnosis for appropriate treatment and suggest that District hospitals may benefit from conducting regular malaria microscopy diagnosis quality control/assurance activities at health center laboratories.

Asymptomatic and Sub-Microscopic Malaria: a Challenge to Elimination Efforts

WHO says that, “In settings where malaria is actively being eliminated or has been eliminated, a “case” is the occurrence of any confirmed malaria infection with or without symptoms.” Several recent studies describe the importance of paying attention to asymptomatic infections.

In the Bagamoyo District of Tanzania Sumari and colleagues collected blood samples and examined them for Plasmodium falciparum prevalence using rapid diagnostic test (RDT), light microscopy (LM) and reverse transcription quantitative PCR. While overall prevalence was higher in symptomatic children using all three methods, asymptomatic children had a higher prevalence of gametocytes using light microscopy and PCR.  They concluded that, “The higher gametocytemia observed in asymptomatic children indicates the reservoir infections and points to the need for detection and treatment of both asymptomatic and symptomatic malaria.”

The health effects of asymptomatic plasmodial infections (API) on children were documented in Rwanda. These included “Plasmodium infection was associated with anaemia, fever, underweight, clinically assessed malnutrition and histories of fever, tiredness, weakness, poor appetite, abdominal pain, and vomiting” and were generally more common with submicroscopic infection.

Besides children other groups are at risk from API.  Malaria during pregnancy is a life and health threat to both the pregnant woman and the unborn child. Thirty-seven percent of asymptomatic pregnant women who had just delivered in Colombia were found to have parasitemia. Using microscopy only 8% were identified, such that without PCR the true extent of the problem would not have been identified. Thus, there is also concern for submicroscopic malaria and well as API generally. Asymptomatic and submicroscopic infections in areas co-endemic for P. falciparum and P. vivax are major contributors to anemia, not only in children but also in adults.

Working along the China-Myanmar border area, Zhao et al. explained that, “Sensitive methods for detecting asymptomatic malaria infections are essential for identifying potential transmission reservoirs and obtaining an accurate assessment of malaria epidemiology in low-endemicity areas aiming to eliminate malaria.” Thus they tried three molecular detection methods side-by-side, namely nested PCR targeting the rRNA genes, nested RT-PCR to detect parasite rRNA, and CLIP-PCR to detect parasite rRNA.

Interestingly the presence of fever is no guarantee that malaria parasites will be found. A study in Gabon demonstrated that among febrile patients only 1% had parasites found through microscopy compared to 32% through molecular testing. These studies have demonstrated the need for a better understanding of malaria transmission across different zones and strata in a country in the light of asymptomatic and submicroscopic malaria, especially gametocytemia. This should lead to better targeting of case detection, improved treatment and better compliance with preventive measures.

Nepal on the Path to Malaria Elimination

Jhpiego’s Emmanuel Le Perru has been placed with Nepal’s malaria control program by the Maternal and Child Survival Program (USAID) to strengthen the agency’s overall response to malaria as well as ensure top performance of Nepal’s Global Fund Malaria grant. Emmanuel shares his experiences with us here.

From 3,000 cases in 2010, Nepal reported around 1,000 cases in 2016, including 85% Plasmodium vivax cases. However private sector reporting is almost null so number of total cases may be the double. Nepal’s National Malaria Strategic Plan (NMSP) targets Elimination by 2022 (0 indigenous cases) with WHO certification by 2026.

Ward Level Micro-stratification is an important step for targeting appropriate interventions. Key interventions in the NMSP include case notification system by SMS (from health post workers or district vector control inspectors) to a Malaria Disease Information System, later to be merged with DHIS2. Case investigation teams conduct case and foci profiling as well as “passive cases” active detection and treatment (including staff from district such as surveillance coordinator, vector control inspector, and entomologist).

Malaria Mobile Clinics actively search/treat new cases in high risk areas (slums, brick factories, river villages or flooded areas, migrant workers villages, etc.). PCR diagnosis with Dry Blood Spot or Whole Blood is used to identify low density parasite cases, relapses or re-introduction. Coming up in April-June 2018 will be a Pilot of MDA (primaquine) for Plasmodium vivax in isolated settings (80% of cases in the country are P vivax).

Recent successes in the national malaria effort include the number of cases notified by SMS went from 0% to 45%. Also the number of cases fully investigated went from 22% to 52%, though this needs to go up to 95% for elimination. 73% of districts are now submitting timely malaria data reports per national guidelines, an increase from 52% in November 2015.

The border runs right through this town making importation of malaria cases easy

The Global Fund (GFATM) malaria grant rating went from B2 to A2. Nepal Epidemiology Disease Control Division (EDCD), WHO and GFATM are keen to pilot MDA for P vivax in isolated setting which MCSP/Jhpiego Advisor taking the lead.

Moving forward the malaria elimination effort needs to address Indo-Nepal Cross boarder collaboration since 45% cases are imported. Hopefully WHO will help EDCD Nepal to propose a plan of action to India. The program still needs to convince partners of relevance of malaria mobile clinics vs community testing and of the relevance of MDA for P vivax. More entomological and PCR/laboratory expertise is needed. With these measures malaria elimination should be in sight.

World Health Workers Week, a Time to Recognize Health Worker Contributions to Malaria Care

Since the beginning of the Roll Back malaria Partnership in 1998 there has been strong awareness that malaria control success is inextricably tied to the quality of health systems. Achieving coverage of malaria interventions involves all aspects of the health system but most particularly the human resources who plan, deliver and assess these services. World Health Worker Week is a good opportunity to recognize health worker contributions to ridding the world of malaria.

We can start with community health workers who may be informal but trained volunteers or front line formal health staff.  According to the Frontline Health Workers Coalition, “Frontline health workers provide immunizations and treat common infections. They are on the frontlines of battling deadly diseases like Ebola and HIV/AIDS, and many families rely on them as trusted sources of information for preventing, treating and managing a variety of leading killers including diarrhea, pneumonia, malaria and tuberculosis.”

The presence of CHWs exemplifies the ideal of a partnership between communities and the health system. With appropriate training and supervision CHWs ensure that malaria cases are diagnosed and treated promptly and appropriately, malaria prevention activities like long lasting insecticide-treated nets are implemented and pregnant women are protected from the dangers of the disease. CHWs save lives according to Nkonki and colleagues who “found evidence of cost-effectiveness of community health worker (CHW) interventions in reducing malaria and asthma, decreasing mortality of neonates and children, improving maternal health, increasing exclusive breastfeeding and improving malnutrition, and positively impacting physical health and psychomotor development amongst children.”

CHWs do not act in isolation but depend on health workers at the facility and district levels for training, supervision and maintenance of supplies and inventories. These health staff benefit from capacity building – when they are capable of performing malaria tasks, they can better help others learn and practice.

A good example of this capacity building is the Improving Malaria Care (IMC) project in Burkina Faso, implemented by Jhpiego and supported by USAID and the US President’s malaria Initiative. IMC builds capacity of health workers at facility and district level to improve malaria prevention service delivery and enhance accuracy in malaria diagnosis and treatment. Additionally capacity building is provided to health staff in the National Malaria Control Program to plan, design, manage and coordinate a comprehensive malaria control program. As a result of capacity building there has been a large increase in malaria cases diagnosed using parasitological techniques and in the number of women getting more doses of intermittent preventive treatment to prevent malaria during pregnancy.

Malaria care is much more than drugs, tests and nets. Health worker capacity is required to get the job done and move us forward on the pathway to eliminate malaria.

Leadership and Support for Malaria Pre-Elimination in Nepal

Emmanuel Le Perru, Jhpiego field staff in Nepal, shared his experiences in aiding the malaria pre-elimination efforts in the country during a retreat that preceded the 65th Annual Meeting of the American Society of Tropical Medicine and Hygiene in Atlanta. Here are some highlights of his talk.

risk-mapMalaria Pre-Elimination efforts are targeting 0 deaths as well as investigation of 100% of confirmed cases in Nepal. Systematic entomology investigation/interventions are required. Glucose-6-Phosphate Dehydrogenase deficiency (enzyme genetic defect causing hemolysis with primaquine) testing for Plasmodium vivax in high G6PDd prevalence communities is required. Cases should receive treatment within 72 hours of symptoms for Pf (to quickly prevent transmission and gametocyte reservoir). There is also a need to distinguish between indigenous and imported cases.

Jhpiego is providing technical assistance and capacity building for Nepal’s Ministry of Health pre-elimination efforts as follows:

  • Integrated Vector Management
  • Micro-stratification
  • Entomology curriculum to be conducted in medical college (need new positions)
  • Case-based Surveillance guidelines
  • Private-sector engagement (for increased reporting and product quality control/procurement such as Antigen RDTs)
  • Capacity Assessments in 9 health systems strengthening components at central and district levels (Jhpiego Malaria Implementation Guide)
  • Human resources: clear job descriptions and performance goals
  • Leadership & Management development program

gfatm-bednets-distProgram highlights include the fact that the Global Fund malaria grant rating improved from B2 (inadequate but demonstrating potential) in January 2016, but now A2 (meeting expectations) in November 2016. Concept note for operational research at 2 or 3 border check points has been developed in order to determine whether such intervention (communication & voluntary screening) is cost-effective and relevant to catch/target imported cases, raise awareness on malaria available services, detect/prevent sources of potential outbreaks. This will inform GFATM on the relevance to fund such intervention. A similar approach was done at the China-Myanmar border but was not recognized by not WHO.

Nepal's Global Fund Grant Indicators for Malaria Case Management

Nepal’s Global Fund Grant Indicators for Malaria Case Management

Although the National Malaria Strategic Plan refers to high risk groups (forest workers, national parks security personnel, refugees, prisoners, etc.) evidence is needed to back this up. A study or improved investigation forms are needed to identify such groups and use this information to design appropriate behavior change communications and other interventions.

Special Programming Highlights include proposing a focus on Closed/Isolated Settings/Foci (limited migration, duration and population) to WHO and GFATM. Considering a targeted mass drug administration (MDA) Plasmodium vivax (not yes recommended by WHO) with Primaquine/G6PD testing. Consideration is being given to new drugs in the pipeline such as Ivermectin. Molecular Testing using Polymerase Chain Reaction (PCR) to detect low parasitemia, asymptomatic or re-infection cases (Pv includes inactive/dormant sporozoites known as hypnozoites) is being proposed.

Community based testing as proposed in the Global Fund grant needs strengthening. Therefore RDT use by Female Community Health Volunteer is being considered. Active case detection is another possibility for those areas moving toward pre-elimination. As mentioned, there is also need for studies of asymptomatic infection.

Lessons learned so far for best practices for efforts in identifying specific pre-elimination interventions include the value of getting consensus at national level through the Malaria Technical Working Group. There is also need to challenge WHO recommendations and engage dialogue to get creative. At present there is a risk of a Catch 22 situation wherein the GFATM asks for innovative interventions but at the same time tries to adhere strictly WHO to existing guidance.

The Nepalese malaria program is in constant dialogue with the GFATM Fund Portfolio Manager and team on the local context and technical challenges in order to get them involved in looking for innovative solutions.

Challenges arise in malaria diagnostics. While systematic microscopy is the gold standard, quality can be poor because of low stain/re-agent quality, constant staff turnover and donor reluctance to fund additional training. Also microscopy confirmation and slide quality control are time consuming, and often this process is not clear or well followed. PCR require specific equipment, training and qualifications. Takes time to be operational.

There are opportunities moving forward.  Progress could be made if there were more “elimination experts” to position to influencer to WHO to seek and propose new interventions for the pre-elimination stage. Nepal provides an ideal opportunity to test new ideas. It will also be necessary for the national malaria program staff to receive regular technical updates on program issues such as new drugs (Ivermectin?) and on-going pilots of MDA.

Identifying a More Accurate Test for Schistosomiasis in The Gambia

During the recently concluded 65th Annual Meeting of the American Society of Tropical Meicine and Hygiene colleagues from The Gambian Ministry of Health and Social Welfare, the World Health Organization and the NTD Support Center presented a poster entitled, “Field Performance of a Circulating Cathodic Antigen Rapid Test at Point-Of-Care for Mapping Schistosomiasis-Endemic Districts in Gambia.” The authors included Bakary Sanneh, Kristen Renneker, Joof  Ebrima, Sanyang M. Abdoulie, Camara Yaya, Sambou M. Sana, Sey Alhagie Papa, Jagne Sherifo, Baldeh Ignacious, Louis-Albert Tchuem Tchuente, Patrick J Lammie, and Kisito Ogoussan. Their abstract appears below.

figureBackground: The traditional parasitological Kato Katz smears and urine filtration methods recommended by the World Health Organization (WHO) to implement mapping of schistosomiasis have been found to be less sensitive in the detection of light-intensity schistosomiasis infections. Field surveys in Sub-Sahara Africa have shown that the Circulating Cathodic Antigen (CCA) point-of-care (POC) test is more accurate for detecting Schistosoma mansonia than the microscopic Kato Katz technique.

Aim: To establish the field sensitivity and specificity of POC CCA as mapping tool to provide the endemicity of schistosomiasis in The Gambia.

Methods: A cross-section study …

  • Ten school per region in 4 regions with historical known risk
  • Fifty children aged 7 to 14 years: 25 boys and 25 girls (WHO Mapping sampling guide)
  • Stool, urine and finger pricks samples were examined for Schistosomiasis
  • Parasitological tests: 2 Kato-katz slides to read from each stool sample, and urine filtration technique, urine dip-stick and Circulating Cathodic Antigen (CCA) techniques,

table-1Discussion: The CCA prevalence in this study was 23.34% (95% CI, 21.51-25.26%) two times higher than the prevalence based on  egg-detection for S. haematobium and S.mansoni (10.13,95% CI 8.87-11.55; and 0.26%, (95% CI, 0.09-0.62, respectively).  Although The Gambia is thought to be endemic for only S. haematobium, yet 5 subjects were found to harbor S. mansoni. Three of the 5 individuals from the high endemic schistosomiasis regions were co-infected with S. haematobium and S. mansoni.

table-2The sensitivity of the POC-CCA proved to be relatively high (60.0%), using double Kato-Katz as a reference for S. mansoni detection, although few infections were found, 5 out 1954  tested. The specificity of the POC CCA was 76.8%, respectively.  Using urine filtration as reference standard for the detection of S. haematobium, the sensitivity of POC-CCA was 47.9% and the specificity was 79.4%.

Conclusion: The Gambia is endemic for both urinary and intestinal schistosomiasis although most of the infections are due to S. haematobium in the 4 regions investigated. The results of the study showed a low sensitivity of the POC-CCA test in detecting S. haematobium and therefore we conclude further research is needed  to develop an ideal rapid diagnosis tool for urinary schistosomiasis.

schisto-acknowledgementAcknowledgement: Thanks to the Mapping Team,  Consultants, MoHSW, WHO,  Task Force for Global Health (TFGH) for all their support. For questions please contact: Dr. Kisito Ogoussan, kogoussan@taskforce.org; or Mr. Bakary Sanneh, sheikbakary@yahoo.com

Mobile suitcase laboratory: A tool for the rapid detection of emerging and endemic infectious disease

Ahmed Abd El Wahed who is based at Georg-August University, Goettingen, Germany shares his experiences with development and use of field diagnostics that can fit in a suitcase. This work received support from the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, Geneva, Switzerland. He explains the concept here …

Laboratory diagnosis mainly depends on nucleic acid detection by real-time polymerase chain reaction (PCR), which is available in central laboratories and has a turnaround time of more than two hours. Since real-time RT-PCR assays are not suitable for on-site screening, samples collected from local hospitals, treatment center or at the site of an outbreak have to be sent to laboratories over long distances for testing.

In developing countries, the necessary equipment for diagnosis is only available in few central laboratories, which are not accessible and of limited capacity to test large numbers of incoming samples. Moreover, transport conditions of samples are inadequate and therefore lead to unreliable results.

lab-in-a-suitcaseFor decentralizing of the molecular diagnostics, there is a need for a simple molecular point-of-need test. We have developed a mobile suitcase laboratory (62+49+30 cm) containing all reagents and equipment for the detection of the nucleic acid of infectious agents using the recombinase polymerase amplification (RPA) technology. The RPA assay run at a constant temperature (42°C) for a maximum of 15 minutes.

Moreover, all reagents are cold-chain independent and the mobile laboratory is operated by a solar power battery. The nucleic acid extraction is performed by a magnetic bead based method, in which a simple fast lysis protocol is applied. In case of highly infectious agents such as Ebola virus, the inactivation step was performed in a glovebox.

The suitcase lab is designed to detect almost 30 pathogens such as Dengue, Zika, Chikungunya, Ebola, Coronaviruses as well as Tuberculosis, Leptospira, Salmonella typhi and paratyphi, malaria, avian influenza, and Leishmania.

The suitcase lab featured in a presentation at the 65th Annual Meeting of the American Society of Tropical Medicine in Atlanta under the title of “Novel Extraction Protocol and Recombinase Polymerase Amplification Assay for Detection of Leishmania Donovani In 30 Minutes.” Authors/presenters included Dinesh Mondal, Prakash Ghosh, Md. Anik Ashfaq Khan, Faria Hossain, Susanne Böhlken-Fascher, Greg Matlashewski, Axel Kroeger, Piero Olliaro, and Ahmed Abd El Wahed.

Their work highlighted Leishmania donovani (LD), a protozoan parasite transmitted to humans by sand flies, which causes Visceral Leishmaniasis (VL). Currently, diagnosis is based on presence of anti-LD antibodies and clinical symptoms. Molecular diagnosis would require real-time PCR, which is not easy to implement at field settings.

In this study, we report on the development and testing of a novel extraction protocol in combination with recombinase polymerase amplification (RPA) assay for the detection of LD. The LD RPA assay detected equivalent to one LD genomic DNA. The RPA assay was performed at constant temperature (42°C) and the total assay runtime including the extraction procedure was 30 minutes.

The RPA assay also detected other Leishmania species (L. major, L. aethiopica and L. infantum), but did not identify nucleic acid of other pathogens. Forty-eight samples from VL, asymptomatic and post-kala-azar dermal leishmaniasis subjects were detected positive and 48 LD negative samples were negative by both LD RPA and real-time PCR assays, which indicates 100% agreement.

To allow the use of the assay at field settings, a mobile suitcase laboratory (56+45.5+26.5 cm) was developed and operated at the local hospital in Mymensingh, Bangladesh by using a solar-powered battery. DNA extraction was performed by a novel magnetic bead based method, in which a simple fast lysis protocol was applied.

Towards Malaria Pre-Elimination in Rwanda: Active Case Investigation in a Low Endemic District

A poster entitled “Towards Malaria Pre-Elimination in Rwanda: Active Case Investigation in a Low Endemic District” was presented by members of Jhpiego’s Rwanda Team and colleagues:

Noella Umulisa, Angelique Mugirente, Veneranda Umubyeyi, Beata Mukarugwiro, Stephen Mutwiwa, Jean Pierre Habimana, and Corrine Karema, at the 65th annual meeting of the American Society of Tropical Medicine and Hygiene in Atlanta. The abstract follows …

case-detectionRwanda has seen an increase in malaria cases recently with an increase from 514,173 cases in 2012 to 1,957,402 cases in 2015. This change can be attributed to an increase in temperature, rainfall, and resistance to insecticides.

Despite this setback, Rwanda is aiming to reach the pre-elimination phase by 2018. In January 2015, 11 health facilities in Rubavu, a low endemic district, started implementing reactive active case detection after training 55 health care providers and 11 lab technicians on the topic. This strategy involves screening and treating individuals living in close proximity to passively detected cases, also known as index cases. Index cases can be used to identify population groups that are sources of infection.

cases-confirmed-investigatedFrom January 2015 to December 2015, 16,434 cases of Malaria were detected and treated at 11 health facilities in Rubavu District. Among these cases, 2,917(17.8%) index cases were investigated and 4,943 individuals (between 1 and 2 contacts for each index case) living in proximity of index cases were tested using rapid diagnostic tests by health care providers. Of these, 508 (10.3%) tested positive for malaria and were treated according to national guidelines.

These data shows that the number of investigated cases is still lower than the national guidelines of screening 5 individuals residing between 100 to 500 meters of every confirmed case. This low rate could be due to the increase of malaria cases in Rwanda which has placed a burden on health care providers and health facilities in areas like Rubavu which used to be low endemic malaria areas. Additionally, data gathered through supervision activities has indicated a need for additional training on screening investigations in order to adhere to national guidelines and conduct the investigations more efficiently.

Active case investigation could be improved by training and involving more health care providers such as community health workers who could reduce the burden on health center staff. The additional support for case investigation activities and improved training can help to achieve higher coverage of individuals located near index cases.

A Pilot to Use Malaria RDTs at the Community Level in Burkina Faso

A poster entitled “The Improving Malaria Care (IMC) Project’s Contribution to follow up a Pilot to Use Rapid Diagnostic Tests (RDTs) at the Community Level in Burkina Faso” was presented by members of Jhpiego’s Burkina Faso Team: Ousmane Badolo, Stanislas P. Nebie, Moumouni Bonkoungou, Mathurin Dodo, Rachel Waxman, Danielle Burke, William Brieger at the 65th annual meeting of the American Society of Tropical Medicine and Hygiene in Atlanta. The abstract follows …

CHWs provide malaria testing, treatment and health education

CHWs provide malaria testing, treatment and health education

Early and correct case management of malaria in health facilities and at the community level is among the priorities of Burkina Faso’s National Malaria Control Program (NMCP). In line with this initiative, the NMCP piloted use of Rapid Diagnostic Tests (RDTs) by Community Health Workers (CHWs) to confirm malaria cases in the three health districts of Kaya, Saponé and Nouna between 2013 and 2015. With PMI support, follow-up visits were organized to document best practices, as well as challenges, on RDT use by CHWs that could serve as lessons learned for scale-up.

During follow-up visits, malaria commodities management (supply, storage and use) at the community level was examined, use of RDTs was assessed, and implementation at the community stockoutlevel was discussed with all actors at regional, district, health facilities, and community levels. The team examined the monitoring/supervision processes at all levels, used a check list on malaria commodities management, and employed a questionnaire for each type of actor. Both qualitative and quantitative data have been collected. A total of 108 persons were contacted including 32 CHWs, 42 community leaders and 34 health care providers and managers.

chw-drug-kitFindings revealed frequent stock-outs of RDTs and artemisinin-based combination therapies, non-payment of stipends to CHWs (a demotivator) and insufficient supervision of CHW by health teams. From the community perspective, 66% of community leaders were satisfied with their CHW’s work (diagnosis and treatment of uncomplicated malaria concernsand referral of severe cases to health facilities). However, 46% of community leaders complained of frequent stock-outs and unanimously agreed on the importance of regular payment of premiums to CHW.

Follow up of the pilot was valuable in obtaining community, CHW and health worker perspectives for improving the program. While the community finds the program acceptable, its sustainability will require that solutions be found for stock-outs, non-payment, and insufficient supervision before scale up takes place.

Urine Rapid Diagnostic Test for Malaria: Results Published

Results of testing the innovative Urine Rapid Diagnostic Test for Malaria developed by Fyodor Biotech have been published in the Journal of Clinical Microbiology. Authors from multiple collaborating institutions include Wellington A. Oyibo, Nnenna Ezeigwe, Godwin Ntadom, Oladipo O. Oladosu, Kaitlin Rainwater, Wendy O’Meara, Evaezi Okpokoro, and William Brieger. The abstract appears below.

fydor_0 Background: The need to expand malaria diagnosis alongside policy requirements for mandatory testing before treatment motivates exploration of non-invasive rapid diagnostic tests (RDTs). We report the outcome of the first cross-sectional, single-blind clinical performance evaluation of a Urine Malaria Test (UMT) for Plasmodium falciparum (Pf) malaria diagnosis in febrile patients.

Methods: Matched urine and fingerprick blood from participants ?2 years with fever (axillary temperature ?37.5°C) or history of fever in the preceding 48 hours were tested with UMT and microscopy (as gold standard). BinaxNOW® (Pf/Pan) blood RDT was done to assess relative performance. Urinalysis and Rheumatoid Factor (RF) tests were conducted to evaluate possible interference. Diagnostic performance characteristics were computed at 95% CI.

UNT is winner of innovations prize

UMT is winner of innovations prize

Results: Of 1,800 participants screened, 1,691 were enrolled; 566 (34%) were febrile, 1,125 (66%) afebrile; test positivity among enrolled participants: 341 (20%) by microscopy, 419 (25%) UMT, 676 (40%) BinaxNow Pf and 368 (22%) BinaxNow Pan. UMT sensitivity among febrile patients (for whom the test is indicated) was 85% and specificity 84%. Among febrile children ?5 years, UMT sensitivity was 93%, specificity 83%. Area under receiver-operator characteristic curve (AUC) of UMT (0.84) was not significantly different from Binax Pf (0.86) or Binax Pan (0.87), indicating that the tests do not differ in overall performance. Gender, seasons, and RF did not impact UMT performance. Leukocytes, hematuria and urobilinogen concentration in urine were associated with lower UMT specificity.

Conclusion: UMT performance was comparable to BinaxNOW Pf/Pan tests, and is a promising tool to expand malaria testing in public and private healthcare settings where there are challenges to blood-based malaria diagnosis testing.