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Preeclampsia and eclampsia contribute significantly to maternal and newborn deaths worldwide. Early and accurate identification of pregnant women at risk can avert these deaths, but the necessary diagnostics are not widely available. A protein and creatinine ratio, rather than a measurement of protein alone, may provide better identification of proteinuria. The objective of this study was to assess the operational and performance characteristics of the LifeAssay Diagnostics (LAD) Test-it™ protein-to-creatinine ratio (PrCr) urinalysis dipstick test in a representative antenatal care setting (ANC).Mixed methods were used to assess the operational and performance characteristics of the PrCr test, including a usability study with 25 participants, a prospective cross-sectional diagnostic accuracy study (N = 1483), and a targeted reassessment of discordant frozen samples (N = 200). Several other commonly used proteinuria tests were included for comparison.The test demonstrated improved clinical performance for detection of proteinuria over the current standard-of-care tests widely used in Ghana. The LAD PrCr test showed a sensitivity of 50.7% and specificity of 69.2% when run at the point of care. In contrast, the standard-of-care Accu-Tell® protein dipstick test was found to have a sensitivity of 32.4% and a specificity of 82.2%. The LAD test shows minor improvement over the tests currently used in Ghana to detect proteinuria.The PrCr test offers the potential for improved detection of proteinuria over the standard-of-care tests used in ANC. However, this test and the others evaluated for this study demonstrate limited performance, particularly among samples with a low level of proteinuria. Additional exploration in other clinical use cases, such as triage among high-risk populations, is warranted. The LAD test can also be considered a transition product, as health systems consider adopting next-generation biomarker tests when more readily available.

BackgroundThe coronavirus disease (COVID-19) pandemic has led to an unprecedented public health crisis. Insufficient testing continues to limit the effectiveness of the global response to the COVID-19 pandemic. Molecular testing methods such as reverse transcriptase polymerase chain reaction (RT-PCR) continue to be highly centralized and are a sub-optimal option for population surveillance. Rapid antigen tests (Ag-RDTs) offer multiple benefits including low costs, high flexibility to conduct tests in a wide variety of settings, and faster return of results. Recently, self-test Ag-RDTs (STs) have gained approval in several markets and offer the possibility to expand testing, reaching at-risk populations. While STs have the potential to assist the COVID-19 response, test result integrity, reporting, and appropriate linkage to care continue to hinder the widespread implementation of self-testing programs.MethodsThis protocol presents a mixed-methods pragmatic trial (ISRCTN91602092) to better understand the feasibility of self-testing as part of a contact tracing strategy within the Brazilian public health system. Approximately 604 close contacts of 150 index cases testing positive for COVID-19 will be enrolled. Close contacts will be randomized to either serial (daily) self-testing over a 10-day follow-up period or a more traditional approach to contact tracing with a professional Ag-RDT at one time point post-exposure. Usability workshops and focus group discussions will also be conducted.DiscussionThis study protocol presents a comprehensive plan to assess the effectiveness, operational feasibility, and stakeholder preferences of a serial self-testing strategy for contact tracing within the Brazilian public health system. Our results will contribute to better understanding of the feasibility of a self-testing strategy within the public sector. Potential risks and limitations are discussed. Our findings will have important implications as governments continue working to mitigate the impact of COVID-19, particularly in the context of where to direct limited resources for testing and healthcare infrastructure.

IntroductionScreening for G6PD deficiency can inform disease management including malaria. Treatment with the antimalarial drugs primaquine and tafenoquine can be guided by point-of-care testing for G6PD deficiency.Methods and FindingsData from similar clinical studies evaluating the performance of the STANDARD™G6PD Test (SD Biosensor, South Korea) conducted in Bangladesh, Brazil, Ethiopia, India, Thailand, the United Kingdom, and the United States were pooled. Test performance was assessed in a retrospective analysis on capillary and venous specimens. All study sites used spectrophotometry for reference G6PD testing, and either the HemoCue or complete blood count for reference hemoglobin measurement.The sensitivity of the STANDARD™G6PD Test using the manufacturer thresholds for G6PD deficient and intermediate cases in capillary specimens from 4212 study participants was 100% (95% Confidence Interval (CI): 97.5%–100%) for G6PD deficient cases with 60% on the reference assay. Negative predictive values for females with G6PD activity >60% was 99.6% (95% CI 99.1%–99.8%) on capillary specimens. Test sensitivity among 396P. vivaxmalaria cases was 100% (69.2%–100.0%) for both deficient and intermediate cases. In the study population, a high proportion of those classified as G6PD deficient or intermediate resulted from true normal cases. Despite this, the majority cases would receive the correct medication and no true G6PD deficient cases would be treated inappropriately.ConclusionsThe STANDARD G6PD Test enables safe access to drugs which are contraindicated for individuals with G6PD deficiency. Operational considerations will inform test uptake in specific settings.

The relationship between N-antigen concentration and viral load within a specimen and across different specimens is essential for interpretation of rapid diagnostic tests (RDT) clinical performance in different use cases. A prospective study was conducted in Porto Velho, Brazil, to investigate RDT performance in different specimen types as a function of the correlation between antigen concentration and viral load. The study included 214 close contacts with recent exposures to confirmed cases, aged 12 years and older and with various levels of vaccination. Antigen concentration was measured in nasopharyngeal swab (NPS), anterior nares swab (ANS), and saliva specimens. Reverse transcriptase (RT)–PCR was conducted on the NPS and saliva specimens, and two RDTs were conducted on ANS and one on saliva. Antigen concentration correlated with viral load when measured in the same specimen type but not across specimen types. Antigen levels were higher in symptomatic cases compared to asymptomatic/oligosymptomatic cases and lower in saliva compared to NPS and ANS samples. Discordant results between the RDTs conducted on ANS and the RT-PCR on NPS were resolved by antigen concentration values. The analytical limit-of-detection of RDTs can be used to predict the performance of the tests in populations for which the antigen concentration is known. The antigen dynamics across different sample types observed in SARS-CoV-2 disease progression support use of RDTs in nasal samples. Given lower antigen concentrations in saliva, tests using saliva is expected to require improved analytical sensitivity to achieve clinical sensitivity similar to testing of nasal samples.

New diagnostics and treatment options for the radical cure of Plasmodium vivax malaria are now available. At the 2019 annual meeting of the Vivax Working Group of the Asia Pacific Malaria Elimination Network, participants took part in a roundtable discussion to identify further evidence required to introduce these new tools into policy and practice. Key gaps identified were accuracy and reliability of glucose‐6‐phosphate‐dehydrogenase deficiency tests, health system capacity, and feasibility and cost effectiveness of novel treatment strategies in routine clinical practice. As expected, there were differences in the priorities between country partners and researcher partners. To achieve the 2030 target for the regional elimination of malaria, evidence to address these issues should be generated as a matter of priority. Review of global guidelines alongside locally generated data will help to ensure the timely revision and optimisation of national treatment guidelines that will be vital to meet regional elimination goals.

Background Point-of-care and decentralized testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critical to inform public health responses. Performance evaluations in priority use cases such as contact tracing can highlight trade-offs in test selection and testing strategies. Methods A prospective diagnostic accuracy study was conducted among close contacts of coronavirus disease 2019 (COVID-19) cases in Brazil. Two anterior nares swabs (ANS), a nasopharyngeal swab (NPS), and saliva were collected at all visits. Vaccination history and symptoms were assessed. Household contacts were followed longitudinally. Three rapid antigen tests and 1 molecular method were evaluated for usability and performance against reference reverse-transcription polymerase chain reaction (RT-PCR) on nasopharyngeal swab specimens. Results Fifty index cases and 214 contacts (64 household) were enrolled. Sixty-five contacts were RT-PCR positive during ≥1 visit. Vaccination did not influence viral load. Gamma variants were most prevalent; Delta variants emerged increasingly during implementation. The overall sensitivity of evaluated tests ranged from 33% to 76%. Performance was higher among symptomatic cases and those with cycle threshold (Ct) values 70% and almost 90% after 4 days. Conclusions The near-immediate time to results for antigen tests significantly offsets lower analytical sensitivity in settings where RT-PCR results are delayed or unavailable.

BackgroundPoint-of-care and decentralized testing for SARS-CoV-2 is critical to inform public health responses. Performance evaluations in priority use cases such as contact tracing can highlight trade-offs in test selection and testing strategies.MethodsA prospective diagnostic accuracy study was conducted among close contacts of COVID-19 cases in Brazil. Two anterior nares swabs (ANS), a nasopharyngeal swab (NPS), and saliva were collected at all visits. Vaccination history and symptoms were assessed. Household contacts were followed longitudinally. Three rapid antigen tests and one molecular method were evaluated for usability and performance against reference RT-PCR on NPS.ResultsFifty index cases and 214 contacts (64 household) were enrolled. Sixty-five contacts were RT-PCR positive during at least one visit. Vaccination did not influence viral load. Gamma variants were most prevalent; Delta emerged increasingly during implementation. Overall sensitivity of evaluated tests ranged from 33%–76%. Performance was higher among symptomatic cases and cases with Ct70% and almost 90% after four days.ConclusionsThe near immediate time-to-result for antigen tests significantly offsets lower analytical sensitivity in settings where RT-PCR results are delayed or unavailable.

Certain clinical indications and treatments such as the use of rasburicase in cancer therapy and 8-aminoquinolines for Plasmodium vivax malaria treatment would benefit from a point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. Three studies were conducted to evaluate the performance of one such test: the STANDARD™ G6PD Test (SD BIOSENSOR, South Korea). First, biological interference on the test performance was evaluated in specimens with common blood disorders, including high white blood cell (WBC) counts. Second, the test precision on fingerstick specimens was evaluated against five individuals of each, deficient, intermediate, and normal G6PD activity status. Third, clinical performance of the test was evaluated at three point-of-care settings in the United States. The test performed equivalently to the reference assay in specimens with common blood disorders. High WBC count blood samples resulted in overestimation of G6PD activity in both the reference assay and the STANDARD G6PD Test. The STANDARD G6PD Test showed good precision on multiple fingerstick specimens from the same individual. The same G6PD threshold values (U/g Hb) were applied for a semiquantitative interpretation for fingerstick- and venous-derived results. The sensitivity/specificity values (95% confidence intervals) for the test for G6PD deficiency were 100 (92.3–100.0)/97 (95.2–98.2) and 100 (95.7–100.0)/97.4 (95.7–98.5) for venous and capillary specimens, respectively. The same values for females with intermediate (> 30% to ≤ 70%) G6PD activity were 94.1 (71.3–99.9)/88.2 (83.9–91.7) and 82.4 (56.6–96.2)/87.6(83.3–91.2) for venous and capillary specimens, respectively. The STANDARD G6PD Test enables point-of-care testing for G6PD deficiency.

Background Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a common enzyme deficiency, prevalent in many malaria-endemic countries. G6PD-deficient individuals are susceptible to hemolysis during oxidative stress, which can occur from exposure to certain medications, including 8-aminoquinolines used to treat Plasmodium vivax malaria. Accordingly, access to point-of-care (POC) G6PD testing in Brazil is critical for safe treatment of P. vivax malaria. Methodology/Principal findings This study evaluated the performance of the semi-quantitative, POC STANDARD G6PD Test (SD Biosensor, Republic of Korea). Participants were recruited at clinics and through an enriched sample in Manaus and Porto Velho, Brazil. G6PD and hemoglobin measurements were obtained from capillary samples at the POC using the STANDARD and HemoCue 201+ (HemoCue AB, Sweden) tests. A thick blood slide was prepared for malaria microscopy. At the laboratories, the STANDARD and HemoCue tests were repeated on venous samples and a quantitative spectrophotometric G6PD reference assay was performed (Pointe Scientific, Canton, MI). G6PD was also assessed by fluorescent spot test. In Manaus, a complete blood count was performed. Samples were analyzed from 1,736 participants. In comparison to spectrophotometry, the STANDARD G6PD Test performed equivalently in determining G6PD status in venous and capillary specimens under varied operating temperatures. Using the manufacturer-recommended reference value thresholds, the test’s sensitivity at the, Author summary G6PD deficiency affects an estimated 500 million people worldwide and is prevalent in many malaria-endemic settings. People with G6PD deficiency are at risk of hemolysis when exposed to certain medications, including 8-aminoquinoline drugs used to treat Plasmodium vivax malaria. Increased access to testing for G6PD deficiency at or near the point of care is critical for expanding the safe treatment of P. vivax malaria. In this study, we aimed to evaluate the performance of a point-of-care, semi-quantitative test for G6PD deficiency, the STANDARD G6PD Test, in a malaria-endemic setting in Brazil. The test was evaluated on both capillary and venous blood samples across a broad range of operating temperatures. The findings show that the STANDARD G6PD Test performed equivalently to the reference test in its ability to diagnose G6PD deficiency at the point of care. The STANDARD G6PD Test is a promising tool to aid in detecting G6PD deficiency at the point of care in Brazil.

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

Patricia S Coffey,Emily Gerth-Guyette PATH, Seattle, WA, USABackground:Vitamin K prophylaxis can prevent vitamin K deficiency bleeding (VKDB), and current global recommendations support universal prophylactic use in newborns. Data about access to and use of vitamin K in low and middle income countries (LMIC) are scarce. To address this gap, we explored current perspectives and practices of newborn vitamin K administration in LMIC in order to better understand the barriers to more widespread coverage of this lifesaving preventative treatment.Methods: We conducted an online survey of stakeholders involved in newborn health. We sent the survey via e-mail to 109 individuals who were based primarily in LMIC and 23 responses were received, resulting in a response rate of 21%. Respondents were generally health or development professionals from sub-Saharan Africa and Asia. Results: Incidence rates at the country level were mostly unknown or not supported by adequate data. Many respondents (17/23) indicated that vitamin K prophylaxis is included in their national newborn care guidelines and policies, while 12 respondents indicated that administration at birth was widely practiced. Around half of respondents reported that health workers were trained in the diagnosis and treatment of VKDB. The most frequently cited barriers to more widespread vitamin K prophylaxis were (in rank order) high rates of home birth (which preclude injections that must be given by skilled health workers), lack of access to and availability of vitamin K, perception that vitamin K prophylactic treatment is not a priority among health workers, lack of vitamin K formulations appropriate for infants, cultural practices suggesting that injection at birth is not acceptable to parents, and vitamin K not being included in national guidelines and policies. There was no consensus as to the ideal formulation, respondents preferring both the current intramuscular (IM) injection and oral formulation. Reported product attributes of IM and oral formulations are summarized.Conclusion: Prophylactic administration of vitamin K to newborns is relatively well integrated into policy at the global and country levels, but its practice is underutilized. Barriers to use are access, supply chain logistics, provider attitudes, and restrictions on the use of injections by providers at the community level. Technology innovation may offer some promise to mitigate these barriers, although advocacy and health system strengthening might be more likely to yield improved coverage. Further investigation using in-depth bottleneck analysis at the country level could help identify specific health system improvements. Keywords: newborn, vitamin K, prophylaxis, LMIC

ObjectivesWe conducted a study to evaluate the use of job aids and simple user instructions to improve adherence for the treatment of childhood pneumonia with amoxicillin dispersible tablet (DT).DesignA mixed-method study implemented in three phases between October 2015 and February 2016.SettingsThe study was implemented in two subdistricts of Bangladesh.ParticipantsCaregivers of children aged 2–59 months, health service providers and key stakeholders at national and district level.InterventionsAn intervention including training and job aids and user-friendly instructions was introduced in one subdistrict while standard amoxicillin DT packaging and instructions with no training served as the control in the comparison subdistrict.Primary outcomeAdherence behaviour of caregivers of children aged 2–59 months for the treatment of childhood pneumonia with amoxicillin DT.MethodsWe conducted a survey with 56 caregivers in the intervention subdistrict and 38 caregivers in the comparison subdistrict. We also conducted 44 in-depth interviews to evaluate the job aids and user-friendly instructions with healthcare providers and caregivers to assess the feasibility, usability and acceptability of the tools in intervention subdistrict.ResultsFor 5-day treatment course, 32.1% (95% CI 23.1% to 41.1%) of caregivers in the intervention subdistrict and 2.6% (95% CI 0.3% to 7.8%) in the comparison subdistrict maintained full adherence to the amoxicillin DT treatment for pneumonia. More children under 12 months were given age-appropriate treatment than older children. Key stakeholders and healthcare providers considered the use and integration of the tools into the health system to be feasible and acceptable.ConclusionsThe provision of tools for the treatment of childhood pneumonia with amoxicillin DT had a positive influence on adherence behaviours. These tools can help close information gaps and overcome the barriers posed by medical illiteracy and remembering instructions from providers.

People living with HIV in Sub-Saharan Africa face significant challenges accessing care. Community-based peer support groups can increase linkage to treatment, though the effectiveness of structured, scalable groups has not been demonstrated. This study aimed to measure the impact of the structured Integrated Access to Care and Treatment intervention on clients' knowledge, attitudes, and practice regarding HIV/AIDS, including their experiences of stigma, in KwaZulu-Natal, South Africa. Data collection involved pre-/post-tests and client interviews. Pre-/post-test data from 66 clients were collected. 17 participants were interviewed. Paired t-tests did not detect significant changes in the main outcomes. Qualitative results suggested a psychosocial benefit as participants connected with their peers, expressed themselves openly, and re-engaged with their communities. Unfortunately, this study did not quantitatively measure psychosocial changes, and the results have limited generalizability to men. I ACT may be an effective complement to clinic-based support services, though further study should quantify the psychosocial benefit.

In low- and middle-income countries, many women experience anemia during pregnancy due to insufficient dietary intake of key micronutrients, parasitic infections, hemoglobinopathies, and chronic infections. Maternal anemia increases perinatal risks for both mothers and infants, and slow progress to reduce the prevalence may be due in part to the lack of affordable tools to quantify hemoglobin levels in antenatal care (ANC) clinics. A simple, inexpensive, accurate, and robust diagnostic is needed to measure hemoglobin in ANC. This study evaluated the performance and usability of the TrueHb Hemometer. A cross-sectional diagnostic accuracy study was conducted to compare the accuracy of the TrueHb and the HemoCue® 201+ using capillary samples. Next, analytical performance (precision, coefficient of variation, R2) of the TrueHb was evaluated in varying environmental conditions using linearity panels with serial dilutions of venous blood samples. Lastly, the usability of the TrueHb Hemometer was assessed across three domains (effectiveness, efficiency, and satisfaction) by 20 ANC providers in Ghana. Capillary blood test results were not well correlated (R2 = 0.35) between the TrueHB and HemoCue201+, but 80% of TrueHb measurements were within +/-1.0 g/dl of the HemoCue® 201+ hemoglobin values. Precision tests indicated similar mean values across the three environmental conditions (CV 0.90) but begins to underestimate the hemoglobin concentration below 7.0 g/dl. The usability study identified potential failure modes due to inadequate instructions and device feedback. With some modifications, both to the product and to the instructions for use, the TrueHb may be suitable for use in ANC settings to help fill the diagnostic gap for anemia screening during pregnancy. Further testing is required with anemic populations in LMIC settings.

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.

IntroductionPneumonia is the leading cause of death from infection in children worldwide. Despite global treatment recommendations that call for children with pneumonia to receive amoxicillin dispersible tablets, only one-third of children with pneumonia receive any antibiotics and many do not complete the full course of treatment. Poor adherence to antibiotics may be driven in part by a lack of user-friendly treatment instructions.ObjectiveIn order to optimise childhood pneumonia treatment adherence at the community level, we developed a user-friendly product presentation for caregivers and a job aid for healthcare providers (HCPs). This paper aims to document the development process and offers a model for future health communication tools.MethodsWe employed an iterative design process that included document review, key stakeholder interviews, engagement with a graphic designer and pre-testing design concepts among target users in India and Kenya. The consolidated criteria for reporting qualitative research were used in the description of results.ResultsThough resources for pneumonia treatment are available in some countries, their content is incomplete and inconsistent with global recommendations. Document review and stakeholder interviews provided the information necessary to convey to caregivers and recommendations for how to present this information. Target users in India and Kenya confirmed the need to support better treatment adherence, recommended specific modifications to design concepts and suggested the development of a companion job aid. There was a consensus among caregivers and HCPs that these tools would be helpful and improve adherence behaviours.ConclusionsThe development of user-friendly instructions for medications for use in low-resource settings is a critically important but time-intensive and resource-intensive process that should involve engagement with target audiences.

Background and aim Influenza diagnostics play a critical role informing in clinical management decisions and defining the global epidemiology of the disease to support public health responses. Use of influenza diagnostics within most low‐income and middle‐income countries remains limited, including in the Philippines, where they are currently used only for epidemiologic surveillance. The aim of this study was to define key considerations, including product characteristics, which may influence future adoption, uptake, and integration of influenza diagnostics into public and private clinical settings in this emerging Asian market. Methods Our study was conducted using a convenience sample of public and private hospital laboratories in Metro Manila. A usability assessment was conducted that included interviews with decision‐makers and direct observation of laboratory end users using 2 platforms representative of emerging diagnostic products: (1) a point‐of‐care antigen‐based rapid immunoassay diagnostic test paired with a reader and (2) a molecular diagnostic platform intended for decentralized use. Data were analyzed to assess user errors and device failure modes with each platform and to determine key considerations related to product adoption and uptake. Results The most difficult test step for most users on both platforms involved sample preparation. When deciding to adopt a new test, priority product attributes include performance, potential volume of demand from clinicians, equipment cost, and ease of use. Demand for new tests is likely going to be driven by clinicians, and policies and guidelines will be needed to support the introduction of new products. Conclusion Adoption of influenza diagnostics in Metro Manila is feasible but will require affordable products capable of satisfying needs for use in both epidemiologic surveillance and clinical management.

Objective To better understand the availability of oxygen and pulse oximetry, barriers to use, clinician perceptions and practices regarding their role in the management of childhood pneumonia, and the formal education and training regarding these technologies received by student clinicians in Cambodia. Methods In the clinician survey, we surveyed 81 clinicians practising at all national paediatric, provincial and district referral hospitals throughout Cambodia. Respondents were primarily physicians whose scope of practice included paediatrics, and most reported the presence of oxygen (93% (95% confidence interval (CI) [87, 98])) but less availability of pulse oximetry (51% (95% CI [39, 61])). Results Common barriers to use included a lack of policies and guidelines, as well as a lack of training. In the student clinician survey, 332 graduating medical and nursing students were surveyed, and most reported learning about oxygen (96% (95% CI [94, 98])) and pulse oximetry (72% (95% CI [67, 77])) during their training. Conclusions Data from both surveys indicate that despite their utility, oxygen and pulse oximetry may be underused in Cambodia. The reported barriers and perceptions of the tools indicate a clear role for improved training for clinicians and students on the use of oxygen and pulse oximetry, the value of oxygen and pulse oximetry for managing childhood pneumonia, and the need for improved policies and guidelines governing their use. Objectif Mieux comprendre la disponibilite de l'oxygene et l'oxymetrie de pouls, les obstacles a l'utilisation, les perceptions et les pratiques des cliniciens quant a leur role dans la prise en charge de la pneumonie infantile, et l’education et la formation officielle sur ces technologies recues par les etudiants cliniciens au Cambodge Methodes Dans une etude aupres des cliniciens, nous avons sonde 81 cliniciens exercant dans tous les hopitaux pediatriques nationaux, provinciaux et de reference de district a travers le Cambodge. Les repondants etaient principalement des medecins dont le domaine de pratique comprenait la pediatrie et la plupart ont rapporte la presence d'oxygene (93% (intervalle de confiance (IC) a 95% [87%, 98%])), mais moins de disponibilite de l'oxymetrie de pouls (51% (IC 95% [39%, 61%])). Resultats Les obstacles communs a l'utilisation comprenaient un manque de politiques et de directives, ainsi que d'un manque de formation. Dans l'enquete sur les etudiants cliniciens, 332 etudiants en fin de cycle en medecine et en soins infirmiers ont ete interroges et la plupart ont rapporte des cours sur l'oxygene (96% (IC 95% [94%, 98%])) et l'oxymetrie de pouls (72% (IC 95% [67%, 77%])) durant leur formation. Conclusions Les donnees des deux enquetes indiquent que malgre leur utilite l'oxygene et l'oxymetrie de pouls seraient sous-utilises au Cambodge. Les obstacles et les perceptions rapportes sur les outils indiquent un role clair pour l'amelioration de la formation des cliniciens et des etudiants sur l'utilisation de l'oxygene et de l'oxymetrie de pouls, la valeur de l'oxygene et de l'oxymetrie de pouls pour la prise en charge de la pneumonie infantile et le besoin de politiques et de lignes directrices ameliorees regissant leur utilisation. Objetivo Entender la disponibilidad del oxigeno y la oximetria de pulso, las barreras para su uso, las percepciones de los clinicos y las practicas en lo que respecta a su rol en el manejo de la neumonia infantil, y la educacion formal y el entrenamiento que reciben los estudiantes clinicos en Camboya en el uso de estas tecnologias. Metodos En un estudio clinico, evaluamos a 81 clinicos ejerciendo en todos los hospitales pediatricos de referencia nacionales, provinciales y distritales de Camboya. Quienes respondian eran principalmente medicos cuya practica incluia la pediatria. La mayoria reportaban la presencia de oxigeno (93% (intervalo de confianza (IC) 95% [87%, 98%])) pero una menor disponibilidad de la oximetria de pulso (51% (IC 95% [39%, 61%])). Resultados Las barreras mas comunes al uso incluian la falta de politicas y guias, al igual que una falta de entrenamiento. En el estudio con estudiantes sanitarios, 332 estudiantes de medicina y de enfermeria fueron encuestados y la mayoria reportaron haber aprendido sobre el oxigeno (96% (IC 95% [94%, 98%])) y la oximetria de pulso (72% (IC 95% [67%, 77%])) durante su entrenamiento. Conclusiones Los datos de ambos estudios indicaban que a pesar de su utilidad, el oxigeno y la oximetria de pulso podrian estar siendo subutilizados en Camboya. Las barreras reportadas y las percepciones de las herramientas indican la necesidad clara de mejorar el entrenamiento de medicos y estudiantes en lo que respecta al uso del oxigeno y la oximetria de pulso, y su importancia en el manejo de la neumonia infantil, asi como la necesidad de mejorar las politicas y las guias sobre su uso.

Introduction Accurate and timely diagnosis of women at high risk for preeclampsia (PE) is key to accessing proper interventions and improving clinical outcomes. In collaboration with LifeAssay Diagnostics (LAD; South Africa), we have developed a new low-cost protein-to-creatinine (Pr/Cr) ratiometric strip test that improves the accuracy of proteinuria screening over the commonly-used protein-only dipstick by adjusting for urine dilution. Objectives Developmental efforts by PATH and its partners have focused on optimizing and evaluating the PrCr test characteristics to advance the prototype to downstream field validation and early introduction. Methods Performance evaluation : PATH and Magee Women’s Research Institute (USA) performed a laboratory-based evaluation of the LAD Pr/Cr test and the Siemens Multistix PRO LS, a commercial urinary dipstick that measures protein and creatinine but costs about US $7 per test. Each test was evaluated using 137 repository urine samples. Samples were selected across the capable dynamic range of the Pr/Cr test, based on protein and creatinine levels determined using a reference clinical laboratory analyzer. Usability : PATH, in collaboration with Kintampo Health Research Center (Ghana), conducted a field usability study with community antenatal care (ANC) providers. Data was collected through observation and interviews of 25 participants, including midwives and community health nurses, who performed and interpreted the test using urine control samples and multiple versions of prototype instructions. Thermal stability : A six-month longitudinal study is being conducted to evaluate both shelf-life stability of unopened product and in-use stability where the same product is repetitively opened over time. Three lots stored at 25 °C, 37 °C, and 45 °C were used for shelf-life evaluations, while the in-use stability study examined test performance on two manufacturing lots at either 25 °C or 45 °C. Results Performance evaluation : Compared to the reference standard assay, the LAD Pr/Cr dipstick demonstrated performance of 85% sensitivity and 71% specificity (95%CI) for proteinuria determination using a normal to abnormal cutoff of 0.19 Pr-to-Cr ratio. The Siemens Multistix demonstrated a 82% sensitivity and 79% specificity (95%CI). Usability : Participants found the test to be simple and easy to use. All participants accurately matched the color of the protein marker on the strip to the instructions, while 80% of participants correctly matched colors for the creatinine marker. Participants overwhelmingly preferred a linear test interpretation chart that outlines each possible permutation of Pr and Cr. Thermal stability : After four months, the Pr/Cr test strips demonstrated stable performance across all temperatures and manufacturing lots in both shelf-life and in-use stability testing. Conclusions The LAD Pr/Cr test provides a similar performance to the Siemens product as compared to the reference test at much lower cost comparable to the protein-only dipstick commonly used in low-resource countries. Other evaluation results indicate the test characteristics are compatible for field use. Additionally, the Pr/Cr test may offer additional advantages to the current protein-only dipstick in providing clearer interpretation to inform proper care.