The World Health Organization recommends parasitological confirmation of malaria prior to treatment Malaria rapid diagnostic tests (RDTs) represent one diagnostic method that is used in a variety of contexts to overcome limitations of other diagnostic techniques Malaria RDTs increase the availability and feasibility of accurate diagnosis and may result in improved quality of care Though RDTs are used in a variety of contexts, no studies have compared how well or effectively RDTs are used across these contexts This review assesses the diagnostic use of RDTs in four different contexts: health facilities, the community, drug shops and schools A comprehensive search of the Pubmed database was conducted to evaluate RDT execution, test accuracy, or adherence to test results in sub-Saharan Africa Original RDT and Plasmodium falciparum focused studies conducted in formal health care facilities, drug shops, schools, or by CHWs between the year 2000 and December 2016 were included Studies were excluded if they were conducted exclusively in a research laboratory setting, where staff from the study team conducted RDTs, or in settings outside of sub-Saharan Africa The literature search identified 757 reports A total of 52 studies were included in the analysis Overall, RDTs were performed safely and effectively by community health workers provided they receive proper training Analogous information was largely absent for formal health care workers Tests were generally accurate across contexts, except for in drug shops where lower specificities were observed Adherence to RDT results was higher among drug shop vendors and community health workers, while adherence was more variable among formal health care workers, most notably with negative test results Malaria RDTs are generally used well, though compliance with test results is variable – especially in the formal health care sector If low adherence rates are extrapolated, thousands of patients may be incorrectly diagnosed and receive inappropriate treatment resulting in a low quality of care and unnecessary drug use Multidisciplinary research should continue to explore determinants of good RDT use, and seek to better understand how to support and sustain the correct use of this diagnostic tool

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Use of malaria RDTs in various health contexts across sub-Saharan Africa: a systematic review.

Infectious diseases claim millions of lives each year. Robust and accurate diagnostics are essential tools for identifying those who are at risk and in need of treatment in low-resource settings. Inorganic complexes and metal-based nanomaterials continue to drive the development of diagnostic platforms and strategies that enable infectious disease detection in low-resource settings. In this review, we highlight works from the past 20 years in which inorganic chemistry and nanotechnology were implemented in each of the core components that make up a diagnostic test. First, we present how inorganic biomarkers and their properties are leveraged for infectious disease detection. In the following section, we detail metal-based technologies that have been employed for sample preparation and biomarker isolation from sample matrices. We then describe how inorganic- and nanomaterial-based probes have been utilized in point-of-care diagnostics for signal generation. The following section discusses instrumentation for signal readout in resource-limited settings. Next, we highlight the detection of nucleic acids at the point of care as an emerging application of inorganic chemistry. Lastly, we consider the challenges that remain for translation of the aforementioned diagnostic platforms to low-resource settings.

Inorganic Complexes and Metal-Based Nanomaterials for Infectious Disease Diagnostics.

'Point-of-care' (POC) diagnostics are a powerful emerging healthcare approach. They can rapidly provide statistically significant results, are simple to use, do not require specialized equipment and are cost-effective. For these reasons, they have the potential to play a major role in revolutionizing the diagnosis, initiation and monitoring of treatment of major global diseases. This review focuses on antibody-based POC devices that target four major global diseases: cardiovascular diseases, prostate cancer, HIV infection and tuberculosis. The key statistics and pathology of each disease is described in detail, followed by an in-depth discussion on emerging POC devices that target each disease, highlighting their potential and limitations.

Point-of-care diagnostics, a major opportunity for change in traditional diagnostic approaches: potential and limitations

Massive implementation of malaria diagnostics in low-resource countries is regarded as a pivotal strategy in control and elimination efforts. Although malaria rapid diagnostic tests (RDTs) are considered a viable alternative, there are still obstacles to the widespread implementation of this strategy, such as reporting constraints and lack of proper quality assurance of RDT-based programmes at point-of-care (POC). A prospective cohort of patients, seeking routine care for febrile episodes at health centres in malaria-endemic areas of Colombia, was used to assess the diagnostic performance of a device based on smartphone technology (Deki ReaderTM, former codename “GenZero”), that assists users at POC to process RDTs. After informed consent, patients were enrolled into the study and blood samples were collected for thick blood smear (TBS) and RDT. The RDT results were interpreted by both visual inspection and Deki Reader device and concordance between visual and device interpretation was measured. Microscopy corrected by real-time polymerase chain reaction (PCR) and microscopy were “gold standard” tests to assess the diagnostic performance. In total, 1,807 patients were enrolled at seven health centres in malaria-endemic areas of Colombia. Thirty-three Plasmodium falciparum and 100 Plasmodium vivax cases were positive by corrected microscopy. Both sensitivity and specificity were 93.9% (95% CI 69.7-95.2) and 98.7% (95% CI 98.5-99.4) for P. falciparum, and 98.0% (95% CI 90.3-98.9) and 97.9% (95% CI 97.1-98.5) for P. vivax. Percentage concordance between visual and device interpretation of RDT was 98.5% and 99.0% for P. vivax and P. falciparum, respectively.The RDT, when compared to TBS, showed high sensitivity and specificity for P. falciparum in both visual and device interpretation, and good overall diagnostic performance for P. vivax. Comparison between PCR as gold standard and visual and device interpretation showed acceptable overall performance for both species. The diagnostic performance of the Deki Reader was comparable to visual interpretation of RDTs (without significant differences) for both malaria species. Providing standardized automated interpretation of RDTs at POC in remote areas, in addition to almost real-time reporting of cases and enabling quality control would greatly benefit large-scale implementation of RDT-based malaria diagnostic programmes.

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Field evaluation of an automated RDT reader and data management device for Plasmodium falciparum/Plasmodium vivax malaria in endemic areas of Colombia

The cornerstone of decision making aimed at improving health services is accurate and timely health information. The Ministry of Public Health and Sanitation in Kenya decided to pilot feasibility of Fionet, an innovation that integrates diagnostics, data capture and cloud services, in its malaria control programme to demonstrate usability and feasibility by primary level workers in a remote setting in Kenya. Eleven sites comprising one sub-district hospital, ten health centres and dispensaries were selected in three districts of Kisumu County to participate. Two health workers per site were selected, trained over a two-day period in the use of the Deki Reader™ to undertake rapid diagnostic testing (RDT) for malaria and data capture of patients’ records. Health managers in the three districts were trained in the use of Fionet™ portal (web portal to cloud based information) to access the data uploaded by the Deki Readers. Field Support was provided by the Fio Corporation representative in Kenya. A total of 5812 malaria RDTs were run and uploaded to the cloud database during this implementation research study. Uploaded data were automatically aggregated into predetermined reports for use by service managers and supervisors. The Deki Reader enhanced the performance of the health workers by not only guiding them through processing of a malaria RDT test, but also by doing the automated analysis of the RDT, capturing the image, determining whether the RDT was processed according to guidelines, and capturing full patient data for each patient encounter. Supervisors were able to perform remote Quality assurance/Quality control (QA/QC) activities almost in real time. Quality, complete and timely data collection by health workers in a remote setting in Kenya is feasible. This paperless innovation brought unprecedented quality control and quality assurance in diagnosis, care and data capture, all in the hands of the health worker at point of care in an integrated way.

/pdf/feasibility-of-an-innovative-electronic-mobile-system-to-h19ks8expq.pdf

Feasibility of an innovative electronic mobile system to assist health workers to collect accurate, complete and timely data in a malaria control programme in a remote setting in Kenya

Abstract Background Achieving viral suppression (VS) for persons living with HIV is key to reaching epidemic control. We assessed the prevalence of VS and the frequency of HIV drug resistance mutations (HIVDRM) among children and adolescents living with HIV (CALHIV) in the Southern Highland zone of Tanzania. Methods From 2019 to 2021, we enrolled CALHIV aged 1–19 years on ART for >6 months in a cross-sectional study. Participants had viral load (VL) testing; those with VL ≥ 1000 copies/mL underwent HIVDRM testing. VS (<1000 copies/mL) prevalence estimates were calculated and robust Poisson regression was used to estimate prevalence ratios (PRs) and 95% confidence intervals (CIs) for associations with potential predictors of VS. Results Of 707 participants, 595 had VS (PR: 0.84, 95% CI: 0.81–0.87). Use of an integrase strand transfer inhibitor-containing regimen (aPR 1.15, 95% CI: 0.99–1.34), age 5–9 years (aPR 1.16, 95% CI: 1.07–1.26), and seeking care at a referral center (aPR 1.12, 95% CI: 1.04–1.21) were associated with VS. Factors inversely associated with VS included having one (aPR 0.82, 95% CI: 0.72–0.92) or two or more (aPR 0.79, 95% CI: 0.66–0.94) referrals for adherence counselling, and self-reporting missing one to two (aPR 0.88, 95% CI: 0.78–0.99) or three or more (aPR 0.77, 95% CI: 0.63–0.92) doses of ART in the past month. Of 74 participants with PRRT and INT sequencing done, 60 (81.1%) had HIVDRMs at the following frequencies: 71.6%, 67.6%, 1.4%, and 4.1% for major NNRTI, NRTI, PI, and INSTI respectively. Conclusions Higher rates of VS were observed in this cohort, and HIVDRMs were common in those without VS. This evidence supports ART optimization using dolutegravir-based regimens. However, better strategies to improve adherence are needed.

Factors Associated With Viral Suppression and Drug Resistance in Children and Adolescents Living With HIV in Care and Treatment Programs in Southern Tanzania

The World Health Organization early warning indicators (EWIs) permit surveillance of factors associated with the emergence of HIV drug resistance (HIVDR). We examined cross- and within-region performance on HIVDR EWIs for selected HIV care and treatment clinics (CTCs) in five regions of southern Tanzania. We retrospectively abstracted EWI data from 50 CTCs for the January to December 2013 period. EWIs included the following: on time ART pick-up, retention on ART, ARV stockouts, and pharmacy prescribing and dispensing practices. Data for pediatric and adult people living with HIV were abstracted from source files, and frequencies and proportions were calculated for each EWI overall, as well as stratified by region, facility, and age group. Across and within all regions, on average, on-time pick-up of pills (63.0%), retention on ART (76.0%), and pharmacy stockouts (69.0%) were consistently poor for the pediatric population. Similarly, on-time pill pick up (66.0%), retention on ART (72.0%) and pharmacy stockouts (53.0%) for adults were also poor. By contrast, performance on pharmacy prescribing and dispensing practices were as desired for both pediatric and adult populations with few facility-level exceptions. In this study, regions and facilities in the southern highlands of Tanzania reported widespread presence of HIVDR risk factors, including sub-optimal timeliness of pill pickup, retention on ART, and drug stockouts. There is an urgent need to implement the WHO EWIs monitoring to minimize the emergence of preventable HIV drug resistance and to maintain the effectiveness of first and second-line ART regimens. This is particularly critical in the context of new ART drug roll-out such as dolutegravir during the COVID-19 pandemic when resultant HIV service disruptions require careful monitoring, and for virologic suppression as countries move closer to epidemic control.

Early warning indicators of HIV drug resistance in the southern highlands region of Tanzania: Lessons from a cross-sectional surveillance study

Background
Parasitological confirmation of malaria is now recommended in all febrile patients by the World Health Organization (WHO) to reduce inappropriate use of anti-malarial drugs. Widespread implementation of rapid diagnostic tests (RDTs) is regarded as an effective strategy to achieve this goal. However, the quality of diagnosis provided by RDTs in remote rural dispensaries and health centres is not ideal. Feasible RDT quality control programmes in these settings are challenging. Collection of information regarding diagnostic events is also very deficient in low-resource countries.

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Clinical performance of an automated reader in interpreting malaria rapid diagnostic tests in Tanzania

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Factors Associated With Viral Suppression and Drug Resistance in Children and Adolescents Living With HIV in Care and Treatment Programs in Southern Tanzania

Early warning indicators of HIV drug resistance in the southern highlands region of Tanzania: Lessons from a cross-sectional surveillance study

Clinical performance of an automated reader in interpreting malaria rapid diagnostic tests in Tanzania