Performance of the BD-FACS Presto for CD4 count and hemoglobin measurement in a district hospital and rural laboratory in Ghana

Introduction In Ghana, initiation of Antiretroviral Therapy (ART) is recommended for all patients with an HIV diagnosis, regardless of CD4+ T-cell count. However, measurement of CD4 count remains an important metric for identifying patients with advanced HIV disease, and assessing a person’s overall immune status, which informs the decision to offer opportunistic infection screening and prophylaxis. Access to CD4+ T cell count in rural health facilities remains a major challenge in Ghana and other resource-limited settings. This study aimed to validate the accuracy of the BD FACSPresto near-patient device for measurement of CD4 count and hemoglobin concentration against the FACSCount (CD4) and Sysmex (hemoglobin) diagnostic machines when operated in both a district hospital and rural laboratory, serving a network of health posts in Ashanti Region, Ghana. Methodology In the first phase of the study, patients were recruited from a district hospital, and both venous and capillary blood samples were tested using the FACSCount and Sysmex as reference tests and compared to results of the FACSPresto performed in the clinic laboratory at the district hospital. In the second phase, patients were recruited from both the hospital and from rural health clinics, and samples were tested using the FACSPresto at a rural laboratory. Sensitivity and specificity among samples categorized into different clinically relevant CD4 count ranges were calculated, along with correlation between the Presto and the reference measurements, and mean and relative bias with limits of agreement. Results The FACSPresto was successfully operated in both clinical settings. A total of 59 samples in the first phase and 48 samples in the second phase were included. Positive bias was observed when comparing CD4 count measured by BD FACSPresto to FACSCount in the district hospital (bias = 44, LOA -72,160) and in the rural laboratory setting (bias = 74, LOA -96, 244). In addition, capillary blood samples were shown to give higher measures when compared to venous blood samples from the same participant. All results were statistically significant (p<0.05) apart from hemoglobin measurement in venous blood in the rural laboratory. Correlation coefficients were high for CD4 count measures and lower for hemoglobin measures. Conclusion Overall, the Presto gave higher estimates of CD4 count compared to FACSCount, and hemoglobin measurements were higher than from Sysmex. Samples of capillary blood in turn gave higher results for both measurements compared to venous blood, consistent with previous analyses. These findings should be considered when selecting CD4 count machines for use at the point of care, especially in remote areas where capillary blood sampling may be preferable, but are likely balanced by device’s ease of use, portability, and ability to expand access to services. These results are some of the first to demonstrate the accuracy of the FACSPresto in West Africa and show that this device can be successfully operated in a very rural lab setting and may therefore assist to provide CD4 count and hemoglobin concentration measurement to populations in need

Could the Recent Zika Epidemic Have Been Predicted?

Given knowledge at the time, the recent 2015–2016 zika virus (ZIKV) epidemic probably could not have been predicted. Without the prior knowledge of ZIKV being already present in South America, and given the lack of understanding of key epidemiologic processes and long-term records of ZIKV cases in the continent, the best related prediction could be carried out for the potential risk of a generic Aedes-borne disease epidemic. Here we use a recently published two-vector basic reproduction number model to assess the predictability of the conditions conducive to epidemics of diseases like zika, chikungunya, or dengue, transmitted by the independent or concurrent presence of Aedes aegypti and Aedes albopictus. We compare the potential risk of transmission forcing the model with the observed climate and with state-of-the-art operational forecasts from the North American Multi Model Ensemble (NMME), finding that the predictive skill of this new seasonal forecast system is highest for multiple countries in Latin America and the Caribbean during the December-February and March-May seasons, and slightly lower—but still of potential use to decision-makers—for the rest of the year. In particular, we find that above-normal suitable conditions for the occurrence of the zika epidemic at the beginning of 2015 could have been successfully predicted at least 1 month in advance for several zika hotspots, and in particular for Northeast Brazil: the heart of the epidemic. Nonetheless, the initiation and spread of an epidemic depends on the effect of multiple factors beyond climate conditions, and thus this type of approach must be considered as a guide and not as a formal predictive tool of vector-borne epidemics

Comparative performance study of three Ebola rapid diagnostic tests in Guinea

Background The 2014/15 Ebola outbreak in West Africa resulted in 11,000 deaths and massive strain on local health systems, and the ongoing outbreak in Democratic Republic of Congo has afflicted more than 3000 people. Accurate, rapid Ebola diagnostics suitable for field deployment would enable prompt identification and effective response to future outbreaks, yet remain largely unavailable. The purpose of this study was to assess the accuracy of three novel rapid diagnostic tests (RDTs): an Ebola, an Ebola-Malaria, and a Fever Panel test that includes Ebola, all from a single manufacturer. Methods We evaluated the three RDTs in 109 Ebola-positive and 96 Ebola-negative stored serum samples collected during the outbreak in Guinea in 2014/15, and tested by real-time polymerase chain reaction (RT-PCR). Sensitivity, specificity, and overall percent agreement were calculated for each RDT using RT-PCR as a reference standard, stratified by Ct value ranges. Results All tests performed with high accuracy on samples with low Ct value (high viral load). The Fever Panel test performed with the highest accuracy, with a sensitivity of 89.9% and specificity of 90.6%. The Ebola and Ebola-Malaria tests performed comparably to each other: sensitivity was 77.1 and 78% respectively, and specificity was 91.7% for the Ebola test and 95.8% for the Ebola-Malaria test. Conclusions This study evaluated the accuracy of three novel rapid diagnostic tests for Ebola. The tests may have significant public health relevance, particularly the Fever Panel test, which detects seven pathogens including Ebola. Given limitations to the study resulting from uncertain sample quality, further evaluation is warranted. All tests performed with highest accuracy on samples with low Ct value (high viral load), and the data presented here suggests that these RDTs may be useful for point-of-care diagnosis of cases in the context of an outbreak. Restrictions to their use in non-severe Ebola cases or for longitudinal monitoring, when viral loads are lower, may be appropriate. Highlighting the challenge in developing and evaluating Ebola RDTs, there were concerns regarding sample integrity and reference testing, and there is a need for additional research to validate these assays

Could the Recent Zika Epidemic Have Been Predicted?

Given knowledge at the time, the recent 2015–2016 zika virus (ZIKV) epidemic probably could not have been predicted. Without the prior knowledge of ZIKV being already present in South America, and given the lack of understanding of key epidemiologic processes and long-term records of ZIKV cases in the continent, the best related prediction could be carried out for the potential risk of a generic Aedes-borne disease epidemic. Here we use a recently published two-vector basic reproduction number model to assess the predictability of the conditions conducive to epidemics of diseases like zika, chikungunya, or dengue, transmitted by the independent or concurrent presence of Aedes aegypti and Aedes albopictus. We compare the potential risk of transmission forcing the model with the observed climate and with state-of-the-art operational forecasts from the North American Multi Model Ensemble (NMME), finding that the predictive skill of this new seasonal forecast system is highest for multiple countries in Latin America and the Caribbean during the December-February and March-May seasons, and slightly lower—but still of potential use to decision-makers—for the rest of the year. In particular, we find that above-normal suitable conditions for the occurrence of the zika epidemic at the beginning of 2015 could have been successfully predicted at least 1 month in advance for several zika hotspots, and in particular for Northeast Brazil: the heart of the epidemic. Nonetheless, the initiation and spread of an epidemic depends on the effect of multiple factors beyond climate conditions, and thus this type of approach must be considered as a guide and not as a formal predictive tool of vector-borne epidemics

Adaptation of the Wound Healing Questionnaire universal-reporter outcome measure for use in global surgery trials (TALON-1 study): mixed-methods study and Rasch analysis

BackgroundThe Bluebelle Wound Healing Questionnaire (WHQ) is a universal-reporter outcome measure developed in the UK for remote detection of surgical-site infection after abdominal surgery. This study aimed to explore cross-cultural equivalence, acceptability, and content validity of the WHQ for use across low- and middle-income countries, and to make recommendations for its adaptation.MethodsThis was a mixed-methods study within a trial (SWAT) embedded in an international randomized trial, conducted according to best practice guidelines, and co-produced with community and patient partners (TALON-1). Structured interviews and focus groups were used to gather data regarding cross-cultural, cross-contextual equivalence of the individual items and scale, and conduct a translatability assessment. Translation was completed into five languages in accordance with Mapi recommendations. Next, data from a prospective cohort (SWAT) were interpreted using Rasch analysis to explore scaling and measurement properties of the WHQ. Finally, qualitative and quantitative data were triangulated using a modified, exploratory, instrumental design model.ResultsIn the qualitative phase, 10 structured interviews and six focus groups took place with a total of 47 investigators across six countries. Themes related to comprehension, response mapping, retrieval, and judgement were identified with rich cross-cultural insights. In the quantitative phase, an exploratory Rasch model was fitted to data from 537 patients (369 excluding extremes). Owing to the number of extreme (floor) values, the overall level of power was low. The single WHQ scale satisfied tests of unidimensionality, indicating validity of the ordinal total WHQ score. There was significant overall model misfit of five items (5, 9, 14, 15, 16) and local dependency in 11 item pairs. The person separation index was estimated as 0.48 suggesting weak discrimination between classes, whereas Cronbach's α was high at 0.86. Triangulation of qualitative data with the Rasch analysis supported recommendations for cross-cultural adaptation of the WHQ items 1 (redness), 3 (clear fluid), 7 (deep wound opening), 10 (pain), 11 (fever), 15 (antibiotics), 16 (debridement), 18 (drainage), and 19 (reoperation). Changes to three item response categories (1, not at all; 2, a little; 3, a lot) were adopted for symptom items 1 to 10, and two categories (0, no; 1, yes) for item 11 (fever).ConclusionThis study made recommendations for cross-cultural adaptation of the WHQ for use in global surgical research and practice, using co-produced mixed-methods data from three continents. Translations are now available for implementation into remote wound assessment pathways