Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy study.

BACKGROUND: Acute febrile illness is a common presentation for patients at hospitals globally. Assays that can diagnose a variety of common pathogens in blood could help to establish a diagnosis for targeted disease management. We aimed to evaluate the performance of the BioFire Global Fever Panel (GF Panel), a multiplex nucleic acid amplification test performed on whole blood specimens run on the BioFire FilmArray System, in the diagnosis of several pathogens that cause acute febrile illness. METHODS: We did a prospective, multicentre, cross-sectional diagnostic accuracy study to evaluate the GF Panel. Consenting adults and children older than 6 months presenting with fever in the previous 2 days were enrolled consecutively in sub-Saharan Africa (Ghana, Kenya, Tanzania, Uganda), southeast Asia (Cambodia, Thailand), central and South America (Honduras, Peru), and the USA (Washington, DC; St Louis, MO). We assessed the performance of six analytes (chikungunya virus, dengue virus [serotypes 1-4], Leptospira spp, Plasmodium spp, Plasmodium falciparum, and Plasmodium vivax or Plasmodium ovale) on the GF Panel. The performance of the GF Panel was assessed using comparator PCR assays with different primers followed by bidirectional sequencing on nucleic acid extracts from the same specimen. We calculated the positive percent agreement and negative percent agreement of the GF Panel with respect to the comparator assays. This study is registered with ClinicalTrials.gov, NCT02968355. FINDINGS: From March 26, 2018, to Sept 30, 2019, 1965 participants were enrolled at ten sites worldwide. Of the 1875 participants with analysable results, 980 (52·3%) were female and the median age was 22 years (range 0-100). At least one analyte was detected in 657 (35·0%) of 1875 specimens. The GF Panel had a positive percent agreement for the six analytes evaluated as follows: chikungunya virus 100% (95% CI 86·3-100), dengue virus 94·0% (90·6-96·5), Leptospira spp 93·8% (69·8-99·8), Plasmodium spp 98·3% (96·3-99·4), P falciparum 92·7% (88·8-95·6), and P vivax or P ovale 92·7% (86·7-96·6). The GF Panel had a negative percent agreement equal to or greater than 99·2% (98·6-99·6) for all analytes. INTERPRETATION: This 1 h sample-to-answer, molecular device can detect common causative agents of acute febrile illness with excellent positive percent agreement and negative percent agreement directly in whole blood. The targets of the assay are prevalent in tropical and subtropical regions globally, and the assay could help to provide both public health surveillance and individual diagnoses. FUNDING: BioFire Defense, Joint Project Manager for Medical Countermeasure Systems and US Army Medical Materiel Development Activity, and National Institute of Allergy and Infectious Diseases.

Community engagement and feedback of results in the H3Africa AWI-Gen project: Experiences from the Navrongo Demographic and Health Surveillance site in Northern Ghana.

Community and Public engagement (CE) have gained traction as an ethical best practice for the conduct of genomics research, particularly in the context of Africa. In the past 10 years, there has been growing scholarship on the value and practice of engaging key stakeholders including communities involved in genomics research. However, not much has been documented on how research teams, particularly in international collaborative research projects, are navigating the complex process of engagement including the return of key research findings. This paper is part of a series of papers describing the CE processes used in the AWI-Gen study sites. We describe the key processes of engagement, challenges encountered and the major lessons learned. We pay particular attention to the experiences in returning research results to participants and communities within the Demographic and Health Surveillance site in northern Ghana.

Blood Pressure Indices and Associated Risk Factors in a Rural West African Adult Population: Insights from an AWI-Gen Substudy in Ghana.

Systolic (SBP) and diastolic blood pressure (DBP) are commonly used for cardiovascular disease (CVD) risk prediction, and pulse pressure (PP) and mean arterial blood pressure (MAP) can provide additional information. It is therefore important to understand the factors associated with these cardiovascular risk markers. This cross-sectional study involved 1839 men and women aged 40-60 years. Data on SBP, DBP, MAP, PP, sociodemography, lifestyle, anthropometry, and lipids were collected. Gender-stratified linear regression analyses were performed to determine the association between log-transformed blood pressure indices and the study variables. Age was associated with all measured blood pressure indices (p < 0.001) among men and women. Men had higher SBP (p=0.007) and PP (p < 0.001) than women. Nankana ethnicity was associated with higher PP levels (p < 0.005) in the total population. Vendor meal consumption among women was associated with higher PP levels (p < 0.05). Fruit intake among men was associated with lower PP levels (p < 0.05). Currently unmarried women had higher SBP (p < 0.005), DBP (p < 0.05), MAP (p < 0.005), and PP (p < 0.005) than currently married women. Pesticide exposure was negatively associated with SBP (p < 0.005), DBP (p < 0.005), MAP (p < 0.005), and PP (p < 0.05) among women. Increased subcutaneous fat was associated with DBP (p < 0.005) and MAP (p < 0.05) among women. Among men, hip circumference was associated with higher DBP and MAP (p < 0.05 for both associations), subcutaneous fat associated with higher SBP (p < 0.005), DBP (p < 0.001), and MAP (p < 0.001) and visceral fat was associated with higher PP (p < 0.05). In the total population, visceral fat was associated with higher DBP (p < 0.05) and MAP (p < 0.001). High-density lipoprotein cholesterol was positively associated with SBP (p < 0.005), DBP (p < 0.005), and MAP (p < 0.001) for women and positively associated with SBP, DBP, and MAP (p < 0.001 for all three) and PP (p < 0.05) for men. The association of blood pressure indices with modifiable risk factors suggests that targeted health interventions may reduce CVD risk in this population.

Trends and risk factors associated with stillbirths: A case study of the Navrongo War Memorial Hospital in Northern Ghana.

BACKGROUND: Maternal and Child health remains at the core of global health priorities transcending the Millennium Development Goals into the current era of Sustainable Development Goals. Most low and middle-income countries including Ghana are yet to achieve the required levels of reduction in child and maternal mortality. This paper analysed the trends and the associated risk factors of stillbirths in a district hospital located in an impoverished and remote region of Ghana. METHODS: Retrospective hospital maternal records on all deliveries conducted in the Navrongo War Memorial hospital from 2003-2013 were retrieved and analysed. Descriptive and inferential statistics were used to summarise trends in stillbirths while the generalized linear estimation logistic regression is used to determine socio-demographic, maternal and neonatal factors associated with stillbirths. RESULTS: A total of 16,670 deliveries were analysed over the study period. Stillbirth rate was 3.4% of all births. There was an overall decline in stillbirth rate over the study period as stillbirths declined from 4.2% in 2003 to 2.1% in 2013. Female neonates were less likely to be stillborn (Adjusted Odds ratio = 0.62 and 95%CI [0.46, 0.84]; p = 0.002) compared to male neonates; neonates with low birth weight (4.02 [2.92, 5.53]) and extreme low birth weight (18.9 [10.9, 32.4]) were at a higher risk of still birth (p<0.001). Mothers who had undergone Female Genital Mutilation had 47% (1.47 [1.04, 2.09]) increase odds of having a stillbirth compared to non FGM mothers (p = 0.031). Mothers giving birth for the first time also had a 40% increase odds of having a stillbirth compared to those who had more than one previous births (p = 0.037). CONCLUSION: Despite the modest reduction in stillbirth rates over the study period, it is evident from the results that stillbirth rate is still relatively high. Primiparous women and preterm deliveries leading to low birth weight are identified factors that result in increased stillbirths. Efforts aimed at impacting on stillbirths should include the elimination of outmoded cultural practices such as FGM.

Prevalence and adverse obstetric outcomes of female genital mutilation among women in rural Northern Ghana.

BACKGROUND: Female genital mutilation (FGM) is commonly practiced in sub-Saharan Africa and results in adverse pregnancy outcomes among affected women. This paper assessed the prevalence and effects of FGM on pregnancy outcomes in a rural Ghanaian setting. METHODS: We analyzed 9306 delivery records between 2003 and 2013 from the Navrongo War Memorial Hospital. Multivariable logistic regression analyses were used to determine the effects of FGM on pregnancy outcomes such as stillbirth, birth weight, postpartum haemorrhage, caesarean and instrumental delivery. We also assessed differences in the duration of stay in the hospital by FGM status. RESULTS: A greater proportion of mothers with FGM (24.7%) were older than 35 years compared with those without FGM (7.6%). FGM declined progressively from 28.4% in 2003 to 0.6% in 2013. Mothers with FGM were nearly twice as likely to have caesarean delivery (adjusted odds ratios = 1.85 with 95%CI [1.72, 1.99]) and stillbirths (1.60 [1.21, 2.11]) compared with those without. Similarly, they had a 4-fold increased risk of post-partum haemorrhage (4.69 [3.74, 5.88]) and more than 2-fold risk lacerations/episiotomy (2.57 [1.86, 3.21]) during delivery. Average duration of stay in the hospital was higher for mothers with FGM from 2003 to 2007. CONCLUSIONS: Despite significant decline in prevalence of FGM, adverse obstetric outcomes are still high among affected women. Increased public health education of circumcised women on these outcomes would help improve institutional deliveries and heighten awareness and prompt clinical decisions among healthcare workers. Further scale-up of community level interventions are required to completely eliminate FGM.

Descriptive epidemiology of anaemia among pregnant women initiating antenatal care in rural Northern Ghana.

BACKGROUND:  Anaemia in pregnancy is associated with adverse obstetric outcomes. When detected early in pregnancy, it can be treated; however, information on its prevalence and associated factors is limited in rural Ghana. AIM:  The aim of this study was to determine the prevalence and maternal factors associated with anaemia in pregnancy at first antenatal care (ANC) visits. SETTING:  The study was conducted in the Navrongo War Memorial Hospital, a secondary referral facility in the Kassena-Nankana district in rural northern Ghana. METHODS:  A retrospective analysis of antenatal clinic records of pregnant women collected from January to December 2014. All pregnant women initiating antenatal clinic, who had initial haemoglobin (Hb) levels measured, were included in the study. Logistic regression analyses were carried out to determine factors associated with anaemia at the initiation of ANC. RESULTS:  We analysed data from 506 women with median Hb of 11.1 g/dL (IQR 7.31-13.8). The median gestational age at booking was 14 weeks (5-36 weeks). The prevalence of anaemia was 42.7%, with 95% confidence interval (CI) [38.4-47.1], and was high among teenage mothers (52% [34.9-67.8]), mothers who booked in the third trimester (55% [33.6-74.7]) and grand multiparous women (58% [30.7-81.6]). Factors associated with anaemia included grand multiparity (odds ratio [OR] = 1.94 with 95% CI [1.58-2.46]), booking during the third trimester (OR = 2.06 [1.78-2.21]) and mother who were underweight compared to those with normal weight (OR = 3.17 [1.19-8.32]). CONCLUSION:  Burden of anaemia in pregnancy is still high in rural northern Ghana. We advocate further strengthening of the primary health care system to improve early access to ANC delivery.