Fingerstick Blood Samples Research Articles

FebriDx®: A Rapid Diagnostic Test for Differentiating Bacterial and Viral Aetiologies in Acute Respiratory Infections.

FebriDx® is a rapid, point-of-care diagnostic test that is designed to aid in the differentiation of bacterial and viral acute respiratory infections (ARIs), thus helping to guide decisions regarding the prescription of antibiotics in the outpatient setting. FebriDx carries a CE mark for use in the EU and is also approved in several other countries, including Canada, Saudi Arabia and Singapore. It is indicated for use in patients > 2 years old with symptoms consistent with a community-acquired ARI. The test involves the use of an immunoassay on a fingerstick blood sample to provide simultaneous, qualitative measurement of elevated levels of C-reactive protein (CRP) and myxovirus resistance protein A (MxA). In two prospective, multicentre studies in patients with acute upper respiratory tract infections, FebriDx was shown to be both sensitive and specific in identifying patients with a clinically significant infection and in differentiating between infections of bacterial and viral aetiology. The test is simple, requires no additional equipment and produces actionable results in ~ 10 min. As was demonstrated in a small, retrospective analysis, FebriDx results can help guide (improve) antibiotic prescribing decisions. Reducing the unnecessary or inappropriate prescription of antibiotics for ARIs of probable viral aetiology is important for antibiotic stewardship and can also reduce the unnecessary exposure of patients to the risk of antibiotic-related adverse events. FebriDx thus represents a useful diagnostic tool in the outpatient setting.

Acceptability and Feasibility of Self-Collecting Biological Specimens for HIV, Sexually Transmitted Infection, and Adherence Testing Among High-Risk Populations (Project Caboodle!): Protocol for an Exploratory Mixed-Methods Study.

BackgroundMen who have sex with men (MSM) in the United States experience a disproportionate burden of HIV and bacterial sexually transmitted infections (STIs), such as gonorrhea and chlamydia. Screening levels among MSM remain inadequate owing to barriers to testing such as stigma, privacy and confidentiality concerns, transportation issues, insufficient clinic time, and limited access to health care. Self-collection of specimens at home and their return by mail for HIV and bacterial STI testing, as well as pre-exposure prophylaxis (PrEP) adherence monitoring, could be a resource-efficient option that might mitigate some of these barriers.ObjectiveProject Caboodle! is a mixed-methods study that explores the acceptability and feasibility of self-collecting and returning a bundle of 5 different specimens for HIV and bacterial STI testing, as well as PrEP adherence monitoring, among sexually active HIV-negative or unknown status MSM in the United States aged 18 to 34 years.MethodsParticipants will be recruited using age, race, and ethnicity varied advertising on social networking websites and mobile gay dating apps. In Phase 1, we will send 100 participants a box containing materials for self-collecting and potentially returning a finger-stick blood sample (for HIV testing), pharyngeal swab, rectal swab, and urine specimen (for gonorrhea and chlamydia testing), and hair sample (to assess adequacy for potential PrEP adherence monitoring). Specimen return will not be incentivized, and participants can choose to mail back all, some, or none of the specimens. Test results will be delivered back to participants by trained counselors over the phone. In Phase 2, we will conduct individual in-depth interviews using a video-based teleconferencing software (VSee) with 32 participants from Phase 1 (half who returned all specimens and half who returned some or no specimens) to examine attitudes toward and barriers to completing various study activities.ResultsProject Caboodle! was funded in May 2018, and participant recruitment began in March 2019. The processes of designing a study logo, creating advertisements, programming Web-based surveys, and finalizing step-by-step written instructions accompanied by color images for specimen self-collection have been completed. The boxes containing 5 self-collection kits affixed with unique identification stickers are being assembled, and shipping procedures (for mailing out boxes to participants and for specimen return by participants using prepaid shipping envelopes) and payment procedures for completing the surveys and in-depth interviews are being finalized.ConclusionsSelf-collection of biological specimens at home and their return by mail for HIV and bacterial STI testing, as well as PrEP adherence monitoring, might offer a practical and convenient solution to improve comprehensive prevention efforts for high-risk MSM. The potentially reduced time, expense, and travel associated with this approach could facilitate a wider implementation of screening algorithms and remote monitoring strategies.International Registered Report Identifier (IRRID)PRR1-10.2196/13647

Accuracy and Precision of a Point-of-Care HbA1c Test.

Point-of-care (POC) hemoglobin A1c (HbA1c) testing has advantages over laboratory testing, but some questions have remained regarding the accuracy and precision of these methods. The accuracy and the precision of the POC Afinion™ HbA1c Dx test were investigated. Samples spanning the assay range were collected from prospectively enrolled subjects at three clinical sites. The accuracy of the POC test using fingerstick and venous whole blood samples was estimated via correlation and bias with respect to values obtained by an NGSP secondary reference laboratory (SRL). The precision of the POC test using fingerstick samples was estimated from duplicate results by calculating the coefficient of variation (CV) and standard deviation (SD), and separated into its components using analysis of variance (ANOVA). The precision of the POC test using venous blood was evaluated from samples run in four replicates on each of three test cartridge lots, twice per day for 10 consecutive days. The SD and CV by study site and overall were calculated. Across the assay range, POC test results from fingerstick and venous whole blood samples were highly correlated with results from the NGSP SRL (r = .99). The mean bias was -0.021% HbA1c (-0.346% relative) using fingerstick samples and -0.005% HbA1c (-0.093% relative) using venous samples. Imprecision ranged from 0.62% to 1.93% CV for fingerstick samples and 1.11% to 1.69% CV for venous samples. The results indicate that the POC test evaluated here is accurate and precise using both fingerstick and venous whole blood.

Fingerstick Precision and Total Error of a Point-of-Care HbA1c Test.

Point-of-care (POC) HbA1c tests hold the promise of reducing the rates of undiagnosed diabetes, provided they exhibit acceptable analytical performance. The precision and total error of the POC (Afinion™ HbA1c Dx) test were investigated using whole blood samples obtained by fingerstick and venipuncture. Fingerstick samples spanning the assay range were collected from 61 subjects at three representative POC sites. At each site, six fingerstick samples were obtained from each subject and tested on the POC test across two (Afinion AS100) instruments. Repeatability, between-operator, and between-instrument components of variance were calculated using analysis of variance (ANOVA). Four venous samples (low, threshold, medium, and high HbA1c) were measured in duplicate across three instruments using three reagent lots, twice per day over 20-days. Repeatability, between-run, between-day, between-lot, and between-instrument components of variance were calculated. These fingerstick and venous blood results, combined with estimates of imprecision and bias from a prior investigation, allowed for the calculation of the total coefficient of variation (CV) and total error of the POC test using fingerstick and venous whole blood samples. The total imprecision ranged from 1.30% to 2.03% CV using fingerstick samples and from 1.31% to 1.64% CV using venous samples. The total error ranged from 2.87% to 4.75% using fingerstick samples and from 2.93% to 3.80% using venous samples. The POC test evaluated here is precise across its measuring range using both fingerstick and venous whole blood. The calculated total error of the test is well under the accepted quality requirement of ≤6%.

Development of a biodosimeter for radiation triage using novel blood protein biomarker panels in humans and non-human primates

Purpose: In a significant nuclear event, hundreds of thousands of individuals will require rapid triage for absorbed radiation to ensure effective medical treatment and efficient use of medical resources. We are developing a rapid screening method to assess whether an individual received an absorbed dose of ≥2 Gy based on the analysis of a specific panel of blood proteins in a fingerstick blood sample.Materials and methods: We studied a data set of 1051 human blood samples obtained from radiotherapy patients, normal healthy individuals, and several special population groups. We compared the findings in humans with those from irradiation studies in non-human primates (NHPs).Results: We identified a panel of three protein biomarkers, salivary alpha amylase (AMY1), Flt3 ligand (FLT3L), and monocyte chemotactic protein 1 (MCP1), which are upregulated in human patients receiving fractionated doses of total body irradiation (TBI) therapy as a treatment for cancer. These proteins exhibited a similar radiation response in NHPs after single acute or fractionated doses of ionizing radiation.Conclusion: Our work provides confidence in this biomarker panel for biodosimetry triage using fingerstick blood samples and in the use of NHPs as a model for irradiated humans.

Short-term changes in added sugar consumption by adolescents reflected in the carbon isotope ratio of fingerstick blood.

Consumption of added sugars (AS) and sugar-sweetened beverages (SSB) may adversely affect adolescents' weight and cardiovascular disease risk. Reliance on self-reported dietary assessment methods is a common research limitation, which could be overcome by dietary intake biomarkers. The investigation was a proof-of-concept study to evaluate the proposed carbon isotope ratio (δ13C) biomarker of AS intake in adolescents, using a controlled feeding design. Participants (n = 33, age 15.3 years, 53% female) underwent two seven-day controlled feeding periods in a randomly assigned order. Diets were matched in composition except for AS content (5% or 25% of total energy). Fasting fingerstick blood samples were collected daily during each diet period. Fingerstick δ13C values changed from day 1 to 8 by -0.05 ± 0.071‰ on 5% AS, and +0.03 ± 0.083‰ on 25% AS (p ≤ 0.001). Reliability was demonstrated between day 7 and 8 δ13C values on the 5% (ICC = 0.996, p ≤ 0.001) and 25% (ICC = 0.997, p ≤ 0.001) AS diets. Larger scale investigations are warranted to determine if this technique could be applied to population-level research in order to help assess the effectiveness of interventions aimed at reducing the consumption of AS or SSB intake.

Rate of Diabetes in Maricopa County, AZ

The prevalence of type 2 diabetes mellitus (T2DM) is well documented at the national, state, and even county level. Results are captured in the Behavior Risk Factor Surveillance System (BRFSS), a U.S. survey that collects data on disease rates and health-related risk behavior. The 2015 BRFSS audit revealed Arizona has an overall adult T2DM prevalence of 9.1%. Further, in Maricopa County, the region which includes the greater Phoenix area, the T2DM prevalence is higher at 10.8%. Conversely, there is limited data available on prediabetes rates in Maricopa County; therefore, we examined the rate of diabetes and prediabetes during community-partnered events as part of an educational “A1C initiative.” Basic demographic data as well as a fingerstick blood sample were obtained. HbA1c was measured with a hand-held monitor. 794 participants (272 men) were screened at 15 events from April 2016 to Sept 2017. The majority of participants were of Hispanic descent (54%). HbA1c results were categorized according to the ADA guidelines; normal (< 5.7%), prediabetes (5.7-6.4%) and diabetes (≥6.5%) ranges. Mean HbA1c for all participants was 6.0% +1.2%, with 16% and 35% falling in the diabetes and prediabetes ranges respectively. Diabetes and prediabetes rates for males and females were similar. By ethnicity, prediabetes was highest among African Americans (AA) (41%), followed by white non-Hispanics (35%) then Hispanics (33%). Despite AA having a higher diabetes rate at 21%, HbA1c was significantly higher in Hispanics vs. AA diabetes only subjects (8.6% +2.0 vs. 7.4% +1.4, p<0.001), suggesting worse glycemic control for the Hispanic group. In line with the national average of prediabetes prevalence at 33.9%, the overall rate we observed was similar, yet higher in certain groups. Notably, the diabetes rate was nearly double than that of the BRFSS report. The initiative provided vital (pre)diabetes awareness to Maricopa County residents. These findings were shared with our community partners, to aid in developing strategies to best assist those at risk of developing T2DM. Disclosure S.H. Jaycox: None. S. Paglialunga: Employee; Self; Celerion.

Observe Before You Leap: Why Observation Provides Critical Insights for Formative Research and Intervention Design That You'll Never Get From Focus Groups, Interviews, or KAP Surveys.

Formative research is essential to designing both study instruments and interventions in global health. While formative research may employ many qualitative methods, focus group discussions and in-depth interviews are the most common. Observation is less common but can generate insights unlikely to emerge from any other method. This article presents 4 case studies in which observation revealed critical insights: corralling domestic poultry to reduce childhood diarrhea, promoting insecticide-treated bed nets (ITNs) to prevent malaria, evaluating skilled birth attendant competency to manage life-threatening obstetric and neonatal complications, and assessing community health worker (CHW) ability to use malaria rapid diagnostic tests (RDTs). Observation of Zambian CHWs to design malaria RDT training materials revealed a need for training on how to take finger-stick blood samples, a procedure second nature to many health workers but one that few CHWs had ever performed. In Lima, Peru, study participants reported keeping their birds corralled "all the time," but observers frequently found them loose, a difference potentially explained by an alternative interpretation of the phrase "all the time" to mean "all the time (except at some specific seemingly obvious times)." In the Peruvian Amazon, observation revealed a potential limitation of bed net efficacy due to the built environment: In houses constructed on stilts, many people sleep directly on the floor, allowing mosquitoes to bite from below through gaps in the floorboards. Observation forms and checklists from each case study are included as supplemental files; these may serve as models for designing new observation guides. The case studies illustrate the value of observation to clearly understanding clinical practices and skills, details about how people carry out certain tasks, routine behaviors people would most likely not think to describe in an interview, and environmental barriers that must be overcome if an intervention is to succeed. Observation provides a way to triangulate for social desirability bias and to measure details that interview or focus group participants are unlikely to recognize, remember, or be able to describe with precision.

A prospective, multi-centre US clinical trial to determine accuracy of FebriDx point-of-care testing for acute upper respiratory infections with and without a confirmed fever

Background: FebriDx is a 10-minute disposable point-of-care test designed to identify clinically significant systemic host immune responses and aid in the differentiation of bacterial and viral respiratory infection by simultaneously detecting C-reactive protein (CRP) and myxovirus resistance protein A (MxA) from a fingerstick blood sample. FebriDx diagnostic accuracy was evaluated in the emergency room and urgent care setting.Methods: A prospective, multicentre, observational cohort study of acute upper respiratory tract infections (URIs), with and without a confirmed fever at the time of enrolment, was performed to evaluate the diagnostic accuracy of FebriDx to identify clinically significant bacterial infection with host response and acute pathogenic viral infection. The reference method consisted of an algorithm with physician override that included bacterial cell culture, respiratory PCR panels for viral and atypical pathogens, procalcitonin, and white blood cell count.Results: Among 220 patients enrolled, 100% reported fever 100.5°F within the last 72 hours while 55% had a measured hyperthermia (T > 100.4) at the time of enrolment. FebriDx demonstrated a sensitivity of 95% (95% CI: 77–100%), specificity of 94% (88–98%), PPV of 76% (59–87%), and a NPV of 99% (93–100%).Conclusion: FebriDx may identify clinically significant bacterial URI’s and supports outpatient antibiotic decisions.Key messagesFebriDx is an outpatient POC test designed to identify a clinically significant systemic host immune response and aid in the differentiation of viral and bacterial infection through rapid measurement of MxA and CRP from a fingerstick blood sample. FebriDx test was determined to be an accurate test, with a 85% sensitivity, 93% specificity and 97% NPV to rule out bacterial infection for any patient presenting with symptoms and reported fever within the prior 3 days, and when confirming fever (hyperthermia) at the time of testing, the test was even more sensitive (95%) and specific (94%) with a 99% NPV. FebriDx may support antibiotic stewardship by rapidly identifying clinically significant bacterial URIs.

Web-Based Recruitment and Survey Methodology to Maximize Response Rates from Followers of Popular Diets: the Adhering to Dietary Approaches for Personal Taste (ADAPT) Feasibility Survey

BackgroundAlthough there is interest in popular diets such as vegan and vegetarian, Paleo, and other “whole food” diets, existing cohort studies lack data for these subgroups. The use of electronic data capture and Web-based surveys in nutrition research may be valuable for future studies by allowing targeting of specific dietary subgroups. ObjectiveThe aim was to perform a Feasibility Survey (FS) to assess the practicality of Web-based research methods to gather data and to maximize response rates among followers of popular diets. MethodsThe FS was an open, voluntary, 15-min survey conducted over 8 wk in the summer of 2015. Recruitment targeted self-identified followers of popular diets from a convenience sample, offering no incentives, via social media and e-newsletters shared by recruitment partners. Feasibility was assessed by number of responses, survey completion rate, distribution of diets, geographic location, and willingness to participate in future research. ResultsA total of 14,003 surveys were initiated; 13,787 individuals consented, and 9726 completed the survey (71% of consented). The numbers of unique visitors to the questionnaire site, view rate, and participation rate were not captured. Among respondents with complete demographic data, 83% were female and 93% were white. Diet designations were collapsed into the following groups: whole-food, plant-based (25%); vegan and raw vegan (19%); Paleo (14%); try to eat healthy (11%); vegetarian and pescatarian (9%); whole food (8%); Weston A Price (5%); and low-carbohydrate (low-carb) (4%). Forced-response, multiple-choice questions produced the highest response rates (0–2% selected “prefer not to answer”). The percentage who were willing to complete future online questionnaires was 86%, diet recall was 93%, and food diary was 75%; the percentages willing to provide a finger-stick blood sample, venipuncture blood sample, urine sample, and stool sample were 60%, 44%, 58%, and 42%, respectively. ConclusionsThis survey suggests that recruiting followers of popular diets is feasible with the use of Web-based methods. The unbalanced sample with respect to sex and race/ethnicity could be corrected with specific recruitment strategies using targeted online marketing techniques.

Non-invasive, transdermal, path-selective and specific glucose monitoring via a graphene-based platform.

Currently, there is no available needle-free approach for diabetics to monitor glucose levels in the interstitial fluid. Here, we report a path-selective, non-invasive, transdermal glucose monitoring system based on a miniaturized pixel array platform (realized either by graphene-based thin-film technology, or screen-printing). The system samples glucose from the interstitial fluid via electroosmotic extraction through individual, privileged, follicular pathways in the skin, accessible via the pixels of the array. A proof of principle using mammalian skin ex vivo is demonstrated for specific and 'quantized' glucose extraction/detection via follicular pathways, and across the hypo- to hyper-glycaemic range in humans. Furthermore, the quantification of follicular and non-follicular glucose extraction fluxes is clearly shown. In vivo continuous monitoring of interstitial fluid-borne glucose with the pixel array was able to track blood sugar in healthy human subjects. This approach paves the way to clinically relevant glucose detection in diabetics without the need for invasive, finger-stick blood sampling.

Pertussis and the Minnesota State Fair: Demonstrating a Novel Setting for Efficiently Conducting Seroepidemiologic Studies.

Seroepidemiologic studies, which measure serum antibody levels produced in response to infection and/or vaccination, can be valuable tools for gaining insight into population level dynamics of infectious diseases. However, because seroepidemiologic studies are expensive and logistically challenging, they are not routinely conducted for surveillance purposes. We have identified a novel venue, state fairgrounds, in which annual sera samples from a population may be rapidly collected with minimal recruitment expenses. We conducted a pilot pertussis seroepidemiologic study over the course of 3days at the 2016 Minnesota State Fair to determine if this setting, which hosts nearly 2million visitors over 12days each year, is viable for facilitating larger seroepidemiologic studies. A total of 104 adults and children were enrolled to provide a finger stick blood sample for serologic testing and to take a written survey regarding recent cough illness and pertussis vaccination. The survey was used to distinguish between antibodies induced by vaccination and pertussis infection. Elevated antibodies suggestive of recent infection were found among two adults. The prevalence of undetectable antibodies, suggestive of susceptibility, was 72.3% (95% CI 59.6, 85.1%) among 7-17year olds, 53.8% (95% CI 26.7, 80.9%) among 1-6year olds, and 23.3% (95% CI 8.2, 38.5%) among adults. Our ability to rapidly enroll participants and collect satisfactory specimens suggests that seroepidemiologic studies with 1000-2000 participants could efficiently be completed over the 12-day course of the Minnesota State Fair. This setting raises the possibility of efficiently conducting annual population-based seroepidemiologic studies to supplement traditional public health surveillance in estimating disease prevalence, monitoring vaccine impact, and identifying at-risk groups.

Community-based diagnosis of non-communicable diseases and their risk factors in rural and urban Haiti: a cross-sectional prevalence study

ObjectiveTo estimate the prevalence of hypertension, diabetes and chronic kidney disease and their risk factors in a rural and urban region of Haiti.Setting and participantsCommunity health workers enumerated 2648 households...

Iodine status of pregnant women and children age 6 to 12 years feeding from the same food basket in Mopani district, Limpopo province, South Africa

Objectives: The aim of the study was to assess the iodine status of pregnant women and children age 6 to 12 years feeding from the same food basket in Mopani District.Design: A cross-sectional study was conducted.Setting: The setting was primary health care clinics and households from five municipalities of Mopani District in Limpopo province.Subjects: A total of 565 conveniently selected pregnant women and 116 children aged 6 to 12 years were recruited, of which 116 were mother–child pairs.Methods: The demographic information, iodine nutrition knowledge and salt consumption patterns were obtained using a validated questionnaire. Spot urine, household drinking water and salt samples were collected and analysed for iodine using standard procedures. A professional nurse, using filter paper to determine thyroid stimulating hormone (TSH) levels, collected spot finger-stick blood samples from pregnant women.Results: The findings showed that only 52.5% of household salt had an iodine concentration level of more than and equal to 15 ppm. The median iodine concentration of household drinking water was 46.2 μg/l (interquartile range [IQR] 10.8–73.4 μg/l). The TSH levels of the majority of pregnant women were normal and the maternal overall median urinary iodine concentration (UIC) was 164 μg/l (IQR 92–291 μg/l), indicating maternal iodine sufficiency. However, median UIC in the first and third trimesters was below 150 μg/l, indicating iodine insufficiency. The UIC level of children in the study was 386 μg/l (IQR 200–525 μg/l), signifying iodine excess.Conclusion: Iodine status of pregnant women in this study was sufficient, with UIC for children excessively high, more than two times higher than the iodine status of pregnant women. The reasons for the excessive UIC in school-age children need to be elucidated.

US Family Physicians Overestimate Personal ω-3 Fatty Acid Biomarker Status: Associations with Fatty Fish and ω-3 Supplement Intake

BackgroundThe health benefits of ω-3 (n–3) fatty acids are well established. Only a small percentage of Americans consume the recommended amounts of fatty fish, the main dietary source of ω-3 fatty acids, and most have low ω-3 fatty acid blood concentrations. ObjectiveWe aimed to measure biomarkers of long-chain ω-3 fatty acid (EPA and DHA) status among family physicians, and determine whether having their ω-3 status tested would influence attitudes and patient recommendations. MethodsFamily physicians attending a medical conference (n = 340) completed an ω-3 intake survey and had a finger stick blood sample taken. ω-3 Index, percentage of ω-6 (%n–6) in highly unsaturated fatty acids (HUFAs), and EPA:arachidonic acid (AA) ratio were calculated from whole blood fatty acid profiles. Post-conference, a subsample of participants (n = 100) responded to a survey regarding attitudes and recommendations about ω-3s. ResultsAverage age (mean ± SEM) of participants was 48.0 ± 0.7 y and 59% were women. Average ω-3 Index was 5.2% ± 0.1%, %n–6 in HUFA was 75% ± 0.4%, and EPA:AA ratio was 0.076 ± 0.004. 57% of family physicians reported consuming <2 servings/wk of fatty fish, and 78% reported using ω-3 supplements ≤1/wk. Although 51% believed ω-3 status was in a desirable range, only 5% had an ω-3 Index ≥8%. Biomarkers of ω-3 status were significantly associated with fatty fish intake and supplement use, and were correlated (R2 ranging from 0.59 to 0.77). Physicians who had ω-3 status tested (n = 65) were more likely to agree with statements affirming the health benefits of ω-3 fatty acids and more willing to recommend ω-3 fatty acids to their patients (P = 0.004). ConclusionsBlood concentrations of ω-3 fatty acids in family physicians were below recommendations, and were associated with fatty fish intake and ω-3 supplement use. There was a discrepancy between perceived and actual ω-3 status. Increased awareness of personal ω-3 status among physicians may facilitate patient communication and recommendations about ω-3 fatty acid intake. This trial was registered at clinicaltrials.gov as, NCT03056898.

Evaluation of HbA1c screening during outreach events for prediabetes subject recruitment for clinical research

BackgroundThere are a number of obstacles which may impede the recruitment of underserved populations in clinical research studies; some of these factors include mistrust of medical research, socioeconomic constraints, cultural factors, and language barriers. For chronic metabolic disease indications, these barriers may also include lack of disease awareness. Recently, national organizations such as the American Diabetes Association (ADA) and Centers for Disease Control and Prevention (CDC) have highlighted the need for prediabetes recognition. Therefore the aim of the study was twofold: to raise prediabetes awareness in an under-represented Hispanic community and to engage prediabetes participants in clinical research.MethodsHemoglobin A1c (HbA1c) screening was performed at major outreach events catered to the Hispanic community. All participants signed an ethics review board approved waiver which collected basic demographic information and the HbA1c test was performed with a hand-held monitor and finger-stick blood sample. Participants were given their HbA1c results at the event as well as information on prediabetes and upcoming clinic studies. After the event, participants were contacted by a study participant recruiter to assess interest in participating in clinical research.ResultsThe majority of participants screened fell within a prediabetes HbA1c range. Mean HbA1c was similar among men and women, yet higher in individuals aged 45–65 years compared to adults aged < 45 years (p < 0.05). For recruitment purposes, the highest number of leads came from participants attending a faith-based community event. In all, 17% of individuals contacted expressed interest in participating in clinical research and created a profile within our database to be eligible for future studies.ConclusionsProviding no-cost HbA1c screening is an excellent recruitment tool for clinical research as well as an opportunity to raise prediabetes awareness in a traditionally underserved population.

Abstract WP212: Rapid Point-of-care Nr2 Peptide Test for Acute Stroke Detection

Background and Objectives: Time delay is a challenge in using biomarkers in guiding acute ischemic stroke (IS) therapy. Therapeutic decisions must be made quickly and standard blood draws with transport to a laboratory results in delay of results and possible degradation of biomarkers. We report the initial experience with rapid nanoparticle lateral flow (nLF) tests on fingerstick blood samples for the NR2 peptide (NP), a fragment of the NMDA receptor. This extends our prior research (PLoS ONE, 2012, 7, e42362). Methods: Capillary blood (20 microliter) withdrawn less than 15 hours after IS onset was developed within 5 min yielding test (T) and control ( C ) bands in a nLF assay (DRD/CIS Biotech, Inc, Atlanta, GA). An Epson V700 scanner and ImageJ software (Rasband, W.S., ImageJ, U. S. NIH, Bethesda, Maryland) were used to quantify the LF bands. Plasma measurements of NP using MP-ELISA were carried out as well. Patient Selection: Patients (n=13) with thrombotic and embolic stroke and controls (n=16) with non-vascular disease of the CNS and healthy volunteers were enrolled. Diagnosis of ischemic stroke was confirmed by clinical evaluation and neuroimaging (CT, MRI and transcranial doppler). Increased NR2 peptide was detected in plasma of 9/13 patients with IS, i.e., the rapid test showed 2 lines (control and test). In some patients both lines are visualized equally others the T-line is stained less intensively. In the control group there is only one band (16/16) Elevated NP correlated with new lesion areas on DWI/MRI with a slope of ~ 1ng per 5 ml stroke volume. Conclusions: NR2 peptide is elevated with IS and may be detected by rapid fingerstick tests. Plasma NR2 peptide levels correlate with stroke volume.

The δ13C Value of Fingerstick Blood Is a Valid, Reliable, and Sensitive Biomarker of Sugar-Sweetened Beverage Intake in Children and Adolescents

Reliance on self-reported dietary intake methods is a commonly cited research limitation, and dietary misreporting is a particular problem in children and adolescents. Objective indicators of dietary intake, such as dietary biomarkers, are needed to overcome this research limitation. The added sugar (AS) biomarker δ13C, which measures the relative abundance of 13C to 12C, has demonstrated preliminary validity in adults. The purpose of this investigation was to determine the comparative validity, test-retest reliability, and sensitivity of the δ13C biomarker to detect AS and sugar-sweetened beverage (SSB) intake using fingerstick blood samples in children and adolescents. Children (aged 6-11 y, n = 126, 56% male, mean ± SD age: 9 ± 2 y) and adolescents (aged 12-18 y, n = 200, 44% male, mean ± SD age: 15 ± 2 y) completed 4 testing sessions within a 3-wk period. Participants' height, weight, demographic characteristics, and health history were determined at the first session; 24-h recalls were obtained at each visit and fingerstick blood samples were collected at visits 1 and 3. Samples were analyzed for δ13C value using natural abundance stable isotope mass spectrometry. δ13C value was compared with dietary outcomes in the full sample, and in child and adolescent subgroups. t Tests and correlational analyses were used to assess biomarker validity and reliability, whereas logistic regression and area under the receiver-operator characteristic curve (AUC) were used to evaluate sensitivity. Reported mean ± SD AS consumption was 82.2 ± 35.8 g/d and 329 ± 143 kcal/d, and SSB consumption was 222 ± 243 mL/d and 98 ± 103 kcal/d. Mean δ13C value was -19.65 ± 0.69‰, and was lower in children than in adolescents (-19.80 ± 0.67‰ compared with -19.56 ± 0.67‰, P = 0.002). δ13C values were similar across sessions (visit 1: -19.66 ± 0.68‰; visit 3: -19.64 ± 0.68‰; r = 0.99, P < 0.001) and were associated (P < 0.001) with intake of total AS (grams, kilocalories: r = 0.29) and SSB (milliliters, kilocalories: r = 0.35). The biomarker was able to better discriminate between high and low SSB consumers than high and low AS consumers, as demonstrated by the AUC (0.75 and 0.62, respectively). The δ13C biomarker is a promising, minimally invasive, objective biomarker of SSB intake in children and adolescents. Further evaluation using controlled feeding designs is warranted. Registered at clinicaltrials.gov as NCT02455388.

Cardiovascular Disease in American Indian and Alaska Native Youth: Unique Risk Factors and Areas of Scholarly Need.

In August 2016, the National Heart, Lung, and Blood Institute convened a scientific forum with 18 investigators active in the field of population health disparities. The purpose was to discuss heart, lung, and sleep disorders in children and adolescents of American Indian/Alaska Native (AI/AN)

Asymptomatic Lymphogranuloma Venereum among Nigerian Men who have Sex with Men

BackgroundAmong men who have sex with men (MSM), lymphogranuloma venereum (LGV) has been associated with proctocolitis that can lead to chronic complications and requires a longer course of antibiotic therapy than is recommended for infections due to other serovars of Chlamydia trachomatis (CT). We describe the prevalence and clinical features of LGV among Nigerian MSM diagnosed with anorectal CT.MethodsMSM were recruited into the ongoing RV368 cohort in Lagos, Nigeria, using respondent-driven sampling. Participants were screened for HIV and bacterial sexually transmitted infections (STIs) every three months for up to 18 months. HIV was diagnosed using a parallel algorithm of rapid tests on fingerstick blood samples. PCR testing for Neisseria gonorrheae and CTwas performed on voided urine, oropharyngeal swab, and rectal swab specimens. For this analysis, prevalent and incident cases of rectal CT infection underwent additional testing to identify LGV serovars utilizing novel real-time PCR assays specific for the L serovars of CT Chlamydia trachomatis.ResultsFrom 28 April 2014–19 July 2016, 420 men underwent screening for rectal STIs, including 66 (15.7%) who had prevalent rectal infection with CT. An additional 68 participants developed incident infections during 208 person-years of follow-up. Of 134 eligible rectal swab specimens, 128 underwent further testing for LGV serovars. Seven (5.5%) of the tested samples were identified as LGV serovars of CT. None of the seven participants with LGV reported any symptoms such as fever or rectal pain. Two of the participants with LGV were simultaneously co-infected with rectal gonorrhea. HIV co-infection was common among participants with both LGV and non-LGV serovars of CT (71% and 77%, respectively, P = 0.74).ConclusionLGV was uncommon but present among Nigerian MSM in this study. LGV needs to be considered even in asymptomatic cases, particularly if anorectal CT infection fails to respond to the usual course of therapy. Consistent screening for L serovars of CT, or empiric treatment for LGV in cases with a high suspicion for this diagnosis, could potentially improve patient outcomes and decrease transmission.Disclosures All authors: No reported disclosures.