Fingerstick Testing Research Articles

Noninvasive Monitoring of Blood Glucose with Raman Spectroscopy.

The successful development of a noninvasive blood glucose sensor that can operate reliably over sustained periods of time has been a much sought after but elusive goal in diabetes management. Since diabetes has no well-established cure, control of elevated glucose levels is critical for avoiding severe secondary health complications in multiple organs including the retina, kidney and vasculature. While fingerstick testing continues to be the mainstay of blood glucose detection, advances in electrochemical sensing-based minimally invasive approaches have opened the door for alternate methods that would considerably improve the quality of life for people with diabetes. In the quest for better sensing approaches, optical technologies have surfaced as attractive candidates as researchers have sought to exploit the endogenous contrast of glucose, notably its absorption, scattering, and polarization properties. Vibrational spectroscopy, especially spontaneous Raman scattering, has exhibited substantial promise due to its exquisite molecular specificity and minimal interference of water in the spectral profiles acquired from the blood-tissue matrix. Yet, it has hitherto been challenging to leverage the Raman scattering signatures of glucose for prediction in all but the most basic studies and under the least demanding conditions. In this Account, we discuss the newly developed array of methodologies that address the key challenges in measuring blood glucose accurately using Raman spectroscopy and unlock new prospects for translation to sustained noninvasive measurements in people with diabetes. Owing to the weak intensity of spontaneous Raman scattering, recent research has focused on enhancement of signals from the blood constituents by designing novel excitation-collection geometries and tissue modulation methods while our attempts have led to the incorporation of nonimaging optical elements. Additionally, invoking mass transfer modeling into chemometric algorithms has not only addressed the physiological lag between the actual blood glucose and the measured interstitial fluid glucose values but also offered a powerful tool for predictive measurements of hypoglycemia. This framework has recently been extended to provide longitudinal tracking of glucose concentration without necessitating extensive a priori concentration information. These findings are advanced by the results of recent glucose tolerance studies in human subjects, which also hint at the need for designing nonlinear calibration models that can account for subject-to-subject variations in skin heterogeneity and hematocrit levels. Together, the emerging evidence underscores the promise of a blood withdrawal-free optical platform-featuring a combination of high-throughput Raman spectroscopic instrumentation and data analysis of subtle variations in spectral expression-for diabetes screening in the clinic and, ultimately, for personalized monitoring.

Feasibility and acceptability of HIV self-testing among pre-exposure prophylaxis users in Kenya.

Introduction: HIV testing is key to the delivery of pre-exposure prophylaxis (PrEP): testing HIV-uninfected at-risk persons is the first step for PrEP initiation and ongoing HIV testing is an essential part of PrEP delivery. Thus, novel and cost-effective HIV-testing approaches to streamline delivery of PrEP are urgently needed. Within a demonstration project of PrEP for HIV prevention among high-risk HIV serodiscordant couples in Kenya (the Partners Demonstration Project), we conducted a pilot evaluation of HIV self-testing. Methods: Clinic visits were scheduled quarterly and included in-clinic HIV testing using fingerstick rapid HIV tests and refills of PrEP prescriptions. HIV oral fluid self-test kits were provided for participants to use in the two-month interval between scheduled quarterly clinic visits. Acceptability of HIV self-testing was assessed using both quantitative and qualitative methods. Results: We found that 222 of 226 (98%) HIV-uninfected persons who were offered accepted self-testing. Nearly all (96.8%) reported that using the self-testing kit was easy. More than half (54.5%) reportedly did not share the HIV results from self-testing with anyone and almost all (98.7%) the participants did not share the HIV self-testing kits with anyone. Many participants reported that HIV self-testing was empowering and reduced anxiety associated with waiting between clinic HIV tests. Conclusions: HIV self-testing was highly acceptable and may therefore be a feasible strategy to efficiently permit routine HIV testing between PrEP refills.

388 Implementation of an Emergency Department Syphilis and HIV Point-of-Care Screening Process During an Outbreak of Syphilis in Detroit, MI in Collaboration With the Infectious Disease Department and the Centers for Disease Control and Prevention

The number of primary and secondary syphilis cases in Detroit, Michigan increased from 73 in 2010 to 199 to 2013. Cases were predominantly in young African American men with who have sex with men and with had a high rate of HIV co-infection. The infectious disease (ID) department at Henry Ford Hospital (HFH), in collaboration with the Centers for Disease Control and Prevention (CDC) determined the emergency department (ED) would be the optimal setting to implement a screening program. Young men in Detroit are typically non-health care seeking; however, EDs are venues they do frequent when they access the health care system. We hypothesized that the implementation of an ED screening model would detect an increased number of syphilis and HIV cases than were seen with standard care. Point-of-care (POC) testing would allow presumptive treatment of active syphilis cases in the emergency department, whereas traditional testing would not typically result and allow for care within a typical ED visit time frame. Syphilis and HIV screening was offered to men aged 18-34 years seen in the HFH ED with an Emergency Severity Index (ESI) of 2-5. Dedicated, non-ED staff employed 2 rapid finger-stick POC tests: the Alere Determine HIV-1/2 Ag/ab Combo test (Determine) and the Syphilis Heath Check (SHC) treponemal tests. Participants also underwent venipuncture for standard lab-based testing for HIV and syphilis. Screening took place from 7:30am to 5pm, Monday through Friday. Patients were first approached by screeners, typically before the initial clinician contact and were offered screening. Confirmatory lab-based testing using the Biorad 4th generation HIV test, RPR, and TPPA tests were drawn in conjunction with ED nursing staff during their routine bloodwork. ED clinicians were notified of positive SHC POC testing and patients were treated presumptively in the ED. From 6/10/2015 to 3/11/2016, 871 patients were enrolled. Active syphilis (RPR + TPPA +) was identified in 6 (0.7%) participants, and newly diagnosed HIV in 7 (0.8%). There was one case of syphilis-HIV coinfection, and the combined prevalence was 1.4%. Three patients were treated in the ED for syphilis based on their POC testing results without treatment complications. The implementation of an ED syphilis and HIV POC screening program is a feasible method to detect new cases of disease. The screening process can be incorporated into ED patient flow and provide clinicians with immediate test results to determine the need for treatment. POC HIV and syphilis testing are particularly important to ED providers, who may not otherwise receive important test results for their patients before they leave the emergency department.

A Novel Approach to the Management of Neonatal Diabetes Using Sensor-Augmented Insulin Pump Therapy With Threshold Suspend Technology at Diagnosis.

Neonatal diabetes mellitus (NDM) is a rare genetic condition with an incidence of 1 in 100,000 (1) that presents before 1 year of age (2). There are two main clinical forms of NDM: permanent NDM (PNDM), which requires lifelong treatment with insulin, and transient NDM (TNDM), which may spontaneously remit and sometimes recurs in the second to third decade of life. In most cases, TNDM and PNDM cannot be distinguished clinically at the time of diagnosis, and genetic analysis needs to be performed. The genetic origin for >90% of TNDM cases has been established. In TNDM, 68% of the cases have abnormalities in an imprinted region on chromosome 6q24; 10% have KCNJ11 gene mutations; and 13% have an ABCC8 gene mutation (3). Multiple genes involved in pancreatic development, β-cell apoptosis, or dysfunction cause PNDM (4). The most common mutations are in the KATP channel genes KCNJ11 (30%) and ABCC8 (11%) or the insulin (INS) gene (13%) (3). Insulin is acutely required in most infants to establish metabolic control in NDM (5). Early initiation of sulfonylurea treatment is also recommended (6) as a treatment option in selected cases of NDM caused by ABCC8 and KCNJ11 mutations, and, in responsive cases, sulfonylurea therapy provides better long-term metabolic control (7,8) and could even improve neurodevelopmental outcomes (9). The MiniMed 530G (Medtronic, Inc., Northridge, CA) is a first-generation artificial pancreas system approved by the U.S. Food and Drug Administration (FDA) on 26 September 2013 for the management of diabetes in people ≥16 years of age. The system includes an external glucose sensor and insulin pump, transmitter, glucose meter, and therapy management software. Sensor signals are transmitted to the MiniMed 530G insulin pump and converted into glucose values every 5 minutes. Fingerstick blood glucose testing is still required for both …

Blood Lead Levels and Potential Risk Factors for Lead Exposures Among South Asians in New York City

New York City’s South Asian children and pregnant women have a disproportionate burden of elevated blood lead levels. This study is the first to investigate blood lead levels and risk factors for lead exposures among South Asian New Yorkers. A survey and a finger-stick blood lead test using a portable analyzer were administered to 230 South Asian adults and children. Blood lead levels of 5 µg/dL or higher were found in 20 % of the adults and 15 % of the children, as compared to 5 % of adults and 2.5 % of children citywide. Factors associated with elevated blood lead levels were recent repair work at home, not speaking English, Bangladeshi or Indian ethnicity, and occupational risk factors. Public health professional should be aware that South Asians may be at an increased risk for elevated blood lead levels.

Hiv/Aids prevalence at the accident & emergency centre of a tertiary and referral health institution in Ghana

Background : Ghana has an estimated HIV prevalence of 1.4%, but the HIV prevalence of patients presenting at emergency departments in Ghana is not well documented in published literature. This study evaluated the prevalence of HIV infection at the Accident & Emergency Department, Komfo Anokye Teaching Hospital (KATH AE consenting patients were screened for HIV using rapid HIV finger-stick testing with HIV 1-2 STAT-PAK. Sero-positivity was confirmed by OraQuick HIV 1-2 test. Data was analysed using multivariate logistic regression. Results : 1125 patients presenting at the KATH AE HIV Screening; Prevalence, Diagnosis, Emergency Department

Prevalence and risk factors of anemia in children

ObjectiveTo identify the prevalence and factors associated with anemia in children attending Municipal Early Childhood Education Day Care Center (Centros Municipais de Educação Infantil [CMEI]) nurseries in Colombo-PR. MethodsAnalytical, cross-sectional study with a representative sample of 334 children obtained by stratified cluster sampling, with random selection of 26 nurseries. Data collection was conducted through interviews with parents, assessment of iron intake by direct food weighing, and hemoglobin measurement using the finger-stick test. Bivariate association tests were performed followed by multiple logistic regression adjustment. ResultsThe prevalence of anemia was 34.7%. Factors associated with anemia were: maternal age younger than 28 years old (p=0.03), male children (p=0.02), children younger than 24 months (p=0.01), and children who did not consume iron food sources (meat+beans+dark green leafy vegetables) (p=0.02). There was no association between anemia and iron food intake in CMEI. However, iron intake was well below the recommended levels according to the National Education Development Fund resolution, higher prevalence of anemia was observed in children whose intake of iron, heme iron, and nonheme iron was below the median. ConclusionsIn terms of public health, the prevalence of anemia is characterized as a moderate problem in the studied population and demonstrates the need for coordination of interdisciplinary actions for its reduction in CMEI nurseries.

Performance of Determine Combo and other point-of-care HIV tests among Seattle MSM

Background and objectiveThe rapid test study was a real-time comparison of point-of-care (POC) HIV tests to determine their abilities to detect early HIV infection. Study designMen and transgender persons reporting sex with men in the prior year were recruited at the Public Health—Seattle & King County STD Clinic, Gay City Health Project, and University of Washington Primary Infection Clinic. Study tests included the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids and tests performed on fingerstick whole blood specimens including OraQuick, Uni-Gold Recombigen HIV test, Determine HIV-1/2 Ag/Ab Combo, and INSTI HIV-1 Rapid Antibody Test. Specimens from subjects with negative results were sent for EIA and nucleic acid amplification testing. McNemar's exact tests compared the numbers of HIV-infected subjects detected. ResultsBetween February 2010 and August 2014, there were 3438 study visits. Twenty-four subjects had discordant POC results with at least one reactive and one non-reactive test, including one subject with a reactive Determine p24 antigen. OraQuick performed on oral fluids identified fewer persons compared to all fingerstick tests. OraQuick performed on fingerstick whole blood detected fewer persons compared to the Determine Combo antibody component (p=.008) and Combo overall (p=.004), and there was a trend when compared to INSTI (p=.06). The Determine Combo specificity was 98.99%. ConclusionsAs reported by others, Determine Combo underperforms compared to laboratory-based testing, but it did detect one acute infection. If these results are validated, the specificity of Determine Combo may limit its usefulness in populations with lower HIV incidence.

Accuracy and Acceptability of Oral Fluid HIV Self-Testing in a General Adult Population in Kenya.

We evaluated performance, accuracy, and acceptability parameters of unsupervised oral fluid (OF) HIV self-testing (HIVST) in a general population in western Kenya. In a prospective validation design, we enrolled 240 adults to perform rapid OF HIVST and compared results to staff administered OF and rapid fingerstick tests. All reactive, discrepant, and a proportion of negative results were confirmed with lab ELISA. Twenty participants were video-recorded conducting self-testing. All participants completed a staff administered survey before and after HIVST to assess attitudes towards OF HIVST acceptability. HIV prevalence was 14.6 %. Thirty-six of the 239 HIVSTs were invalid (15.1 %; 95 % CI 11.1–20.1 %), with males twice as likely to have invalid results as females. HIVST sensitivity was 89.7 % (95 % CI 73–98 %) and specificity was 98 % (95 % CI 89–99 %). Although sensitivity was somewhat lower than expected, there is clear interest in, and high acceptability (94 %) of OF HIV self-testing.

Type 2 Diabetes and Anxiety Symptoms Among Women in New Delhi, India.

We explored the relationship between mental health and type 2 diabetes among women in New Delhi, India, in 2011. We recruited a convenience sample of 184 diabetic women from 10 public and private clinics. They completed a finger-stick blood test and a questionnaire assessing demographic characteristics, depression and anxiety symptoms, and diabetes-related disabilities restricting their performance of daily tasks. A subsample of 30 women participated in follow-up qualitative interviews at their homes. More than one quarter of our sample of diabetic women reported high levels of anxiety symptoms, whereas 18% reported high levels of depression symptoms. Anxiety symptoms were patterned according to recency of diabetes diagnosis, with 40% of women diagnosed less than 2 years before their interview reporting high anxiety symptom levels, as opposed to 23% of women diagnosed more than 2 years in the past. Depression and anxiety scores differed with respect to their relationship to recency of diagnosis, number of children, blood glucose level, and functional disabilities restricting performance of daily tasks. Screening for anxiety among people with diabetes has been overlooked in the past. Anxiety appears more prevalent than depression, especially during the first 2 years of the disease.

Can Ophthalmologists Achieve Better Blood Glucose Control in Their Diabetic Patients?

Ophthalmology is generally considered to be limited to disorders of the eye and its adnexa. Diabetes mellitus, however, is a systemicdisease thatweencounter frequently in our ophthalmic practices because of its ocular complications, especially diabetic retinopathy. When, after years of controversy, 2 seminal randomized clinical trials, the Diabetes Control andComplications Trial (DCCT)1 and theUKProspectiveDiabetes Study (UKPDS),2 clearly found that near-normal bloodglucosecontrol significantly slows thedevelopmentand progressionof diabetic retinopathy inpatientswith type 1 and type 2 diabetes, with a marked effect on the protection of vision, ophthalmologists were offered an important opportunity toadviseourdiabeticpatientson themanagementof their systemicdisease.Consequently, theDiabeticRetinopathyClinical ResearchNetwork (DRCR.net), a large groupof collaborating centers funded by theNational Eye Institute, conducted a randomizedclinical trial to investigatewhethermeasuringhemoglobinA1c (HbA1c) in the ophthalmology clinic, counseling patients on the relevanceof goodbloodglucose control toprevent retinopathy, and providing personalized risk assessments toeachpatient could significantly improveglucose control in patients during a 1-year period. The negative results of thisprojectarepresented inthis issueofJAMAOphthalmology.3 An earlier study4 indicated that only approximately half of adults with diabetes knew their HbA1c levels, the association of those levels with blood glucose control, and the level (≤7.0%) that is recommended to minimize the risk of developing retinopathy or other microvascular complications of diabetes. A substantially smaller number (24%) have HbA1c values less than or equal to that level.4 The present investigation had a complex protocol. Forty-two clinical centers and 1746 patients participated. Participating clinics comprised 34 that randomized patients by center and 8 that randomized by physician within the center. Patients, who had to have a recent HbA1c value of 7.5% or higher and meet several other criteria to be eligible, were divided into 2 groups. The larger group (990 patients) had multiple (up to 4) ophthalmologic clinic visits during the year, whereas the smaller group (756 patients) was seen only twice, at the beginning and end of the study. Each of these 2 groups was then randomized to standard care, including regular ophthalmic examination but no supplemental information, or to intervention, including measurement of HbA1c and blood pressure, an eye examination, and photographs taken in the ophthalmology clinic at each visit. This was followed by a personalized risk assessment for the development or progression of retinopathy and nephropathy based on past and present HbA1c levels. Patients were tested on their understanding of the importance of good diabetes control, and they received immediate feedback if this understanding was insufficient. The study was planned for 2 years but was stopped after 1 year when it became clear that no significant differences in HbA1c levels were developing between the standard care and intervention groups in either the annual or the more frequent follow-up cohorts. In addition, in none of these groups was there a significant decrease in HbA1c level during the follow-up period. The authors of this study do not speculate why their interventions failed, but they suggest several possible additional approaches, all of which involve interventions performed by the ophthalmologist and his or her associates. I suggest that none of these are likely to be successful. Diabetesmanagement is an extremely challenging problem that involves intensive, personal interactions of medical personnel with patients from a variety of educational, cultural, and socioeconomic backgrounds to achieve adherence of these patients to a strict medication regimen and an array of lifestyle changes that involve diet, exercise, and frequent monitoring of bloodglucoseperformedathome through frequent andunpleasant fingerstick tests. Several recent efforts in the United States to enable patients with diabetes to better control their blood glucose levels have met with only limited success, including recommendationsby theUSDepartmentofHealthand Human Services for community blood glucose control monitoringprogramsand for evaluating the efficacyof psychological interventions. Those programs that were successful in improving blood glucosecontrol indiabeticpatientshave involved intensivepersonal involvement with patients during a substantial period. Patients in the DCCT intensive treatment cohort maintained a mean HbA1c value of slightly more than 7% during a mean follow-up of 6.5 years,with ameanblood glucose value of 155 mg/dL (to convert tomillimoles per liter,multiply by0.0555).1 By contrast, patients in the conventional care cohort had a meanHbA1c value of 9%andameanbloodglucose level of 231 mg/dL. The DCCT protocol required monthly clinic visits by each patient assigned to the intensive therapy regimen, with weekly telephonecalls fromthe studycoordinator.At the conclusionof theDCCT, the follow-up study, theEpidemiologyof Diabetes Interventions and Complications (EDIC), found that by 10 years after the end of the DCCT the mean HbA1c values inpatients inboththeoriginal intensiveandconventional treatmentgroupswereapproximately8%.5Similarly, in theUKPDS, between-groupdifferences inHbA1cvaluesdisappearedwithin 1 year of the conclusion of the study.6 Comparison of the DCCT and UKPDS results with the presentDRCR.net results indicates that a successful intervention to improve glycemic control in diabetic patients must be Related article page 888 Effect of Personalized Diabetes Risk Assessments on Glycemic Control Original Investigation Research

Low perfusion index affects the difference in glucose level between capillary and venous blood.

AimIn emergency cases, finger stick testing is primarily used to check the blood glucose value of patients since it takes longer to obtain the venous value. In critical patients, under conditions that cause an increase in metabolic state and level of stress, there occurs considerable difference in glucose levels between capillary and venous measurements. This study aimed to investigate the comparability of capillary and venous glucose values, according to the perfusion index level obtained with the Masimo Radical-7® device, in critical patients aged 18 years and over.MethodWe conducted this prospective and observational study in the emergency department of the Eskisehir Osmangazi University hospital between November 3, 2008 and February 2, 2009.ResultsThe blood glucose of 300 critical patients was checked by finger stick in the emergency unit. The participants with normal vital signs had perfusion index between 0 and 5; the results obtained by the two methods were more consistent for perfusion index values of 6 and over. The results were most consistent in aged participants with normal vital sign findings and low perfusion index and in young patients with high perfusion index. In the cases where at least one of the vital signs was abnormal, the glucose values obtained by the two methods were more consistent when the perfusion index was 6 or over. In this group, independently from the perfusion index value, the consistency was higher in younger patients compared with aged patients.ConclusionIn the emergency department, perfusion index value measured by Masimo Radical-7 and capillary blood glucose levels can serve in blood sugar management in critically ill patients.

Stick it to me

Stick it to me

Headache, Blurred Vision and Seizure in Hemodialysis Patient

A 53-year-old man with severe headache, blurred vision, and single generalized tonic-clonic seizure during hemodialysis presented to the emergency department (ED). On admission to the ED, the patient was in postictal state and measured at the following levels: blood pressure 203/113 mmHg, pulse rate 80/ min, respiratory rate of 17/min, body temperature of 36,5 °C, peripheral O2 saturation of 96%, and GCS of 9. Neurologic examination revealed no focal deficit. Bedside finger-stick glucose test was detected at 59 mg/dl. ECG of the patient was in normal sinus rhythm and revealed no ischemic sign. Intravenous 25 g glucose was administered to the patient and control of finger stick glucose test was detected at 281 mg/dl. However, the mental status of the patient did not improve. The patient had complaints of headache and blurred vision for at least one day according to family members. The patient had chronic renal failure and hemodialysis for 1.5 years and was on eye drops for glaucoma. On fundoscopic examination, acute pathology was not detected. Noncontrast enhanced cranial computerized tomography (CT) was performed and CT revealed no acute pathology. Laboratory tests of the patient showed creatinin 5.8 and urea 79 mg/dl and no electrolyte imbalance, leucositosis, or thrombocytopenia. GCS of the patient was detected at 14 without focal deficits at two hours after admission to the ED. Contrast enhanced magnetic resonance imaging (MRI) of cranial and diffusion MRI was also performed (Figure 1). Figure 1 The patient's flair (a) and T2-weighted (b, c) cranial MRI images. DIAGNOSIS: Posterior Reversible Encephalopathy Syndrome MRI revealed hyperintensity compatible with vasogenic edema on FLAIR and t2 weighted sequences in the bilateral occipital, parietal, and frontal region (Figure 2). After magnetic resonance imaging, the patient had generalized tonic-clonic seizures. Reduction of the patient's blood pressure from 203/113 mmHg to 179/95 mmHg did not cause any clinical improvement. Loading dose of valproic acid was given intravenously to the patient. The patient was intubated due to uncontrolled seizures and shallow breathing and was admitted to intensive care unit. The patient died after 6 days due to intracranial hemorrhage. Figure 2 MRI of cranial showed hyperintensity on FLAIR (a) and t2 weighted sequences (b, c) in the posterior, frontal, occipital ve parietal region. Posterior reversible encephalopathy syndrome (PRES), initially described in 1996 by Hinchey et al., is a clinical-neuroradiological entity characterized by headache, vomiting, altered mental status, blurred vision, and seizures.[1] This syndrome is most commonly encountered in association with acute hypertension, preeclampsia or eclampsia, autoimmune diseases, renal failure, post-transplantation, sepsis, shock, and exposure to immunosuppressants.2, 3, 4 Although the lesions in PRES are due to vasogenic edema, the mechanism responsible for the imaging appearance remains unclear and controversial.1, 2 There are two main hypotheses: 1) Cerebral hypoperfusion related to disruption of the blood-brain barrier results in vasogenic edema (e.g. eclampsia/preeclampsia, cyclosporine toxicity, and infection/sepsis/septic shock), and 2) Cerebral hyperperfusion results in vasogenic edema by exceeding the capacity for autoregulation of perfusion pressure (e.g. acute hypertension).[5] In our patient, we considered that hypertension induced by renal failure led to regional dysautoregulation, consequently causing hypoperfusion. Radiologic findings of PRES are best seen on MRI of the brain. The typical imaging findings of PRES are most apparent as hyperintensity on FLAIR and t2 weighted sequences of cranial MRI in the parietooccipital and posterior, frontal, cortical, and subcortical white matter and are reversible with appropriate management.4, 5 The treatment is based in the management or withdrawal of the triggering factor. Hypoglycemia should be looked for routinely and corrected. Antiepileptic treatment should be initiated at the emergency department. Control of hypertensive emergency is an important part of the symptomatic management.1, 5 Mortality has been reported in 15% of patients. Cause of death in PRES may be due to the underlying disease, increased cerebral edema, and intracerebral hemorrhage.[6] The early recognition and treatment of PRES is important to prevent permanent neurological sequelae. Awareness of the clinical and radiographic findings of acute PRES is essential to avoid misdiagnosis and treatment delay.

The Acceptability and Feasibility of Routine Pediatric HIV Testing in an Outpatient Clinic in Durban, South Africa

Limited access to HIV testing of children impedes early diagnosis and access to antiretroviral therapy. Our objective was to evaluate the feasibility and acceptability of routine pediatric HIV testing in an urban, fee-for-service, outpatient clinic in Durban, South Africa. We assessed the number of patients (0-15 years) who underwent HIV testing upon physician referral during a baseline period. We then established a routine, voluntary HIV testing study for pediatric patients, regardless of symptoms. Parents/caretakers were offered free rapid fingerstick HIV testing of their child. For patients <18 months, the biological mother was offered HIV testing and HIV DNA polymerase chain reaction was used to confirm the infant's status. The primary outcome was the HIV testing yield, defined as the average number of positive tests per month during the routine compared with the baseline period. Over a 5-month baseline testing period, 931 pediatric patients registered for outpatient care. Of the 124 (13%) patients who underwent testing on physician referral, 21 (17%, 95% confidence interval: 11-25%) were HIV infected. During a 13-month routine testing period, 2790 patients registered for care and 2106 (75%) were approached for participation. Of these, 1234 were eligible and 771 (62%) enrolled. Among those eligible, 637 (52%, 95% confidence interval: 49-54%) accepted testing of their child or themselves (biological mothers of infants <18 months). There was an increase in the average number of HIV tests during the routine compared with the baseline HIV testing periods (49 versus 25 tests/month, P = 0.001) but no difference in the HIV testing yield during the testing periods (3 versus 4 positive HIV tests/month, P = 0.06). However, during the routine testing period, HIV prevalence remains extraordinarily high with 39 (6%, 95% confidence interval: 4-8%) newly diagnosed HIV-infected children (median 7 years, 56% female). Targeted and symptom-based testing referral identifies an equivalent number of HIV-infected children as routine HIV testing. Routine HIV testing identifies a high burden of HIV and is a feasible and moderately acceptable strategy in an outpatient clinic in a high prevalence area.

Field Evaluation of a Prototype Paper-Based Point-of-Care Fingerstick Transaminase Test

Monitoring for drug-induced liver injury (DILI) via serial transaminase measurements in patients on potentially hepatotoxic medications (e.g., for HIV and tuberculosis) is routine in resource-rich nations, but often unavailable in resource-limited settings. Towards enabling universal access to affordable point-of-care (POC) screening for DILI, we have performed the first field evaluation of a paper-based, microfluidic fingerstick test for rapid, semi-quantitative, visual measurement of blood alanine aminotransferase (ALT). Our objectives were to assess operational feasibility, inter-operator variability, lot variability, device failure rate, and accuracy, to inform device modification for further field testing. The paper-based ALT test was performed at POC on fingerstick samples from 600 outpatients receiving HIV treatment in Vietnam. Results, read independently by two clinic nurses, were compared with gold-standard automated (Roche Cobas) results from venipuncture samples obtained in parallel. Two device lots were used sequentially. We demonstrated high inter-operator agreement, with 96.3% (95% C.I., 94.3–97.7%) agreement in placing visual results into clinically-defined “bins” (<3x, 3–5x, and >5x upper limit of normal), >90% agreement in validity determination, and intraclass correlation coefficient of 0.89 (95% C.I., 0.87–0.91). Lot variability was observed in % invalids due to hemolysis (21.1% for Lot 1, 1.6% for Lot 2) and correlated with lots of incorporated plasma separation membranes. Invalid rates <1% were observed for all other device controls. Overall bin placement accuracy for the two readers was 84% (84.3%/83.6%). Our findings of extremely high inter-operator agreement for visual reading–obtained in a target clinical environment, as performed by local practitioners–indicate that the device operation and reading process is feasible and reproducible. Bin placement accuracy and lot-to-lot variability data identified specific targets for device optimization and material quality control. This is the first field study performed with a patterned paper-based microfluidic device and opens the door to development of similar assays for other important analytes.

Comparison of two HIV testing strategies in primary care centres: indicator‐condition‐guided testing vs. testing of those with non‐indicator conditions

The aim of the study was to compare prospectively indicator-condition (IC)-guided testing versus testing of those with non-indicator conditions (NICs) in four primary care centres (PCCs) in Barcelona, Spain. From October 2009 to February 2011, patients aged from 18 to 65 years old who attended a PCC for a new herpes zoster infection, seborrhoeic eczema, mononucleosis syndrome or leucopenia/thrombopenia were included in the IC group, and one in every 10 randomly selected patients consulting for other reasons were included in the NIC group. A proportion of patients in each group were offered an HIV test; those who agreed to be tested were given a rapid finger-stick HIV test (€6 per test). Epidemiological and clinical data were collected and analysed. During the study period, 775 patients attended with one of the four selected ICs, while 66,043 patients presented with an NIC. HIV screening was offered to 89 patients with ICs (offer rate 11.5%), of whom 85 agreed to and completed testing (94.4 and 100% acceptance and completion rates, respectively). In the NIC group, an HIV test was offered to 344 persons (offer rate 5.2%), of whom 313 accepted (90.9%) and 304 completed (97.1%) testing. HIV tests were positive in four persons [prevalence 4.7%; 95% confidence interval (CI) 1.3-11.6%] in the IC group and in one person in the NIC group (prevalence 0.3%; 95% CI 0.01-1.82%; P < 0.009). If every eligible person had taken an HIV test, we would have spent €4650 in the IC group and €396,258 in the NIC group, and an estimated 36 (95% CI 25-49) and 198 persons (95% CI 171-227), respectively, would have been diagnosed with HIV infection. The estimated cost per new HIV diagnosis would have been €129 (95% CI €107-153) in the IC group and €2001 (95% CI €1913-2088) in the NIC group. Although the number of patients included in the study was small and the results should be treated with caution, IC-guided HIV testing, based on four selected ICs, in PCCs seems to be a more feasible and less expensive strategy to improve diagnosis of HIV infection in Spain than a nontargeted HIV testing strategy.

Diagnostic Accuracy of Fingerstick β-Hydroxybutyrate for Ketonuria in Pregnant Women With Nausea and Vomiting

The aim of this study was to determine whether a rapid, fingerstick β-hydroxybutyrate (β-OHB) test predicts ketonuria in pregnant women with nausea and vomiting. A convenience sample of 82 pregnant women who presented to the Barnes-Jewish Hospital emergency department (ED) with complaints of nausea or vomiting were enrolled into an institutional review board-approved, prospective, observational study. Exclusion criteria were temperature of >38.3°C, altered mental status, prisoners, and >1 L of any intravenous (IV) fluid before screening. Subjects had fingerstick β-OHB tests, with results reported in increments of 0.1 mmol/L. Urine ketone results were made available once reported as part of standard care and varied from 0 (trace) to +4 values. Ketonuria was defined as a urine ketone value of 3+ or 4+ and was analyzed as a dichotomous, categorical variable. A contingency table and receiver operator characteristic (ROC) curve were constructed for comparing the β-OHB values to those urine ketone values for each patient. Mean (±SD) β-OHB was 0.43 (±0.52) mmol/L, and median urine was 1+ for the cohort as a whole. The area under the ROC curve equaled 0.95. The sensitivity and specificity for a fingerstick test of >0.45 mmol/L were 89 and 94.5%, respectively. The positive likelihood ratio (LR) was 16, and the negative LR was 0.12. Fingerstick β-OHB is a rapid and reliable diagnostic tool that correlates well with ketonuria and identifies ketonemia in pregnant women with nausea and vomiting. Fingerstick β-OHB testing has the potential to increase triage efficiency, shorten length-of-stay times, and positively affect patient outcomes in an ED setting.

Bumps on the Neck and Groin of a 2-Year-Old Male

Patient: 2-year-old white male. Chief Complaint: Bumps on neck and groin. History of Present Illness: A 2-year-old boy arrived at the emergency department with a 1- to 2-week history of bumps on his neck and groin. He had been referred to the emergency department by his primary care physician (PCP) when the results of an in-office fingerstick blood test revealed a high white blood cell (WBC) count and a low platelet count. The parents of the patient say that he had had bilateral knee pain a few days previously, which had resolved spontaneously, and had had a cough for the past week. The parents mentioned that when their son had started coughing one week prior, they had contacted the PCP and had mentioned the bumps on his neck and his cough. The physician diagnosed the boy as having lymphadenopathy attributed to a viral illness. Medical and Family History: As of this writing, the patient’s immunizations are up to date. He experiences seasonal allergies, with symptoms that include itchy eyes and runny nose. His recurrent ear infections have been resolved by pressure-equalization tubes and adenoidectomy. The patient’s maternal grandmother and maternal uncle have long QT syndrome. His paternal great-grandfather has a low platelet count (specificity not given). The patient lives with his parents; as of this writing, his mother is currently at 31 weeks’ gestation, originally with triplets but currently with twins (one fetus recently died in utero). Physical Examination: During examination to determine the extent of symptoms, abnormalities were found in the respiratory, lymphatic, and musculoskeletal systems. The patient was observed to cough and have leg and knee pain; he also had swollen lymph glands. Laboratory Findings: Table 1, Table 2; Figure 1 ; Image 1, Image 2, Image 3 Additional Diagnostic Tests: Results of flow …

Continuous glucose monitoring in pregnancy: we have the technology but not all the answers.

Huge progress has been made in the management of pregnant women with type 1 diabetes. With increasing recognition of the importance of good glycemic control (before and during pregnancy) and improvements in obstetric and neonatal care, the vast majority of women with diabetes can expect to deliver a healthy live-born infant. However, the problem of macrosomia, present in the era after insulin was first introduced (1), persists, as highlighted in recent reports from Scandinavia (2,3). Near-optimal glucose control, defined as HbA1c ≤7.0% (53 mmol/mol) in the nonpregnant state, does not prevent neonatal morbidity (macrosomia, preterm delivery, neonatal hypoglycemia) (4). The U.K. National Institute for Health and Care Excellence (NICE) now recommends more stringent glucose control targets, with an HbA1c <6.1% (43 mmol/mol) throughout pregnancy (5). However, the dilemma of how best to balance the daily risk of maternal hypoglycemia with the longer-term risks of the effect of hyperglycemia to the fetus remains. In this issue of Diabetes Care , Secher at al. (6) report on their results from a randomized controlled trial of intermittent real-time continuous glucose monitoring (CGM) in pregnant women with diabetes. They included 154 pregnant women (123 with type 1 diabetes, 31 with type 2 diabetes) randomized to either real-time CGM or routine capillary glucose monitoring. Women in both groups were advised to perform at least seven finger-stick tests daily (before and after meals and before bed). The …