Accuracy of Bilistick (a Point-of-Care Device) to Detect Neonatal Hyperbilirubinemia.

INTRODUCTION: Early diagnosis and appropriate management of neonatal jaundice is crucial in avoiding severe hyperbilirubinemia and brain injury. A low-cost, minimally invasive, point-of-care (PoC) tool for total bilirubin (TB) estimation which can be useful across all ranges of bilirubin values and all settings is the need of the hour. OBJECTIVE: To assess the accuracy of Bilistick system, a PoC device, for measurement of TB in comparison with estimation by spectrophotometry. DESIGN/METHODS: In this cross-sectional clinical study, in infants who required TB estimation, blood samples in 25-µl sample transfer pipettes were collected at the same time from venous blood obtained for laboratory bilirubin estimation. The accuracy of Bilistick in estimating TB within ±2 mg/dl of bilirubin estimation by spectrophotometry was the primary outcome. RESULTS: Among the enrolled infants, 198 infants were eligible for study analysis with the mean gestation of 36 ± 2.3 weeks and the mean birth weight of 2368 ± 623 g. The median age at enrollment was 68.5 h (interquartile range: 48-92). Bilistick was accurate only in 54.5% infants in measuring TB within ±2 mg/dl difference of TB measured by spectrophotometry. There was a moderate degree of correlation between the two methods (r = 0.457; 95% CI: 0.339-0.561, p value < 0.001). Bland-Altman analysis showed a mean difference of 0.5 mg/dl (SD ± 4.4) with limits of agreement between -8.2 and +9.1 mg/dl. CONCLUSION: Bilistick as a PoC device is not accurate to estimate TB within the clinically acceptable difference (±2 mg/dl) of TB estimation by spectrophotometry and needs further improvement to make it more accurate.

Emerging design strategies for constructing multiplex lateral flow test strip sensors.

Conventional lateral flow test strip (LFTS) sensors are insufficiently accurate and reliable due to their single-target detection with limited sample information in a single test. The increasing demand for the simultaneous determination of multiple analytes has recently been accelerating the rapid development of high-throughput and multiplexed LFTS sensing technologies. In this contribution, we systematically summarize the recent achievements on the design, development, and application of multiplexed LFTS sensors for improved rapid on-site diagnostics. The discussion focuses on emerging design strategies to increase multiplexing capacity for enhancing analytical efficiency and precision. As a proof-of-concept, several typical examples are presented. The advantages and disadvantages of such approaches are critically analyzed. Finally, we briefly discuss the current challenges and future perspectives.

A laser-induced breakdown spectroscopy-integrated lateral flow strip (LIBS-LFS) sensor for rapid detection of pathogen.

Incorporation of new readout methods with established analytical devices allows methodological innovations in analytical sciences. Herein, we present a new sensing platform by combining an ultrasensitive element analyzer, namely the laser-induced breakdown spectroscopy (LIBS) and a lateral flow strip (LFS). AgxAuy bimetallic nanoparticles (AgxAuyBNPs) are selected as the labels to deliver the optimal quantitative performance by analyzing the Ag (I) signal from the test (T) line of LFS. For prototypical application in pathogen detection, the LIBS-LFS sensor can achieve a detection limit of 1.6 cfu mL-1 of Staphylococcus aureus (S. aureus) within 10 min, which is superior to conventional methods. Importantly, the signals of AgxAuyBNPs for visual and LIBS analysis are stable and still readable after the detection is finished and the test strip is stored for up to 13 days, suggesting a potential for long-term data preservation. This combination of LIBS with LFS provides a new concept toward integrated nano/analytical devices that can benefit various application scenarios.

The impact of free medical supplies and regular telephonic contact on glycemic control in Indian children and adolescents with type 1 diabetes.

BACKGROUND/OBJECTIVE: The effect of economic assistance to underprivileged families with type 1 diabetes has never been described. Such a study is relevant as logistic and cultural factors may preclude an anticipated good outcome. The objective of the study is to determine the impact of economic and educational intervention on hemoglobin A1c (HbA1c) and diabetes knowledge. METHODS: Eighty-five consecutive participants were prospectively provided insulin and glucose strips for 1 year. From the 6th to 12th month, patients were randomized such that half of them (telephone group) received proactive telephonic advice by a diabetes educator, while the non-telephone group received usual care. HbA1c and diabetes knowledge were measured at baseline, 6 and 12 months. RESULTS: Significant improvement was seen in HbA1c with provision of free diabetes supplies, when patients were compared with their own HbA1c values during the prior 36 months (baseline [8.38 ± 2.0%], at 3 months [8.0 ± 1.6%] and at 6 months [8.1 ± 1.5%, P = 0.0106]). Knowledge score increased from baseline (48 ± 15) to 6 months (58 ± 13, P < 0.001). No difference was seen between the telephone and non-telephone groups in HbA1c from the 6th to 9th and 12th month. The knowledge score showed significant improvement in the telephone group during the proactive telephonic advice study compared with the non-telephone group (P = 0.002). CONCLUSIONS: The provision of free medical supplies improved HbA1c and diabetes knowledge. Intensive telephone contact improved knowledge, not HbA1c. These results provide important background for policy makers and diabetes management teams.

Diagnostic accuracy of self-administered urine glucose test strips as a diabetes screening tool in a low-resource setting in Cambodia.

OBJECTIVE: Screening for diabetes in low-resource countries is a growing challenge, necessitating tests that are resource and context appropriate. The aim of this study was to determine the diagnostic accuracy of a self-administered urine glucose test strip compared with alternative diabetes screening tools in a low-resource setting of Cambodia. DESIGN: Prospective cross-sectional study. SETTING: Members of the Borey Santepheap Community in Cambodia (Phnom Penh Municipality, District Dangkao, Commune Chom Chao). PARTICIPANTS: All households on randomly selected streets were invited to participate, and adults at least 18 years of age living in the study area were eligible for inclusion. OUTCOMES: The accuracy of self-administered urine glucose test strip positivity, Hemoglobin A1c (HbA1c)>6.5% and capillary fasting blood glucose (cFBG) measurement ≥126 mg/dL were assessed against a composite reference standard of cFBGmeasurement ≥200 mg/dL or venous blood glucose 2 hours after oral glucose tolerance test (OGTT) ≥200 mg/dL. RESULTS: Of the 1289 participants, 234 (18%) had diabetes based on either cFBG measurement (74, 32%) or the OGTT (160, 68%). The urine glucose test strip was 14% sensitive and 99% specific and failed to identify 201 individuals with diabetes while falsely identifying 7 without diabetes. Those missed by the urine glucose test strip had lower venous fasting blood glucose, lower venous blood glucose 2 hours after OGTT and lower HbA1c compared with those correctly diagnosed. CONCLUSIONS: Low cost, easy to use diabetes tools are essential for low-resource communities with minimal infrastructure. While the urine glucose test strip may identify persons with diabetes that might otherwise go undiagnosed in these settings, its poor sensitivity cannot be ignored. The massive burden of diabetes in low-resource settings demands improvements in test technologies.

Leveraging benefit design for better diabetes self-management and A1C control.

OBJECTIVES: To evaluate the relationship between cost sharing for blood glucose testing strips and glycemic control rates. STUDY DESIGN: A retrospective observational study using medical and pharmacy claims data integrated with laboratory glycated hemoglobin (A1C) values for patients using insulin and testing strips. A new user study design was utilized to identify individuals from 14 commercial US health plans who filled testing strips with assumed intention to monitor blood glucose. METHODS: Patients were divided into low (<20% of annual testing strip cost; n = 3575) and high (≥20%; n = 3580) cost-sharing categories. We compared the likelihood of patients in low and high cost-sharing categories achieving glycemic control (A1C <8.0%) through modified Poisson regression models. RESULTS: Patients with low cost sharing for testing strips had higher rates of control than those with high cost sharing (58.1% vs 50.3%; P <.001). Low cost sharing was associated with greater probability of glycemic control (adjusted risk ratio [aRR], 1.14; 95% CI, 1.09-1.20; P <.0001). Glycemic control was more likely for patients in areas with median household income greater than $60,000 versus less than $40,000 (aRR, 1.16; 95% CI, 1.07-1.25; P <.01) and greater than $80,000 versus less than $40,000 (aRR, 1.18; 95% CI, 1.06-1.32; P <.01). CONCLUSIONS: We found a statistically significant correlation between cost sharing for testing strips and better A1C control for patients using insulin medication. Lower cost sharing for testing strips can remove a barrier to diabetes self-management and may lead to improved glycemic control at the population level. Future efforts should study the potential benefits of reducing diabetic complications and associated cost savings.

Low-cost and reagent-free paper-based device to detect chloride ions in serum and sweat.

The recent goal of sustainability in analytical chemistry has boosted the development of eco-designed analytical tools to deliver fast and cost-effective analysis with low economic and environmental impact. Due to the recent focus in sustainability, we report the use of low-cost filter paper as a sustainable material to print silver electrodes and to load reagents for a reagent-free electrochemical detection of chloride in biological samples, namely serum and sweat. The electrochemical detection of chloride ions was carried out by exploiting the reaction of the analyte (i.e. chloride) with the silver working electrode. During the oxidation wave in cyclic voltammetry the silver ions are produced, thus they react with chloride ions to form AgCl, while in the reduction wave, the following reaction occurs: AgCl + e- -->Ag + Cl-. These reactions at the electrode surface resulted in anodic/cathodic peaks directly proportional to the chloride ions in solution. Chloride ions were detected with the addition of only 10µL of the sample on the paper-based electrochemical cell, obtaining linearity up to 200mM with a detection limit equal to 1mM and relative standard deviation lower than 10%. The accuracy of the sensor was evaluated in serum and sweat samples, with percentage recoveries between 93 ± 10 and 108 ± 8%. Moreover, the results achieved with the paper-based device were positively compared with those obtained by using the gold standard method (Ion Selective Electrode) adopted in routine clinical analyses.

Synergistic Tailoring of Electrostatic and Hydrophobic Interactions for Rapid and Specific Recognition of Lysophosphatidic Acid, an Early-Stage Ovarian Cancer Biomarker.

Early detection of ovarian cancer, the most lethal type of gynecologic cancer, can dramatically improve the efficacy of available treatment strategies. However, few screening tools exist for rapidly and effectively diagnosing ovarian cancer in early stages. Here, we present a facile "lock-key" strategy, based on rapid, specific detection of plasma lysophosphatidic acid (LPA, an early stage biomarker) with polydiacetylenes (PDAs)-based probe, for the early diagnosis of ovarian cancer. This strategy relies on specifically inserting LPA "key" into the PDAs "lock" through the synergistic electrostatic and hydrophobic interactions between them, leading to conformation transition of the PDA backbone with a concomitant blue-to-red color change. The detailed mechanism underlying the high selectivity of PDAs toward LPA is revealed by comprehensive theoretical calculation and experiments. Moreover, the level of LPA can be quantified in plasma samples from both mouse xenograft tumor models and patients with ovarian cancer. Impressively, this approach can be introduced into a portable point-of-care device to successfully distinguish the blood samples of patients with ovarian cancer from those of healthy people, with 100% accuracy. This work provides a valuable portable tool for early diagnosis of ovarian cancer and thus holds a great promise to dramatically improve the overall survival.

The Diagnosis of Urinary Tract Infection in Young Children (DUTY) Study Clinical Rule: Economic Evaluation.

OBJECTIVE: To estimate the cost-effectiveness of a two-step clinical rule using symptoms, signs and dipstick testing to guide the diagnosis and antibiotic treatment of urinary tract infection (UTI) in acutely unwell young children presenting to primary care. METHODS: Decision analytic model synthesising data from a multicentre, prospective cohort study (DUTY) and the wider literature to estimate the short-term and lifetime costs and healthcare outcomes (symptomatic days, recurrent UTI, quality adjusted life years) of eight diagnostic strategies. We compared GP clinical judgement with three strategies based on a 'coefficient score' combining seven symptoms and signs independently associated with UTI and four strategies based on weighted scores according to the presence/absence of five symptoms and signs. We compared dipstick testing versus laboratory culture in children at intermediate risk of UTI. RESULTS: Sampling, culture and antibiotic costs were lowest in high-specificity DUTY strategies (£1.22 and £1.08) compared to clinical judgement (£1.99). These strategies also approximately halved urine sampling (4.8% versus 9.1% in clinical judgement) without reducing sensitivity (58.2% versus 56.4%). Outcomes were very similar across all diagnostic strategies. High-specificity DUTY strategies were more cost-effective than clinical judgement in the short- (iNMB = £0.78 and £0.84) and long-term (iNMB =£2.31 and £2.50). Dipstick tests had poorer cost-effectiveness than laboratory culture in children at intermediate risk of UTI (iNMB = £-1.41). CONCLUSIONS: Compared to GPs' clinical judgement, high specificity clinical rules from the DUTY study could substantially reduce urine sampling, achieving lower costs and equivalent patient outcomes. Dipstick testing children for UTI is not cost-effective.

Multiplex Dipstick Technologies for Rapid and Simultaneous Screening of Analytes of Importance in Agri-Food-Nutrition and Health Care: A Review.

Dipstick test kits are being widely used for the rapid screening of a range of antigens or toxins in food, agriculture, and health care. They provide specific results on-site within 10 min with suitable accuracy and are, therefore, cost-effective. Multiplex dipsticks also provide the opportunity for simultaneous detection of multiple antigens in the target sample without using expensive instrumentation, minimizing the cost of analysis as well as the duration of assay. Because of these benefits, dipstick kits are widely being used in the simultaneous detection of several antigens/toxins in large number of samples and in high-throughput manner. This review focuses on the current status of developed multiplex strips and its working principles and future direction of the technology in the agriculture, food, nutrition, and health care sectors.

Promoting health and reducing costs: a role for reform of self-monitoring of blood glucose provision within the National Health Service.

AIM: To determine the cost-effectiveness of all options for the self-monitoring of blood glucose funded by the National Health Service, providing guidance for disinvestment and testing the hypothesis that advanced meter features may justify higher prices. METHODS: Using data from the Health and Social Care Information Centre concerning all 8 340 700 self-monitoring of blood glucose-related prescriptions during 2013/2014, we conducted a cost-minimization analysis, considering both strip and lancet costs, including all clinically equivalent technologies for self-monitoring of blood glucose, as determined by the ability to meet ISO-15197:2013 guidelines for meter accuracy. RESULTS: A total of 56 glucose monitor, test strip and lancet combinations were identified, of which 38 met the required accuracy standards. Of these, the mean (range) net ingredient costs for test strips and lancets were £0.27 (£0.14-£0.32) and £0.04 (£0.02-£0.05), respectively, resulting in a weighted average of £0.28 (£0.18-£0.37) per test. Systems providing four or more advanced features were priced equal to those providing just one feature. A total of £12 m was invested in providing 42 million self-monitoring of blood glucose tests with systems that fail to meet acceptable accuracy standards, and efficiency savings of £23.2 m per annum are achievable if the National Health Service were to disinvest from technologies providing lesser functionality than available alternatives, but at a much higher price. CONCLUSION: The study uncovered considerable variation in the price paid by the National Health Service for self-monitoring of blood glucose, which could not be explained by the availability of advanced meter features. A standardized approach to self-monitoring of blood glucose prescribing could achieve significant efficiency savings for the National Health Service, whilst increasing overall utilisation and improving safety for those currently using systems that fail to meet acceptable standards for measurement accuracy.

Avis sur les mesures relatives au remboursement des bandelettes / Notice of measures relating to the repayment of strips

INTRODUCTION: Le diabète mellitus est une maladie chronique qui se caractérise par une hyperglycémie, qui apparaît lorsque l'organisme est incapable de sécréter une quantité suffisante d'insuline, en présence ou non de résistance à celle-ci. Selon les estimations publiées par l'Association canadienne du diabète, environ 3,4 millions de Canadiens étaient atteints de diabète, en 2015. Parmi les différentes formes existantes, le diabète de type 2 est de loin le plus répandu. L'autosurveillance glycémique (ASG) est l' une des approches offertes pour aider la personne atteinte de diabète à contrôler sa glycémie. L'utilisation de bandelettes et d'un glucomètre permet de mesurer la glycémie capillaire et d'ajuster, si nécessaire, les habitudes de vie ou la médication. En 2015, les dépenses liées à la classe des bandelettes ont totalisé près de 104 millions de dollars et concerné environ 285 000 personnes couvertes par le régime public d'assurance médicaments (RPAM) du Québec. Or, d'après les mesures instaurées dans les autres provinces anadiennes, près de 30 % des utilisateurs assurés au RPAM et non traités à l'insuline semblent en faire un usage non optimal, ce qui entraîne des coûts pour le réseau de la santé et des services sociaux, sans gain de santé pour les utilisateurs. Les autres provinces canadiennes, à l'exception du Québec, ont mis en place des mesures encadrant le remboursement des bandelettes afin de favoriser un usage optimal et de limiter les coûts. C'est dans ce contexte

INTRODUCTION: Diabetes mellitus is a chronic disease characterized by hyperglycemia, which occurs when the body is unable to produce sufficient insulin, whether or not in the presence of insulin resistance. According to the estimates published by the Canadian Diabetes Association (CDA), around 3.4 million Canadians lived with diabetes in 2015. Of the different existing forms, type 2 diabetes is by far the most widespread. Self-monitoring of blood glucose (SMBG) is one of the approaches offered to help people with diabetes control their blood glucose (BG) levels. The use of BG test strips and a meter helps to measure capillary glycemia and to make any necessary lifestyle or medication adjustments. In 2015, expenditures tied to the class of BG test strips totalled nearly $104 million and concerned around 285,000 people covered by Québec's public prescription drug insurance plan (PPDIP). Based on the measures introduced in the other Canadian provinces, about 30% of users covered by the PPDIP and not treated with insulin seem to make non-optimal use of them, which leads to costs for the health and social services system, without health benefits for users. The other Canadian provinces, except for Québec, have introduced measures governing the reimbursement of BG test strips to encourage their optima

A Low-Cost Inkjet-Printed Glucose Test Strip System for Resource-Poor Settings.

BACKGROUND: The prevalence of diabetes is increasing in low-resource settings; however, accessing glucose monitoring is extremely difficult and expensive in these regions. Work is being done to address the multitude of issues surrounding diabetes care in low-resource settings, but an affordable glucose monitoring solution has yet to be presented. An inkjet-printed test strip solution is being proposed as a solution to this problem. METHODS: The use of a standard inkjet printer is being proposed as a manufacturing method for low-cost glucose monitoring test strips. The printer cartridges are filled with enzyme and dye solutions that are printed onto filter paper. The result is a colorimetric strip that turns a blue/green color in the presence of blood glucose. RESULTS: Using a light-based spectroscopic reading, the strips show a linear color change with an R(2) = .99 using glucose standards and an R(2) = .93 with bovine blood. Initial testing with bovine blood indicates that the strip accuracy is comparable to the International Organization for Standardization (ISO) standard 15197 for glucose testing in the 0-350 mg/dL range. However, further testing with human blood will be required to confirm this. A visible color gradient was observed with both the glucose standard and bovine blood experiment, which could be used as a visual indicator in cases where an electronic glucose meter was unavailable. CONCLUSIONS: These results indicate that an inkjet-printed filter paper test strip is a feasible method for monitoring blood glucose levels. The use of inkjet printers would allow for local manufacturing to increase supply in remote regions. This system has the potential to address the dire need for glucose monitoring in low-resource settings.

Paper test cards for presumptive testing of very low quality antimalarial medications.

Carrying out chemical analysis of antimalarials to detect low-quality medications before they reach a patient is a costly venture. Here, we show that a library of chemical color tests embedded on a paper card can presumptively identify formulations corresponding to very low quality antimalarial drugs. The presence or absence of chloroquine (CQ), doxycycline (DOX), quinine, sulfadoxine, pyrimethamine, and primaquine antimalarial medications, in addition to fillers used in low-quality pharmaceuticals, are indicated by patterns of colors that are generated on the test cards. Test card sensitivity for detection of these pure components ranges from 90% to 100% with no false positives in the absence of pharmaceutical. The color intensities from reactions characteristic of CQ or DOX allowed visual detection of formulations of these medications cut with 60% or 100% filler, although samples cut with 30% filler could not be reliably detected colorimetrically. However, the addition of unexpected fillers, even in 30% quantities, or substitute pharmaceuticals, could sometimes be detected by other color reactions on the test cards. Tests are simple and inexpensive enough to be carried out in clinics, pharmacies, and ports of entry and could provide a screening method to presumptively indicate very low quality medicines throughout the supply chain.

Transitioning to a national (New Zealand) sole supply scheme for glucose meters: lessons learned, problems yet to be solved.

This case study describes the clinical impact of moving to a single brand of glucose test strips. In 2013 the New Zealand public health system completed a move to procure test strips at a significant discount. The associated direct savings is estimated at around 40% of the total glucose strip budget. Half the local diabetes population undertake glucose monitoring using government-funded diabetes supplies. These patients no longer have a choice of brand of meters and strips. Although the majority of patients adapted well to this change, a small percentage did not. Also, some consumers expressed concerns about analytical performance of the new strips, when used in everyday life. A pragmatic postmarketing surveillance system, designed with consumer input, may help address these residual concerns.