In-Field Implementation of Near-Infrared Quantitative Methods for Analysis of Medicines in Tropical Environments.

Near-infrared (NIR) spectroscopy is actually a well-established technique that demonstrates its performance in the frame of detection of poor-quality medicines. The use of low-cost handheld NIR spectrophotometers in low-resource contexts can allow an inexpensive and more rapid detection compared to laboratory methods. Considering these points, it was decided to develop, validate, and transfer methods for the quantification of ciprofloxacin and metronidazole tablet samples using a NIR handheld spectrophotometer in transmission mode (NIR-M-T1) coupled to chemometrics such as partial least squares regression (PLSR) algorithm. All of the models were validated with the total error approach using an accuracy profile as a decision tool, with ±10% specifications and a risk α set at 5%. Quantitative PLSR models were first validated in Belgium, which is a temperate oceanic climate zone. Second, they were transferred to Cameroon, a tropical climate zone, where issues regarding the prediction of new validation series with the initial models were highlighted. Two augmentation strategies were then envisaged to make the predictive models robust to environmental conditions, incorporating the potential variability linked to environmental effects in the initial calibration sets. The resulting models were then used for in-field analysis of ciprofloxacin and metronidazole tablet samples collected in three cities in Cameroon. The contents results obtained for each sample with the two strategies were close and not statistically different. Nevertheless, the first one is easier to implement and the second is the best regarding model diagnostic measures and accuracy profiles. Two samples were found to be noncompliant in terms of content, and these results were confirmed using high-performance liquid chromatography taken as the reference method.

Immunochromatography screening devices for cannabinoids in oral fluid sample

Abstract Cannabis sativa L. is one of the most consumed drugs in the world and recent studies have associated its use with an increase in the number of traffic accidents in different countries. In many countries, like Brazil, simple and reliable methodologies are still needed for the detection of drugs on site, mainly cannabinoids, considering its prevalence of use and oral fluid (OF) has been proved as an appropriate biological matrix for this purpose. Considering that, this work aims to review previous studies on immunochromatographic devices for on-site detection of cannabinoids in OF, discussing their sensitivity, specificity, cut-offs values and confirmatory methods. This data shows the importance of choosing a screening device and it reinforces the need for its implementation in Brazil. The research was conducted on 5 databases and all original articles, published in the last 10 years, were selected. A total of 32 articles were found, providing data for 17 screening devices of distinct brands. Only 2 screening devices showed satisfactory sensitivity and specificity in the evaluated studies (≥80% and ≥90% respectively). However, it should be considered that the screening devices still have some limitations, such as a higher cut-off than those recommended by international guidelines (cut-off > 2 ng/mL), therefore demonstrating the need for more studies in the area and the importance of confirmatory analysis usually fulfilled by LC-MS/MS, GC-MS/MS or GC-MS. Thus, the screening analyzes should not be evaluated by itself, but in association with confirmatory results and observational traits (behavioral changes), for a better understanding of the traffic scenario

Incidence of Referable Retinal Disease in Diabetic Patients at a Primary Care Practice.

Purpose: This work tests the feasibility of remote ophthalmic imaging to identify referable retinal abnormalities and assesses the effectiveness of color fundus photography (CFP) vs optical coherence tomography (OCT) for this purpose. Methods: This prospective, nonrandomized study included 633 patients with diabetes at Duke Primary Care. Undilated patients underwent screening with CFP and OCT camera (MaestroCare, Topcon). Images were graded independently for interpretability and the presence of predetermined retinal disease. Retinal disease was classified as diabetic retinopathy (DR) referable to a retina specialist or incidental findings referable to either a retina specialist or a general ophthalmologist, depending on severity. Results: Mean (SD) age of screened patients was 66 (13) years, and 49% were women. The average glycated hemoglobin A1c level was 7.6 % (SD, 1.7%), and 30% of the patients were on insulin. The average duration of diabetes was 5.9 (SD, 7.3) years. Remote images from OCT were significantly more interpretable than CFP (98% vs 83%, respectively; P < .001). Referral rates were 9% for DR and 28% for incidental findings. Among patients with DR, OCT and CFP were helpful in 58% and 87% of cases, respectively (P < .001). Conclusions: Remote diagnosis of ophthalmic imaging at the point of service may allow for early identification of retinal disease and timely referral and treatment. Our approach showed that OCT had significantly better interpretability, while CFP was more helpful in identifying DR. These findings may be important when choosing the screening device in a specific context.

Use of mHealth Devices to Screen for Atrial Fibrillation: Cost-Effectiveness Analysis.

BACKGROUND: With an estimated prevalence of around 3% and an about 2.5-fold increased risk of stroke, atrial fibrillation (AF) is a serious threat for patients and a high economic burden for health care systems all over the world. Patients with AF could benefit from screening through mobile health (mHealth) devices. Thus, an early diagnosis is possible with mHealth devices, and the risk for stroke can be markedly reduced by using anticoagulation therapy. OBJECTIVE: The aim of this work was to assess the cost-effectiveness of algorithm-based screening for AF with the aid of photoplethysmography wrist-worn mHealth devices. Even if prevented strokes and prevented deaths from stroke are the most relevant patient outcomes, direct costs were defined as the primary outcome. METHODS: A Monte Carlo simulation was conducted based on a developed state-transition model; 30,000 patients for each CHA2DS2-VASc (Congestive heart failure, Hypertension, Age≥75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65-74 years, Sex category [female]) score from 1 to 9 were simulated. The first simulation served to estimate the economic burden of AF without the use of mHealth devices. The second simulation served to simulate the economic burden of AF with the use of mHealth devices. Afterwards, the groups were compared in terms of costs, prevented strokes, and deaths from strokes. RESULTS: The CHA2DS2-VASc score as well as the electrocardiography (ECG) confirmation rate had the biggest impact on costs as well as number of strokes. The higher the risk score, the lower were the costs per prevented stroke. Higher ECG confirmation rates intensified this effect. The effect was not seen in groups with lower risk scores. Over 10 years, the use of mHealth (assuming a 75% ECG confirmation rate) resulted in additional costs (€1=US $1.12) of €441, €567, €536, €520, €606, €625, €623, €692, and €847 per patient for a CHA2DS2-VASc score of 1 to 9, respectively. The number of prevented strokes tended to be higher in groups with high risk for stroke. Higher ECG confirmation rates led to higher numbers of prevented strokes. The use of mHealth (assuming a 75% ECG confirmation rate) resulted in 25 (7), -68 (-54), 98 (-5), 266 (182), 346 (271), 642 (440), 722 (599), 1111 (815), and 1116 (928) prevented strokes (fatal) for CHA2DS2-VASc score of 1 to 9, respectively. Higher device accuracy in terms of sensitivity led to even more prevented fatal strokes. CONCLUSIONS: The use of mHealth devices to screen for AF leads to increased costs but also a reduction in the incidence of stroke. In particular, in patients with high CHA2DS2-VASc scores, the risk for stroke and death from stroke can be markedly reduced.

Grafting of 3D Bioprinting to In Vitro Drug Screening: A Review.

The inadequacy of conventional cell-monolayer planar cultures and animal experiments in predicting the toxicity and clinical efficacy of drug candidates has led to an imminent need for in vitro methods with the ability to better represent in vivo conditions and facilitate the systematic investigation of drug candidates. Recent advances in 3D bioprinting have prompted the precise manipulation of cells and biomaterials, rendering it a promising technology for the construction of in vitro tissue/organ models and drug screening devices. This review presents state-of-the-art in vitro methods used for preclinical drug screening and discusses the limitations of these methods. In particular, the significance of constructing 3D in vitro tissue/organ models and microfluidic analysis devices for drug screening is emphasized, and a focus is placed on the grafting process of 3D bioprinting technology to the construction of such models and devices. The in vitro methods for drug screening are generalized into three types: mini-tissue, organ-on-a-chip, and tissue/organ construct. The revolutionary process of the in vitro methods is demonstrated in detail, and relevant studies are listed as examples. Specifically, the tumor model is adopted as a precedent to illustrate the possible grafting of 3D bioprinting to antitumor drug screening.