Evaluation of Antiretroviral Drug Concentrations in Minimally Invasive Specimens for Potential Development of Point-of-Care Drug Assays

Author(s):  
Richard E. Haaland ◽  
Amy Martin ◽  
Melkam Mengesha ◽  
Chuong Dinh ◽  
Jeffrey Fountain ◽  
...  
2021 ◽  
Vol 14 ◽  
pp. 175628482199990
Author(s):  
Sonia Facchin ◽  
Andrea Buda ◽  
Romilda Cardin ◽  
Nada Agbariah ◽  
Fabiana Zingone ◽  
...  

Anti-drug antibodies can interfere with the activity of anti-tumor necrosis factor (TNF) agents by increasing drug clearance via direct neutralization. The presence of anti-drug antibodies is clinically relevant when trough drug concentrations are undetectable or sub-therapeutic. However, traditional immunoassay is not easily and rapidly accessible, making the translation of the results into treatment adjustment difficult. The availability of a point-of-care (POC) test for therapeutic drug monitoring (TDM) might represent an important step forward for improving the management of inflammatory bowel disease (IBD) patients in clinical practice. In this pilot study, we compared the results obtained with POC tests with those obtained by enzyme-linked immunosorbent assay (ELISA) in a group of IBD patients treated with Infliximab (IFX). We showed that POC test can reliably detect presence of antibody-to-IFX with 100% of specificity and 76% sensitivity, in strong agreement with the ELISA test ( k-coefficient = 0.84).


AIDS ◽  
2020 ◽  
Vol 34 (13) ◽  
pp. 1907-1914 ◽  
Author(s):  
Micol Ferrara ◽  
Namandjé N. Bumpus ◽  
Qing Ma ◽  
Ronald J. Ellis ◽  
Virawudh Soontornniyomkij ◽  
...  

2019 ◽  
Vol 80 (4) ◽  
pp. 467-473
Author(s):  
Nicole L. Davis ◽  
Amanda Corbett ◽  
Josh Kaullen ◽  
Julie A. E. Nelson ◽  
Charles S. Chasela ◽  
...  

2001 ◽  
Vol 45 (10) ◽  
pp. 2902-2907 ◽  
Author(s):  
Rieneke M. E. van Praag ◽  
Sjoerd Repping ◽  
Jan W. A. de Vries ◽  
Joep M. A. Lange ◽  
Richard M. W. Hoetelmans ◽  
...  

ABSTRACT Limited data are available on antiretroviral drug concentrations in seminal plasma during a dosing interval. Further, since human ejaculate is composed of fluids originating from the testes, the seminal vesicles, and the prostate, all having different physiological characteristics, drug concentrations in total seminal plasma do not necessarily reflect concentrations in the separate compartments. Five human immunodeficiency virus type 1-infected patients on nevirapine (NVP; 200 mg twice a day [b.i.d.]) and/or indinavir (IDV; 800 mg b.i.d. with ritonavir, 100 mg b.i.d.) regimens used a split ejaculate technique to separate seminal plasma in two fractions, representing fluids from the testes and prostate (first fraction) and fluids from the seminal vesicles (second fraction). Split-ejaculate samples were provided at 0, 2, 5, and 8 h after drug ingestion, on separate days after 3 days of sexual abstinence. NVP and IDV showed time-dependent concentrations in seminal plasma, with peak concentrations in both fractions at 2 and 2 to 5 h, respectively, after drug ingestion. The NVP concentrations were not significantly different between the first and second fractions of the ejaculate at all time points measured and were in the therapeutic range, except for the predose concentration in two patients. The median (range) predose IDV concentrations in the first and second fractions of the ejaculate were 448 (353 to 1,015) ng/ml and 527 (240 to 849) ng/ml, respectively (P = 0.7). In conclusion, NVP and IDV concentrations in seminal plasma are dependent on the time after drug ingestion. Furthermore, our data suggest that NVP and IDV achieve therapeutic concentrations in both the testes and prostate and the seminal vesicles throughout the dosing interval.


2019 ◽  
Author(s):  
Youngjin Moon ◽  
Jeongmin Oh ◽  
Jaeho Hyun ◽  
Youngkyu Kim ◽  
Jaesoon Choi ◽  
...  

BACKGROUND Endoscopes are widely used for visualizing the respiratory tract, urinary tract, uterus, and gastrointestinal tracts. Despite high demand, people in underdeveloped and developing countries cannot obtain proper access to endoscopy. Moreover, commercially available endoscopes are mostly nonarticulable as well as not actively controlled, limiting their use. Articulating endoscopes are required for some diagnosis procedures, due to their ability to image wide areas of internal organs. Furthermore, actively controlled articulating endoscopes are less likely to harm the lumen than rigid endoscopes because they can avoid contact with endothelial tissues. OBJECTIVE The study aimed to demonstrate the feasibility and acceptability of smartphone-based wide-field articulable endoscope system for minimally invasive clinical applications in developing and less developed countries. METHODS A thin articulable endoscope system that can be attached to and actively controlled by a smartphone was designed and constructed. The system consists of a flexible endoscopic probe with a continuum mechanism, 4 motor modules for articulation, a microprocessor for controlling the motor with a smartphone, and a homebuilt app for streaming, capturing, adjusting images and video, and controlling the motor module with a joystick-like user interface. The smartphone and motor module are connected via an integrated C-type On-The-Go (OTG) USB hub. RESULTS We tested the device in several human-organ phantoms to evaluate the usability and utility of the smartphone-based articulating endoscope system. The resolution (960 × 720 pixels) of the device was found to be acceptable for medical diagnosis. The maximum bending angle of 110° was designed. The distance from the base of the articulating module to the tip of the endoscope was 45 mm. The angle of the virtual arc was 40.0°, for a curvature of 0.013. The finest articulation resolution was 8.9°. The articulating module succeeded in imaging all 8 octants of a spherical target, as well as all 4 quadrants of the indices marked in human phantoms. CONCLUSIONS The portable wide-field endoscope was successfully controlled using a smartphone, yielding clear images with a resolution of 960 × 720 pixels at realistic focal distances. Actively and precisely controlled articulating movements have resulted in minimally invasive monitoring in the narrow space of internal organs providing a wide-area view. We found our smartphone-based active articulated endoscope to be suitable for point-of-care applications in developing and less developed countries.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S514-S515
Author(s):  
A Volkers ◽  
M Löwenberg ◽  
K Bray ◽  
B Bahur ◽  
M Braad ◽  
...  

Abstract Background Point-of-Care tests (POCTs) allow instant measurement of inflammatory markers and/or drug concentrations. However, currently available POCTs for infliximab (IFX) and adalimumab (ADL) serum concentrations are time consuming. Recently, a new POCT device (ProciseDx, San Diego, CA, USA) was developed which conveniently measures C-reactive protein (CRP), IFX and ADL capillary concentrations within minutes. We aimed to validate this device by comparing POCT results with conventional laboratory tests for serum CRP, IFX and ADL in patients with inflammatory bowel disease (IBD). Methods IBD patients requiring routine measurement of serum CRP, IFX or ADL were invited to participate. Along with serum collection, 20μl of capillary blood was obtained via finger prick and dispensed in a cartridge with a buffer, and placed in the POCT device providing results within two to four minutes. Forty patients were needed to validate the CRP POCT, as this assay was already previously validated in a different population. For the IFX and ADL assays, 120 patients using IFX or ADL were required to validate the POCT. Agreement between the laboratory serum assay and POCT was visualized on a scatter diagram and a Bland-Altman plot. Deming regression was calculated to demonstrate agreement. In addition, Pearson’s correlation coefficient was calculated. Results Until now, 41 patients have been enrolled for the CRP assay, 120 patients for the IFX and 46 patients for the ADL assay. Two ADL patients were sampled twice (n=48). Significant correlations were found for CRP, IFX and ADL (r=0.98, r=0.88 and r=0.86 respectively, Fig. 1). Deming regression analysis of the CRP assay resulted in a slope of 0.71 (95% CI 0.49 to 0.93) and 1.5 (95% CI -0.44 to 3.50) for the intercept. For the IFX assay, the slope was 1.1 (95% CI 0.83 to 1.3) and the intercept was 1.4 (95% CI -0.47 to 3.4). For the ADL assay, the slope was 0.97 (95% CI 0.64 to 1.3) and the intercept was 2.3 (95% CI -0.64 to 5.2). Conclusion A novel POCT using a finger prick approach provides a rapid, user friendly and reliable measurement of CRP, IFX and ADL concentrations within minutes. The capillary CRP was slightly lower than the venous serum CRP, which was consistently observed and considered clinically irrelevant in this cohort.


JCI Insight ◽  
2019 ◽  
Vol 4 (4) ◽  
Author(s):  
Anna K. Polomska ◽  
Steven T. Proulx ◽  
Davide Brambilla ◽  
Daniel Fehr ◽  
Mathias Bonmarin ◽  
...  

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