- Research Article
- 10.1016/j.ajt.2025.07.591
Clinical Validation of a Novel Rapid Test for Point-of-Care Tacrolimus Monitoring in Kidney Transplant Recipients
- Aug 01, 2025
- American Journal of Transplantation
- T Nguyen + 7 more +7
Publications from 2021 to 2026
Showing 10 of 26 papers
Clinical Validation of a Novel Rapid Test for Point-of-Care Tacrolimus Monitoring in Kidney Transplant Recipients
Real-Time Hydration Biomarker Monitoring via Optical Sensor Microneedle Arrays
Dehydration poses significant risks to operators, impacting cognitive and physical performance. We developed a wearable monitor using microneedle optical sensing, tracking hydration biomarkers in interstitial fluid. Validation studies showed strong correlations with urine specific gravity, highlighting its potential to mitigate dehydration risks.
Read moreA-383 A Novel Lateral Flow Immunoassay for Health Biomarker and Immunosuppressive Drug Monitoring in Fingerstick Blood in a Point-of-Care Setting
Abstract Background Rapid, CLIA-waived quantitative testing can help eliminate delays in receiving care, improve telemedicine, enhance the management of chronic diseases and clinical trials, and reduce healthcare costs. Intelligent Optical Systems has developed an innovative Enhanced Lateral Flow Assay (ELFA) platform and partnered with the University of California, Irvine Nephrology Division and Wake Forest Institute for Regenerative Medicine for the clinical validation of the assay. The ELFA platform quantitatively measures the immunosuppressive drug tacrolimus (TAC), and health biomarkers such as proinflammatory cytokines IL6, IL8, matrix metalloproteinase-3 (MMP3), glial fibrillary acidic protein (GFAP, an indicator of traumatic brain injury), and cystatin C (CysC, an indicator of kidney function) from fingerstick blood at the point of care. The testing panel is continuously expanding. Methods The ELFA platform is an in vitro, quantitative, single plex or multiplexed lateral flow immunoassay that consists of three main components: (i) simple fingerstick whole blood sampling kit; (ii) lateral flow test strip with running buffer and dried fluorescent labeled affinity reagents; and (iii) miniaturized readout device that can be further developed with a controlled user interface, enabling untrained users to easily record results and instantly transmit them to the physician. Depending on the analytes, the ELFA point-of-care platform has undergone bench testing or clinical validation studies, including: (1) Single plex for TAC: Clinical validation using 5 uL of capillary fingerstick whole blood from kidney transplant recipients (KTR, n = 50) compared to standard LC-MS/MS laboratory method. (2) Multiplexed ELFA for TAC, IL6, and MMP3: In vitro assessment of limit of detection (LoD), detection range, specificity, and repeatability (n = 5) with 10 uL spiked whole blood. (3) Single plex ELFA for GFAP, IL8, and CysC: In vitro determination of the LoD, detection range, CV%, and correlation of spiked and estimated analyte levels with 10 uL of spiked whole blood. For all analytes, a 4-parameter logistic calibration curve with n = 3 for each level of analyte was constructed to determine the LoD, detection range, and CV%. Pearson correlation and Bland-Altman analysis were applied to correlate and compare data between spiked and estimated levels, or between ELFA and standard lab test methods. Results Study (1) demonstrated excellent correlation between ELFA and LC-MS/MS, with a correlation coefficient r-value of 0.89, and at 95% limit of agreement, a mean difference of 0.7 ng/mL in the clinically compared samples from 50 KTRs. Study (2) showed an LoD and range of detection of 2 ng/mL to 20 ng/mL, 1 ng/mL to 5 ng/mL, and 10 ng/mL to 200 ng/mL for the multiplexed detection of TAC, IL6, and MMP3, respectively. The repeatability assessment showed a <10%CV for all analytes. Study (3) showed an LoD and range of detection of 1 ng/mL to 10 ng/mL, 0.5 ng/mL to 5 ng/mL, and 0 to 5 mg/L for GFAP, IL8, and CysC, respectively. Conclusion The ELFA platform delivers minimally invasive, convenient sampling in a POC device using capillary fingerstick blood, and provides accurate, rapid measurements of TAC, which demonstrate good repeatability and strong correlation against LC-MS standard reference measurements.
Read moreIntegrated sensor biopsy device for real time tissue metabolism analysis
Current methods for guiding cancer biopsies rely almost exclusively on images derived from X-ray, ultrasound, or magnetic resonance, which essentially characterize suspected lesions based only on tissue density. This paper presents a sensor integrated biopsy device for in situ tissue analysis that will enable biopsy teams to measure local tissue chemistry in real time during biopsy procedures, adding a valuable new set of parameters to augment and extend conventional image guidance. A first demonstrator integrating three chemical and biochemical sensors was tested in a mice strain that is a spontaneous breast cancer model. In all cases, the multisensory probe was able to discriminate between healthy tissue, the edge of the tumor, and total insertion inside the cancer tissue, recording real-time information about tissue metabolism.
Read moreMonitoring dissolved CO2 in groundwater for CO2 leakage detection in a shallow aquifer
Characteristics of two-wave mixing adaptive interferometer with CdTe:Ge at 106 and 155 μm and improved temporal adaptability with temperature control
We have characterized a two-wave mixing adaptive interferometer based on dc-biased photorefractive CdTe:Ge crystal at 1.06 and 1.55 μm. Excellent performance is shown at both wavelengths by demonstration of high sensitivity for measurement of small displacements and high cutoff frequency at low intensity. We have achieved a considerable reduction of the undesired low-frequency response using controlled heating of the crystal, which ensures depopulation of corresponding traps. The experimental data are used for measurement of the real and imaginary parts of the coupling constant, as well as the dielectric relaxation time of the crystal and the mobility-lifetime product of the free charge carriers.
Read moreMiniature multi-analyte fiber-optic sensor probe
A miniature fiber-optic chemical sensor system allowing for simultaneous detection of gas concentrations and physical parameters is described, fabricated and tested. The design is focused on minimizing influence of the sensor onto the system under test, therefore employing very thin and pliable fiber probes. Microfabrication of the sensor structure is described and a suitable interrogation setup is introduced. Measurements of O<sub>2</sub> and CO<sub>2</sub> concentrations are presented and discussed. Applications in continuous medical monitoring and necessary design and operating parameters are described.
Read moreProgress in circulating tumor cell capture and analysis: implications for cancer management
The hematogenous dissemination of cancer and development of distant metastases is the cause of nearly all cancer deaths. Detection of circulating tumor cells (CTCs) as a surrogate biomarker of metastases has gained increasing interest. There is accumulating evidence on development of novel technologies for CTC detection, their prognostic relevance and their use in therapeutic response monitoring. Many clinical trials in the early and metastatic cancer setting, particularly in breast cancer, are including CTCs in their translational research programs and as secondary end points. We summarize the progress of detection methods in the context of their clinical importance and speculate on the possibilities of wider implementation of CTCs as a diagnostic oncology tool, the likelihood that CTCs will be used as a useful biomarker, especially to monitor therapeutic response, and what may be expected from the future improvements in technologies.
Read moreBattery outgassing sensor for electric drive vehicle energy storage systems
Lithium-ion batteries have been proven efficient as high power density and low self-discharge rate energy storage systems, specifically in electrical drive vehicles. An important safety factor associated with these systems is the potential hazardous release and outgassing of toxic chemical vapors such as hydrogen fluoride (HF) and hydrogen sulfides (H 2 S), and relatively elevated levels of carbon dioxide (CO 2 ). The release and accumulation of such gases emphasizes an in-line monitoring need. Intelligent Optical Systems, Inc. (IOS) has identified a viable approach for the development of an onboard optical sensor array that can be used to monitor battery outgassing. This paper discusses the potential of developing a battery outgas sensing approach that will meet sensitivity and response time requirements.
Read morePneumatically deployed net system for endoscopic removal of foreign object
Endoscopic tools are widely used for removal of a foreign object from hard-to-reach areas in various applications including medical ones. However, metallic grabbers typically used for such endoscopic removal always bear the risk of accidently damaging surrounding surfaces or losing the grabbed object. Use of flexible grabbing systems such as a net would greatly reduce such risks by gently handling the object and yielding upon contact with the surroundings. In this study, a new object removing plan using a flexible grabbing system with object-locking is presented along with its realization through a pneumatically operated net and designated hook.
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