Research Statement
Title: Designed and Ex -Vivo evaluation for vancomycin detection in Human Plasma Employing
Gold Nanomaterials Immunochromatography Test Strip Assay
Introduction
Developments in diagnostic tools are necessary to monitor therapeutic drug levels, as an increasing
number of microorganisms resistant to antibiotics presents a serious threat to public health. The
goal of this research is to use the unique properties of nanomaterials to create an
immunochromatography test strip assay for the rapid and precise identification of vancomycin in
human plasma.
Objective
Designing, developing, and improving an immunochromatography test strip with nanomaterials as
fundamental elements is the main goal in order to improve the sensitivity, cross reactivity,
specificity and storage stability condition of vancomycin detection in human plasma.
Methodology
The study will synthesize and characterize nanomaterials, with a concentration on using them in
immunoassays. The immobilization of vancomycin-specific antibodies onto the nanoparticles
ensures great affinity and selectivity. Preparation of anti-vancomycin antibody conjugate and
characterization by using UV- Vis spectrometer. For preparation of Immunochromatography test
strip assay were prepared by using different type of membrane and pads along with pre and post
treatment. For effective analyses capture and detection, the integration of these nanomaterials into
the test strip will be optimized. In the last part of this study was to integrate the
immunochromatography test strip with biosensor technology and get quantitative result of
vancomycin within 15 minutes turnaround time. The immunochromatography test strip were used
not only in laboratory it is also useful for patient in emergency and in intensive care unit.
Expertise in instruments
During this research project was well aware in using a variety of analytical laboratory equipment,
such as X-ray diffraction, BET Surface Area Analysis, Gas Chromatography-Mass Spectrometry
(GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), Ultra-High Performance Liquid
Chromatography (UHPLC), High-Performance Liquid Chromatography (HPLC), UV-Vis
Spectroscopy, Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy
(SEM), Transmission Electron Microscopy (TEM), and Zetasizer. I have experience conducting
pre-formulation investigations, such as solubility enhancement and drug/excipient compatibility
assessments, as part of my skill set for developing new formulations.
Ex Vivo examination
Using human plasma samples that have been spiked with various amounts of vancomycin, the
resulting test strips will go through an extensive ex vivo examination. Evaluations of the assays
sensitivity, specificity, and limit of detection will yield vital information about the way it functions
as well as how accurate it is in an environment which is relevant to clinical practice.
Significance
This immunochromatography test strips successful development had significant clinical
implications since it provides an easy and inexpensive means to measure patients’ vancomycin
levels. A device such that can help doctors improve patient outcomes, minimize the risk of
antibiotic resistance, and optimize dosing.
Expected Contribution
This study advances the field by providing a novel diagnostic approach that combines the enhanced
detection capabilities of nanomaterials with the simple method of applying
immunochromatography. It is expected that the results will be beneficial to the expanding
understanding of assays based on nanomaterials for therapeutic drugs monitoring.
Future Projects
The immunochromatography test strip for vancomycin detection was successfully developed,
opening up new research and development opportunities. Potential future directions are
represented by the following areas:
1. Multiplexed Detection: Determine if the test strip can be multiplexed to detect several
antibiotics simultaneously. This would take care of the requirement for thorough therapeutic drug
monitoring, particularly when using combination antibiotic regimens.
2. Point of Care devise: Investigate into incorporating the created test strip into a point-of-care
(POC) device that is affordable, portable, and easy to use. This would speed up turnaround times
and improve accessibility in a wide range of healthcare settings by facilitating on-site testing.
3. Clinical Validation: To evaluate the test strip’s performance in real-life scenarios, carry out
thorough clinical validation studies using a larger patient population. In order to determine the
assay’s accuracy and dependability over a range of patient demographics, this step is essential.
4. Long-Term Stability experiments: To assess the test strips’ resistance and shelf life under
varying storage conditions, perform long-term stability experiments. Understanding the stability
profile is important for both widespread distribution and practical application.
5. Integration with Electronic Platforms: For quantitative data analysis and remote monitoring,
investigate how the test strip might be integrated with smartphone applications or digital platforms.
This will improve data accuracy, deliver results instantly, and enable smooth communication
between patients and healthcare professionals.
6. Adaptation for Other Therapeutic Agents: Examine how adaptable the created platform is in
terms of detecting drugs other than vancomycin. To increase the range of uses, this can involve
altering the antibody’s specificity or adding more capture agents.
7. Improvement of Sensitivity and Specificity: To further improve the assay’s sensitivity and
specificity, continuously optimize the components based on nanomaterials. In order to increase
analyte capture efficiency, this may entail investigating modern nanomaterials or surface changes.
8. Field Testing in Resource-Limited Settings: To evaluate the test strip’s robustness and
sustainability during times when access to advanced laboratory equipment is difficult to obtain,
conduct field testing in resource-limited settings. This stage is essential for evaluating the assay’s
applicability in various global healthcare settings.
9. Collaboration with Regulation firms: Work together with regulatory agencies to guarantee
that diagnostic device standards are followed and to negotiate the regulatory approval procedure.
The test strip’s future incorporation into clinical practice depends on this.
10. Economic Feasibility Studies: To determine how cost-effective the new test strip is in
comparison to current techniques, conduct economic feasibility studies. Determining the
diagnostic tool’s sustainability and economic viability requires this information.
In addition to improving the current immunochromatography test strip, further research in these
areas will advance the fields of personalized medicine and diagnostic development to a greater
extent.
Conclusion
In conclusion, our study aims to fill the gap in existing diagnostic techniques by creating a novel
immunochromatography test strip that can detect vancomycin in human plasma with specificity
and sensitivity. Integrated the immunochromatography test strip with biosensor devise for
quantitative detection of vancomycin. It is expected that the assay’s performance will increase
with the inclusion of nanomaterials, opening the door for improved antibotic treatment in clinical
situations