In Vitro Diagnostics

A special issue of Diagnostics (ISSN 2075-4418).

Deadline for manuscript submissions: closed (31 March 2015) | Viewed by 103135

Special Issue Editor

Special Issue Information

Dear Colleagues,

There have been tremendous advances in the field of in vitro diagnostics (IVD) during the last two decades, which have led to the development of new IVD technologies and devices. Apart from remarkable advances in biomolecular immobilization, conjugation and surface modification strategies, significant improvements have been made in conventional IVD formats, such as enzyme-linked immunosorbent assay (ELISA) and lateral flow assays. The surface plasmon resonance-based instruments have led to a plethora of real-time label-free assays and have been widely adopted in industries, academia and healthcare. On the other hand, microfluidics-based IVD assays and lab-on-a-chip diagnostic platforms have inculcated tremendous interest among researchers based on their numerous advantages that are apparent to the scientific community. The ongoing research efforts are focused on the integration of microfluidics with lab-on-a-chip, automation and multiplexing capabilities. The use of nanomaterials has further led to naked-eye and signal enhanced assays, which are paving way to interesting bioanalytical applications. The development of paper-based IVD assays will be highly useful for developing nations, due to the significantly reduced analysis cost. Various novel biosensors and assay formats have also been developed. The last few years have seen a dramatic change in the landscape of IVD based on the emergence of smartphones as a point-of-care diagnostic device. Several low-cost smartphone-based devices have been developed and a wide range of diagnostic assays and bioanalytical applications have been demonstrated. These devices hold tremendous potential for mobile Healthcare and personalized medicine. The coming years will witness breakthroughs in IVD that will pave way to next-generation of rapid, low-cost, analytically superior and robust assays and devices.

Dr. Sandeep Kumar Vashist
Guest Editor

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Keywords

  • in vitro diagnostics
  • immunoassays
  • lateral flow assays
  • nanomaterial-based assays
  • biomarkers
  • lab-on-a-chip
  • microfluidics
  • electrochemistry
  • biosensors
  • signal enhancement
  • surface plasmon resonance
  • microarrays
  • paper-based assays
  • smartphone-based devices
  • mobile healthcare
  • point-of-care
  • bioanalytical applications

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Published Papers (7 papers)

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Research

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649 KiB  
Article
A Novel Point-of-Care Biomarker Recognition Method: Validation by Detecting Marker for Diabetic Nephropathy
by Sahana Pentyala, John Muller, Thomas Tumillo, Avijit Roy, Pooja Mysore and Srinivas Pentyala
Diagnostics 2015, 5(2), 177-188; https://doi.org/10.3390/diagnostics5020177 - 23 Apr 2015
Cited by 5 | Viewed by 6652
Abstract
Biological fluid collection to identify and analyze different disease markers is a routine and normal procedure in health care settings. Body fluids are as varied as urine, blood, mucus, cerebrospinal fluid (CSF), tears, semen, etc. The volumes of the collected fluids range from [...] Read more.
Biological fluid collection to identify and analyze different disease markers is a routine and normal procedure in health care settings. Body fluids are as varied as urine, blood, mucus, cerebrospinal fluid (CSF), tears, semen, etc. The volumes of the collected fluids range from micro liters (e.g., tears, CSF) to tens and hundreds of milliliters (blood, urine, etc.). In some manifestations, a disease marker (particularly protein markers) can occur in trace amounts, yet the fluids collected are in large volumes. To identify these trace markers, cumbersome methods, expensive instruments, and trained personnel are required. We developed an easy method to rapidly capture, concentrate, and identify protein markers in large volumes of test fluids. This method involves the utilization of two antibodies recognizing two different epitopes of the protein biomarker. Antibody-1 helps to capture and concentrate the biomarker and Antibody-2 adsorbed or conjugated to nanogold beads will detect the biomarker. This method was validated in capturing and detecting lipocalin type prostaglandin-D2 synthase, a marker in urine that implicates diabetic nephropathy. A one-step collection, concentration, and detection device was designed based on this method. This device can replace many of the normal body fluid collection devices such as tubes and containers. A one-step fluid collection and biomarker capture and concentration device for rapid diagnosis of diseases has tremendous advantage in terms of cost and providing timely results. Full article
(This article belongs to the Special Issue In Vitro Diagnostics)
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2515 KiB  
Article
Screen Printed Carbon Electrode Based Electrochemical Immunosensor for the Detection of Dengue NS1 Antigen
by Om Parkash, Chan Yean Yean and Rafidah Hanim Shueb
Diagnostics 2014, 4(4), 165-180; https://doi.org/10.3390/diagnostics4040165 - 20 Nov 2014
Cited by 48 | Viewed by 12832
Abstract
An electrochemical immunosensor modified with the streptavidin/biotin system on screen printed carbon electrodes (SPCEs) for the detection of the dengue NS1 antigen was developed in this study. Monoclonal anti-NS1 capture antibody was immobilized on streptavidin-modified SPCEs to increase the sensitivity of the assay. [...] Read more.
An electrochemical immunosensor modified with the streptavidin/biotin system on screen printed carbon electrodes (SPCEs) for the detection of the dengue NS1 antigen was developed in this study. Monoclonal anti-NS1 capture antibody was immobilized on streptavidin-modified SPCEs to increase the sensitivity of the assay. Subsequently, a direct sandwich enzyme linked immunosorbent assay (ELISA) format was developed and optimized. An anti-NS1 detection antibody conjugated with horseradish peroxidase enzyme (HRP) and 3,3,5,5'-tetramethybezidine dihydrochloride (TMB/H2O2) was used as an enzyme mediator. Electrochemical detection was conducted using the chronoamperometric technique, and electrochemical responses were generated at −200 mV reduction potential. The calibration curve of the immunosensor showed a linear response between 0.5 µg/mL and 2 µg/mL and a detection limit of 0.03 µg/mL. Incorporation of a streptavidin/biotin system resulted in a well-oriented antibody immobilization of the capture antibody and consequently enhanced the sensitivity of the assay. In conclusion, this immunosensor is a promising technology for the rapid and convenient detection of acute dengue infection in real serum samples. Full article
(This article belongs to the Special Issue In Vitro Diagnostics)
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1318 KiB  
Article
Spectro-Fluor™ Technology for Reliable Detection of Proteins and Biomarkers of Disease: A Pioneered Research Study
by Farid Menaa, Bouzid Menaa and Olga N. Sharts
Diagnostics 2014, 4(4), 140-152; https://doi.org/10.3390/diagnostics4040140 - 29 Sep 2014
Cited by 4 | Viewed by 8314
Abstract
Quantitative and qualitative characterization of fluorinated molecules represents an important task. Fluorine-based medicinal chemistry is a fast-growing research area due to the positive impact of fluorine in drug discovery, and clinical and molecular imaging (e.g., magnetic resonance imaging, positron emission tomography). Common detection [...] Read more.
Quantitative and qualitative characterization of fluorinated molecules represents an important task. Fluorine-based medicinal chemistry is a fast-growing research area due to the positive impact of fluorine in drug discovery, and clinical and molecular imaging (e.g., magnetic resonance imaging, positron emission tomography). Common detection methods include fluorinated-based labelling using radioactive isotopes or fluorescent dyes. Nevertheless, these molecular imaging methods can be harmful for health due to the potential instability of fluorochromes and cytoxicity of radioisotopes. Therefore, these methods often require expensive precautionary measures. In this context, we have developed, validated and patented carbon-fluorine spectroscopy (CFS™), recently renamed Spectro-Fluor™ technology, which among a non-competitive family of in-house made devices called PLIRFA™ (Pulsed Laser Isochronic Raman and Fluorescence Apparatus™), allows reliable detection of Carbon-Fluorine (C-F) bonds. C-F bonds are known to be stable and safe labels once incorporated to any type of molecules, cells, compounds or (nano-) materials. In this pioneered research study, we used Spectro-Fluor™ to assess biomarkers. As a proof-of-principle experiment, we have established a three-step protocol intended to rapid protein detection, which simply consisted of: (i) incorporating a sufficient concentration of an aromatic amino-acid (fluorinated versus non-fluorinated) into cultured cells; (ii) simultaneously isolating the fluorinated protein of interest and the non-fluorinated form of the protein (control) by immune-precipitation; (iii) comparatively analyzing the respective spectrum obtained for the two protein forms by Spectro-Fluor™. Thereby, we were able to differentiate, from colon cancer cells HCT-116, the fluorinated and non-fluorinated forms of p21, a key transcriptional factor and downstream target of p53, the so-called “guardian of the genome”. Taken together, our data again demonstrates the beneficial alternative use of Spectro-Fluor™, which once combined with an innovative methodology permits one to quickly, reliably, safely and cost-effectively detect physiological or pathological proteins in cells. Full article
(This article belongs to the Special Issue In Vitro Diagnostics)
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Review

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2008 KiB  
Review
Technologies for Clinical Diagnosis Using Expired Human Breath Analysis
by Thalakkotur Lazar Mathew, Prabhahari Pownraj, Sukhananazerin Abdulla and Biji Pullithadathil
Diagnostics 2015, 5(1), 27-60; https://doi.org/10.3390/diagnostics5010027 - 2 Feb 2015
Cited by 111 | Viewed by 13591
Abstract
This review elucidates the technologies in the field of exhaled breath analysis. Exhaled breath gas analysis offers an inexpensive, noninvasive and rapid method for detecting a large number of compounds under various conditions for health and disease states. There are various techniques to [...] Read more.
This review elucidates the technologies in the field of exhaled breath analysis. Exhaled breath gas analysis offers an inexpensive, noninvasive and rapid method for detecting a large number of compounds under various conditions for health and disease states. There are various techniques to analyze some exhaled breath gases, including spectrometry, gas chromatography and spectroscopy. This review places emphasis on some of the critical biomarkers present in exhaled human breath, and its related effects. Additionally, various medical monitoring techniques used for breath analysis have been discussed. It also includes the current scenario of breath analysis with nanotechnology-oriented techniques Full article
(This article belongs to the Special Issue In Vitro Diagnostics)
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3738 KiB  
Review
Commercial Smartphone-Based Devices and Smart Applications for Personalized Healthcare Monitoring and Management
by Sandeep Kumar Vashist, E. Marion Schneider and John H.T. Luong
Diagnostics 2014, 4(3), 104-128; https://doi.org/10.3390/diagnostics4030104 - 18 Aug 2014
Cited by 184 | Viewed by 30540
Abstract
Smartphone-based devices and applications (SBDAs) with cost effectiveness and remote sensing are the most promising and effective means of delivering mobile healthcare (mHealthcare). Several SBDAs have been commercialized for the personalized monitoring and/or management of basic physiological parameters, such as blood pressure, weight, [...] Read more.
Smartphone-based devices and applications (SBDAs) with cost effectiveness and remote sensing are the most promising and effective means of delivering mobile healthcare (mHealthcare). Several SBDAs have been commercialized for the personalized monitoring and/or management of basic physiological parameters, such as blood pressure, weight, body analysis, pulse rate, electrocardiograph, blood glucose, blood glucose saturation, sleeping and physical activity. With advances in Bluetooth technology, software, cloud computing and remote sensing, SBDAs provide real-time on-site analysis and telemedicine opportunities in remote areas. This scenario is of utmost importance for developing countries, where the number of smartphone users is about 70% of 6.8 billion cell phone subscribers worldwide with limited access to basic healthcare service. The technology platform facilitates patient-doctor communication and the patients to effectively manage and keep track of their medical conditions. Besides tremendous healthcare cost savings, SBDAs are very critical for the monitoring and effective management of emerging epidemics and food contamination outbreaks. The next decade will witness pioneering advances and increasing applications of SBDAs in this exponentially growing field of mHealthcare. This article provides a critical review of commercial SBDAs that are being widely used for personalized healthcare monitoring and management. Full article
(This article belongs to the Special Issue In Vitro Diagnostics)
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190 KiB  
Review
Trends in Nanomaterial-Based Non-Invasive Diabetes Sensing Technologies
by Prashanth Makaram, Dawn Owens and Juan Aceros
Diagnostics 2014, 4(2), 27-46; https://doi.org/10.3390/diagnostics4020027 - 21 Apr 2014
Cited by 133 | Viewed by 15130
Abstract
Blood glucose monitoring is considered the gold standard for diabetes diagnostics and self-monitoring. However, the underlying process is invasive and highly uncomfortable for patients. Furthermore, the process must be completed several times a day to successfully manage the disease, which greatly contributes to [...] Read more.
Blood glucose monitoring is considered the gold standard for diabetes diagnostics and self-monitoring. However, the underlying process is invasive and highly uncomfortable for patients. Furthermore, the process must be completed several times a day to successfully manage the disease, which greatly contributes to the massive need for non-invasive monitoring options. Human serums, such as saliva, sweat, breath, urine and tears, contain traces of glucose and are easily accessible. Therefore, they allow minimal to non-invasive glucose monitoring, making them attractive alternatives to blood measurements. Numerous developments regarding noninvasive glucose detection techniques have taken place over the years, but recently, they have gained recognition as viable alternatives, due to the advent of nanotechnology-based sensors. Such sensors are optimal for testing the amount of glucose in serums other than blood thanks to their enhanced sensitivity and selectivity ranges, in addition to their size and compatibility with electronic circuitry. These nanotechnology approaches are rapidly evolving, and new techniques are constantly emerging. Hence, this manuscript aims to review current and future nanomaterial-based technologies utilizing saliva, sweat, breath and tears as a diagnostic medium for diabetes monitoring. Full article
(This article belongs to the Special Issue In Vitro Diagnostics)

Other

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761 KiB  
Commentary
Diagnostics for Developing Countries
by Ruth McNerney
Diagnostics 2015, 5(2), 200-209; https://doi.org/10.3390/diagnostics5020200 - 19 May 2015
Cited by 77 | Viewed by 12351
Abstract
Improving the availability of high quality diagnostic tests for infectious diseases is a global priority. Lack of access by people living in low income countries may deprive them of life saving treatment and reduces opportunities to prevent onward transmission and spread of the [...] Read more.
Improving the availability of high quality diagnostic tests for infectious diseases is a global priority. Lack of access by people living in low income countries may deprive them of life saving treatment and reduces opportunities to prevent onward transmission and spread of the disease. Diagnostic laboratories are often poorly resourced in developing countries, and sparsely distributed. Improved access may be achieved by using tests that do not require laboratory support, including rapid tests for use at the point-of-care. Despite increased interest, few new in vitro diagnostic (IVD) products reach the majority populations in low income countries. Barriers to uptake include cost and lack of robustness, with reduced test performances due to environmental pressures such as high ambient temperatures or dust. In addition to environmental factors test developers must consider the local epidemiology. Confounding conditions such as immunosuppression or variations in antigen presentation or genotype can affect test performance. Barriers to product development include access to finance to establish manufacturing capacity and cover the costs of market entry for new devices. Costs and delays may be inflated by current regulatory preregistration processes to ensure product safety and quality, and more harmonized approaches are needed. Full article
(This article belongs to the Special Issue In Vitro Diagnostics)
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