Editorial

3 pages, 395 KiB

Open AccessEditorial

Integration of Mobile Devices and Point-Of-Care Diagnostic Devices—The Case of C-Reactive Protein Diagnosis

by Xin-Fang Wu, Ching-Fen Shen and Chao-Min Cheng

Diagnostics 2019, 9(4), 181; https://doi.org/10.3390/diagnostics9040181 - 08 Nov 2019

Cited by 2 | Viewed by 3227

In recent years, the misuse and overuse of antibiotics has promoted antibiotic resistance, which has now become a global public health concern [...] Full article

(This article belongs to the Special Issue Point-of-Care Detection Devices for Healthcare)

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Research

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15 pages, 1500 KiB

Open AccessArticle

Requirements Analysis and Specification for a Molecular Tumor Board Platform Based on cBioPortal

by Philipp Buechner, Marc Hinderer, Philipp Unberath, Patrick Metzger, Martin Boeker, Till Acker, Florian Haller, Elisabeth Mack, Daniel Nowak, Claudia Paret, Denny Schanze, Nikolas von Bubnoff, Sebastian Wagner, Hauke Busch, Melanie Boerries and Jan Christoph

Diagnostics 2020, 10(2), 93; https://doi.org/10.3390/diagnostics10020093 - 10 Feb 2020

Cited by 24 | Viewed by 6486

Abstract

Clinicians in molecular tumor boards (MTB) are confronted with a growing amount of genetic high-throughput sequencing data. Today, at German university hospitals, these data are usually handled in complex spreadsheets from which clinicians have to obtain the necessary information. The aim of this [...] Read more.

Clinicians in molecular tumor boards (MTB) are confronted with a growing amount of genetic high-throughput sequencing data. Today, at German university hospitals, these data are usually handled in complex spreadsheets from which clinicians have to obtain the necessary information. The aim of this work was to gather a comprehensive list of requirements to be met by cBioPortal to support processes in MTBs according to clinical needs. Therefore, oncology experts at nine German university hospitals were surveyed in two rounds of interviews. To generate an interview guideline a scoping review was conducted. For visual support in the second round, screenshot mockups illustrating the requirements from the first round were created. Requirements that cBioPortal already meets were skipped during the second round. In the end, 24 requirements with sometimes several conceivable options were identified and 54 screenshot mockups were created. Some of the identified requirements have already been suggested to the community by other users or are currently being implemented in cBioPortal. This shows, that the results are in line with the needs expressed by various disciplines. According to our findings, cBioPortal has the potential to significantly improve the processes and analyses of an MTB after the implementation of the identified requirements. Full article

(This article belongs to the Special Issue Point-of-Care Detection Devices for Healthcare)

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13 pages, 626 KiB

Open AccessArticle

Percussion Entropy Analysis of Synchronized ECG and PPG Signals as a Prognostic Indicator for Future Peripheral Neuropathy in Type 2 Diabetic Subjects

by Hai-Cheng Wei, Na Ta, Wen-Rui Hu, Sheng-Ying Wang, Ming-Xia Xiao, Xiao-Jing Tang, Jian-Jung Chen and Hsien-Tsai Wu

Diagnostics 2020, 10(1), 32; https://doi.org/10.3390/diagnostics10010032 - 09 Jan 2020

Cited by 13 | Viewed by 3805

Abstract

Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of diabetes. It has become an essential public health crisis, especially for care in the home. Synchronized electrocardiogram (ECG) and photoplethysmography (PPG) signals were obtained from healthy non-diabetic (n = [...] Read more.

Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of diabetes. It has become an essential public health crisis, especially for care in the home. Synchronized electrocardiogram (ECG) and photoplethysmography (PPG) signals were obtained from healthy non-diabetic (n = 37) and diabetic (n = 85) subjects without peripheral neuropathy, recruited from the diabetic outpatient clinic. The conventional parameters, including low-/high-frequency power ratio (LHR), small-scale multiscale entropy index (MEI_SS), large-scale multiscale entropy index (MEI_LS), electrocardiogram-based pulse wave velocity (PWV_mean), and percussion entropy index (PEI), were computed as baseline and were then followed for six years after the initial PEI measurement. Three new diabetic subgroups with different PEI values were identified for the goodness-of-fit test and Cox proportional Hazards model for relative risks analysis. Finally, Cox regression analysis showed that the PEI value was significantly and independently associated with the risk of developing DPN after adjustment for some traditional risk factors for diabetes (relative risks = 4.77, 95% confidence interval = 1.87 to 6.31, p = 0.015). These findings suggest that the PEI is an important risk parameter for new-onset DPN as a result of a chronic complication of diabetes and, thus, a smaller PEI value can provide valid information that may help identify type 2 diabetic patients at a greater risk of future DPN. Full article

(This article belongs to the Special Issue Point-of-Care Detection Devices for Healthcare)

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10 pages, 1538 KiB

Open AccessArticle

Blood Ketone Bodies and Breath Acetone Analysis and Their Correlations in Type 2 Diabetes Mellitus

by Valentine Saasa, Mervyn Beukes, Yolandy Lemmer and Bonex Mwakikunga

Diagnostics 2019, 9(4), 224; https://doi.org/10.3390/diagnostics9040224 - 17 Dec 2019

Cited by 77 | Viewed by 9461

Abstract

Analysis of volatile organic compounds in the breath for disease detection and monitoring has gained momentum and clinical significance due to its rapid test results and non-invasiveness, especially for diabetes mellitus (DM). Studies have suggested that breath gases, including acetone, may be related [...] Read more.

Analysis of volatile organic compounds in the breath for disease detection and monitoring has gained momentum and clinical significance due to its rapid test results and non-invasiveness, especially for diabetes mellitus (DM). Studies have suggested that breath gases, including acetone, may be related to simultaneous blood glucose (BG) and blood ketone levels in adults with types 2 and 1 diabetes. Detecting altered concentrations of ketones in the breath, blood and urine may be crucial for the diagnosis and monitoring of diabetes mellitus. This study assesses the efficacy of a simple breath test as a non-invasive means of diabetes monitoring in adults with type 2 diabetes mellitus. Human breath samples were collected in Tedlar™ bags and analyzed by headspace solid-phase microextraction and gas chromatography-mass spectrometry (HS-SPME/GC-MS). The measurements were compared with capillary BG and blood ketone levels (β-hydroxybutyrate and acetoacetate) taken at the same time on a single visit to a routine hospital clinic in 30 subjects with type 2 diabetes and 28 control volunteers. Ketone bodies of diabetic subjects showed a significant increase when compared to the control subjects; however, the ketone levels were was controlled in both diabetic and non-diabetic volunteers. Worthy of note, a statistically significant relationship was found between breath acetone and blood acetoacetate (R = 0.89) and between breath acetone and β-hydroxybutyrate (R = 0.82). Full article

(This article belongs to the Special Issue Point-of-Care Detection Devices for Healthcare)

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11 pages, 1987 KiB

Open AccessArticle

Two Potential Clinical Applications of Origami-Based Paper Devices

by Zong-Keng Kuo, Tsui-Hsuan Chang, Yu-Shin Chen, Chao-Min Cheng and Chia-Ying Tsai

Diagnostics 2019, 9(4), 203; https://doi.org/10.3390/diagnostics9040203 - 26 Nov 2019

Cited by 3 | Viewed by 2909

Abstract

Detecting small amounts of analyte in clinical practice is challenging because of deficiencies in specimen sample availability and unsuitable sampling environments that prevent reliable sampling. Paper-based analytical devices (PADs) have successfully been used to detect ultralow amounts of analyte, and origami-based PADs (O-PADs) [...] Read more.

Detecting small amounts of analyte in clinical practice is challenging because of deficiencies in specimen sample availability and unsuitable sampling environments that prevent reliable sampling. Paper-based analytical devices (PADs) have successfully been used to detect ultralow amounts of analyte, and origami-based PADs (O-PADs) offer advantages that may boost the overall potential of PADs in general. In this study, we investigated two potential clinical applications for O-PADs. The first O-PAD we investigated was an origami-based enzyme-linked immunosorbent assay (ELISA) system designed to detect different concentrations of rabbit IgG. This device was designed with four wing structures, each of which acted as a reagent loading zone for pre-loading ELISA reagents, and a central test sample loading zone. Because this device has a low limit of detection (LOD), it may be suitable for detecting IgG levels in tears from patients with a suspected viral infection (such as herpes simplex virus (HSV)). The second O-PAD we investigated was designed to detect paraquat levels to determine potential poisoning. To use this device, we sequentially folded each of two separate reagent zones, one preloaded with NaOH and one preloaded with ascorbic acid (AA), over the central test zone, and added 8 µL of sample that then flowed through each reagent zone and onto the central test zone. The device was then unfolded to read the results on the test zone. The three folded layers of paper provided a moist environment not achievable with conventional paper-based ELISA. Both O-PADs were convenient to use because reagents were preloaded, and results could be observed and analyzed with image analysis software. O-PADs expand the testing capacity of simpler PADs while leveraging their characteristic advantages of convenience, cost, and ease of use, particularly for point-of-care diagnosis. Full article

(This article belongs to the Special Issue Point-of-Care Detection Devices for Healthcare)

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8 pages, 1294 KiB

Open AccessArticle

Comparison of Procalcitonin Assays on KRYPTOR and LIAISON^® XL Analyzers

by Mariella Dipalo, Cecilia Gnocchi, Paola Avanzini, Roberta Musa, Martina Di Pietro and Rosalia Aloe

Diagnostics 2019, 9(3), 94; https://doi.org/10.3390/diagnostics9030094 - 08 Aug 2019

Cited by 11 | Viewed by 3931

Abstract

Our laboratory performs procalcitonin (PCT) assays on a Brahms KRYPTOR analyzer with the Brahms PCT sensitive Kryptor kit. In this study, we wanted to compare the assays obtained in this way with the ones performed on the LIAISON^® XL. From January to [...] Read more.

Our laboratory performs procalcitonin (PCT) assays on a Brahms KRYPTOR analyzer with the Brahms PCT sensitive Kryptor kit. In this study, we wanted to compare the assays obtained in this way with the ones performed on the LIAISON^® XL. From January to May 2017, 171 samples were analyzed, of which 65 from female patients (age: 22–98 years) and 106 from male patients (age: 16–97 years). The PCT determination was performed using the LIAISON^® XL and KRYPTOR analyzers, by chemiluminescence (Chemiluminescence immunoassay—CLIA) (LIAISON^® BRAHMS PCT^® II GEN) and immunofluorescence (Brahms PCT sensitive Kryptor) assay, respectively. For the LIAISON^® BRAHMS PCT^® II GEN, 52% of the results were placed between 0.0 and 0.5 ng/mL, 18% between 0.5 and 2.0 ng/mL, and 30% between 2.0 and 100 ng/mL; the mean was 4.09 ng/mL, the median 0.456 ng/mL, the maximum value 97.2 ng/mL, and the minimum value 0.02 ng/mL. For the Brahms PCT sensitive Kryptor, 55% of the results were positioned between 0.0 and 0.5 ng/mL, 21% between 0.5 and 2.0 ng/mL, and 24% between 2.0 and 100 ng/mL; the mean was 3.72 ng/mL, the median 0.39 ng/mL, the maximum value 103 ng/mL, and the minimum value 0.01 ng/mL. The mean of the results obtained with the two methods showed no significant differences (3.717 for Kryptor and 4.094 for LIAISON^®). PCT assay with Brahms reagents, both on the Kryptor and LIAISON^®XL platforms, offers excellent performance in terms of sensitivity and specificity. Full article

(This article belongs to the Special Issue Point-of-Care Detection Devices for Healthcare)

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Review

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15 pages, 2230 KiB

Open AccessReview

Capillary-Driven Flow Microfluidics Combined with Smartphone Detection: An Emerging Tool for Point-of-Care Diagnostics

by Sammer-ul Hassan, Aamira Tariq, Zobia Noreen, Ahmed Donia, Syed Z. J. Zaidi, Habib Bokhari and Xunli Zhang

Diagnostics 2020, 10(8), 509; https://doi.org/10.3390/diagnostics10080509 - 22 Jul 2020

Cited by 28 | Viewed by 6723

Abstract

Point-of-care (POC) or near-patient testing allows clinicians to accurately achieve real-time diagnostic results performed at or near to the patient site. The outlook of POC devices is to provide quicker analyses that can lead to well-informed clinical decisions and hence improve the health [...] Read more.

Point-of-care (POC) or near-patient testing allows clinicians to accurately achieve real-time diagnostic results performed at or near to the patient site. The outlook of POC devices is to provide quicker analyses that can lead to well-informed clinical decisions and hence improve the health of patients at the point-of-need. Microfluidics plays an important role in the development of POC devices. However, requirements of handling expertise, pumping systems and complex fluidic controls make the technology unaffordable to the current healthcare systems in the world. In recent years, capillary-driven flow microfluidics has emerged as an attractive microfluidic-based technology to overcome these limitations by offering robust, cost-effective and simple-to-operate devices. The internal wall of the microchannels can be pre-coated with reagents, and by merely dipping the device into the patient sample, the sample can be loaded into the microchannel driven by capillary forces and can be detected via handheld or smartphone-based detectors. The capabilities of capillary-driven flow devices have not been fully exploited in developing POC diagnostics, especially for antimicrobial resistance studies in clinical settings. The purpose of this review is to open up this field of microfluidics to the ever-expanding microfluidic-based scientific community. Full article

(This article belongs to the Special Issue Point-of-Care Detection Devices for Healthcare)

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14 pages, 5001 KiB

Open AccessReview

Viscoelastic Hemostatic Assays: Moving from the Laboratory to the Site of Care—A Review of Established and Emerging Technologies

by Jan Hartmann, Matthew Murphy and Joao D. Dias

Diagnostics 2020, 10(2), 118; https://doi.org/10.3390/diagnostics10020118 - 21 Feb 2020

Cited by 54 | Viewed by 8208

Abstract

Viscoelastic-based techniques to evaluate whole blood hemostasis have advanced substantially since they were first developed over 70 years ago but are still based upon the techniques first described by Dr. Hellmut Hartert in 1948. Today, the use of thromboelastography, the method of testing [...] Read more.

Viscoelastic-based techniques to evaluate whole blood hemostasis have advanced substantially since they were first developed over 70 years ago but are still based upon the techniques first described by Dr. Hellmut Hartert in 1948. Today, the use of thromboelastography, the method of testing viscoelastic properties of blood coagulation, has moved out of the research laboratory and is now more widespread, used commonly during surgery, in emergency departments, intensive care units, and in labor wards. Thromboelastography is currently a rapidly growing field of technological advancement and is attracting significant investment. This review will first describe the history of the viscoelastic testing and the established first-generation devices, which were developed for use within the laboratory. This review will then describe the next-generation hemostasis monitoring devices, which were developed for use at the site of care for an expanding range of clinical applications. This review will then move on to experimental technologies, which promise to make viscoelastic testing more readily available in a wider range of clinical environments in the endeavor to improve patient care. Full article

(This article belongs to the Special Issue Point-of-Care Detection Devices for Healthcare)

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Other

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12 pages, 7485 KiB

Open AccessTechnical Note

Optical Density Optimization of Malaria Pan Rapid Diagnostic Test Strips for Improved Test Zone Band Intensity

by Prince Manta, Rupak Nagraik, Avinash Sharma, Akshay Kumar, Pritt Verma, Shravan Kumar Paswan, Dmitry O. Bokov, Juber Dastagir Shaikh, Roopvir Kaur, Ana Francesca Vommaro Leite, Silas Jose Braz Filho, Nimisha Shiwalkar, Purnadeo Persaud and Deepak N. Kapoor

Diagnostics 2020, 10(11), 880; https://doi.org/10.3390/diagnostics10110880 - 29 Oct 2020

Cited by 7 | Viewed by 4382

Abstract

For the last few decades, the immunochromatographic assay has been used for the rapid detection of biological markers in infectious diseases in humans and animals The assay, also known as lateral flow assay, is utilized for the detection of antigen or antibody in [...] Read more.

For the last few decades, the immunochromatographic assay has been used for the rapid detection of biological markers in infectious diseases in humans and animals The assay, also known as lateral flow assay, is utilized for the detection of antigen or antibody in human infectious diseases. There are a series of steps involved in the development of these immuno-chromatographic test kits, from gold nano colloids preparation to nitrocellulose membrane coating (NCM). These tests are mostly used for qualitative assays by a visual interpretation of results. For the interpretation of the results, the color intensity of the test zone is therefore very significant. Herein, the study was performed on a malaria antigen test kit. Several studies have reported the use of gold nanoparticles (AuNPs) with varying diameters and its binding with various concentrations of protein in order to optimize tests. However, none of these studies have reported how to fix (improve) test zone band intensity (color), if different sized AuNPs were synthesized during a reaction and when conjugated equally with same amount of protein. Herein, different AuNPs with average diameter ranging from 10 nm to 50 nm were prepared and conjugated equally with protein concentration of 150 µg/mL with K_D = 1.0 × 10⁻³. Afterwards, the developed kits’ test zone band intensity for all different sizes AuNPs was fixed to the same band level (high) by utilization of an ultraviolet-visible spectrophotometer. The study found that the same optical density (OD) has the same test zone band intensity irrespective of AuNP size. This study also illustrates the use of absorption maxima (λ max) techniques to characterize AuNPs and to prevent wastage of protein while developing immunochromatographic test kits. Full article

(This article belongs to the Special Issue Point-of-Care Detection Devices for Healthcare)

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