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Diagnostics
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Advanced Diagnostic Kit Development for Laboratory Diagnosis
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Advanced Diagnostic Kit Development for Laboratory Diagnosis

A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Point-of-Care Diagnostics and Devices".

Deadline for manuscript submissions: closed (30 September 2021) | Viewed by 40455

Special Issue Editors

Dr. Chao-Min Cheng

E-Mail Website
Guest Editor
Institute of Biomedical Engineering, National Tsing Hua University, Hsinchu City 300, Taiwan
Interests: biomedical engineering; diagnostic methods; vaccines
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Majid Ebrahimi Warkiani

E-Mail Website
Guest Editor
School of Biomedical Engineering, University of Technology Sydney, Sydney 2007, Australia
Interests: microfluidics; organ-on-a-chip
Special Issues, Collections and Topics in MDPI journals
Dr. Meysam Rezaei

E-Mail Website
Guest Editor
Institute for Biomedical Materials & Devices (IBMD), Faculty of Science, University of Technology Sydney, Sydney, NSW 2007, Australia
Interests: microfluidics; micro and nanotechnology; single cell isolation and analysis; fetal genetic disorders; cancer

Special Issue Information

Dear Colleagues,

A critical need for new diagnostic kit development is a longstanding issue for laboratory diagnosis—for example, the new laboratory-based diagnostic kit for the recent COVID-19 pandemic. The Special Issue that we are currently organizing aims to bridge diagnostic kit development and advanced technologies based on bioengineering, micro-/nanotechnologies, biomaterials science and translational medicine, and in particular, the potential applications of laboratory diagnosis. The topics in this Special Issue would cover point-of-care diagnostic kits, laboratory diagnostic kits, new materials for making diagnostic kits, new diagnostic biomarker development, and others. Please directly discuss with the Guest Editor, and we are more than happy to discuss with the authors about the potential manuscript.

Dr. Chao-Min Cheng
Dr. Majid Ebrahimi Warkiani
Dr. Meysam Rezaei
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Diagnostics is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Published Papers (7 papers)

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Editorial

Jump to: Research, Review

4 pages, 759 KiB  
Editorial
Potential Trends of Point-of-Care Diagnostics—The Next Generation of the Laboratory Diagnosis
by Sheng-Wen Lin, Ching-Fen Shen and Chao-Min Cheng
Diagnostics 2020, 10(10), 774; https://doi.org/10.3390/diagnostics10100774 - 30 Sep 2020
Cited by 1 | Viewed by 1744
Abstract
With the current worldwide outbreak of COVID-19, developing rapid, effective, and convenient detection tools has become imperative [...] Full article
(This article belongs to the Special Issue Advanced Diagnostic Kit Development for Laboratory Diagnosis)
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Research

Jump to: Editorial, Review

13 pages, 1274 KiB  
Article
Development of Two-Tube Loop-Mediated Isothermal Amplification Assay for Differential Diagnosis of Plasmodium falciparum and Plasmodium vivax and Its Comparison with Loopamp™ Malaria
by Mudsser Azam, Kirti Upmanyu, Ratan Gupta, Karugatharayil Sasi Sruthy, Monika Matlani, Deepali Savargaonkar and Ruchi Singh
Diagnostics 2021, 11(9), 1689; https://doi.org/10.3390/diagnostics11091689 - 16 Sep 2021
Cited by 3 | Viewed by 2297
Abstract
To strengthen malaria surveillance, field-appropriate diagnostics requiring limited technical resources are of critical significance. Loop-mediated isothermal amplification (LAMP) based malaria diagnostic assays are potential point-of-care tests with high sensitivity and specificity and have been used in low-resource settings. Plasmodium vivax–specific consensus repeat [...] Read more.
To strengthen malaria surveillance, field-appropriate diagnostics requiring limited technical resources are of critical significance. Loop-mediated isothermal amplification (LAMP) based malaria diagnostic assays are potential point-of-care tests with high sensitivity and specificity and have been used in low-resource settings. Plasmodium vivax–specific consensus repeat sequence (CRS)-based and Plasmodium falciparum–specific 18S rRNA primers were designed, and a two-tube LAMP assay was developed. The diagnostic performance of a closed-tube LAMP assay and Loopamp™ Malaria Detection (Pan/Pf, Pv) kit was investigated using nested PCR confirmed mono- and co-infections of P. vivax and P. falciparum positive (n = 149) and negative (n = 67) samples. The closed-tube Pv LAMP assay showed positive amplification in 40 min (limit of detection, LOD 0.7 parasites/µL) and Pf LAMP assay in 30 min (LOD 2 parasites/µL). Pv LAMP and Pf LAMP demonstrated a sensitivity and specificity of 100% (95% CI, 95.96–100% and 89.85–100%, respectively). The LoopampTM Pan/Pf Malaria Detection kit demonstrated a sensitivity and specificity of 100%, whereas LoopampTM Pv showed a sensitivity of 98.36% (95% CI, 91.28–99.71%) and specificity of 100% (95% CI, 87.54–100%). The developed two-tube LAMP assay is highly sensitive (LOD ≤ 2 parasite/µL), demonstrating comparable results with the commercial Loopamp™ Malaria Detection (Pf/pan) kit, and was superior in detecting the P. vivax co-infection that remained undetected by the Loopamp™ Pv kit. The developed indigenous two-tube Pf/Pv malaria detection can reliably be used for mass screening in resource-limited areas endemic for both P. falciparum and P. vivax malaria. Full article
(This article belongs to the Special Issue Advanced Diagnostic Kit Development for Laboratory Diagnosis)
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16 pages, 2259 KiB  
Article
Identification and Quantification of Anti-Gp.Mur Antibodies in Human Serum Using an Insect-Cell-Based System
by Robert John S. Lamis, Tsong-Shi Chiueh, Chih-Hsuan Tsai, Huei-Ru Lo, Sung-Chan Wei and Yu-Chan Chao
Diagnostics 2021, 11(6), 966; https://doi.org/10.3390/diagnostics11060966 - 27 May 2021
Cited by 4 | Viewed by 2990
Abstract
Gp.Mur is a clinically relevant antigen of the MNS blood group system that is highly prevalent in several Asian populations. Its corresponding antibody, anti-Gp.Mur, has been implicated in hemolytic transfusion reactions and hemolytic disease of the fetus and newborn. Currently, identifying and confirming [...] Read more.
Gp.Mur is a clinically relevant antigen of the MNS blood group system that is highly prevalent in several Asian populations. Its corresponding antibody, anti-Gp.Mur, has been implicated in hemolytic transfusion reactions and hemolytic disease of the fetus and newborn. Currently, identifying and confirming anti-Gp.Mur antibody presence in sera via agglutination of a panel of red blood cells (RBCs) is inefficient and difficult to quantify. Using a baculovirus expression system to express Gp.Mur antigen on insect cell surfaces, we have developed a quantitative cell-based system to confirm the presence of anti-Gp.Mur antibody in human serum. We obtained 10 serum samples preidentified as having anti-Gp.Mur antibody and another 4 samples containing noncorresponding antibodies from hospital patients. Insect cells displaying Gp.Mur antigen successfully adsorbed anti-Gp.Mur antibody in the sera and inhibited the RBC agglutination mediated by this antibody. By varying the concentration of Gp.Mur-displaying cells, we could grade levels of RBC agglutination by anti-Gp.Mur antibody. Densitometric analysis further enabled quantitative determinations of hemagglutination inhibition by Gp.Mur-displaying cells. We believe that this cell-based hemagglutination inhibition system greatly improves or supplements existing technology and is a convenient means for accurately identifying and quantifying anti-Gp.Mur antibody. Full article
(This article belongs to the Special Issue Advanced Diagnostic Kit Development for Laboratory Diagnosis)
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10 pages, 8233 KiB  
Article
Development of Immunochromatographic Test Kit for Rapid Detection of Specific IgG4 Antibody in Whole-Blood Samples for Diagnosis of Human Gnathostomiasis
by Penchom Janwan, Pewpan M. Intapan, Lakkhana Sadaow, Rutchanee Rodpai, Hiroshi Yamasaki, Patcharaporn Boonroumkaew, Oranuch Sanpool, Tongjit Thanchomnang, Phuangphaka Sadee and Wanchai Maleewong
Diagnostics 2021, 11(5), 862; https://doi.org/10.3390/diagnostics11050862 - 11 May 2021
Cited by 4 | Viewed by 3234
Abstract
Human gnathostomiasis is a harmful food-borne zoonosis caused by roundworms of the genus Gnathostoma. The parasite can occasionally migrate to the central nervous system, causing life-threatening disease and death. Here, we report a new point-of-care (POC) test kit, the gnathostomiasis blood immunochromatographic [...] Read more.
Human gnathostomiasis is a harmful food-borne zoonosis caused by roundworms of the genus Gnathostoma. The parasite can occasionally migrate to the central nervous system, causing life-threatening disease and death. Here, we report a new point-of-care (POC) test kit, the gnathostomiasis blood immunochromatographic test (GB-ICT) kit. The kit is based on recombinant Gnathostoma spinigerum antigen and detects specific IgG4 antibody in whole-blood samples (WBSs). The GB-ICT kit showed potentially high diagnostic values with simulated WBSs (n = 248), which were obtained by spiking patients’ sera with red blood cells. The accuracy, sensitivity, specificity, and positive and negative predictive values were 95.2%, 100%, 93.8%, 81.5%, and 100%, respectively. Ten WBSs from clinically suspected gnathostomiasis patients were all positive according to the GB-ICT kit, while 10 WBSs from healthy volunteers were negative. The GB-ICT kit is a simple and convenient POC testing tool using finger-prick blood samples: venous blood sampling and serum separation processes are not required. The GB-ICT kit can support clinical diagnosis in remote areas and field settings without sophisticated equipment facilities. Full article
(This article belongs to the Special Issue Advanced Diagnostic Kit Development for Laboratory Diagnosis)
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11 pages, 6945 KiB  
Article
A Paper-Based Analytical Device for Analysis of Paraquat in Urine and Its Validation with Optical-Based Approaches
by Tse-Yao Wang, Yi-Tzu Lee, Hsien-Yi Chen, Cheng-Hao Ko, Chi-Tsung Hong, Jyun-Wei Wen, Tzung-Hai Yen and Chao-Min Cheng
Diagnostics 2021, 11(1), 6; https://doi.org/10.3390/diagnostics11010006 - 22 Dec 2020
Cited by 4 | Viewed by 2864
Abstract
Paraquat is a highly toxic herbicide. Paraquat poisoning is often fatal and is an important public health threat in many places. The quick identification and timely initiation of treatment based on timely analysis of the paraquat concentration in urine/serum could improve the prognosis [...] Read more.
Paraquat is a highly toxic herbicide. Paraquat poisoning is often fatal and is an important public health threat in many places. The quick identification and timely initiation of treatment based on timely analysis of the paraquat concentration in urine/serum could improve the prognosis for patients. However, current paraquat concentration measurements are time-consuming and difficult to implement due to the expensive and bulky equipment required. To address these practical challenges, paper-based devices have emerged as alternative diagnostic tools for improving point-of-care testing. In this study, we demonstrate the successful use of a paper-based analytical device for the accurate detection of urine paraquat concentration. The developed paper-based analytical device employs colorimetric paraquat concentration measurements. The R2 value for the urine paraquat standard curve was 0.9989, with a dynamic range of 0–100 ppm. The limit of detection was 3.01 ppm. Two other optical-based approaches, Spectrochip and NanoDrop, were used for comparison. The results suggest that the developed paper-based analytical device is comparable to other colorimetric measurements, as determined by Bland–Altman analysis. The device was clinically validated using urine from six paraquat-poisoned patients. The results prove that the developed paper-based analytical device is accurate, easy-to-use, and efficient for urine paraquat concentration measurement, and may enable physicians to improve clinical management. Full article
(This article belongs to the Special Issue Advanced Diagnostic Kit Development for Laboratory Diagnosis)
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Review

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12 pages, 893 KiB  
Review
Vaginal pH Value for Clinical Diagnosis and Treatment of Common Vaginitis
by Yen-Pin Lin, Wei-Chun Chen, Chao-Min Cheng and Ching-Ju Shen
Diagnostics 2021, 11(11), 1996; https://doi.org/10.3390/diagnostics11111996 - 27 Oct 2021
Cited by 28 | Viewed by 10767
Abstract
In modern society, 75% of all women worldwide have had vaginitis at least once in their lives. The vagina has a dynamic microbial ecosystem with varying vaginal pH levels. An imbalance in that ecosystem can alter the vaginal pH and tip the scale [...] Read more.
In modern society, 75% of all women worldwide have had vaginitis at least once in their lives. The vagina has a dynamic microbial ecosystem with varying vaginal pH levels. An imbalance in that ecosystem can alter the vaginal pH and tip the scale to the point of causing issues, such as vaginitis, that require medical attention. Although vaginitis is not an incurable disease, it causes discomfort and pain that disrupt women’s daily lives. The most common causes of vaginitis include bacterial vaginosis, trichomoniasis, and vulvovaginal candidiasis. In this review, we discuss the causes, diagnostic methods, and symptoms of different types of vaginitis, the relationship of vaginitis to the prevalence of other diseases, issues associated with recurrent vaginitis and the immune system, and a variety of effective available treatments. In our article, we summarize the relationship of pH with the vaginal ecosystem, discuss the associated factors of vaginal pH, and finally introduce the different available vaginal pH self-test products. Full article
(This article belongs to the Special Issue Advanced Diagnostic Kit Development for Laboratory Diagnosis)
18 pages, 1633 KiB  
Review
Point of Care Diagnostics in the Age of COVID-19
by Meysam Rezaei, Sajad Razavi Bazaz, Sareh Zhand, Nima Sayyadi, Dayong Jin, Martin P. Stewart and Majid Ebrahimi Warkiani
Diagnostics 2021, 11(1), 9; https://doi.org/10.3390/diagnostics11010009 - 23 Dec 2020
Cited by 50 | Viewed by 14088
Abstract
The recent outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its associated serious respiratory disease, coronavirus disease 2019 (COVID-19), poses a major threat to global public health. Owing to the lack of vaccine and effective treatments, many countries have been [...] Read more.
The recent outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its associated serious respiratory disease, coronavirus disease 2019 (COVID-19), poses a major threat to global public health. Owing to the lack of vaccine and effective treatments, many countries have been overwhelmed with an exponential spread of the virus and surge in the number of confirmed COVID-19 cases. Current standard diagnostic methods are inadequate for widespread testing as they suffer from prolonged turn-around times (>12 h) and mostly rely on high-biosafety-level laboratories and well-trained technicians. Point-of-care (POC) tests have the potential to vastly improve healthcare in several ways, ranging from enabling earlier detection and easier monitoring of disease to reaching remote populations. In recent years, the field of POC diagnostics has improved markedly with the advent of micro- and nanotechnologies. Due to the COVID-19 pandemic, POC technologies have been rapidly innovated to address key limitations faced in existing standard diagnostic methods. This review summarizes and compares the latest available POC immunoassay, nucleic acid-based and clustered regularly interspaced short palindromic repeats- (CRISPR)-mediated tests for SARS-CoV-2 detection that we anticipate aiding healthcare facilities to control virus infection and prevent subsequent spread. Full article
(This article belongs to the Special Issue Advanced Diagnostic Kit Development for Laboratory Diagnosis)
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