Submit to Diagnostics Review for Diagnostics Propose a Special Issue

Journal Menu

Journal Browser

Point-of-Care Testing for Infectious Disease

Print Special Issue Flyer
Special Issue Editors
Special Issue Information
Keywords
Benefits of Publishing in a Special Issue
Published Papers

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 November 2023) | Viewed by 17957

Share This Special Issue

Special Issue Editor

Dr. Lusheng Song

E-Mail Website
Guest Editor

Biodesign Center for Personalized Diagnostics, Arizona State University, Tempe, AZ, USA
Interests: personalized diagnostic; biomarker discovery; protein array; biosensor; infectious disease

Special Issue Information

Dear Colleagues,

Infectious diseases, including COVID-19, are still the leading cause of death globally. One of the most efficient strategies to prevent the spread of diseases and guide proper treatment is providing a quick, on-site diagnostic test, such as the point-of-care (POC) test. Various diagnostic methods and/or devices have been advanced in terms of their speed, portability, and readout during the SARS-CoV-2 pandemic. There is still an urgent need effective treatments for the vast majority of other infectious diseases caused by bacteria (Mycobacterium tuberculosis (Mtb), Staphylococcus aureus), viruses (Human papillomavirus, Hepatitis C, Norovirus, influenza), fungi (Coccidioidomycosis), and parasites (Malaria). Thus, innovative POC methods and devices that can be used to identify those infectious diseases is the aim of this Special Issue of Diagnostics. The aims are to (1) standardize the operation design and protocol for manufacturing a POC assay and device and its application for infectious disease including but not limited to common pathogens; (2) extend the pathogen targets including but not limited to proteins (antigen, antibodies etc.), nucleic acid, polysaccharide, and metabolism products; (3) provide a set of novel technologies that can provide improved sensitivity, accuracy, multiplexity capability, and digital readout. This Special Issue of Diagnostics focuses on “Point-of-Care Testing for Infectious Disease” and invites submissions on future possibilities, recent advances, emerging approaches, and the best up-to-date standard operation manufacture for POC devices.

Dr. Lusheng Song
Guest Editor

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.

Keywords

point-of-care device
infectious disease
standard operation protocol
portable
sensitivity
accuracy
multiplexity
digital readout

Benefits of Publishing in a Special Issue

Ease of navigation: Grouping papers by topic helps scholars navigate broad scope journals more efficiently.
Greater discoverability: Special Issues support the reach and impact of scientific research. Articles in Special Issues are more discoverable and cited more frequently.
Expansion of research network: Special Issues facilitate connections among authors, fostering scientific collaborations.
External promotion: Articles in Special Issues are often promoted through the journal's social media, increasing their visibility.
e-Book format: Special Issues with more than 10 articles can be published as dedicated e-books, ensuring wide and rapid dissemination.

Further information on MDPI's Special Issue polices can be found here.

Published Papers (9 papers)

Download All Papers

Order results

Result details

Show export options Show export options

Select all

Export citation of selected articles as:

Research

Jump to: Review

14 pages, 3036 KiB

Open AccessArticle

Flow-S: A Field-Deployable Device with Minimal Hands-On Effort to Concentrate and Quantify Schistosoma Circulating Anodic Antigen (CAA) from Large Urine Volumes

by Daniëlle de Jong, Cody Carrell, Jane K. Maganga, Loyce Mhango, Peter S. Shigella, Maddy Gill, Ryan Shogren, Brianna Mullins, Jay W. Warrick, John M. Changalucha, Govert J. van Dam, Khanh Pham, Jennifer A. Downs and Paul L. A. M. Corstjens

Diagnostics 2024, 14(8), 820; https://doi.org/10.3390/diagnostics14080820 - 16 Apr 2024

Viewed by 1239

Abstract

A laboratory-based lateral flow (LF) test that utilizes up-converting reporter particles (UCP) for ultrasensitive quantification of Schistosoma circulating anodic antigen (CAA) in urine is a well-accepted test to identify active infection. However, this UCP-LF CAA test requires sample pre-treatment steps not compatible with field applications. Flow, a new low-cost disposable, allows integration of large-volume pre-concentration of urine analytes and LF detection into a single field-deployable device. We assessed a prototype Flow-Schistosoma (Flow-S) device with an integrated UCP-LF CAA test strip, omitting all laboratory-based steps, to enable diagnosis of active Schistosoma infection in the field using urine. Flow-S is designed for large-volume (5–20 mL) urine, applying passive paper-based filtration and antibody-based CAA concentration. Samples tested for schistosome infection were collected from women of reproductive age living in a Tanzania region where S. haematobium infection is endemic. Fifteen negative and fifteen positive urine samples, selected based on CAA levels quantified in paired serum, were analyzed with the prototype Flow-S. The current Flow-S prototype, with an analytical lower detection limit of 1 pg CAA/mL, produced results correlated with the laboratory-based UCP-LF CAA test. Urine precipitates occurred in frozen banked samples and affected accurate quantification; however, this should not occur in fresh urine. Based on the findings of this study, Flow-S appears suitable to replace the urine pre-treatment required for the laboratory-based UCP-LF CAA test, thus allowing true field-based applications with fresh urine samples. The urine precipitates observed with frozen samples, though less important given the goal of testing fresh urines, warrant additional investigation to evaluate methods for mitigation. Flow-S devices permit testing of pooled urine samples with applications for population stratified testing. A field test with fresh urine samples, a further optimized Flow-S device, and larger statistical power has been scheduled. Full article

(This article belongs to the Special Issue Point-of-Care Testing for Infectious Disease)

► Show Figures

Figure 1

11 pages, 1431 KiB

Open AccessArticle

Performance Evaluation of the STANDARD i-Q COVID-19 Ag Test with Nasal and Oral Swab Specimens from Symptomatic Patients

by Jong Do Seo, Hee-Won Moon, Eunju Shin, Ji Young Kim, Sang-Gyu Choi, Ju Ae Lee, Jeong Hwa Choi and Yeo-Min Yun

Diagnostics 2024, 14(2), 231; https://doi.org/10.3390/diagnostics14020231 - 22 Jan 2024

Viewed by 1140

Abstract

We evaluated the diagnostic performance of the STANDARD i-Q COVID-19 Ag Test, which was developed to detect viral antigens, using nasal and oral swabs. Sixty positive and 100 negative samples were analyzed. We determined the distribution of the Ct values according to the day of sample collection after symptom onset, the diagnostic performance of the total samples and subgroups separated by Ct value or time of sample collection, and the Ct value at which maximal accuracy was expected. No differences were observed in Ct values, except for the samples obtained on the day of symptom onset. The diagnostic sensitivity and specificity of the oral swabs were 75.0 and 100.0%, respectively, whereas those of the nasal swabs were 85.0 and 98.0%, respectively. The sensitivity was higher in samples with a high viral load collected earlier than those collected later, although the difference was not significant. False-negative results were confirmed in all samples with a Ct value ≥ 30.0. These results indicate that tests using oral and nasal swabs are helpful for diagnosing acute symptomatic cases with suspected high viral loads. Our tests exhibited relatively low sensitivity but high specificity rates, indicating the need to assess negative antigen test results. Full article

(This article belongs to the Special Issue Point-of-Care Testing for Infectious Disease)

► Show Figures

Figure 1

13 pages, 2540 KiB

Open AccessArticle

Integrating Point-of-Care Bacterial Fluorescence Imaging-Guided Care with Continued Wound Measurement for Enhanced Wound Area Reduction Monitoring

by Rosemarie Derwin, Declan Patton, Helen Strapp and Zena Moore

Diagnostics 2024, 14(1), 2; https://doi.org/10.3390/diagnostics14010002 - 19 Dec 2023

Cited by 1 | Viewed by 1818

Abstract

Aim: This prospective observational study investigated wound area reduction (WAR) outcomes in a complex wound population composed of non-healing acute and chronic wounds. The relationship between bacterial autofluorescence signals and WAR was investigated. Area measurements were collected both manually and digitally, and both methods were compared for accuracy. Methods: Twenty-six participants with 27 wounds of varying etiologies were observed twice weekly for two weeks. Digital wound measurement, wound bacterial status assessment, and targeted debridement were performed through a point-of-care fluorescence imaging device (MolecuLight^® i: X, MolecuLight Inc, Toronto, Canada). The wound area reduction (WAR) rate was calculated using baseline and last visit measurements. Statistical analyses, including t-tests, Fisher exact tests, the Wilcoxon signed rank test for method comparison, and ANOVA for bacterial subgroups, were applied as pertinent. Results: The overall average WAR was −3.80 cm², or a decrease of 46.88% (manual measurement), and −2.62 cm², or a 46.05% decrease (digital measurement via MolecuLight^® device). There were no statistically significant differences between the WAR of acute and chronic wounds (p = 0.7877). A stepwise correlation between the WAR and bacterial status classification per fluorescence findings was observed, where persistent bacteria resulted in worse WAR outcomes. An overestimation of wound area by manual measurement was 23% on average. Conclusion: Fluorescence imaging signals were linked to WAR outcome and could be considered predictive. Wounds exhibiting bacterial loads that persisted at the end of the study period had worse WAR outcomes, while those for which management was able to effectively remove them demonstrated greater WAR. Manual measurement of the wound area consistently overestimated wound size when compared to digital measurement. However, if performed by the same operator, the overestimation was uniform enough that the WAR was calculated to be close to accurate. Notwithstanding, single wound measurements are likely to result in overestimation. Full article

(This article belongs to the Special Issue Point-of-Care Testing for Infectious Disease)

► Show Figures

Figure 1

11 pages, 3047 KiB

Open AccessArticle

Simple Point-of-Care Nucleic Acid Amplification Test for Rapid SARS-CoV-2 Infection Diagnosis

by Hyunseul Jee, Minkyeong Choi, In Su Park, Junmin Lee, Woong Sik Jang and Chae Seung Lim

Diagnostics 2023, 13(18), 3001; https://doi.org/10.3390/diagnostics13183001 - 20 Sep 2023

Cited by 2 | Viewed by 1990

Abstract

After three years of the SARS-CoV-2 pandemic, the demand for developing field-deployable point-of-care (PoC) molecular diagnostic tests has increased. Although RT-qPCR is the molecular diagnostic gold standard and is accurate, it is not readily applied to point-of-care testing (POCT). Meanwhile, rapid diagnostic kits have the disadvantage of low sensitivity. Recently, rapid isothermal nucleic acid amplification technology has emerged as an alternative for rapid diagnosis. Here, we developed a rapid SARS-CoV-2 reverse transcription loop-mediated isothermal amplification (RT-LAMP)-lateral flow assay (LFA) kit. This kit includes a Chelex-100/boiling nucleic acid extraction device and a one-step amplification detection apparatus capable of performing the entire process, from RNA extraction to detection, and diagnosing SARS-CoV-2 infection within 40 min without contamination. The detection limits of the rapid SARS-CoV-2 RT-LAMP-LFA kit were 100 plaque-forming units (PFUs) mL⁻¹ and 10⁻¹ PFU mL⁻¹ for RNA samples extracted using the Chelex-100/boiling nucleic acid extraction device and commercial AdvansureTM E3 system, respectively. The sensitivity and specificity of the rapid SARS-CoV-2 RT-LAMP-LFA kit were 97.8% and 100%, respectively. Our SARS-CoV-2 RT-LAMP-LFA kit exhibited high sensitivity and specificity within 40 min without requiring laboratory instruments, suggesting that the kit could be used as a rapid POC molecular diagnostic test for SARS-CoV-2. Full article

(This article belongs to the Special Issue Point-of-Care Testing for Infectious Disease)

► Show Figures

Figure 1

7 pages, 1521 KiB

Open AccessCommunication

Rapid Detection of SARS-CoV-2 Based on the LAMP Assay Associated with the CRISPRCas12a System

by Karoline Almeida Felix de Sousa, Carolina Kymie Vasques Nonaka, Ricardo Khouri, Clarissa Araújo Gurgel Rocha, Carlos Gustavo Regis-Silva and Bruno Solano de Freitas Souza

Diagnostics 2023, 13(13), 2233; https://doi.org/10.3390/diagnostics13132233 - 30 Jun 2023

Cited by 1 | Viewed by 1595

Abstract

Background: The global public health system has been severely tested by the COVID-19 pandemic. Mass testing was essential in controlling the transmission of the SARS-CoV-2; however, its implementation has encountered challenges, particularly in low-income countries. The urgent need for rapid and accurate tests for SARS-CoV-2 has proven to be extremely important. Point-of-care tests using the CRISPR system for COVID-19 have shown promise, with a reported high sensitivity and rapid detection. The performance of a CRISPR-based SARS-CoV-2 testing system was reported in this study. Methods: A total of 29 nasopharyngeal samples were evaluated, including 23 samples from individuals suspected of COVID-19, and six samples positive for H3N2 or respiratory syncytial virus. Two reference samples with known concentrations of SARS-CoV-2 RNA (3000 RNA copies/mL) or viral titer determined by plaque assay (105 PFU/mL) were also evaluated. The LAMP technique was employed to amplify the ORF1ab gene and the results were analyzed using a Gemini XPS fluorescence reader. Results: The RT-LAMP-CRISPR/Cas12 assay showed 100% concordance compared to RT-PCR. The RT-PCR presented a detection limit of 0.01 PFU/mL and the CRISPR/Cas12 system showed a limit of 15.6 PFU/mL. The RT-PCR sensitivity was approximately 8 RNA copies/µL and CRISPR/Cas12 at 84 RNA copies/µL. Conclusion: The RT-LAMP-CRISPR/Cas12a assay offered a promising alternative for the detection of SARS-CoV-2 and reinforces that CRISPR-based diagnostic techniques can be an alternative for fast and accurate assays. Full article

(This article belongs to the Special Issue Point-of-Care Testing for Infectious Disease)

► Show Figures

Figure 1

12 pages, 442 KiB

Open AccessArticle

Positive Point-of-Care Influenza Test Significantly Decreases the Probability of Antibiotic Treatment during Respiratory Tract Infections in Primary Care

by Aneta Rzepka and Anna Mania

Diagnostics 2023, 13(12), 2031; https://doi.org/10.3390/diagnostics13122031 - 12 Jun 2023

Viewed by 1226

Abstract

This study aimed to analyse clinical and laboratory findings in primary care patients with respiratory tract infections to distinguish the group more likely to receive antibiotic treatment. The study group consisted of 631 patients (264 males; 367 females) with a median age of 48 years (IQR 36–63 years). Analysed groups included patients treated with antibiotics (n = 269 patients; 43%) and those who recovered without antibiotic treatment (n = 362 patients; 57%). Patients receiving antibiotics were older (median 51 vs. 47 years; p = 0.008) and more commonly developed fever (77% vs. 25%, p < 0.0001) and cough (63% vs. 30%; p = 0.0014). Moreover, they more frequently presented wheezing and crackles upon physical examination (28% vs. 4% and 9% vs. 0.3%; p < 0.0001 and p < 0.0001, respectively). They also had more comorbidities and came to more follow-up visits (median of 4 vs. 3 and 2 vs. 1, p < 0.0001 and p < 0.0001, respectively). Patients receiving symptomatic therapy more often had positive point-of-care tests (POCTS)—20% vs. 7%; p = <0.0001. Multivariate analysis in our cohort found comorbidities complexity (odds ratio—OR 2.62; 95% confidence interval—1.54–4.46), fever (OR 32.59; 95%CI 19.15–55.47), crackles (OR 26.35; 95%CI 2.77–250.81) and the number of visits (OR 4.15; 95%CI 2.39–7.20) as factors increasing the probability of antibiotic treatment. Positive influenza POCTS reduced the risk of antibiotic therapy (OR 0.0015; 95%CI 0.0001–0.0168). Full article

(This article belongs to the Special Issue Point-of-Care Testing for Infectious Disease)

► Show Figures

Figure 1

15 pages, 2195 KiB

Open AccessArticle

Clinical Validation of a Colorimetric Loop-Mediated Isothermal Amplification Using a Portable Device for the Rapid Detection of SARS-CoV-2

by Bruna W. Raddatz, Felipe J. Rabello, Rafael Benedetti, Gisleine J. Steil, Louise M. Imamura, Edson Y. S. Kim, Erika B. Santiago, Luís F. Hartmann, João V. Predebon, Bruna M. Delfino, Meri B. Nogueira, Jucélia S. dos Santos, Breno G. da Silva, Diego R. P. Nicollete, Bernardo M. M. de Almeida, Sergio R. Rogal, Jr. and Marcus V. M. Figueredo

Diagnostics 2023, 13(7), 1355; https://doi.org/10.3390/diagnostics13071355 - 6 Apr 2023

Cited by 4 | Viewed by 2772

Abstract

Quick and reliable mass testing of infected people is an effective tool for the contingency of SARS-CoV-2. During the COVID-19 pandemic, Point-of-Care (POC) tests using Loop-Mediated Isothermal Amplification (LAMP) arose as a useful diagnostic tool. LAMP tests are a robust and fast alternative to Polymerase Chain Reaction (PCR), and their isothermal property allows easy incorporation into POC platforms. The main drawback of using colorimetric LAMP is the reported short-term stability of the pre-mixed reagents, as well as the relatively high rate of false-positive results. Also, low-magnitude amplification can produce a subtle color change, making it difficult to discern a positive reaction. This paper presents Hilab Molecular, a portable device that uses the Internet of Things and Artificial Intelligence to pre-analyze colorimetric data. In addition, we established manufacturing procedures to increase the stability of colorimetric RT-LAMP tests. We show that ready-to-use reactions can be stored for up to 120 days at −20 °C. Furthermore, we validated both the Hilab Molecular device and the Hilab RT-LAMP test for SARS-CoV-2 using 581 patient samples without any purification steps. We achieved a sensitivity of 92.93% and specificity of 99.42% (samples with CT ≤ 30) when compared to RT-qPCR. Full article

(This article belongs to the Special Issue Point-of-Care Testing for Infectious Disease)

► Show Figures

Figure 1

11 pages, 1043 KiB

Open AccessArticle

Performance Evaluation of RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test for the Rapid Detection of SARS-CoV-2 Antibodies

by Ha Nui Kim, Jung Yoon, Woong Sik Jang and Chae Seung Lim

Diagnostics 2023, 13(4), 643; https://doi.org/10.3390/diagnostics13040643 - 9 Feb 2023

Cited by 3 | Viewed by 1732

Abstract

The accurate detection of anti-neutralizing SARS-CoV-2 antibodies can aid in the understanding of the development of protective immunity against COVID-19. This study evaluated the diagnostic performance of the RapiSure (EDGC) COVID-19 S1 RBD IgG/Neutralizing Ab Test. Using the 90% plaque reduction neutralization test (PRNT₉₀) as a reference, 200 serum samples collected from 78 COVID-19-positive and 122 COVID-19-negative patients were divided into 76 PRNT₉₀-positive and 124 PRNT₉₀-negative groups. The ability of the RapiSure test to detect antibodies was compared to that of the STANDARD Q COVID-19 IgM/IgG Plus test and that of PRNT₉₀. The positive, negative, and overall percent agreement between the RapiSure and STANDARD Q test was 95.7%, 89.3%, and 91.5%, respectively, with a Cohen’s kappa of 0.82. The RapiSure neutralizing antibody test results revealed a sensitivity of 93.4% and a specificity of 100% compared to the PRNT results, with an overall percent agreement of 97.5% and Cohen’s kappa of 0.95. The diagnostic performance of the RapiSure test was in good agreement with the STANDARD Q COVID-19 IgM/IgG Plus test and comparable to that of the PRNT. The RapiSure S1 RBD IgG/Neutralizing Ab Test was found to be convenient and reliable and, thus, can provide valuable information for rapid clinical decisions during the COVID-19 pandemic. Full article

(This article belongs to the Special Issue Point-of-Care Testing for Infectious Disease)

► Show Figures

Figure 1

Review

Jump to: Research

15 pages, 318 KiB

Open AccessReview

Point-of-Care Testing for Infectious Diseases Based on Class 2 CRISPR/Cas Technology

by Shiu-Jau Chen, Chung-I Rai, Shao-Cheng Wang and Yuan-Chuan Chen

Diagnostics 2023, 13(13), 2255; https://doi.org/10.3390/diagnostics13132255 - 3 Jul 2023

Cited by 7 | Viewed by 3315

Abstract

The early detection of infectious diseases and microorganisms is critical for effective disease treatment, control, and prevention. Currently, nucleic acid testing and antigen–antibody serum reaction are the two methods most commonly used for the detection of infectious diseases. The former is highly accurate, specific, and sensitive, but it is time-consuming, expensive, and has special technician and instrument requirements. The latter is rapid and economical, but it may not be accurate and sensitive enough. Therefore, it is necessary to develop a quick and on-site diagnostic test for point-of-care testing (POCT) to enable the clinical detection of infectious diseases that is accurate, sensitive, convenient, cheap, and portable. Here, CRISPR/Cas-based detection methods are detailed and discussed in depth. The powerful capacity of these methods will facilitate the development of diagnostic tools for POCT, though they still have some limitations. This review explores and highlights POCT based on the class 2 CRISPR/Cas assay, such as Cas12 and Cas13 proteins, for the detection of infectious diseases. We also provide an outlook on perspectives, multi-application scenarios, clinical applications, and limitations for POCT based on class 2 CRISPR/Cas technology. Full article

(This article belongs to the Special Issue Point-of-Care Testing for Infectious Disease)

Show export options Show export options

Select all

Export citation of selected articles as:

Displaying articles 1-9

Journal Menu

Journal Browser

Point-of-Care Testing for Infectious Disease

Share This Special Issue

Special Issue Editor

Special Issue Information

Keywords

Benefits of Publishing in a Special Issue

Published Papers (9 papers)

Research

Review

Further Information

Guidelines

MDPI Initiatives

Follow MDPI