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Trends in In Vitro Diagnostics Paving the Way to Next-Generation...
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Trends in In Vitro Diagnostics Paving the Way to Next-Generation Healthcare

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: 31 August 2025 | Viewed by 12044

Special Issue Editor

Dr. Sandeep K. Vashist

E-Mail Website
Guest Editor
Fapon Biotech Inc., Reuterweg 48, 52080 Aachen, Germany
Interests: immunoassays; IVD; POC technologies; molecular diagnostics; next-generation sequencing; mobile healthcare
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The last decade has witnessed tremendous advances in the field of in vitro diagnostics (IVDs), which have led to considerably improved clinical diagnostics and better health outcomes. Point-of-care testing formats have been used in much higher numbers during the COVID-19 pandemic, which acted as a catalyst for IVDs. It increased the outreach of diagnostics to the wider general population and led to at-home testing. The use of various smart monitoring technologies for communication, regulation, and healthcare records also enabled the real-time tracking of critical data. Similarly, point-of-care molecular diagnostic tests have proven to be of significant utility and are further extending confirmatory IVD tests to be performed in remote, decentralized, and home settings. The COVID-19 pandemic has also played a predominant role in assessing the tremendous potential of molecular diagnostics as a confirmatory IVD test in healthcare. Similarly, there has been continuously growing interest in next-generation sequencing (NGS), which has proven to be of uttermost importance in analyzing the COVID-19 variants infecting specific populations. Central laboratories based on the use of fully automated high-throughput analyzer and automation systems have led to large-scale IVD testing, which has led to increased clinical diagnoses. Several companies and scientists are investing a great deal in order to bring various novel technologies to the market, such as fully automated mass spectrophotometry systems, large-scale multiplex assay formats, artificial intelligence (AI)-based diagnoses, high-sensitivity assay formats, novel disease biomarkers, and improved clinical-score-based diagnostics. The emerging trends and recent developments in IVDs are paving the way for next-generation healthcare.

The topics of interest for this Special Issue are specified below, although any manuscript related to the theme of the Special Issue will be considered.

  • In vitro diagnostics.
  • Point-of-care testing.
  • Chemiluminescent immunoassays.
  • Lateral flow immunoassays.
  • Molecular diagnostics.
  • Enzyme-linked immunoassays.
  • Next-generation sequencing.
  • Automated assays.
  • Mass spectrophotometry.
  • Multiplex assays.
  • Artificial intelligence.
  • At-home testing.
  • Novel disease biomarkers.
  • Improved clinical diagnostic algorithms.
  • Pandemic response and preparedness.
  • Smart technologies.
  • Novel assay formats.

Dr. Sandeep K. Vashist
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

  • IVDs (in vitro diagnostics)
  • POCT (point-of-care testing)
  • LFA (lateral flow assay)
  • CLIA (clinical laboratory improvement amendments)
  • multiplex assays
  • PCR
  • NGS (next-generation sequencing)
  • AI
  • at-home testing
  • biomarkers
  • smart technologies

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Published Papers (6 papers)

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Research

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8 pages, 1087 KiB  
Article
Improving Antimicrobial Stewardship in Acute Sore Throat: Comparison of FeverPAIN and McIsaac Scores with Molecular Point of Care Testing Using Abbott ID NOW
by Rob Daniels, Tarek El Omda and Kinan Mokbel
Diagnostics 2024, 14(23), 2680; https://doi.org/10.3390/diagnostics14232680 - 27 Nov 2024
Viewed by 1116
Abstract
Background: The diagnosis of streptococcal throat infection is an area where current practice results in significant over-diagnosis of bacterial infection, with the resulting implications for antimicrobial use and resistance. The use of molecular point of care testing (POCT) has previously been shown to [...] Read more.
Background: The diagnosis of streptococcal throat infection is an area where current practice results in significant over-diagnosis of bacterial infection, with the resulting implications for antimicrobial use and resistance. The use of molecular point of care testing (POCT) has previously been shown to alter antibiotic prescribing decisions when compared to Centor scoring. This paper explores the impact of the addition of POCT to clinical assessment using the McIsaac and FeverPAIN scoring systems. Methods: Retrospective analysis of the clinical records of 144 patients who had previously received point of care testing as part of a trial of POCT as an adjunct to usual care was undertaken. The McIsaac and FeverPAIN scores were calculated and then compared with the POCT result originally obtained. The records were also reviewed to identify further consultations within 10 days of being tested. Results: Sufficient clinical data were available to calculate the FeverPAIN and McIsaac scores in 81% of patients and outcome data were available for 96.5% of patients. For patients with a FeverPAIN score of 4 or 5, 50–67% of patients had a positive POCT result, while for patients with a McIsaac score of 4 or 5, 50–68% had a positive POCT result. Moreover, 16.7% of patients who tested negative, and 16.3% of patients who tested positive, had a further consultation within 10 days of being assessed. Conclusions: Although relatively few patients in this study had maximum scores on the FeverPAIN and McIsaac scoring, the addition of POCT was shown to alter antibiotic prescribing decisions in a significant number of patients, supporting the use of Abbott ID NOW point of care testing to reduce antibiotic prescribing. Larger studies are required to confirm these results and explore the health economic aspects and potential impacts on health inequalities. Full article
(This article belongs to the Special Issue Trends in In Vitro Diagnostics Paving the Way to Next-Generation Healthcare)
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11 pages, 695 KiB  
Article
Comparing Point-of-Care Technology to ELISA Testing for Infliximab and Adalimumab Levels in Adult Inflammatory Bowel Disease Patients: A Prospective Pilot Study
by Erica Bonazzi, Daria Maniero, Greta Lorenzon, Luisa Bertin, Kurtis Bray, Bayda Bahur, Brigida Barberio, Fabiana Zingone and Edoardo Vincenzo Savarino
Diagnostics 2024, 14(19), 2140; https://doi.org/10.3390/diagnostics14192140 - 26 Sep 2024
Viewed by 1194
Abstract
Introduction: Therapeutic drug monitoring (TDM) has proven to be a valuable strategy for optimizing biologic therapies, among which are anti-tumor necrosis factor (anti-TNF) treatments in inflammatory bowel disease (IBD). In particular, reactive TDM has been shown to manage treatment failures more cost-effectively than [...] Read more.
Introduction: Therapeutic drug monitoring (TDM) has proven to be a valuable strategy for optimizing biologic therapies, among which are anti-tumor necrosis factor (anti-TNF) treatments in inflammatory bowel disease (IBD). In particular, reactive TDM has been shown to manage treatment failures more cost-effectively than empirical dose adjustments for anti-TNF drugs. However, several challenges currently impede the widespread adoption of TDM in clinical practice, particularly addressing the delay between sample collection and result availability. To overcome this limitation, the use of point-of-care technology tests (POCTs) is a potential solution. Point-of-care technology tests are medical diagnostic tests performed at the site of patient care to provide immediate results, allowing for quicker decision-making and treatment. The current standard of care (SOC) for drug level measurement relies on the enzyme-linked immunosorbent assay (ELISA), a method that is time-consuming and requires specialized personnel. This study aims to evaluate a novel, user-friendly, and efficient POCT method (ProciseDx Inc.) and compare its performance with the SOC ELISA in assessing infliximab and adalimumab levels in blood samples from IBD patients. Methods: In this prospective, single-center study, we collected blood samples from IBD patients, both CD and UC, receiving infliximab (87 IBD patients; 50% UC and 50% CD) or adalimumab (60 patients; 14% UC and 48% CD) and we analyzed the blood’s drugs levels using both the ProciseDx Analyzer POC and the SOC ELISA. We examined the correlation between the two methods using statistical analyses, including the Deming regression test. Additionally, we assessed the ease of use, turnaround time, and overall practicality of the POCT in a clinical setting. Results: The ProciseDx test demonstrated a strong correlation with the SOC ELISA for measuring both infliximab and adalimumab levels. In particular, the overall correlation between the ProciseDx POCT and the ELISA assessments showed an r coefficient of 0.83 with an R squared value of 0.691 (95% CI 0.717–0.902) for IFX measurements, and an r coefficient of 0.85 with an R squared value of 0.739 (95% CI 0.720–0.930). Conclusions: the ProciseDx POC test offers significantly faster turnaround times and is more straightforward to use, making it a viable alternative for routine clinical monitoring. Despite its promising potential, further refinement and validation of the ProciseDx test are necessary to ensure its effectiveness across diverse patient populations and clinical settings. Future research should focus on optimizing the POC tests’ performance and evaluating its long-term impact on IBD management. Full article
(This article belongs to the Special Issue Trends in In Vitro Diagnostics Paving the Way to Next-Generation Healthcare)
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16 pages, 5672 KiB  
Article
Detection of Internal Hemorrhage via Sequential Inference: An In Silico Feasibility Study
by Yekanth Ram Chalumuri, Xin Jin, Ali Tivay and Jin-Oh Hahn
Diagnostics 2024, 14(17), 1970; https://doi.org/10.3390/diagnostics14171970 - 6 Sep 2024
Cited by 1 | Viewed by 743
Abstract
This paper investigates the feasibility of detecting and estimating the rate of internal hemorrhage based on continuous noninvasive hematocrit measurement. A unique challenge in hematocrit-based hemorrhage detection is that hematocrit decreases in response to hemorrhage and resuscitation with fluids, which makes hemorrhage detection [...] Read more.
This paper investigates the feasibility of detecting and estimating the rate of internal hemorrhage based on continuous noninvasive hematocrit measurement. A unique challenge in hematocrit-based hemorrhage detection is that hematocrit decreases in response to hemorrhage and resuscitation with fluids, which makes hemorrhage detection during resuscitation challenging. We developed two sequential inference algorithms for detection of internal hemorrhage based on the Luenberger observer and the extended Kalman filter. The sequential inference algorithms use fluid resuscitation dose and hematocrit measurement as inputs to generate signatures to enable detection of internal hemorrhage. In the case of the extended Kalman filter, the signature is nothing but inferred hemorrhage rate, which allows it to also estimate internal hemorrhage rate. We evaluated the proof-of-concept of these algorithms based on in silico evaluation in 100 virtual patients subject to diverse hemorrhage and resuscitation rates. The results showed that the sequential inference algorithms outperformed naïve internal hemorrhage detection based on the decrease in hematocrit when hematocrit noise level was 1% (average F1 score: Luenberger observer 0.80; extended Kalman filter 0.76; hematocrit 0.59). Relative to the Luenberger observer, the extended Kalman filter demonstrated comparable internal hemorrhage detection performance and superior accuracy in estimating the hemorrhage rate. The analysis of the dependence of the sequential inference algorithms on measurement noise and plant parametric uncertainty showed that small (≤1%) hematocrit noise level and personalization of sequential inference algorithms may enable continuous noninvasive detection of internal hemorrhage and estimation of its rate. Full article
(This article belongs to the Special Issue Trends in In Vitro Diagnostics Paving the Way to Next-Generation Healthcare)
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14 pages, 2926 KiB  
Article
Comparative Analysis of Four Different Intraoral Scanners: An In Vitro Study
by Lucian Toma Ciocan, Vlad Gabriel Vasilescu, Sabina-Ana Răuță, Mihaela Pantea, Silviu-Mirel Pițuru and Marina Imre
Diagnostics 2024, 14(13), 1453; https://doi.org/10.3390/diagnostics14131453 - 8 Jul 2024
Cited by 3 | Viewed by 5532
Abstract
(1) Background: Intraoral scanners undergo rapid advancements in hardware and software, prompting frequent updates by manufacturers. (2) Aim: This study aimed to quantitatively assess the precision of full dental arch digital impressions obtained from four different intraoral scanners: Trios 5—3SHAPE, Copenhagen, Denmark, CEREC [...] Read more.
(1) Background: Intraoral scanners undergo rapid advancements in hardware and software, prompting frequent updates by manufacturers. (2) Aim: This study aimed to quantitatively assess the precision of full dental arch digital impressions obtained from four different intraoral scanners: Trios 5—3SHAPE, Copenhagen, Denmark, CEREC Primescan— Dentsply Sirona, New York, NY, USA, Planmeca Emerald S—Planmeca Oy, Helsinki, Finland, and Medit i700—Medit Corp, Seoul, Republic of Korea. (3) Methods: A maxillary virtual dental model (digital master model) was created in accordance with ISO standard 20896-1. Subsequently, a 3D-printed model was obtained from the master model’s STL file and scanned 15 times consecutively with each scanner. STL files were aligned with the master model’s STL using Medit Link—Medit Design software v.3.1.0. The accuracy was evaluated by measuring deviations in micrometers between each scanner’s scans and the master model. (4) Results: The study revealed variations in accuracy ranging from 23 to 32 µm across scans of the same dental arch, irrespective of the scanner used and scanning strategy employed. The anterior regions exhibited higher precision (Mean Absolute Deviation of 112 µm) compared to the posterior regions (Mean Absolute Deviation of 127 µm). Trios 5 demonstrated the smallest deviation (average 112 µm), indicating superior accuracy among the scanners tested. Emerald S and Medit i700 exhibited balanced performance (average 117 µm and 114 µm, respectively), while Primescan consistently displayed high deviation (average 127 µm). (5) Conclusions: Based on clinically accepted thresholds for accuracy in intraoral scanning, which are typically 200 µm for full arch scans, Trios 5 surpasses these benchmarks with its average deviation falling within the 200 µm range. Emerald S and Medit i700 also meet these standards, while Primescan, although showing high overall deviation, approaches the upper limit of clinical acceptability. Considering the limitations of an in vitro investigation, the findings demonstrate that each intraoral scanner under evaluation is capable of reliably and consistently capturing a full arch scan for dentate patients. Full article
(This article belongs to the Special Issue Trends in In Vitro Diagnostics Paving the Way to Next-Generation Healthcare)
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Review

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50 pages, 438 KiB  
Review
The Value of Clinical Decision Support in Healthcare: A Focus on Screening and Early Detection
by Hendrik Schäfer, Nesrine Lajmi, Paolo Valente, Alessandro Pedrioli, Daniel Cigoianu, Bernhard Hoehne, Michaela Schenk, Chaohui Guo, Ruby Singhrao, Deniz Gmuer, Rezwan Ahmed, Maximilian Silchmüller and Okan Ekinci
Diagnostics 2025, 15(5), 648; https://doi.org/10.3390/diagnostics15050648 - 6 Mar 2025
Viewed by 1784
Abstract
In a rapidly changing technology landscape, “Clinical Decision Support” (CDS) has become an important tool to improve patient management. CDS systems offer medical professionals new insights to improve diagnostic accuracy, therapy planning, and personalized treatment. In addition, CDS systems provide cost-effective options to [...] Read more.
In a rapidly changing technology landscape, “Clinical Decision Support” (CDS) has become an important tool to improve patient management. CDS systems offer medical professionals new insights to improve diagnostic accuracy, therapy planning, and personalized treatment. In addition, CDS systems provide cost-effective options to augment conventional screening for secondary prevention. This review aims to (i) describe the purpose and mechanisms of CDS systems, (ii) discuss different entities of algorithms, (iii) highlight quality features, and (iv) discuss challenges and limitations of CDS in clinical practice. Furthermore, we (v) describe contemporary algorithms in oncology, acute care, cardiology, and nephrology. In particular, we consolidate research on algorithms across diseases that imply a significant disease and economic burden, such as lung cancer, colorectal cancer, hepatocellular cancer, coronary artery disease, traumatic brain injury, sepsis, and chronic kidney disease. Full article
(This article belongs to the Special Issue Trends in In Vitro Diagnostics Paving the Way to Next-Generation Healthcare)

Other

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8 pages, 391 KiB  
Brief Report
Evaluating the Compatibility of the Digit-in-Noise Test with Hearing Screening in Individuals with Intellectual Disabilities: A Pilot Study
by Noa Shmerler, Ronit Saban-Bezalel and Leah Fostick
Diagnostics 2024, 14(11), 1202; https://doi.org/10.3390/diagnostics14111202 - 6 Jun 2024
Cited by 1 | Viewed by 1047
Abstract
Hearing impairment among adults with intellectual disability (ID) is notably prevalent yet frequently underdiagnosed due, in part, to the challenges associated with traditional hearing screening methods in this population. This study explores the effectiveness of the Digit-in-Noise (DIN) test as a viable alternative [...] Read more.
Hearing impairment among adults with intellectual disability (ID) is notably prevalent yet frequently underdiagnosed due, in part, to the challenges associated with traditional hearing screening methods in this population. This study explores the effectiveness of the Digit-in-Noise (DIN) test as a viable alternative for hearing screening within natural settings and with familiar personnel. A total of 16 Hebrew-speaking adults with ID were recruited from supported employment programs, 10 of whom completed the study. The DIN test, which was administered in a daily environment using a simple digital device, evaluated the speech recognition threshold in noise. Results indicated that while some participants performed comparably to typically developing individuals, others showed varying levels of hearing thresholds, suggesting diverse auditory capabilities within the ID population. This pilot study confirms that the DIN test can be feasibly integrated into routine care settings, offering a friendly and accessible method for assessing hearing abilities in adults with ID. The findings advocate for the broader adoption of and potential modifications to the DIN Test to enhance its applicability and inclusiveness, thereby improving diagnostic accuracy and subsequent auditory care for this underserved population. Full article
(This article belongs to the Special Issue Trends in In Vitro Diagnostics Paving the Way to Next-Generation Healthcare)
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