21st Century Point-of-Care, Near-Patient and Critical Care Testing

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 October 2024 | Viewed by 15587

Special Issue Editor


E-Mail Website
Guest Editor
Pathology and Laboratory Medicine, POCT.CTR, School of Medicine, University of California, Davis, CA 95616, USA
Interests: point-of-care testing; critical limits/values; global warming; pre-hospital diagnostics; crisis response

Special Issue Information

Dear Colleagues,

Point-of-care testing is medical testing at or near the site of patient care. COVID-19 brought the worldwide acceptance of point-of-care strategies for a major infectious threat. This collection builds on that progress. We welcome papers with point-of-care themes addressing: (a) rapid pathogen detection; (b) discovery, mitigation, and management of outbreaks; (c) antimicrobial resistance; (d) home and self-testing; (e) mobile identification of community contagion; (f) rapid diagnostics for disasters, emergencies, and public health crises; (g) instrument robustness in harsh environments; (h) multiplex pathogen detection for targeted therapeutics; (i) results in interpretation in different prevalence settings; (j) smartphone-enabled tests; (k) land, sea, and air ambulance prehospital technologies; (l) cost-effectiveness for limited resource users; and generally, point-of-care inventions and innovations for the diagnosis of infectious diseases with the goals of enhanced decision making, standards of care, and public health resilience at points of critical need.

Dr. Gerald J. Kost
Guest Editor

Mr. Amanullah Zadran from the University of California will co-manage this special issue with Dr. Gerald Kost.

Manuscript Submission Information

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Keywords

  • point-of-care testing
  • infectious diseases
  • early detection
  • emergency management
  • disaster readiness
  • prehospital diagnosis
  • health promotion
  • public health resilience

Published Papers (13 papers)

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Research

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16 pages, 2915 KiB  
Article
A Comparison Study: Possible Bias in Troponin I Measurement Obtained with a Point of Care Testing and a Central Laboratory Analyzers Employing Different Biological Matrices and Anticoagulants
by Antonino Sammartano, Ruggero Buonocore, Roberto Fiorini, Elisabetta Dieci, Anna Di Franco, Bruna Di Stasi, Giovanni Tortorella and Luigi Ippolito
Diagnostics 2024, 14(14), 1482; https://doi.org/10.3390/diagnostics14141482 - 10 Jul 2024
Viewed by 112
Abstract
Background: high-sensitive cardiac TroponinI (hs-cTnI) is widely used for diagnosis of acute coronary syndromes. The latest recommendation for hs-cTnI determination is the protocol 0–1 h finalized to improve the rule out accuracy of the test. A Point of Care Testing able to guarantee [...] Read more.
Background: high-sensitive cardiac TroponinI (hs-cTnI) is widely used for diagnosis of acute coronary syndromes. The latest recommendation for hs-cTnI determination is the protocol 0–1 h finalized to improve the rule out accuracy of the test. A Point of Care Testing able to guarantee these performances could be very useful due to reducing the turnaround time and ruling out patients suspected of ACS, especially by using biological matrices that are not required for centrifuge. The aim of our work is to compare the results for hs-cTnI obtained using different biological matrices and anticoagulants, obtained between Atellica® VTLi hs-cTnI POCT and Access AccuTnI+3 DxI800 performances, in order to establish a possible bias derived directly from these pre-analytical conditions. Methods: Li-heparinized pool samples were primary employ for hs-cTnI with Atellica® VTLi as whole blood, then centrifuged and tested on Atellica® VTLi and DxI800. K3EDTA pool samples were centrifuged and measured on DxI800 too. A comparison of methods was performed according to CLSI_EP-09A2 protocol. Constant and proportional errors were investigated with Deming regression. Bias between methods was evaluated with the Bland Altman test. Results: comparing whole blood lithium heparin results obtained with Atellica versus lithium heparin and K3EDTA plasma tested on DxI 800, the Deming regression revealed a proportional error, whereas in both cases Bland Altman highlighted a minimal underestimation. A similar performance was revealed when considering plasma lithium heparin tested on Atellica versus lithium heparin and K3EDTA plasma obtained with DxI800, confirming the same underestimation. Considering values close to the cut off, no significant differences were found. Conclusions: in the laboratory, the estimation of the bias of two different analyzers is pivotal. Once more this is crucial when different biological matrices and anticoagulants are employed for the analysis. Our study demonstrates that no significant differences among the two matrices are present when comparing Atellica and DxI800 performances. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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11 pages, 1416 KiB  
Article
Establishing Quality Assurance for HIV-1 Rapid Test for Recent Infection in Thailand through the Utilization of Dried Tube Specimens
by Supaporn Suparak, Petai Unpol, Kanokwan Ngueanchanthong, Sirilada Pimpa Chisholm, Siriphailin Jomjunyoung, Wipawee Thanyacharern, Nitis Smanthong, Pojaporn Pinrod, Kriengkrai Srithanaviboonchai, Thitipong Yingyong, Theerawit Tasaneeyapan, Somboon Nookhai, Archawin Rojanawiwat and Sanny Northbrook
Diagnostics 2024, 14(12), 1220; https://doi.org/10.3390/diagnostics14121220 - 9 Jun 2024
Viewed by 487
Abstract
The present study focuses on establishing the quality assurance of laboratories for recent infections (RTRI) in Thailand. We developed a cold-chain independent method, using fully characterized plasma obtained from the Thai Red Cross Society, and prepared as dried tube specimens (DTS). Twenty microliters [...] Read more.
The present study focuses on establishing the quality assurance of laboratories for recent infections (RTRI) in Thailand. We developed a cold-chain independent method, using fully characterized plasma obtained from the Thai Red Cross Society, and prepared as dried tube specimens (DTS). Twenty microliters of HIV-seronegative, recent, and long-term infected samples were aliquoted into individual tubes and dried at room temperature, 20–30 degrees Celsius, in a biosafety cabinet overnight to ensure optimal preservation. The DTS external quality control and external quality assessment were tested for homogeneity and stability following the ISO/Guide 35 guidelines. The DTS panels were distributed to 48 sites (FY 2022) and 27 sites (FY 2023) across 14 and 9 provinces, respectively, in Thailand. The results from participating laboratories were collected and evaluated for performance. The results were scored, and acceptable performance criteria were defined as the proportion of panels correctly tested, which was set at 100%. The satisfactory performance ranged from 96% to 100% and was not significantly different among the 13 health regions. The developed and implemented DTS panels can be used to monitor the quality of RTRI testing in Thailand. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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13 pages, 2601 KiB  
Article
Diagnostic Accuracy of MMP-8 and IL-6-Based Point-of-Care Testing to Detect Peritoneal Dialysis-Related Peritonitis: A Single-Center Experience
by Rania Ibrahim, Mido Max Hijazi, Fadwa AlAli, Abdullah Hamad, Ahlam Bushra, Lutz Mirow and Timo Siepmann
Diagnostics 2024, 14(11), 1113; https://doi.org/10.3390/diagnostics14111113 - 27 May 2024
Viewed by 434
Abstract
Background: Peritoneal dialysis-related peritonitis (PDRP) is the most common complication of peritoneal dialysis (PD), which can lead to poor outcomes if not diagnosed and treated early. We aimed to investigate the diagnostic accuracy of MMP-8 and IL-6-based point-of-care tests (POCTs) in diagnosing PDRP [...] Read more.
Background: Peritoneal dialysis-related peritonitis (PDRP) is the most common complication of peritoneal dialysis (PD), which can lead to poor outcomes if not diagnosed and treated early. We aimed to investigate the diagnostic accuracy of MMP-8 and IL-6-based point-of-care tests (POCTs) in diagnosing PDRP in PD patients. Methods: This retrospective chart review study was conducted at a comprehensive kidney center in Qatar. It involved all adult PD patients who underwent PDRP from July 2018 to October 2019 and for whom MMP-8 and IL-6-based POCTs were used to diagnose presumptive peritonitis. Measures of diagnostic accuracy were computed. Peritoneal fluid effluent analysis was the reference standard. Results: We included 120 patients (68 [56.7%] females, ages 55.6 ± 15.6 years, treatment duration 39.5 ± 30.4 months [range: 5–142 months]). In this population, MMP-8 and IL-6-based POCTs yielded 100% in all dimensions of diagnostic accuracy (sensitivity, specificity, positive and negative predictive values). Conclusions: MMP-8 and IL-6-based POCTs might be helpful in the early detection of PDRP. This monocentric observation requires further confirmation in a prospective multicentric setting. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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13 pages, 910 KiB  
Article
Clinical Validation of a Machine-Learned, Point-of-Care System to IDENTIFY Functionally Significant Coronary Artery Disease
by Thomas D. Stuckey, Frederick J. Meine, Thomas R. McMinn, Jeremiah P. Depta, Brett A. Bennett, Thomas F. McGarry, William S. Carroll, David D. Suh, John A. Steuter, Michael C. Roberts, Horace R. Gillins, Farhad Fathieh, Timothy Burton, Navid Nemati, Ian P. Shadforth, Shyam Ramchandani, Charles R. Bridges and Mark G. Rabbat
Diagnostics 2024, 14(10), 987; https://doi.org/10.3390/diagnostics14100987 - 8 May 2024
Viewed by 1055
Abstract
Many clinical studies have shown wide performance variation in tests to identify coronary artery disease (CAD). Coronary computed tomography angiography (CCTA) has been identified as an effective rule-out test but is not widely available in the USA, particularly so in rural areas. Patients [...] Read more.
Many clinical studies have shown wide performance variation in tests to identify coronary artery disease (CAD). Coronary computed tomography angiography (CCTA) has been identified as an effective rule-out test but is not widely available in the USA, particularly so in rural areas. Patients in rural areas are underserved in the healthcare system as compared to urban areas, rendering it a priority population to target with highly accessible diagnostics. We previously developed a machine-learned algorithm to identify the presence of CAD (defined by functional significance) in patients with symptoms without the use of radiation or stress. The algorithm requires 215 s temporally synchronized photoplethysmographic and orthogonal voltage gradient signals acquired at rest. The purpose of the present work is to validate the performance of the algorithm in a frozen state (i.e., no retraining) in a large, blinded dataset from the IDENTIFY trial. IDENTIFY is a multicenter, selectively blinded, non-randomized, prospective, repository study to acquire signals with paired metadata from subjects with symptoms indicative of CAD within seven days prior to either left heart catheterization or CCTA. The algorithm’s sensitivity and specificity were validated using a set of unseen patient signals (n = 1816). Pre-specified endpoints were chosen to demonstrate a rule-out performance comparable to CCTA. The ROC-AUC in the validation set was 0.80 (95% CI: 0.78–0.82). This performance was maintained in both male and female subgroups. At the pre-specified cut point, the sensitivity was 0.85 (95% CI: 0.82–0.88), and the specificity was 0.58 (95% CI: 0.54–0.62), passing the pre-specified endpoints. Assuming a 4% disease prevalence, the NPV was 0.99. Algorithm performance is comparable to tertiary center testing using CCTA. Selection of a suitable cut-point results in the same sensitivity and specificity performance in females as in males. Therefore, a medical device embedding this algorithm may address an unmet need for a non-invasive, front-line point-of-care test for CAD (without any radiation or stress), thus offering significant benefits to the patient, physician, and healthcare system. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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10 pages, 1184 KiB  
Article
Commutable Blood Materials from the Fixed-Cell Method for Performance Evaluation of Blood Glucose by a Glucose Meter
by Napaporn Apiratmateekul, Jintana Nammoonnoy, Gerald J. Kost and Wanvisa Treebuphachatsakul
Diagnostics 2024, 14(8), 799; https://doi.org/10.3390/diagnostics14080799 - 11 Apr 2024
Viewed by 729
Abstract
Glucose meters provide a rapid blood glucose status for evidence-based diagnosis, monitoring, and treatment of diabetes mellitus. We aimed to evaluate the commutability of processed blood materials (PBMs) and their use in the performance evaluation of glucose meters. Two PBMs obtained by the [...] Read more.
Glucose meters provide a rapid blood glucose status for evidence-based diagnosis, monitoring, and treatment of diabetes mellitus. We aimed to evaluate the commutability of processed blood materials (PBMs) and their use in the performance evaluation of glucose meters. Two PBMs obtained by the fixed-cell method were analyzed for homogeneity, stability, and commutability. The compatibility of ten pairs between mass spectrometry and each glucose meter was categorized as compatible (mean paired difference ≤ 5%) and incompatible (mean paired difference > 5%). The performance of glucose meter 1 (n = 767) and glucose meter 2 (n = 266) was assessed. The glucose in the PBMs remained homogenized and stable for at least 180 days. Six out of ten pairs had commutable PBMs. Commutability of PBMs was observed in both well-compatible and incompatible glucose results. Target glucose values from mass spectrometry were significantly different (p ≤ 0.05) from consensus values in one group of glucose meters. When commutable PBMs were used, glucose meter 1 showed better performance than glucose meter 2, and the percentage of satisfaction was associated when using target values for glucose from mass spectrometry and consensus values, but the performance of glucose meter 2 was not associated. PBM from a fixed-cell method could be mass produced with acceptable homogeneity and stability. Commutability testing of PBMs is required prior to use in the performance evaluation of glucose meters, as the commutability of glucose in the PBMs obtained by a fixed-cell method was variable and depended on the individual glucose meter. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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18 pages, 1026 KiB  
Article
Instrumented Balance Error Scoring System in Children and Adolescents—A Cross Sectional Study
by Nils K. T. Schönberg, Julius Poppel, David Howell, Johanna Wagner, Michael Höfinger, Nicole Fabri, Elena M. Bonke, Philine Rojczyk, Matthias Hösl, Lorenz Kiwull, Sebastian A. Schröder, Astrid Blaschek, Katharina Vill, Inga K. Koerte, Doreen Huppert, Florian Heinen and Michaela V. Bonfert
Diagnostics 2024, 14(5), 513; https://doi.org/10.3390/diagnostics14050513 - 28 Feb 2024
Viewed by 957
Abstract
Background: The Balance Error Scoring System (BESS) is a commonly used method for clinically evaluating balance after traumatic brain injury. The utilization of force plates, characterized by their cost-effectiveness and portability, facilitates the integration of instrumentation into the BESS protocol. Despite the enhanced [...] Read more.
Background: The Balance Error Scoring System (BESS) is a commonly used method for clinically evaluating balance after traumatic brain injury. The utilization of force plates, characterized by their cost-effectiveness and portability, facilitates the integration of instrumentation into the BESS protocol. Despite the enhanced precision associated with instrumented measures, there remains a need to determine the clinical significance and feasibility of such measures within pediatric cohorts. Objective: To report a comprehensive set of posturographic measures obtained during instrumented BESS and to examine the concurrent validity, reliability, and feasibility of instrumented BESS in the pediatric point of care setting. Methods: Thirty-seven participants (18 female; aged 13.32 ± 3.31 years) performed BESS while standing on a force plate to simultaneously compute stabilometric measures (instrumented BESS). Ellipse area (EA), path length (PL), and sway velocity (VM) were obtained for each of the six BESS positions and compared with the respective BESS scores. Additionally, the effects of sex and age were explored. A second BESS repetition was performed to evaluate the test–retest reliability. Feedback questionnaires were handed out after testing to evaluate the feasibility of the proposed protocol. Results: The BESS total score was 20.81 ± 6.28. While there was no statistically significant age or sex dependency in the BESS results, instrumented posturography demonstrated an age dependency in EA, VM, and PL. The one-leg stance on a soft surface resulted in the highest BESS score (8.38 ± 1.76), EA (218.78 cm2 ± 168.65), PL (4386.91 mm ± 1859.00), and VM (21.93 mm/s ± 9.29). The Spearman’s coefficient displayed moderate to high correlations between the EA (rs = 0.429–0.770, p = 0.001–0.009), PL (rs = 0.451–0.809, p = 0.001–0.006), and VM (rs = 0.451–0.809, p = 0.001–0.006) when compared with the BESS scores for all testing positions, except for the one-leg stance on a soft surface. The BESS total score significantly correlated during the first and second repetition (rs = 0.734, p ≤ 0.001), as did errors during the different testing positions (rs = 0.489–0.799, p ≤ 0.001–0.002), except during the two-legged stance on a soft surface. VM and PL correlated significantly in all testing positions (rs = 0.465–0.675, p ≤ 0.001–0.004; (rs = 0.465–0.675, p ≤ 0.001–0.004), as did EA for all positions except for the two-legged stance on a soft surface (rs = 0.392–0.581, p ≤ 0.001–0.016). A total of 92% of participants stated that the instructions for the testing procedure were very well-explained, while 78% of participants enjoyed the balance testing, and 61% of participants could not decide whether the testing was easy or hard to perform. Conclusions: Instrumented posturography may complement clinical assessment in investigating postural control in children and adolescents. While the BESS score only allows for the consideration of a total score approximating postural control, instrumented posturography offers several parameters representing the responsiveness and magnitude of body sway as well as a more differentiated analysis of movement trajectory. Concise instrumented posturography protocols should be developed to augment neuropediatric assessments in cases where a deficiency in postural control is suspected, potentially stemming from disruptions in the processing of visual, proprioceptive, and/or vestibular information. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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7 pages, 732 KiB  
Communication
Assessing Different PCR Master Mixes for Ultrarapid DNA Amplification: Important Analytical Parameters
by Ivan Brukner, Miltiadis Paliouras, Mark Trifiro, Marc Bohbot, Daniel Shamir and Andrew G. Kirk
Diagnostics 2024, 14(5), 477; https://doi.org/10.3390/diagnostics14050477 - 23 Feb 2024
Viewed by 1643
Abstract
The basic principles of ultrafast plasmonic PCR have been promulgated in the scientific and technological literature for over a decade. Yet, its everyday diagnostic utility remains unvalidated in pre-clinical and clinical settings. Although the impressive speed of plasmonic PCR reaction is well-documented, implementing [...] Read more.
The basic principles of ultrafast plasmonic PCR have been promulgated in the scientific and technological literature for over a decade. Yet, its everyday diagnostic utility remains unvalidated in pre-clinical and clinical settings. Although the impressive speed of plasmonic PCR reaction is well-documented, implementing this process into a device form compatible with routine diagnostic tasks has been challenging. Here, we show that combining careful system engineering and process control with innovative and specific PCR biochemistry makes it possible to routinely achieve a sensitive and robust “10 min” PCR assay in a compact and lightweight system. The critical analytical parameters of PCR reactions are discussed in the current instrument setting. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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10 pages, 1942 KiB  
Article
Home Haemoglobin Monitoring for the Titration of Erythropoietin-Stimulating Agents in Chronic Kidney Disease: A Pragmatic Pilot Trial
by Richard Bodington, Madeline Lok and Sunil Bhandari
Diagnostics 2024, 14(2), 232; https://doi.org/10.3390/diagnostics14020232 - 22 Jan 2024
Viewed by 910
Abstract
Background. No trials of POCT device pathways have been published in the field of anaemia of CKD. We describe the results of a year of use of a novel POCT device with its associated eHealth pathway in the home monitoring of ESA therapy, [...] Read more.
Background. No trials of POCT device pathways have been published in the field of anaemia of CKD. We describe the results of a year of use of a novel POCT device with its associated eHealth pathway in the home monitoring of ESA therapy, with the aim of evaluating device performance and pathway feasibility. Methods: We used a POCT device designed for home self-testing, able to measure Hb from a drop of capillary blood (Luma, Entia, UK). Results were shared with HCPs via an associated mobile application. The pilot ran from August 2020 to March 2022 in a single UK renal centre. All adult non-dialysis-dependent-CKD patients on ESAs were eligible for inclusion. Participants were mailed the device and trained remotely. Participants were encouraged to self-test twice weekly for up to 1 year, with data collected on a pragmatic basis. Lab and Luma’s results were compared. Results: Seventeen participants returned comparable datasets (underwent ≥ 4 lab Hb measurements and self-tested for >5 months) with a mean testing frequency of 1.6 tests/wk. 1062 Luma and 113 lab Hb results were analysed. The coefficient of variation (CV) for raw results was 8.3% with a bias of −2.0% and SD 8.5. The percentage of Luma results differing by >10% lab results was 30.9%, dropping to 17.7% using an 8-point-moving-average. Participants stated they preferred Luma to traditional ESA monitoring and recommended the pathway to others. Conclusion: One year of home self-testing with Luma yielded comparable device utility to other POCT haematology analysers derived via HCP testing. Innovative pilot trials such as this form the basis for new empowering and home-based models of care required and desired by patients and HCPs. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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19 pages, 6077 KiB  
Article
Self-Diagnosis of SARS-CoV-2 from Saliva Samples at Home: Isothermal Amplification Enabled by Do-It-Yourself Portable Incubators and Laminated Poly-ethyl Sulfonate Membranes
by Sergio Bravo-González, Everardo González-González, Valeria Perales-Salinas, Iram Pablo Rodríguez-Sánchez, Jose E. Ortiz-Castillo, Adriana Vargas-Martínez, Victor H. Perez-Gonzalez, Claudia Maribel Luna-Aguirre, Grissel Trujillo-de Santiago and Mario Moisés Alvarez
Diagnostics 2024, 14(2), 221; https://doi.org/10.3390/diagnostics14020221 - 19 Jan 2024
Viewed by 1332
Abstract
COVID-19 made explicit the need for rethinking the way in which we conduct testing for epidemic emergencies. During the COVID-19 pandemic, the dependence on centralized lab facilities and resource-intensive methodologies (e.g., RT-qPCR methods) greatly limited the deployment of widespread testing efforts in many [...] Read more.
COVID-19 made explicit the need for rethinking the way in which we conduct testing for epidemic emergencies. During the COVID-19 pandemic, the dependence on centralized lab facilities and resource-intensive methodologies (e.g., RT-qPCR methods) greatly limited the deployment of widespread testing efforts in many developed and underdeveloped countries. Here, we illustrate the development of a simple and portable diagnostic kit that enables self-diagnosis of COVID-19 at home from saliva samples. We describe the development of a do-it-yourself (DIY) incubator for Eppendorf tubes that can be used to conduct SARS-CoV-2 detection with competitive sensitivity and selectivity from saliva at home. In a proof-of-concept experiment, we assembled Eppendorf-tube incubators at our home shop, prepared a single-tube mix of reagents and LAMP primers in our lab, and deployed these COVID-19 detection kits using urban delivery systems (i.e., Rappifavor or Uber) to more than 15 different locations in Monterrey, México. This straightforward strategy enabled rapid and cost-effective at-home molecular diagnostics of SARS-CoV-2 from real saliva samples with a high sensitivity (100%) and high selectivity (87%). Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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11 pages, 1490 KiB  
Article
A Comparative Evaluation of HbA1c Measurement Methods and Their Implications for Diabetes Management
by Hyeokjun Yun, Joo won Park and Jae Kyung Kim
Diagnostics 2023, 13(22), 3449; https://doi.org/10.3390/diagnostics13223449 - 15 Nov 2023
Viewed by 2320
Abstract
In this study, we assessed the correlations between hemoglobin A1c (HbA1c) measurements obtained using three different diagnostic methods, namely reversed-phase cation-exchange chromatography, high-performance liquid chromatography, and lateral flow immunoassay (LIFA) with an AnyLab F instrument. HbA1c levels measured with the AnyLab F instrument [...] Read more.
In this study, we assessed the correlations between hemoglobin A1c (HbA1c) measurements obtained using three different diagnostic methods, namely reversed-phase cation-exchange chromatography, high-performance liquid chromatography, and lateral flow immunoassay (LIFA) with an AnyLab F instrument. HbA1c levels measured with the AnyLab F instrument and those measured with the HA8190V, HA8180, and D100 instruments were strongly correlated. High R-square values and low p-values indicated significant and reliable correlations, supporting the clinical interchangeability of these methods. Notably, demographic and clinical analyses revealed uniform HbA1c levels across age groups, suggesting minimal age-related variations in HbA1c levels in the cohort. This finding has implications for diabetes management strategies across different age groups, emphasizing the versatility of the AnyLab F instrument. Overall an average HbA1c level of 7.857% among diabetes mellitus-diagnosed participants suggests moderately elevated HbA1c levels, underscoring the need for improved diabetes management. Younger individuals exhibited lower HbA1c levels, potentially owing to heightened awareness and treatment plan adherence. Conversely, older adults had higher HbA1c levels, likely influenced by age-related changes and comorbidities. Larger sample sizes and a comprehensive evaluation of various measurement principles are needed to strengthen the findings herein. Additionally, exploring additional biomarkers and assessing LIFA performance in larger sample sets will advance the clinical utility of HbA1c measurements. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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13 pages, 1893 KiB  
Article
The Impact of Repeating COVID-19 Rapid Antigen Tests on Prevalence Boundary Performance and Missed Diagnoses
by Gerald J. Kost
Diagnostics 2023, 13(20), 3223; https://doi.org/10.3390/diagnostics13203223 - 16 Oct 2023
Cited by 2 | Viewed by 1217
Abstract
A prevalence boundary (PB) marks the point in prevalence in which the false omission rate, RFO = FN/(TN + FN), exceeds the tolerance limit for missed diagnoses. The objectives were to mathematically analyze rapid antigen test (RAgT) performance, determine why PBs are [...] Read more.
A prevalence boundary (PB) marks the point in prevalence in which the false omission rate, RFO = FN/(TN + FN), exceeds the tolerance limit for missed diagnoses. The objectives were to mathematically analyze rapid antigen test (RAgT) performance, determine why PBs are breeched, and evaluate the merits of testing three times over five days, now required by the US Food and Drug Administration for asymptomatic persons. Equations were derived to compare test performance patterns, calculate PBs, and perform recursive computations. An independent July 2023 FDA–NIH–university–commercial evaluation of RAgTs provided performance data used in theoretical calculations. Tiered sensitivity/specificity comprise the following: tier (1) 90%, 95%; tier (2) 95%, 97.5%; and tier (3) 100%, ≥99%. Repeating a T2 test improves the PB from 44.6% to 95.2% (RFO 5%). In the FDA–NIH-university–commercial evaluation, RAgTs generated a sensitivity of 34.4%, which improved to 55.3% when repeated, and then improved to 68.5% with the third test. With RFO = 5%, PBs are 7.37/10.46/14.22%, respectively. PB analysis suggests that RAgTs should achieve a clinically proven sensitivity of 91.0–91.4%. When prevalence exceeds PBs, missed diagnoses can perpetuate virus transmission. Repeating low-sensitivity RAgTs delays diagnosis. In homes, high-risk settings, and hotspots, PB breaches may prolong contagion, defeat mitigation, facilitate new variants, and transform outbreaks into endemic disease. Molecular diagnostics can help avoid these potential vicious cycles. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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9 pages, 820 KiB  
Article
Performance Evaluation of a BZ COVID-19 NALF Assay for Rapid Diagnosis of SARS-CoV-2
by Woong Sik Jang, Hyunseul Jee, Joon Min Lee, Chae Seung Lim and Jeeyong Kim
Diagnostics 2023, 13(6), 1118; https://doi.org/10.3390/diagnostics13061118 - 15 Mar 2023
Viewed by 1520
Abstract
Coronavirus disease (COVID-19) caused by SARS-CoV-2 infection has been a global pandemic for more than two years, and it is important to quickly and accurately diagnose and isolate patients with SARS-CoV-2 infection. The BZ COVID-19 NALF Assay could sensitively detect SARS-CoV-2 from a [...] Read more.
Coronavirus disease (COVID-19) caused by SARS-CoV-2 infection has been a global pandemic for more than two years, and it is important to quickly and accurately diagnose and isolate patients with SARS-CoV-2 infection. The BZ COVID-19 NALF Assay could sensitively detect SARS-CoV-2 from a nasopharyngeal swab because it adopts both a loop-mediated isothermal amplification and lateral flow immunochromatography technology. In this study, a total of 389 nasopharyngeal swab samples, of which 182 were SARS-CoV-2 PCR positive and 207 were negative samples, were recruited. Compared to the Allplex™ SARS-CoV-2 Assay, the BZ COVID-19 NALF Assay showed 95.05% sensitivity and 99.03% specificity for detecting SARS-CoV-2. The concordance rate between the BZ COVID-19 NALF Assay and Allplex™ SARS-CoV-2 Assay was 97.69%. The turnaround time of the BZ COVID-19 NALF Assay is only about 40~55 min. The BZ COVID-19 NALF Assay is an accurate, easy, and quick molecular diagnostic test compared to the conventional PCR test for detection of SARS-CoV-2. In addition, the BZ COVID-19 NALF Assay is thought to be very useful in small size medical facilities or developing countries where it is difficult to operate a clinical laboratory. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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Review

Jump to: Research

25 pages, 3675 KiB  
Review
Artificial Intelligence in Point-of-Care Biosensing: Challenges and Opportunities
by Connor D. Flynn and Dingran Chang
Diagnostics 2024, 14(11), 1100; https://doi.org/10.3390/diagnostics14111100 - 25 May 2024
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Abstract
The integration of artificial intelligence (AI) into point-of-care (POC) biosensing has the potential to revolutionize diagnostic methodologies by offering rapid, accurate, and accessible health assessment directly at the patient level. This review paper explores the transformative impact of AI technologies on POC biosensing, [...] Read more.
The integration of artificial intelligence (AI) into point-of-care (POC) biosensing has the potential to revolutionize diagnostic methodologies by offering rapid, accurate, and accessible health assessment directly at the patient level. This review paper explores the transformative impact of AI technologies on POC biosensing, emphasizing recent computational advancements, ongoing challenges, and future prospects in the field. We provide an overview of core biosensing technologies and their use at the POC, highlighting ongoing issues and challenges that may be solved with AI. We follow with an overview of AI methodologies that can be applied to biosensing, including machine learning algorithms, neural networks, and data processing frameworks that facilitate real-time analytical decision-making. We explore the applications of AI at each stage of the biosensor development process, highlighting the diverse opportunities beyond simple data analysis procedures. We include a thorough analysis of outstanding challenges in the field of AI-assisted biosensing, focusing on the technical and ethical challenges regarding the widespread adoption of these technologies, such as data security, algorithmic bias, and regulatory compliance. Through this review, we aim to emphasize the role of AI in advancing POC biosensing and inform researchers, clinicians, and policymakers about the potential of these technologies in reshaping global healthcare landscapes. Full article
(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing)
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