Diagnostics

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10 pages, 1184 KiB

Open AccessArticle

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

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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

Open AccessArticle

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

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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

Open AccessCommunication

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

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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

Open AccessArticle

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

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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

Open AccessArticle

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

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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

Open AccessArticle

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 1552

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

Open AccessArticle

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

Viewed by 1014

Abstract

A prevalence boundary (PB) marks the point in prevalence in which the false omission rate, R_FO = 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, R_FO = 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% (R_FO 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 R_FO = 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

Open AccessArticle

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 1282

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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