An electrochemical point-of-care testing device for specific diagnosis of the albinism biomarker based on paradigm shift designs.

L-tyrosine is a recognized biomarker of albinism, whose endogenous level in human bodies is directly linked to melanin synthesis while no attention has been paid to its specific diagnosis. To this end, we have developed an electrochemical point-of-care testing device based on a molecularly imprinted gel prepared by a universal paradigm shift design to achieve the enhanced specific recognition of the L-tyrosine. Interestingly, this theoretically optimized molecularly imprinted gel validates the recognition pattern of L-tyrosine and optimizes the structure of the polymer itself with the aid of computational chemistry. Besides, modified extended-layer MXene and Au nanoclusters have significantly improved the sensing activity. As a result, the linear diagnostic range of this electrochemical point-of-care testing device for L-tyrosine is 0.1-100 µM in actual human fluids, which fully covers the L-tyrosine levels of healthy individuals and people with albinism. The diagnosis is completed in 90 s and then the results are transmitted by Bluetooth low energy to the smart mobile terminal. Therefore, we are convinced that this electrochemical point-of-care testing device is a promising tool in the future smart medical system.

Improvement of point of care testing device for accurate whole blood glucose measurement in early neonates.

BACKGROUND: It is important that blood glucose concentrations be accurately and conveniently measured in infants. However, especially in the early neonatal period, point-of-care testing devices used for adults may not accurately measure blood glucose concentrations in neonates. METHODS: In Study 1, the accuracy of neonatal whole-blood glucose measurements was evaluated for the existing glucose analyser Glutest Mint® (hereinafter MINT1; Sanwa Kagaku Kenkyusho, Nagoya, Japan) by comparing the data with reference blood glucose concentrations. In Study 2, we used MINT2, which was modified based on the findings from Study 1, to measure whole-blood glucose concentrations in newborns, and the accuracy of the measurements was compared with that of MINT1. RESULTS: Blood glucose concentrations were measured in 100 infants each in Study 1 and 2. In Study 1, the whole-blood glucose concentrations measured using MINT1 were found to be significantly lower than the reference blood glucose concentrations in early neonates. The results of Study 1 suggested that characteristics of erythrocyte membranes in early neonates affected the measurements. Therefore, we conducted Study 2 using MINT2, which was modified to be less susceptible. MINT2 was found to accurately measure whole-blood glucose concentrations in the early neonatal period. CONCLUSION: The study showed that the point-of-care testing device could be improved to allow for accurate whole-blood glucose measurements in the early neonatal period.

Assessment of measurement accuracy of amplified DNA using a colorimetric loop-mediated isothermal amplification assay.

A colorimetric loop-mediated isothermal amplification assay detects changes in pH during amplification based on color changes at a constant temperature. Currently, various studies have focused on developing and assessing molecular point-of-care testing instruments. In this study, we evaluated amplified DNA concentrations measured using the colorimetric LAMP assay of the 1POT™ Professional device (1drop Inc, Korea). Results of the 1POT analysis of clinical samples were compared with measurements obtained from the Qubit™ 4 and NanoDrop™ 2000 devices (both from Thermo Fisher Scientific, MA, USA). These results showed a correlation of 0.98 (95% CI: 0.96-0.99) and 0.96 (95% CI: 0.92-0.98) between 1POT and the Qubit and NanoDrop. 1POT can measure amplified DNA accurately and is suitable for on-site molecular diagnostics.

Miniaturized Raman Instruments for SERS-Based Point-of-Care Testing on Respiratory Viruses.

As surface-enhanced Raman scattering (SERS) has been used to diagnose several respiratory viruses (e.g., influenza A virus subtypes such as H1N1 and the new coronavirus SARS-CoV-2), SERS is gaining popularity as a method for diagnosing viruses at the point-of-care. Although the prior and quick diagnosis of respiratory viruses is critical in the outbreak of infectious disease, ELISA, PCR, and RT-PCR have been used to detect respiratory viruses for pandemic control that are limited for point-of-care testing. SERS provides quantitative data with high specificity and sensitivity in a real-time, label-free, and multiplex manner recognizing molecular fingerprints. Recently, the design of Raman spectroscopy system was simplified from a complicated design to a small and easily accessible form that enables point-of-care testing. We review the optical design (e.g., laser wavelength/power and detectors) of commercialized and customized handheld Raman instruments. As respiratory viruses have prominent risk on the pandemic, we review the applications of handheld Raman devices for detecting respiratory viruses. By instrumentation and commercialization advancements, the advent of the portable SERS device creates a fast, accurate, practical, and cost-effective analytical method for virus detection, and would continue to attract more attention in point-of-care testing.

Evaluation of point-of-care testing device for anemia detection: A cross-sectional method comparison study from Thailand.

BACKGROUND: A comparison study is crucial before launching a new medical device; therefore, we compared the Mission Ultra Hb Testing System with the Sysmex XN-3000 automated hematology analyzer in Thai adult males and non-pregnant adult females. METHODS: Parallel studies were conducted using discarded venous K2-ethylenediaminetetraacetic acid samples from participants requiring hematological investigations. According to the World Health Organization criteria, the participants were categorized as overall, anemia, and non-anemia for analysis. RESULTS: Three hundred participants were included in this study. In all participants, near-perfect correlation and agreement were observed between the two methods for Hb measurement (r = 0.963, p < 0.001) with an interclass correlation coefficient (ICC) of 0.981 (95% confidence interval [CI]: 0.976-0.985) and Hct measurement (r = 0.941, p < 0.001) with an ICC of 0.965 (95% CI: 0.956-0.972). The sensitivity and specificity of the device in detecting anemia were 86.2% (95% CI: 79.7-91.2) and 98.6% (95% CI: 95.2-99.8), respectively. The area under the curve was 0.976 (95% CI: 0.963-0.989). The device showed average biases of 0.76 g/dl (95% limits of agreement [LOA]: -1.03 to 2.54) for Hb measurement and -2.73% (95% LOA: -9.28 to 3.82) for Hct measurement in all participants. CONCLUSION: Agreement between the Mission Ultra Hb Testing System and Sysmex XN-3000 was observed. The device was excellent for detecting anemia. However, the essential evidence showing biases of the Hb and Hct measurements obtained from the device was revealed. Laboratory interpretation should be carefully performed, particularly at the near cut-off values.

A comparative analysis of four activated clotting time measurement devices in cardiac surgery with cardiopulmonary bypass.

BACKGROUND: In cardiac surgery on cardiopulmonary bypass (CPB), heparin anticoagulation is monitored by point-of-care measurement of activated clotting time (ACT). The objective of this study was to compare four ACT systems in cardiac surgery in terms of their reproducibility, agreement and potential clinical impact at relevant medical decision points. METHODS: The study included 40 cardiac surgery patients. Samples were taken at five time points before (T1), after heparinization for CPB (T2, T3, T4), and after heparin reversal (T5). The reproducibility, correlation, and differences in ACT values were assessed with two devices from each of the four ACT systems: Instrumentation Laboratory Hemochron Elite (Hmch), Medtronic HMS Plus (HMS), Abbott i-STAT, and Helena Abrazo. Subrange analyses were performed for low ACT values (results from T1, T5) and high ACT values (results from T2, T3, T4). RESULTS: Within-system analysis showed strong linear correlation between paired measurements (R = 0.968-0.993). However, Hmch showed poorer reproducibility with highest proportion of values that exceed a difference of 10% and highest overall standard error of 74 seconds across the measurement range compared to that of the others (range 39-47 seconds, respectively). For inter-system comparison, using Hmch as reference, ACTs were strongly correlated as follows: HMS (R = 0.938), i-STAT (R = 0.911), and Abrazo (R = 0.911). Agreement analysis in the high ACT range showed HMS tended to have higher ACT values with +11% bias over Hmch, whereas i-STAT (-8% bias) and Abrazo (-13% bias) tended to underestimate. Post-protamine ACT results were dependent on device type where Hmch yielded highest post-protamine ACT (+13% higher than baseline) compared to -16% for HMS, -10% for iSTAT and 0% for Abrazo. CONCLUSIONS: Each device had individual reproducibility and biases, which may impact peri-operative heparin management. Careful validation must be undertaken when adopting a different method as decision limits would be affected. Clinicians should also be cautious using ACT as the only indicator for full heparin reversal.

Prospective Comparison of Point-of-Care Device and Standard Analyzer for Monitoring of International Normalized Ratio in Outpatient Oral Anticoagulant Clinic.

Point-of-care testing (POCT) coagulometers are increasingly being used in the hospital setting and patients' self-testing. We determined the agreement of prothrombin time international normalized ratio (INR) results by POCT coagulometer and laboratory instrument through a comparative analysis and investigated whether the results of POCT coagulometer can reliably be used without being confirmed by standard laboratory analyzer. A total of 200 INR measurements by POCT coagulometer (CoaguChek XS Pro) and laboratory analyzer (Sysmex CS2000i) were compared using Passing-Bablok regression analysis and Bland-Altman plot. Agreement of the INR measurement was further analyzed in relation to dosing decision. The correlation of INR measurements between CoaguChek XS Pro and Sysmex CS2000i was excellent (correlation coefficient = 0.973). The overall mean difference was 0.21 INR ± 0.32 (range: 1.7-0.44). The mean difference was found to get increased as INR results increased and was 0.09 in the subtherapeutic range (≤1.9 INR), 0.29 INR in the therapeutic range (2.0-3.0 INR), while 0.4 INR in the supratherapeutic range (>3.0 INR). The overall agreement was excellent (κ = 0.916) and overall 11 (5.5%) of 200 INR measurements showed a difference in dosing decision between the 2 instruments. The positive bias of POC-INR is evident in the supratherapeutic range which could affect the dosing decision requiring confirmation with the laboratory INR measurement.