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Performance of two disposable devices for identifying subjects with low anti-SARS-CoV-2 protection was compared with that of automated enzyme-linked immunosorbent (ELISA) and chemiluminescent (CLIA) assay.In July 2021, 123 healthcare workers (HCW), twice vaccinated by BNT162b2/Comirnaty mRNA (BioNTech-Pfizer), underwent Ab iRapid COVID-19 Quant "Neutralizing" Self-test (iRapid Self-test) and "Neutralizing" Professional-use (iRapid pro) (DIESSE, Diagnostica Senese, Siena, Italy). Simultaneously, serum Ab were determined by Maglumi 2000 plus (anti S-RBD CLIA assay, Snibe Diagnostics, Shenzhen, China) and SARS-CoV-2 "Neutralizing" Ab Chorus ELISA (DIESSE, Siena, Italy). Results were evaluated against two "protective-thresholds", 90 kBAU/L and 506 kBAU/L.HCW mean age, 46.2 (±12.6) years; 26 (20.5%), males, 101 (79.5%), females. The mean time interval (and standard deviation) between the first vaccine dose and Ab determination was 129.5 (±36.4) days and was neither gender (p = 0.879) nor age (p = 0.341) related. With Maglumi, 114 (89.7%) and 43 (33.8%) HCW presented Ab ≥ 90 kBAU/L and Ab ≥ 506 kBAU/L, respectively; with Chorus, 96 (75.6%) presented Ab values ≥506 kBAU/L. CLIA and ELISA agreement was 56.7%. At 90 kBAU/L, iRapid self-test and Pro sensitivities were 98.2% (95% CI: 92.7-99.8), specificity 69.2% (95% CI: 38.6-90.9%) and 76.9% (46.2-95%), respectively. At 506 kBAU/L, iRapid sensitivities were 58.1-91.6%, and specificities, 89-96.6%. On evaluating Ab at4 and ≥4 months, protective titers had decreased.iRapid semi-quantitative devices had very good overall agreements of 95.1% and 95.9% for detecting individuals with low anti-SARS-CoV-2 protection.

Background: Haemoglobin levels guide many diagnostic and therapeutic interventions. They form part of the basic daily management of ICU patients. Laboratory results are frequently delayed. This can have important clinical consequences, including withholding potentially life-saving interventions. Point-of-care devices, if accurate, provide a solution to this problem. Inaccurate devices may provide misleading results leading to unnecessary and hazardous blood transfusions or under-estimation of disease severity. The aim was to compare the accuracy and reliability of the DiaSpect Hemoglobin T (DiaSpect. Medical GmbH, Sailauf, Germany) haemoglobinometer with the HemoCue (HemoCue AB, Angelholm Sweden) haemoglobinometer and the gold standard laboratory analyser for this trial (XT-200i Sysmex/Coulter LH750). Methods: Venous blood samples were collected via a central venous line from Intensive Care Unit (ICU) patients (n = 265) for determination of haemoglobin (Hb) concentration by DiaSpect as well as the HemoCue, and the automated haemoglobin analysers: XT-200i Sysmex or the Coulter LH750. Agreement between the methods was tested using Bland–Altman plots. A Hb variation of 0.5 g/dl was considered clinically significant. There were a significant number of wasted samples with the DiaSpect, as a total of 350 cuvettes were used but only 214 complete samples obtained. This wastage was attributed to errors in sampling, cuvette shortage, lack of experience with the device and lack of ‘user-friendliness’. Results: A total of 265 samples were obtained, of which 207 had complete data sets and were analysed further in the study. There were 58 incomplete samples, of which 51 were DiaSpect samples. Mean haemoglobin was 9.11 (standard deviation ± 1.74), 9.07 (standard deviation ± 1.96) and 9.02 (standard deviation ± 2.06) using the laboratory analyser, HemoCue and DiaSpect respectively. Laboratory and HemoCue: the mean difference between the two readings was -0.04 (95% limits of agreement -2.15 to 2.07 g/dl) with an average between 5.00 g/dl and 15.10 g/dl. Laboratory and DiaSpect: the mean difference between the readings was -0.09 (95% limits of agreement -2.64 to 2.46 g/dl) with an average between 5.10 g/dl and 14.9 g/dl. HemoCue and DiaSpect: the mean difference between the two haemoglobin levels was 0.04 (95% limits of agreement 2.73 to -2.64 g/dl). Both methods returned measurements within the pre-defined clinical acceptable limits of ± 0.5 g/dl. Conclusion: The haemoglobin concentration assessment by the HemoCue and DiaSpect showed an acceptable limit of agreement when compared against the laboratory analyser. There were a significant number of wasted samples when using the DiaSpect.

Potassium is the most important intracellular fluid cation that plays a crucial role in the maintenance of cell function. The leading cause of cardiovascular disease is hypertension which has a major effect on mortality rate worldwide. Potassium deficiency and excess can result in various symptoms like an irregular heart rhythm or multiple electrocardiographic abnormalities. So, to determine the potassium levels in saliva, a colorimetric kit is developed which works under the principle of colorimetric optical absorption and follows Beer Lamberts law. The device consists of Red-Green-Blue Light Emitting Diode which gives wide options to select the wavelength from 380 nm to 780 nm. A potassium reagent is developed which is added to the saliva samples and measured at 450 nm as it is most preferrable. The kit is tested with artificial saliva samples in different concentrations of potassium in different samples to check the accuracy of the kit. A mobile application can be developed to have results obtained in the kit to the smartphone through bluetooth connection and it can be used as a point of care device for quick and reliable results.

BACKGROUND Management of coagulopathy during major oncologic surgery can be multifactorial and challenging. Viscoelastic assays (VEAs) can be useful in providing vital data about the mechanism of coagulopathy in these dynamic circumstances. OBJECTIVES A prospective nonrandomized observational study with the aim of describing the coagulation parameters of patients undergoing major oncologic surgery using the Quantra® and TEG® 5000 systems. Our secondary objectives included the correlation between Quantra and TEG parameters, and the times to result for both technologies. METHODS This study included 74 adults undergoing oncologic surgery with an anticipated blood loss of more than 500 ml. For each subject, whole blood samples for each device were collected at multiple points perioperatively for comparison. RESULTS Correlation coefficients between Quantra and TEG parameters were 0.8 and above, indicating a very strong correlation (p

HemoCue® point-of care devices are widely used in Bordeaux university hospital center to assess hemoglobin in critical situations, with 45 devices in 13 health units. Based on our experience, we here propose essential steps in order to prepare the accreditation file. We develop risks analysis, mandatory validation method check points, and caregiver professional training. Among the tasks, precise reference quality instructions i.e. instruction for use, maintenance and troubleshooting should be available. We also share reflections to offer solutions to encountered difficulties. The implemented quality management must rely on a solid and involved laboratory organization. A strong caregiver membership also appears to be the key to move forward.

In this paper, we explore the applications and practices that Stereolithography enables for an enhanced manufacturing process of a nitrate assay chamber for an underwater Point of Care device. Features such as engraved identifiers, creating post for inlet/outlet connections, embedding electromechanical components and optimizing the spatial distribution, were tested as a case of study for an underwater vehicle component. This study is a first approach in proposing a framework for manufacturing practices toward a new generation of customized devices for the application. The case study is validated using Computational Fluid Dynamics for the design and manufacture of an array of micromixing enhanced nitrite assay sensors that employ and exploits the enabling technology of stereolithography.

Measuring alterations in redox homoeostasis in athletes can provide insights into their responses to training such as adaptations or fatigued states. However, redox monitoring is impractical in athletes given the time burden of venepuncture and subsequent laboratory assays. The ability of point-of-care tests (POC): 1) Free Oxygen Radical Test (FORT) and 2) Free Oxygen Radical Defence (FORD), to reliably measure whole blood oxidative stress between days and after exercise is unknown as well as their relationship with laboratory measures (F2-isoprostanes, total antioxidant capacity; TAC). Participants completed two trials performed on separate days comprising blood sampling at rest (n=22) and after treadmill-running (n=14). Between-day CVs for FORT (4.6%) and FORD (4.8%) were acceptable at rest. There was no difference in the between-day magnitude of change in any biomarker from pre- to post-exercise (p0.05), yet the within-trial change in FORD was variable (trial one: +4.5%, p=0.15; trial two: +6.3%, p0.05). TAC and FORD were significantly correlated pre- and post-exercise (r=~0.53, p0.05), whereas F2-isoprostanes and FORT had a significant correlation pre-exercise only (r=0.45, p=0.03). Overall, the POC tests are reliable and could be used for baseline longitudinal redox monitoring. More data is required on POC tests for assessing redox perturbations induced by exercise.

The purpose of this study was to determine whether a point-of-care osmotic device concentrates important human milk (HM) nutrients to support feeding neonates requiring high-nutrient, low-volume feedings. Raw and pasteurized HM samples were concentrated to determine the effects of time and temperature on concentration. Concentrated samples were compared with matched baseline samples to measure changes in selected nutrient concentrations. Furthermore, changes in concentration of certain bioactive components of raw milk samples were measured. The device significantly increased the concentrations of the majority of the measured nutrient and bioactive levels (p 30%. In all cases, the concentration rate of pasteurized HM was greater than that of raw HM. The osmotic concentration of HM is a promising option for neonatal nutrition. Further studies are needed to establish an evidence base for the practical applications of this point-of-care device.

Background Data on the performance of a glucometer in calves with different diseases are currently lacking. Objective The primary objective of this study was to evaluate the reliability of a point of care glucometer in calves affected by different diseases relative to a traditional bench-top autoanalyzer. Animals One hundred ninety-six calves with different disorders in a referral hospital. Methods Prospective study. Venous blood samples were used for the determination of glucose concentrations in blood and plasma using the Freestyle Optium Neo H and autoanalyzer, respectively. Data were subjected to Passing-Bablok regression and Bland-Altman plots. The Freestyle Optium Neo H was the test method and the autoanalyzer was the reference method. The diagnostic performance of the glucometer relative to the autoanalyzer was assessed using 3 different plasma glucose concentrations. Results The Passing-Bablok regression for the glucometer against the reference method revealed the presence of both proportional bias (1.12; 95% confidence interval [CI], 1.07-1.18) and constant bias (-11.25; 95% CI, -16.0 to -7.70). The glucometer yielded 92.2%-100% sensitivity and 86.4%-96% specificity for the assessing glucose concentration based on different concentration thresholds. Conclusions and clinical importance The Freestyle Optium Neo H showed proportional and constant biases relative to the reference method. The glucometer showed poor performance according to criteria recommended by the International Standards Organization and the American Society for Veterinary Clinical Pathology. However, the glucometer determined hypoglycemia with high sensitivity and specificity therefore it might be used to diagnose hypoglycemia in calves with different diseases until calf-specific POC glucometers are developed.

Diabetic foot ulcers, with worldwide prevalence ranging from 12%-25%, are an important cause of nontraumatic lower limb amputation. Evidence-based assessment of early infection can help the clinician provide the right first line treatment thus helping improve the wound closure rate. Illuminate®, a novel point of care device working on multispectral autofluorescence imaging, helps in the rapid identification and classification of bacteria. This study was aimed to evaluate the diagnostic accuracy of the device in detecting bacterial gram type against standard culture methods. A total of 178 patients from a tertiary care center for diabetes was recruited and 203 tissue samples were obtained from the wound base by the plastic surgeon. The device was handled by the trained investigator to take wound images. The tissue samples were taken from the color-coded infected region as indicated by the device's Artificial Intelligence algorithm and sent for microbial assessment. The results were compared against the Gram type inferred by the device and the device was found to have an accuracy of 89.54%, a positive predictive value of 86.27% for detecting Gram-positive bacteria, 80.77% for Gram-negative bacteria, and 91.67% for no infection. The negative predictive value corresponded to 87.25% for Gram-positive, 92% for Gram-negative, and 96.12% for no infection. The Results exhibited the accuracy of this novel autofluorescence device in identifying and classifying the gram type of bacteria and its potential in significantly aiding clinicians towards early infection assessment and treatment.

Sickle cell disease is a major public health problem in India. Lack of rapid and reliable diagnostic methods result in many avoidable deaths in affected population. Current diagnostic tools are laboratory based, expensive and need trained manpower. Here, we evaluated the performance of a microchip-based cellulose acetate electrophoresis test, “Gazelle” in the tribal-dominated Indian states of Chhattisgarh and Madhya Pradesh. A total of 1,050 patients were screened by sickle cell solubility, hemoglobin (cellulose acetate) electrophoresis, high-performance liquid chromatography (HPLC) and Gazelle. Of the total 1,027 test results obtained, 960 tests were “Valid” (93.5%) and included in the analysis. Gazelle identified all patients with disease (HbSS and Thalassemia Major) with 100% accuracy. Gazelle demonstrated 100% sensitivity when comparing sickle cell disease (SCD) vs. sickle cell trait and SCD vs. normal. Specificity was 98.9% and 99.5% when comparing SCD vs. trait and trait vs. normal, respectively. Specificity was 99.8% when comparing SCD vs. normal and sensitivity was 99.3% when comparing trait vs. normal. Overall, Gazelle yielded a high accuracy (99.0%) compared to reference standard tests (hemoglobin electrophoresis and HPLC). Gazelle is a low-cost, rapid diagnostic test with high accuracy for detecting SCD both quantitatively and qualitatively. Gazelle can be a potential screening tool for the rapid diagnosis in resource limited settings and developing countries with high burden of hemoglobin disorders.

World Health Organization (WHO) declares the COVID-19 outbreak as a pandemic. The newly emerging infection has caused around one million deaths worldwide and still counting. There is no specific treatment for the disease, and it can only contain by breaking the spread. So that early and rapid diagnosis of the infection is the only way to control the outbreak. The COVID-19 virus affects the human respiratory system and subsequently infects other vital organs. In consideration of the diagnosis, the present review focuses on the critical diagnostic approaches for COVID-19, including RT-PCR, Chest-CT scan, some biosensor-based systems, etc. Moreover, this review is a specific bird's eye view on recent developments on the point of care devices and related technologies. Additionally, it presented a small glimpse of the pathophysiology and structural aspects of COVID-19. Therefore, the current review can motivate and help the reader to develop cutting-edge diagnostic technologies for the early and rapid detection of the COVID-19., Graphical abstract Image 1

In this paper we present the design of a new point-of-care device for protein quantification. The proposed design is based on a novel aptamer-mediated methodology and real time polymerase chain reaction (RT-PCR), a robust and ultrasensitive method for DNA amplification, which we employ for very sensitive quantification of proteins. In addition, we have also developed an algorithm for the processing of raw fluorescence data from the portable RT-PCR device. The algorithm leads to better linearity than a proprietary software from a commercially available RT-PCR machine. The modular nature of the system allows for easy assembly and adjustment towards a variety of biomarkers for applications in disease diagnosis and personalised medicine.

High-sensitivity troponin has become an essential emergency biomarker for diagnosing or ruling out an ACS. The establishment of a point of care biology related to the reorganization and fusion of laboratories raise a question about transferability of results between techniques. In this study, we propose to compare the bioclinical performances of high-sensitivity troponin measured by two different techniques on laboratory immunoanalyzer (Siemens Advia Centaur XPT) and on point of care device (Mitsubishi Pathfast). The assay of high-sensitivity troponin (n = 90 patients), according to our study, show consistent clinical results with both method.

Sulfane sulfur species are newly recognized signaling molecules that play physiological roles in many biological events. The development of new technologies for the detection of sulfane sulfurs is important. Point-of-care (POC) devices are in-field rapid and low-cost detectors that are more convenient to use than bulky and expensive standard instruments. In this report, a new fluorescent probe (SSP5) was designed to detect sulfane sulfurs using a POC sulfane sulfur smartphone spectrum apparatus (S4A). This probe proved to be sensitive and selective for sulfane sulfur species over other biologically relevant sulfur species such as cysteine and H(2)S. The low-cost and compact S4A has achieved comparable performance to standard laboratory equipment in both a standard buffer system and a synthetic urine system. The proposed system (SSP5 + S4A) has the potential for high accuracy and rapid detection of sulfane sulfur species in remote and low resource settings.

A white blood cell (WBC) count with partial differential is an important clinical laboratory test. However, current methods to perform a WBC count and differential are difficult to use at the point of care or too expensive for use in low-resource settings. To meet this need, we developed the LeukoScope: a low-cost system to measure a WBC and neutrophil count from a single drop of blood at the point of care. The LeukoScope is battery powered and has a sample-to-answer time of

Inadequate blood supply to the intestine can lead to acute mesenteric ischemia (AMI), with a mortality rate ranging from 60% to 90%. This high mortality rate is partially due to late detection and the lack of efficient early diagnostic tests. There is an urgent need for a point-of-care tool for immediate bedside diagnosis. Here we present for the first time a rapid and non-invasive electrochemical biosensor device based on non-faradic impedance spectroscopy to detect intestinal fatty-acid binding protein (I-FABP) as an indication of AMI. The electrochemical biosensors consist of gold interdigitated electrodes that were fabricated using photolithographic techniques on top of silicon dioxide substrates. The electrode surfaces were functionalized with an I-FABP capture antibody (CAnB) to entice the target protein, while gold nanoparticles (GNPs) functionalized with detection antibodies (DAnB-GNPs) were utilized as a novel mechanism to enhance the detection signal. Quantification of the I-FABP concentration in the medium depended on its attachment to CAnB and DAnB-GNPs in a sandwich manner, where the latter boosts the impedance signal through its binding to the I-FABP. This non-invasive non-faradic electric biosensor device demonstrates the potential for bench-to-bedside translation with the goal of decreasing morbidity and mortality from AMI.

Blood glucose measurements provide important diagnostic information regarding stress, disease, and nutritional status. Glucose analytical methodologies include dry chemistry analysis (DCA) of plasma and point-of-care (POC) glucometer analysis of whole blood; however, these 2 methods differ in cost, required sample volume, and processing time. Because POC glucometers use built-in equations based on features of mammalian blood to convert whole blood measurements to plasma equivalent units, obtained glucose data must be compared and validated using gold-standard chemistry analytical methodology in reptiles. For in-water, trawl-captured, immature Kemp’s ridley sea turtles ( Lepidochelys kempii) from Georgia, USA, we observed significant, positive agreement between the 2 glucose determination methods; however, the glucometer overestimated glucose concentrations by 1.4 mmol/L on average in comparison to DCA and produced a wider range of results. The discordance of these results suggests that POC glucometer glucose data should be interpreted in the context of methodology- and brand-specific reference intervals along with concurrent packed cell volume data.

BackgroundPoint of Care Testing (POCT) is being increasingly used to augment the delivery of physical health care in a variety of settings, but their use in mental health has been limited. Research into understanding the barriers faced for successful implementation of POCT in these settings is lacking. We aimed to identify factors affecting engagement and implementation of POCT within mental health teams by exploring the attitudes to POCT, and the perceived impact POCT has on the practice of mental healthcare clinicians.MethodsAlongside a study evaluating the impact of a point of care device in Community Mental Health Teams (CMHTs), qualitative interviews were carried out with CMHT clinicians using POCT as part of annual physical checks for patients with severe and enduring mental illness. Data were collected using semi-structured interviews and analysed using thematic analysis.ResultsFifteen clinicians were interviewed across a range of professional backgrounds. Clinicians identified usability of the technology, positive impact on their patient’s experience and improved self-efficacy as drivers for successful implementation of POCT into their clinical practice. Issues with device functioning and the potential for a negative effect on the therapeutic relationship with their patients were identified as barriers. Level of physical heath training was not found to be a barrier by mental health professionals to using POCT.ConclusionsUnderstanding barriers and drivers for engagement is important to allow co-production of POCT and guidelines to facilitate introduction of POCT into routine clinical practice.

Timely fibrinogen replacement is key to treating critical hemorrhage. Measuring fibrinogen concentration by conventional laboratory tests requires centrifugation of blood samples and is often time-consuming. A point-of-care testing device (AT, Yokohama, Japan), CG02N, has been available in Japan since 2011 to measure fibrinogen concentration without centrifugation. However, it has not been widely used as it requires dilution of blood samples using manual micropipetting. To further speed up and simplify the fibrinogen measurement, an improved device called FibCare (Atom Medical, Tokyo, Japan) was developed to avoid diluting blood samples. The purpose of this study is to verify the reliability of FibCare against laboratory measurement using the Clauss method. Fibrinogen concentrations with 60 sodium citrated whole blood samples were measured by both FibCare and Clauss methods in the laboratory. Measured values with the Clauss method were distributed in the 88-300 mg/dL range. By comparing these results, a significant positive correlation was observed between the FibCare and Clauss method (Y = 12.402 + 0.982 X; R = 0.891; P 0.01). The study indicated that FibCare allows accurate measurement of fibrinogen concentration and shows a possibility to contribute to optimal fibrinogen replacement therapy during critical hemorrhage.

BackgroundRapid antigen-detecting tests (Ag-RDTs) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can transform pandemic control. Thus far, sensitivity (≤85%) of lateral-flow assays has limited scale-up. Conceivably, microfluidic immunofluorescence Ag-RDTs could increase sensitivity for SARS-CoV-2 detection.Materials and MethodsThis multi-centre diagnostic accuracy study investigated performance of the microfluidic immunofluorescence LumiraDx™ assay, enrolling symptomatic and asymptomatic participants with suspected SARS-CoV-2 infection. Participants collected a supervised nasal mid-turbinate (NMT) self-swab for Ag-RDT testing, in addition to a professionally-collected nasopharyngeal (NP) swab for routine testing with reverse transcriptase polymerase chain reaction (RT-PCR). Results were compared to calculate sensitivity and specificity. Sub-analyses investigated the results by viral load, symptom presence and duration. An analytical study assessed exclusivity and limit-of-detection (LOD). In addition, we evaluated ease-of-use.ResultsStudy conduct was between November 2nd 2020 and January 21st 2021. 761 participants were enrolled, with 486 participants reporting symptoms on testing day. 120 out of 146 RT-PCR positive cases were detected positive by LumiraDx™, resulting in a sensitivity of 82.2% (95% CI: 75.2%-87.5%). Specificity was 99.3% (CI: 98.3-99.7%). Sensitivity was increased in individuals with viral load ≥ 7 log10 SARS-CoV2 RNA copies/ml (93.8%; CI: 86.2%-97.3%). Testing against common respiratory commensals and pathogens showed no cross-reactivity and LOD was estimated to be 2-56 PFU/mL. The ease-of-use-assessment was favourable for lower throughput settings.ConclusionThe LumiraDx™ assay showed excellent analytical sensitivity, exclusivity and clinical specificity with good clinical sensitivity using supervised NMT self-sampling.

Exhaled breath test is a typical disease monitoring method for replacing of blood and urine samples that may create discomfort for patients. To monitor exhaled breath markers, gas biomedical sensors have undergone rapid progresses for non‐invasive and point‐of‐care diagnostic devices. Among gas sensors, metal oxide‐based biomedical gas sensors have received remarkable attentions owing to their unique properties, such as high sensitivity, simple fabrication, miniaturization, portability, and real‐time monitoring. Herein, we reviewed the recent advances in chemoresistive metal oxide‐based gas sensors with ZnO, SnO2, and In2O3 as sensing materials for monitoring a range of exhaled breath markers (i.e., NO, H2, H2S, acetone, isoprene, and formaldehyde). We focused on the strategies that improve the sensitivity and selectivity of metal oxide‐based gas sensors. The challenges to fabricate a functional gas sensor with high sensing performance along with suggestions are outlined.

BackgroundIn the emergency of the SARS-CoV-2 pandemic, great efforts were made to quickly provide serology testing to the medical community however, these methods have been introduced into clinical practice without the complete validation usually required by the regulatory organizations.MethodsSARS-CoV-2 patient samples (n=43) were analysed alongside pre-pandemic control specimen (n=50), confirmed respiratory infections (n=50), inflammatory polyarthritis (n=22) and positive for thyroid stimulating immunoglobulin (n=30). Imprecision, diagnostic sensitivity and specificity and concordance were evaluated on IgG serologic assays from EuroImmun, Epitope Diagnostics (EDI), Abbott Diagnostics and DiaSorin and a rapid IgG/IgM test from Healgen.ResultsEDI and EuroImmun imprecision was 0.02-14.0% CV. Abbott and DiaSorin imprecision (CV) ranged from 5.2% - 8.1% and 8.2% - 9.6% respectively. Diagnostic sensitivity of the assays were 100% (CI: 80-100%) for Abbott, EDI and EuroImmun and 95% (CI: 73-100%) for DiaSorin at ≥14 days post PCR. Only the Abbott assay had a diagnostic specificity of 100% (CI: 91-100%). EuroImmun cross-reacted in 3 non-SARS-CoV-2 respiratory infections and 2 controls. The DiaSorin displayed more false negative results and cross-reacted in six cases across all conditions tested. EDI had one cross-reactive sample. The Healgen rapid test showed excellent sensitivity and specificity. Overall, concordance of the assays ranged from 76.1% to 97.9%.ConclusionsSerological tests for SARS-CoV-2 showed good analytical performance. The head-to-head analysis of samples revealed differences in results that may be linked to the use of nucleocapsid or spike proteins. The point of care device tested demonstrated adequate performance for antibody detection.

Background We present the analytical performance of the ivisen IA‐1400, a new point‐of‐care device that features a characteristic built‐in centrifuge system, to measure blood cardiac troponin I (cTnI) levels. Methods Whole blood and plasma samples obtained from patients who visited Korea University Guro Hospital were used to analyze measurement range, cross‐reactivity, interference, and sensitivity and specificity. We performed a correlation analysis of the ivisen IA‐1400 versus the Access AccuTnI+3 immunoassay using the UniCel™ DxI 800 platform and the PATHFAST™ hs‐cTnI assay. Results Within‐run precisions were classified as low, 9.8%; middle, 10.2%; and high, 8.5%. The limit of blank was 3.1 ng/L for plasma samples and 4.3 ng/L for whole blood samples. The limit of detection was 8.4 ng/L for plasma samples and 10.0 ng/L for whole blood samples, respectively. The limit of quantitation at a coefficient of variation of 20% and 10% was 19.5 ng/L and 45.5 ng/L for plasma samples, respectively. The comparative evaluation between the two other assays and ivisen IA‐1400 showed excellent correlation, with Spearman's correlation coefficients (R) of 0.992 and 0.985. The sensitivity and specificity of ivisen IA‐1400 using the optimum cut‐off value of 235 ug/L were 94.6% and 98.2%, respectively. Conclusion The ivisen IA‐1400 showed acceptable and promising performance in cTnI measurements using whole blood and plasma samples, with limited information in the clinical performance. The flexibility for sample selection using the internal centrifugation system is the main advantage of this point‐of‐care device., This study aims to introduce a new point‐of‐care device for measuring the blood cardiac troponin, ivisen IA‐1400, with a characteristic built‐in centrifuge system developed in South Korea.We obtained acceptable performance data of ivisen IA‐1400, including excellent correlation with Access AccuTnI+3 immunoassay using the UniCelTM DxI 800 platform and PATHFASTTM hs‐cTnI assay.

With the recent launch of the Global Development Lab in the Hunter and Stephanie Hunt Institute for Engineering and Humanity, fellows, faculty, and industry professionals have been working to create meaningful solutions to promote a resilient humanity, addressing the UN’s Sustainable Development Goals and challenges. The Institute has taken on Dr. Ali Beskok’s project, the development of a low cost, portable, Point-of-Care-Device for humanitarian and health applications. This paper provides a systematic review of current Point-of-Care-Devices using antibody antigen reactions. Additionally, it provides aspects of a market analysis and a literature review. Its overarching goal is to make recommendations regarding a disease the developing device could test for through antibody antigen reactions that would most positively affect global health. Traditionally, biomedical engineers have developed technologies in response to the needs of the developed world’s medical community. These approaches often do not address the needs of the majority of the world’s peoples afflicted with both communicable and non-communicable diseases as the developments are far too costly and those with most need have, at best, limited access to supporting clinical laboratory infrastructure in developing countries. A gap in care has emerged as a result of these conditions. As a result, Drs. Beskok and Koklu have developed a Lab-on-a-Chip technology that can test for a chosen disease with a turnaround time of just a few seconds and a detection limit of 1 ng of antigen per 1 mL of sample fluid. In contrast to other commonly used PoCD’s, this technology can be adapted for detection of various diseases in various settings. This is a great improvement to current devices on the market in specificity, sensitivity, and ease of use, therefore making it particularly useful in high-throughput, low-skill staffing environments. In creating disease selection criteria for Dr. Beskok and his team’s device, several factors were taken into consideration. Generally, the selection criteria consists of diseases that result in a high DALY value, are communicable, identifiable with antibody-antigen reactions, and can be tested for using urine. The diseases that were identified with this criterion were Tuberculosis and Malaria. Various antibody-antigen recommendations for diagnosis, advantages, and limitations of the proposed Point-of-Care-Device are discussed in the Proposed Disease section. In addition, current funding for each disease is overviewed. In order to make the greatest impact, deployment of the PoCD in the Sub-Saharan region, most specifically the Democratic Republic of Congo and Sierra Leone are recommended. Furthermore, children under the age of 5 who suffer from malnutrition should be given special attention. Focusing in these locations and populations will best aid in accomplishing the third Sustainable Development Goal set out by the UN: to ensure healthy lives and promote wellbeing for all at all ages.

In this paper, we have demonstrated a GRIN (gradient index) rod-lens-based imaging device for the detection of cancer tissue. The imaging has been carried out in transmission mode as well as in reflection mode. Since endoscopic methods are meaningful in reflection mode, thus main focus here is reflection mode imaging. The device has been used for the imaging of biological samples such as onion epithelial cells, normal skin tissue, breast cancer tissue etc. In future, we use this device for detection of cancer during intra-operative procedure with the help of fluorescence microscopic imaging.

Extreme hyperbilirubinemia can cause bilirubin neurotoxicity. Infants with glucose-6-phosphate dehydrogenase (G6PD) deficiency can develop hemolysis and thus are at high risk. We evaluated a device that quantitatively measures G6PD activity kinetically using digital microfluidics (DMF). Intra- and inter-instrument and -day imprecision (CVs) were first assessed. G6PD activity in 86 samples was then measured and compared between DMF and 2 reference methods. Overall DMF reproducibility was 3.8% over 5 days by 2 operators on 2 instruments. Mean intra- and inter-instrument variabilities were 3.6% and 3.9%, respectively (n = 28), with a user variability of 4.3%. Mean G6PD activity was 6.40±4.62 and 6.37±4.62 U/g hemoglobin for DMF and Reference Methods 1 (n = 46) and 12.15±3.86 and 11.48±1.55 for DMF and 2 (n = 40), respectively, and strongly correlated (r = 0.95 and 0.95) with mean biases of +0.04±2.90 and +0.67±1.55 for methods 1 and 2, respectively. The novel device could be used for early newborn G6PD screening.

The StatSensor is a point-of-care device which measures creatinine in capillary whole blood. Previous studies reported an underestimation of the creatinine measurements at high creatinine concentrations and were performed in the prestandardization era for creatinine.This accuracy-based study evaluates the use of this device in kidney-transplanted patients and those with chronic kidney disease (CKD).Cross-sectional diagnostic accuracy study.Nephrology outpatient clinic in an urban tertiary center.Adults with CKD or a functioning kidney transplant.Duplicate StatSensor creatinine measurements were performed on capillary whole blood samples collected by direct fingerstick and SAFE-T-FILL collection device. Results were compared with simultaneous venous blood sampling for serum and plasma creatinine measured by an enzymatic method on the Roche Integra 400 mainframe analyzer with traceability to the ID-GC-MS (isotope dilution gas chromatography mass spectrometry) reference method.Deming regression, Pearson correlation coefficient, and Bland-Altman analysis were used to assess accuracy and comparability between capillary whole blood measured by StatSensor and plasma creatinine measured by routine analyzer with traceability to the reference method. Estimated glomerular filtration (eGFR) rates were calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation and concordance with Kidney Disease Improving Global Outcomes (KDIGO) CKD stage classification was evaluated.There were 60 participants (mean age = 61.9 ± 15.0 years, 55% men, 33% transplant, mean plasma creatinine = 137 ± 59 µmol/L). Bland-Altman analysis indicated a positive mean bias of 12.7 µmol/L between StatSensor fingerstick creatinine measurement and plasma creatinine. Comparison of eGFR (CKD-EPI) calculated from the StatSensor fingerstick creatinine versus plasma creatinine showed misclassification across all KDIGO CKD stages. Postanalytical correction of the bias did not improve misclassifications. The use of mean of duplicate StatSensor creatinine results did not improve performance compared with the use of singlet results.Single center, limited participant numbers.The results of our study suggest that the limiting characteristics of the StatSensor device are not only bias, but also imprecision. The level of imprecision observed may influence clinical decision-making and limit the usefulness of StatSensor as a CKD screening tool. If choosing to utilize it for either screening for or monitoring CKD, it is essential that clinicians understand the limitations of point-of-care devices and apply this knowledge to test interpretation.Le StatSensor est un appareil portatif conçu pour mesurer le taux de créatinine dans le sang capillaire total. Des études antérieures, réalisées avant la standardisation des mesures de la créatinine, ont rapporté une sous-estimation des mesures à des concentrations élevées.Cette étude centrée sur la précision a examiné l’utilisation de cet appareil chez des patients transplantés d’un rein et des patients atteints d’insuffisance rénale chronique (IRC).Étude transversale centrée sur la précision du diagnostic.La clinique ambulatoire de néphrologie d’un centre de soins tertiaires en milieu urbain.Des adultes atteints d’IRC ou transplantés avec un rein fonctionnel.Les mesures de créatinine par StatSensor ont été effectuées en double sur des échantillons de sang capillaire total prélevés par ponction digitale directe et à l’aide du dispositif de prélèvement SAFE-T-FILL. Ces résultats ont été comparés à un prélèvement veineux simultané pour la mesure des taux de créatinine sérique et plasmatique par la méthode enzymatique avec l’analyseur Integra 400 de Roche avec traçabilité à la méthode de référence ID-GC-MS.La régression de Deming, le coefficient de corrélation de Pearson et l’analyse de Bland-Altman ont été utilisés pour évaluer la précision et la comparabilité entre les mesures du sang capillaire total par StatSensor et la mesure de créatinine plasmatique obtenue par l’analyseur de routine avec traçabilité à la méthode de référence. Le débit de filtration glomérulaire estimé (DFGe) a été calculé avec l’équation CKD-EPI, puis la concordance avec la classification des stades KDIGO pour l’IRC a été évaluée.L’étude a inclus 60 patients (55 % d’hommes; âge moyen 61,9 ± 15,0 ans) dont 33 % étaient transplantés. Le taux moyen de créatinine plasmatique s’établissait à 137 ± 59 µmol/L. L’analyse de Bland-Altman indique un biais positif moyen de 12,7 µmol/L entre la mesure de créatinine obtenue avec StatSensor par ponction digitale et le taux de créatinine plasmatique. La comparaison entre le DFGe (CKD-EPI) calculé à partir des mesures obtenues par ponction digitale avec StatSensor et de la mesure de créatinine plasmatique a montré une classification erronée à tous les stades KDIGO pour l’IRC. La correction du biais après l’analyse n’a pas amélioré les erreurs de classification. L’utilisation de la moyenne des résultats obtenus par StatSensor sur les échantillons prélevés en double n’a pas amélioré les performances par rapport à l’utilisation de singulets.Étude monocentrique, nombre de participants limité.Nos résultats suggèrent que les caractéristiques de limitation du StatSensor ne constituent pas qu’un biais, mais également une imprécision. Ce degré d’imprécision peut influencer la prise de décision clinique et limiter l’utilité du StatSensor comme outil de dépistage de l’IRC. Il est essentiel que les cliniciens soient conscients des limites de ces dispositifs et qu’ils appliquent ces connaissances à l’interprétation des résultats s’ils choisissent de les utiliser pour dépister ou surveiller l’IRC.Sans objet, il ne s’agissait pas d’un essai clinique.

The spread of SARS-CoV-2 virus in the ongoing global pandemic has led to infections of millions of people and losses of many lives. The rapid, accurate and convenient SARS-CoV-2 virus detection is crucial for controlling and stopping the pandemic. Diagnosis of patients in the early stage infection are so far limited to viral nucleic acid or antigen detection in human nasopharyngeal swab or saliva samples. Here we developed a method for rapid and direct optical measurement of SARS-CoV-2 virus particles in one step nearly without any sample preparation using a spike protein specific nanoplasmonic resonance sensor. As low as 370 vp/mL were detected in one step within 15 min and the virus concentration can be quantified linearly in the range of 0 to 107 vp/mL. Measurements shown on both generic microplate reader and a handheld smartphone connected device suggest that our low-cost and rapid detection method may be adopted quickly under both regular clinical environment and resource-limited settings., Graphical abstract Image 1, Highlights • Rapidly and sensitively detect the whole SARS-CoV-2 viral particles with extraordinary time efficiency (

Background The SARS-CoV-2 pandemic caused a major surge in needed diagnostic capacity. In response, many EUA assays have become available for clinical laboratories, and more recently, the point of care device, Abbott ID NOW. Objectives To determine the analytical performance of the ID NOW assay for detecting SARS-CoV-2. Study design Residual NP samples collected in viral transport media were tested by the ID NOW platform in two independent laboratories. Results were compared to either the CDC or New York EUA assays, which served as reference methods. Results Overall agreement of ID NOW was 78.7%. Sensitivity was 71.7% and specificity was 100%. Notably, all false-negative results correlated to those samples that were weakly positive. Conclusions ID NOW performs well for strong and moderately positive samples but has reduced sensitivity for weakly positive samples. This sensitivity, among other concerns, should be taken into consideration when using this test for patients with a low suspicion for COVID-19 disease.