Search

Purpose: To assess associations between sedentary time (ST), physical activity (PA), and cardiovascular health in early childhood. Method: Cross-sectional study including 160 children (age 6.1 y [SD 0.5], 86 boys, 93 maternal body mass index ≥ 30 kg/m2, and 73 gestational diabetes) assessed for pulse wave velocity, echocardiography, ultra-high frequency 48–70 MHz vascular ultrasound, and accelerometery. Results: Boys had 385 (SD 53) minutes per day ST, 305 (SD 44) minutes per day light PA, and 81 (SD 22) minutes per day moderate to vigorous PA (MVPA). Girls had 415 (SD 50) minutes per day ST, 283 (SD 40) minutes per day light PA, and 66 (SD 19) minutes per day MVPA. In adjusted analyses, MVPA was inversely associated with resting heart rate (β = −6.6; 95% confidence interval, −12.5 to −0.7) and positively associated with left ventricular mass (β = 6.8; 1.4–12.3), radial intima-media thickness (β = 11.4; 5.4–17.5), brachial intima-media thickness (β = 8.0; 2.0–14.0), and femoral intima-media thickness (β = 1.3; 0.2–2.3). MVPA was inversely associated with body fat percentage (β = −3.4; −6.6 to −0.2), diastolic blood pressure (β = −0.05; −0.8 to −0.1), and femoral (β = −18.1; −32.4 to −0.8) and radial (β = −13.4; −24.0 to −2.9) circumferential wall stress in boys only. ST and pulse wave velocity showed no significant associations. Conclusions: In young at-risk children, MVPA is associated with cardiovascular remodeling, partly in a sex-dependant way, likely representing physiological adaptation, but ST shows no association with cardiovascular health in early childhood. [ABSTRACT FROM AUTHOR]

Objectives Patients and Methods Results Conclusion To investigate patient tolerability and safety (using urinary tract infection (UTI) as a proxy measure) following EndoSheath‐assisted flexible cystoscopy (eFC). EndoSheaths are single‐use, disposable sheaths used in FC. They reduce cystoscope turnaround times as complicated, time‐consuming and costly sterilisation is no longer necessary. This reduces patient waiting times as cystoscope idle time, the most common rate limiting step, is reduced.All adult patients undergoing eFC over a 26‐month period at a single institution were evaluated prospectively. Post‐eFC, participants rated discomfort on a visual analogue scale (discomfort 1 = none, 2–4 = mild, 5–7 = moderate, 8–10 = severe). The diagnosis of UTI was broad and based on any one of patient self‐report, positive urine culture or antibiotic prescription within 30 days of eFC. Data were analysed using chi‐squared testing (P < 0.05, two‐tailed).Of the 1091 eFCs analysed, 33.2% and 48.2% of were ranked as causing no or mild discomfort, respectively, with just 3.1% ranked severe. Discomfort was greater in younger participants but similar between sexes. Overall, post‐eFC UTI incidence was 13.3%, with rates higher in females (18.1%) than males (11.2%). Participants aged ≥65 years reported a higher UTI rate (15.4%) than those aged <65 years (8.8%). No participants developed urosepsis.This large, prospective, unselected, real‐world study reports that eFC is well tolerated. UTI was higher in females than males, and in those aged ≥65 years, in line with other studies using the same broad based diagnostic criteria for UTI. The conclusion is that eFC is both well tolerated and safe. [ABSTRACT FROM AUTHOR]

Current methods for therapeutic drug monitoring (TDM) have a long turnaround time as they involve collecting patients' blood samples followed by transferring the samples to medical laboratories where sample processing and analysis are performed. To enable real‐time and minimally invasive TDM, a microneedle (MN) biosensor to monitor the levels of two important antibiotics, vancomycin (VAN) and gentamicin (GEN) is developed. The MN biosensor is composed of a hydrogel MN (HMN), and an aptamer‐functionalized flexible (Flex) electrode, named HMN‐Flex. The HMN extracts dermal interstitial fluid (ISF) and transfers it to the Flex electrode where sensing of the target antibiotics happens. The HMN‐Flex performance is validated ex vivo using skin models as well as in vivo in live rat animal models. Data is leveraged from the HMN‐Flex system to construct pharmacokinetic profiles for VAN and GEN and compare these profiles with conventional blood‐based measurements. Additionally, to track pH and monitor patient's response during antibiotic treatment, an HMN is developed that employs a colorimetric method to detect changes in the pH, named HMN‐pH assay, whose performance has been validated both in vitro and in vivo. Further, multiplexed antibiotic and pH detection is achieved by simultaneously employing the HMN‐pH and HMN‐Flex on live animals. [ABSTRACT FROM AUTHOR]

Blood and lymphatic vessels in the body are central to molecular and cellular transport, tissue repair, and pathophysiology. Several approaches have been employed for engineering microfabricated blood and lymphatic vessels in vitro, yet traditionally these approaches require specialized equipment, facilities, and research training beyond the capabilities of many biomedical laboratories. Here we present xurography as an inexpensive, accessible, and versatile rapid prototyping technique for engineering cylindrical and lumenized microvessels. Using a benchtop xurographer, or a cutting plotter, we fabricated modular multi-layer poly(dimethylsiloxane) (PDMS)-based microphysiological systems (MPS) that house endothelial-lined microvessels approximately 260 μm in diameter embedded within a user-defined 3-D extracellular matrix (ECM). We validated the vascularized MPS (or vessel-on-a-chip) by quantifying changes in blood vessel permeability due to the pro-angiogenic chemokine CXCL12. Moreover, we demonstrated the reconfigurable versatility of this approach by engineering a total of four distinct vessel-ECM arrangements, which were obtained by only minor adjustments to a few steps of the fabrication process. Several of these arrangements, such as ones that incorporate close-ended vessel structures and spatially distinct ECM compartments along the same microvessel, have not been widely achieved with other microfabrication strategies. Therefore, we anticipate that our low-cost and easy-to-implement fabrication approach will facilitate broader adoption of MPS with customizable vascular architectures and ECM components while reducing the turnaround time required for iterative designs. [ABSTRACT FROM AUTHOR]

Background: The clinical utility of whole genome sequencing (WGS) in paediatric cancer has been demonstrated in recent years. WGS has been routinely available in the National Health Service (NHS) England for all children with cancer in England since 2021, but its uptake has been variable geographically. To explore the underlying barriers to routine use of WGS in this population across England and more widely in the United Kingdom (UK) and the Republic of Ireland (ROI), a one-day workshop was held in Cambridge, United Kingdom in October 2022. Methods: Following a series of talks, delegates participated in open, round-table discussions to outline local and broader challenges limiting routine WGS for diagnostic work-up for children with cancer in their Principal Treatment Centres (PTCs) and Genomic Laboratory Hubs (GLHs). Within smaller groups, delegates answered structured questions regarding clinical capability, education and training needs, and workforce competence and requirements. Data was recorded, centrally collated, and analysed following the event using thematic analysis. Results: Sixty participants attended the workshop with broad representation from the 20 PTCs across the UK and ROI and the seven GLHs in England. All healthcare professionals involved in the WGS pathway were represented, including paediatric oncologists, clinical geneticists, clinical scientists, and histopathologists. The main themes highlighted by the group in ensuring equitable access to WGS identified were: lack of knowledge equity between NHS trusts, with a perception of WGS being for research only; and perception of lack of financial support for the clinical process surrounding WGS, including lack of time to take informed consent from patients. The latter also included limited trained staff available for data interpretation, affecting the turnaround time for reporting. Finally, the need for an integrated digital pathway to order, track, and return data to clinicians was highlighted. Conclusion: At the workshop, the general motivation for including WGS in the diagnostic work up for children with cancer was high throughout the UK, however a perceived lack of resources and education opportunities limit the widespread use of this commissioned assay. This workshop has led to some recommendations to increase access to WGS in this population in England and more widely in the devolved national of the UK and the ROI. [ABSTRACT FROM AUTHOR]

Objectives Demand for rapid coagulation testing for massive transfusion events led to development of an emergency hemorrhage panel (EHP; hemoglobin, platelet count, prothrombin time/international normalized ratio, and fibrinogen), with laboratory turnaround time (TAT) of less than 20 minutes. Ten years on, we asked if current laboratory practices were meeting that TAT goal and differences were evident in TAT between the 2 major institutions in our system. Methods We identified EHPs ordered at our 2 largest hospitals, February 2, 2021, to July 17, 2022, comparing order to specimen draw time, specimen draw to specimen received time, laboratory analytic time, and total TAT results from emergency department and operating room. Site 1 houses a level I trauma center; site 2 includes tertiary care, transplant, and obstetrics services. Results In total, 1137 EHPs were recorded in our study period. Laboratory TAT was significantly faster at site 1 (~14 vs ~27 minutes, P <.01). Average laboratory TAT was under 20 minutes at site 1 but only for 50% of specimens at site 2. Outlier specimens were collection delays at site 1 and specimen processing delays at site 2. Conclusions The EHP can be performed as rapidly as described. However, compromises in laboratory location, available personnel, and processing differences can degrade performance. [ABSTRACT FROM AUTHOR]

Objectives Myeloid neoplasms require comprehensive characterization of genetic abnormalities, including single-nucleotide variants, small insertions and deletions, and fusions and translocations for management. The Oncomine Myeloid Assay GX v2 (Thermo Fisher Scientific) analyzes 17 full genes, 28 hotspot genes, 30 fusion driver genes, and 5 expression genes. Methods The validation set included 192 DNA samples, 28 RNA samples, and 9 cell lines and contrived controls. The DNA and RNA were extracted from both peripheral blood and bone marrow. Library preparation, templating, and sequencing was performed on the fully automated Genexus Integrated Sequencer (Thermo Fisher Scientific). The sequencing data were analyzed by manual curation, default Oncomine filters and the Oncomine Reporter (Thermo Fisher Scientific). Results Of the 600 reference pathogenic DNA variants targeted by the assay, concordance was seen in 98.3% of unfiltered variant call format files. Precision and reproducibility were 100%, and the lower limit of detection was 2% variant allele frequency for DNA. Inability to detect variants in long homopolymer regions intrinsic to the Ion Torrent chemistry led to 7 missed variants; 100% concordance was seen with reference RNA samples. Conclusions This extensive clinical validation of the Oncomine Myeloid Assay GX v2 on the Genexus Integrated Sequencer with its built-in bioinformatics pipeline and Ion Torrent Oncomine Reporter shows robust performance in terms of variant calling accuracy, precision, and reproducibility, with the advantage of a rapid turnaround time of 2 days. The greatest limitation is the inability to detect variants in long homopolymer regions. [ABSTRACT FROM AUTHOR]

Background and Objectives: To develop key performance indicators (KPI) for use in quality assessment of our institutional goal‐directed massive transfusion (GDMT). Materials and Methods: A team comprising our transfusion and emergency medicine departments carried out a cross‐sectional data analysis of GDMT in adult patients from January 2021 to December 2022. The study was rooted in the Define, Measure, Analyse, Improve, Control (DMAIC) approach. Features of KPIs were (a) importance, (b) scientific soundness and (c) feasibility. Study parameters were defined and analysed using measures of central tendencies and benchmark comparison. Results: Ninety‐two massive transfusion events occurred and 1405 blood components were used. Trauma was the leading cause, followed by postpartum haemorrhage and upper gastrointestinal bleeding. Appropriate GDMT activation was observed only in 43.47% of events. The turnaround time (TAT) was within the benchmark in 85.8% of events with an average of 16 ± 10 min. The average utilization of blood components was 20.5 (interquartile range [IQR] = 11.3) in the appropriate group and 5.5 (IQR = 4.25) in the inappropriate group with a wastage rate of 3.5%. Duration of activation was 6.19 ± 4.59 h, and the adherence to thromboelastography was 66.3%. Overall mortality was 45.65%, and the average duration of hospital stay was 6.1 ± 5.9 days. Conclusion: The KPIs developed were easy to capture, and the analysis provided a comprehensive approach to the quality improvement of the GDMT protocol. [ABSTRACT FROM AUTHOR]

Background Test consolidation and total laboratory automation (TLA) were implemented in a core laboratory with a high volume of specimens in a medical center in Taiwan to reduce the costs of laboratory services and improve laboratory workflow and performance. Methods Using a retrospective research approach, 5 stat and 7 routine tests were used to analyze the in-laboratory to report turnaround time (IR-TAT). Mean, SD, medium, 90th percentile, outlier percentage of IR-TAT, full-time equivalents, productivity, tube touch moment (TTM), and financial impact were determined and compared pre- and post-TLA. Results The mean IR-TAT of overall stat chemical tests for inpatient and outpatient were 32.8% and 11.9% reductions, respectively. The productivity of each medical technologist increased by 32.4% per month, and there was a reduction of 5 medical technologists compared with the number required to complete the same tests before consolidation. The TTM of staff per year post-TLA decreased by 74.1% tube touches. Conclusion The efficiency of laboratory services was improved by consolidation to the core laboratory along with TLA implementation coupled with logic rules such as delta-check and autoverification. Effectiveness was improved as measured by an increase in productivity, labor reduction, staff safety, and cost reduction. [ABSTRACT FROM AUTHOR]

Purpose: Urinary Tract Infections (UTIs) are among the most prevalent infections globally. Every year, approximately 150 million people are diagnosed with UTIs worldwide. The current state-of-the-art diagnostic methods are culture-based and have a turnaround time of 2–4 days for pathogen identification and susceptibility testing. Methods: This study first establishes an optical density culture-based method for spiking healthy urine samples with the six most prevalent uropathogens. Urine samples were spiked at clinically significant concentrations of 103-105 CFU/ml. Three DNA extraction kits (BioStic, PowerFood, and Blood and Tissue) were investigated based on the DNA yield, average processing time, elution volume, and the average cost incurred per extraction. After DNA extraction, the samples were sequenced using MinION and Flongle flow cells. Results: The Blood and Tissue kit outperformed the other kits based on the investigated parameters. Using nanopore sequencing, all the pathogens and corresponding genes were only identified at a spike concentration of 105 CFU/ml, achieved after 10 min and 3 hours of sequencing, respectively. However, some pathogens and antibiotic-resistance genes (ARG) could be identified from spikes at 103 colony formation units (CFU/mL). The overall turnaround time was five hours, from sample preparation to sequencing-based identification of pathogen ID and antimicrobial resistance genes. Conclusion: This study demonstrates excellent promise in reducing the time required for informed antibiotic administration from 48 to 72 h to five hours, thereby reducing the number of empirical doses and increasing the chance of saving lives. [ABSTRACT FROM AUTHOR]

Purpose: Bloodstream infections (BSIs) are associated with significant morbidity, mortality and costs, while prolonged blood culture (BC) diagnosis may delay the initiation of targeted therapy. This study evaluates the impact of an optimized microbiology laboratory process on turnaround times, antibiotic use, clinical outcomes and economics for hospitalized BSI patients. Methods: A pre-post study was conducted in a Chinese hospital in which BSI derived BC results before (Oct. 2020- Sep. 2021) and after (Oct. 2021- Sep. 2022) newly implemented microbiology diagnostics and workflow changes were analyzed. Turnaround times, antibiotic initiation, length of stay and in-hospital costs were compared. Results: From 213 included patients, 134 were pre-optimization (pre-op) and 79 were post-optimization (post-op) cases. The median time from blood sample collection (BSC) to pathogen identification (ID) decreased from 70.12 to 47.43 h post-op (P < 0.001). The median time from BSC to the first ID report related initiation of pathogen-directed antibiotic use decreased from 88.48 to 47.85 h post-op (P < 0.001). The average hospital stay decreased from 19.54 to 16.79 days and 30-day readmissions declined from 18.7 to 13.9%, while the mean total antimicrobial drug usage costs decreased by 3,889 CNY per patient (P = 0.022) after optimization. Conclusions: Implementing new diagnostics technologies and optimizing laboratory workflows significantly reduced antimicrobial drug usage costs, shortened the time to ID results and improved the timeliness of appropriate antibiotic choices to treat BSIs. Investments in faster testing and process improvements were clearly beneficial for patient outcomes and healthcare economics. [ABSTRACT FROM AUTHOR]

Background: Lean methodology, originally developed in the manufacturing sector, is a process management philosophy focused on maximizing value by eliminating waste. Its application in laboratory settings, particularly concerning laboratory turnaround times (TAT), involves a systematic approach to identifying inefficiencies and optimizing processes to enhance value for end customers. Methods: This systematic review was registered in PROSPERO with identification number (CRD42024552350) and reported based on the 2020 PRISMA checklist. An extensive search strategy was performed using PubMed, Scopus, and Embase databases and gray literatures. Advanced searching was used using Boolean operators (AND & OR). After articles were exported to endnote x8, duplications were removed and articles were selected based on titles, abstracts, and full texts. The illegibility of the articles was independently assessed by the three authors (NC, DMB, and BBT), and the disagreements were settled through scientific consensus. Methodological quality was assessed using JBI critical appraisal checklist. Discussion: In this review, electronic databases search yielded 1261 articles, of which 7 met the inclusion criteria. The review demonstrated, implementation of lean principle into the routine laboratory testing had an overall impact 76.1% on reducing laboratory TAT. Transportation, manual data processing, inefficient workflow, and the heavy workload were identified as the main wasteful procedures. To eliminate these non-value-added steps, several intervention techniques were implemented, including the use of a barcoding system, process redesign, workflow optimization, hiring additional staff, and relocating the sample collection room closer to the result distribution center. Lean implementation is crucial in the medical laboratory industry for optimizing processes, reducing TAT, and ultimately enhancing customer satisfaction. As a result, all clinical laboratories should adopt and implement lean principles in their routine testing processes. The medical laboratory industry should also proactively look for and apply lean tools, provide ongoing training, and foster awareness among laboratory staffs. [ABSTRACT FROM AUTHOR]

Objective: To investigate the relationship between sample storage time and lactate levels in pediatric blood samples. Methods: Lactate results, sampling times, times of receipt, and review times were collected from biochemistry samples of outpatients and inpatients at our hospital in October 2022. Lactate levels, turnaround times and timing of sample collection were registered and analyzed for outpatients and inpatients. To further examine the relationship between sample storage time and pediatric blood lactate levels, 12 pediatric blood samples were selected randomly. Samples were stored at 4 °C and room temperature. Lactate levels were measured at 0, 15, 30, 60 and 120 minutes to analyze the incremental change in lactate over time. Results: A total of 337 pediatric samples were collected. Lactate levels were found to be significantly higher in inpatient samples compared to outpatient samples (2.10 mmol/L vs 1.50 mmol/L, P<0.001). Additionally, the time between sampling and receipt at the laboratory was significantly longer for inpatient samples compared to outpatient samples (42.00 minutes vs 10.00 minutes, P<0.001). The time between sample collection and receipt for inpatients was not associated with day of the week. However, this time was significantly higher for samples collected between 6:00-7:59 compared to other collection times. Lactate levels increased with longer storage time and higher temperature. The effect of refrigerated storage was unclear, while ambient temperature storage had a more significant effect on lactate levels. Conclusions: The study demonstrates that sample storage time significantly influences lactate level measurements. It is necessary to improve the process management from sampling to review, and strive to detect lactic acid specimens in the shortest time. [ABSTRACT FROM AUTHOR]

Background/Objective: SeptiCyte RAPID is a transcriptional host response assay that discriminates between sepsis and non-infectious systemic inflammation (SIRS) with a one-hour turnaround time. The overall performance of this test in a cohort of 419 patients has recently been described [Balk et al., J Clin Med 2024, 13, 1194]. In this study, we present the results from a detailed stratification analysis in which SeptiCyte RAPID performance was evaluated in the same cohort across patient groups and subgroups encompassing different demographics, comorbidities and disease, sources and types of pathogens, interventional treatments, and clinically defined phenotypes. The aims were to identify variables that might affect the ability of SeptiCyte RAPID to discriminate between sepsis and SIRS and to determine if any patient subgroups appeared to present a diagnostic challenge for the test. Methods: (1) Subgroup analysis, with subgroups defined by individual demographic or clinical variables, using conventional statistical comparison tests. (2) Principal component analysis and k-means clustering analysis to investigate phenotypic subgroups defined by unique combinations of demographic and clinical variables. Results: No significant differences in SeptiCyte RAPID performance were observed between most groups and subgroups. One notable exception involved an enhanced SeptiCyte RAPID performance for a phenotypic subgroup defined by a combination of clinical variables suggesting a septic shock response. Conclusions: We conclude that for this patient cohort, SeptiCyte RAPID performance was largely unaffected by key variables associated with heterogeneity in patients suspected of sepsis. [ABSTRACT FROM AUTHOR]

Patients discharged from Australian hospitals require a list of current medications at the point of discharge, which is commonly in the form of a Patient Friendly Medication List (PFML). Furthermore, the provision of an Interim Medication Administration Chart (IMAC) reduces the number of medication administration delays and omissions for patients discharged to residential aged‐care facilities. To increase the adoption of PFMLs and IMACs, a new process was developed for creating PFMLs and IMACs directly from the discharge prescription in the Electronic Medical Record (EMR). This retrospective pre‐ and post‐intervention audit aimed to evaluate 1 year of PFML and IMAC generation from three acute metropolitan hospitals, prior to and after transitioning from pharmacy dispensing software to EMR‐generated documents. Despite similar hospital activity, the transition to EMR‐generated PFMLs and IMACs was associated with a 157% increase in PFML provision (7930 vs 20 373), a 220% increase in IMAC provision (1569 vs 5022) and a 99% reduction in the number of items typed into the pharmacy dispensing software that did not require supply (−59 171/year). Discharge dispensary turnaround times were lower in the post‐intervention period (36 min vs 30 min, p < 0.01). In conclusion, the transition to EMR‐generated PFMLs and IMACs was associated with increased provision of these documents, reduced data entry for items not required to be supplied, decreased risk of transcription errors and shortened time taken for the hospital pharmacy to process discharge items. This project was exempt due to the local policy requirements that constitute research by the Eastern Health Office of Research and Ethics (Reference no: QA21‐094). The justification for this ethics exemption was as follows: the project complies with the National Health and Medical Research Council's Ethical considerations in quality assurance and evaluation activities and met local requirements for an audit or quality assurance activity. [ABSTRACT FROM AUTHOR]

Objective: The objective of the study is to assess the usefulness of cytology, ZN staining and CBNAAT in diagnosis of suspected tubercular lymphadenopathy and to compare the results of cytology and ZN staining with CBNAAT findings in the diagnosis of suspected tubercular lymphadenopathy. Methods: The study was conducted on 100 patients with clinical suspicion of tubercular lymphadenopathy in Department of Pathology in collaboration with Department of Pulmonary Medicine, GMC, Patiala. The study was started after obtaining approval from the Institutional Ethics Committee. The records of suspected 100 EPTB patients who had under gone FNAC, ZN stain and CBNAAT test for EPTB diagnosis during the study period of 1 year were analysed. Results: The results shows male to female ratio of 1:1.4. The youngest patient was 28 days old and oldest was 77 years old. In this study, Granulomatous lymphadenopathy was the most predominant cytological finding (74%) followed by reactive lymphoid hyperplasia (16%), suppurative (08%), carcinomatous deposits (01%) and lymphoma (01%). Out of the total granulomatous lymphadenopathy i.e 74 cases, ZN stain was positive in 39 cases (52.7%) and CBNAAT was positive in 61 cases (82.4%). Out of the total 100 cases, all 39 ZN-positive cases were diagnosed with tuberculosis on FNAC. Among the 67 CBNAAT-positive cases, 61 were diagnosed with tuberculosis on FNAC, while 4 were diagnosed with suppurative lesions and 2 with reactive lymphoid hyperplasia. Conclusion: FNAC combined with CBNAAT emerged as a reliable diagnostic approach due to its rapid turnaround time and high sensitivity, facilitating early diagnosis and management of tubercular lymphadenopathy. [ABSTRACT FROM AUTHOR]

Introduction: Therapeutic drug monitoring (TDM) has proven to be a valuable strategy for optimizing biologic therapies, among which are anti-tumor necrosis factor (anti-TNF) treatments in inflammatory bowel disease (IBD). In particular, reactive TDM has been shown to manage treatment failures more cost-effectively than empirical dose adjustments for anti-TNF drugs. However, several challenges currently impede the widespread adoption of TDM in clinical practice, particularly addressing the delay between sample collection and result availability. To overcome this limitation, the use of point-of-care technology tests (POCTs) is a potential solution. Point-of-care technology tests are medical diagnostic tests performed at the site of patient care to provide immediate results, allowing for quicker decision-making and treatment. The current standard of care (SOC) for drug level measurement relies on the enzyme-linked immunosorbent assay (ELISA), a method that is time-consuming and requires specialized personnel. This study aims to evaluate a novel, user-friendly, and efficient POCT method (ProciseDx Inc.) and compare its performance with the SOC ELISA in assessing infliximab and adalimumab levels in blood samples from IBD patients. Methods: In this prospective, single-center study, we collected blood samples from IBD patients, both CD and UC, receiving infliximab (87 IBD patients; 50% UC and 50% CD) or adalimumab (60 patients; 14% UC and 48% CD) and we analyzed the blood's drugs levels using both the ProciseDx Analyzer POC and the SOC ELISA. We examined the correlation between the two methods using statistical analyses, including the Deming regression test. Additionally, we assessed the ease of use, turnaround time, and overall practicality of the POCT in a clinical setting. Results: The ProciseDx test demonstrated a strong correlation with the SOC ELISA for measuring both infliximab and adalimumab levels. In particular, the overall correlation between the ProciseDx POCT and the ELISA assessments showed an r coefficient of 0.83 with an R squared value of 0.691 (95% CI 0.717–0.902) for IFX measurements, and an r coefficient of 0.85 with an R squared value of 0.739 (95% CI 0.720–0.930). Conclusions: the ProciseDx POC test offers significantly faster turnaround times and is more straightforward to use, making it a viable alternative for routine clinical monitoring. Despite its promising potential, further refinement and validation of the ProciseDx test are necessary to ensure its effectiveness across diverse patient populations and clinical settings. Future research should focus on optimizing the POC tests' performance and evaluating its long-term impact on IBD management. [ABSTRACT FROM AUTHOR]

Rapid economic growth in Indonesia and Malaysia has widened the gap in emergency care supply and demand, intensifying challenges. Our study, from August to November 2022, assesses current diverse challenges in both countries' emergency care systems from frontline staff perspectives. The online survey involved emergency department (ED) personnel from 11 hospitals in Indonesia and Malaysia, drawing from an existing network. The survey collected data on respondents' characteristics, factors affecting prehospital and ED care quality, missing clinical information, and factors influencing patients' ED stay duration. With 83 respondents from Indonesia and 109 from Malaysia, the study identified common challenges. In both countries, inadequate clinical information from ambulances posed a primary challenge in prehospital care quality, while crowdedness during night shifts affected ED care quality. Frequent gaps in essential clinical information, such as family and medication history, were observed. Prolonged ED stays were associated with diagnostic studies and their turnaround time. This study offers insights into shared challenges in Indonesia and Malaysia's emergency care systems. Our findings stress recognizing common and country-specific challenges for enhanced emergency care quality in Southeast Asia, supporting tailored interventions. [ABSTRACT FROM AUTHOR]

Background: There is a critical need for a rapid and sensitive pathogen detection method for septic patients. This study aimed to investigate the diagnostic efficacy of Digital droplet polymerase chain reaction (ddPCR) in identifying pathogens among suspected septic patients. Methods: We conducted a prospective pilot diagnostic study to clinically validate the multiplex ddPCR panel in diagnosing suspected septic patients. A total of 100 sepsis episodes of 89 patients were included in the study. Results: In comparison to blood culture, the ddPCR panel exhibited an overall sensitivity of 75.0% and a specificity of 69.7%, ddPCR yielded an additional detection rate of 17.0% for sepsis cases overall, with a turnaround time of 2.5 h. The sensitivity of ddPCR in the empirical antibiotic treatment and the non-empirical antibiotic treatment group were 78.6% versus 80.0% (p > 0.05). Antimicrobial resistance genes were identified in a total of 13 samples. Whenever ddPCR detected the genes beta-lactamase-Klebsiella pneumoniae carbapenemase (blaKPC) or beta-lactamase-New Delhi metallo (blaNDM), these findings corresponded to the cultivation of carbapenem-resistant gram-negative bacteria. Dynamic ddPCR monitoring revealed a consistent alignment between the quantitative ddPCR results and the trends observed in C-reactive protein and procalcitonin levels. Conclusions: Compared to blood culture, ddPCR exhibited higher sensitivity for pathogen diagnosis in suspected septic patients, and it provided pathogen and drug resistance information in a shorter time. The quantitative results of ddPCR generally aligned with the trends seen in C-reactive protein and procalcitonin levels, indicating that ddPCR can serve as a dynamic monitoring tool for pathogen load in septic patients. [ABSTRACT FROM AUTHOR]

Purpose: Neuroimaging is often used in the emergency department (ED) to evaluate for posterior circulation strokes in patients with dizziness, commonly with CT/CTA due to speed and availability. Although MRI offers more sensitive evaluation, it is less commonly used, in part due to slower turnaround times. We assess the potential for abbreviated MRI to improve reporting times and impact on length of stay (LOS) compared to conventional MRI (as well as CT/CTA) in the evaluation of acute dizziness. Materials and methods: We performed a retrospective analysis of length of stay via LASSO regression for patients presenting to the ED with dizziness and discharged directly from the ED over 4 years (1/1/2018-12/31/2021), controlling for numerous patient-level and logistical factors. We additionally assessed turnaround time between order and final report for various imaging modalities. Results: 14,204 patients were included in our analysis. Turnaround time for abbreviated MRI was significantly lower than for conventional MRI (4.40 h vs. 6.14 h, p < 0.001) with decreased impact on LOS (0.58 h vs. 2.02 h). Abbreviated MRI studies had longer turnaround time (4.40 h vs. 1.41 h, p < 0.001) and was associated with greater impact on ED LOS than non-contrast CT head (0.58 h vs. 0.00 h), however there was no significant difference in turnaround time compared to CTA head and neck (4.40 h vs. 3.86 h, p = 0.06) with similar effect on LOS (0.58 h vs. 0.53 h). Ordering both CTA and conventional MRI was associated with a greater-than-linear increase in LOS (additional 0.37 h); the same trend was not seen combining CTA and abbreviated MRI (additional 0.00 h). Conclusions: In the acute settings where MRI is available, abbreviated MRI protocols may improve turnaround times and LOS compared to conventional MRI protocols. Since recent guidelines recommend MRI over CT in the evaluation of dizziness, implementation of abbreviated MRI protocols has the potential to facilitate rapid access to preferred imaging, while minimizing impact on ED workflows. [ABSTRACT FROM AUTHOR]

Microsystems represent an alternative but proficient approach of analysis outside the laboratory, and their use could help in reducing the impact of pre-analytical errors, in particular in challenging newborn samples. The study purpose is to compare the Horiba Microsemi CRP LC-767G system for rapid 3-part complete blood count (CBC) and C-reactive protein (CRP) determination with the laboratory reference systems (respectively Sysmex XN-9100™ and Roche Cobas® c702) in samples of adult patients and newborns hospitalized in the neonatal intensive care unit (NICU) samples. The comparison between the analyzers was performed through Passing-Bablok regression analysis and Bland–Altman plot. One hundred eighty-three blood samples were analyzed. The regression analysis results, performed in the newborn (n = 70) and in adult (n = 113) populations, showed a good agreement between the instruments. The evaluation of the Bland–Altman plots showed comparable values of bias < 10% for most of the parameters, but not for MPV, lymphocyte, and monocyte count. Conclusion: The comparison between the Microsemi CRP LC-767G system and the laboratory instrumentations demonstrated comparable results. The Microsemi CRP LC-767G system provides reliable analytical data and faster turnaround time, particularly useful in NICU. What is Known: • Microsystems for point-of-care testing (POCT) represent an alternative but proficient approach of analysis outside the laboratory, in order to perform a rapid, safe, and exhaustive evaluation for critical patients' management, acting as a valid support for treatment in acute care. What is New: • The Microsemi CRP LC-767G system can represent an alternative but effective testing approach outside the laboratory, particularly in NICU, to reduce the impact of pre-analytical errors on newborn samples. [ABSTRACT FROM AUTHOR]

Purpose: Blood culture (BC) is the gold standard for diagnosing blood stream infections (BSI) but is limited by long turnaround times (TAT) and low detection rate. The T2 Magnetic Resonance method (T2MR) offers a rapid, culture-independent alternative. The objective of this study was to compare the performance of the T2Bacteria assay to BCs in a real-world setting. Methods: Retrospective comparative study consisting of T2Bacteria samples and BCs sampled within 72 h from the T2Bacteria sample. The primary outcome was detections by BC and T2Bacteria, respectively. The secondary outcome was difference in TAT. Results: In total, 640 episodes were included, consisting of 640 T2Bacteria samples and 2,117 BCs. A median of three BCs was collected for each T2Bacteria sample. Overall positivity was 101 (15.8%) by either method. In 29 (28.7%) episodes, both T2Bacteria and BC were concordantly positive. In discordant episodes, 46/101 (45.5%) episodes were T2Bacteria positive/BC negative and 26/101 (25.7%) were T2Bacteria negative/BC positive (McNemar χ2, p < 0,05). In T2Bacteria positive/BC negative episodes, eight had growth of the same microorganism in a non-BC culture. Median (IQR) TAT for BC was 35 h and 30 min (25 h 50 min − 45 h 24 min), compared to 21 h and 3 min (17 h 6 min − 27 h 30 m) for T2Bacteria (p < 0.001), with longer delays for samplings occurring outside work hours. Conclusions: The study highlights a high discordance between T2Bacteria and BC and suggests complementary roles of the methods in BSI diagnostics. Furthermore, it is crucial to improve TAT by reducing preanalytical delays. [ABSTRACT FROM AUTHOR]

To evaluate the impact of a new, less-invasive micro-computed tomography (CT) service on autopsy service provision. We recorded parental consent, type of autopsy performed, autopsy reporting times and time taken for the body to be released from the mortuary. A retrospective, single-centre case series was conducted for all perinatal deaths since the introduction of our micro-CT service in 2016, with a detailed review of records extracted from 2019 and 2021. Fetal demographics (gestational age, weight), type of autopsy conducted, and the time taken from receiving the body to releasing the body and issuing a final report were recorded. Micro-CT imaging uptake increased to over two hundred cases/year by 2021. Overall, invasive autopsies reduced from (45.8%, 196/428; 2019) to (32.1%, 125/390; 2021) with an equivalent rise in less-invasive autopsy from 54.2% (232/428;2019) to 67.9% (265/390;2019). Offering a micro-CT service resulted in an increase in consent to imaging-based autopsies from (76.9%, 329/428;2019) to (87.2%, 340/390;2021). Micro-CT has become the most common post-mortem imaging performed in our institution at 54.4% (212/251;2021), although the body preparation time from the tissue staining required has increased the time to provide an autopsy report to 17 days and release of the body to 18 days. Our study shows that introducing a micro-CT post-mortem imaging service was associated with reduced use of conventional invasive procedures, despite a slight increase in turnaround times. Understanding these factors and continued improvements in micro-CT service delivery will help make this accessible to a wider population in the future. • Micro-CT offers parents an alternative investigation following a pregnancy loss. • Offering micro-CT reduced the usage of conventional autopsies. • Increased less-invasive autopsy availability results in increased demand. • Micro-CT takes slightly longer than conventional autopsy but does not affect uptake. [ABSTRACT FROM AUTHOR]

Background and Aims: Monitoring and a continual improvement of turnaround time (TAT) in urine examination and reporting is essential for improved management of laboratory quality as well as ensuring patient satisfaction. TAT can be impacted by multiple factors, some of which appear to be beyond the control of laboratory, especially the preanalytical phase of urine examination such as specimen collection, transportation and sample preparation. The aim of the study was to compare the preanalytical variables like TAT for transportation and incidences of spill between our current urinalysis workflow process and the new urinalysis workflow process using a pneumatic chute-compatible closed urine collection system. Materials and Methods: This observational prospective study was conducted on 4/9/23 from 9 am to 4 pm at the laboratory of Apollo Main Hospital, Chennai. Pneumatic chute compatible closed urine collection cup was given to the patients in Group-A and normal screw cap containers which we are currently using were given to the patients in Group-B. Once the urine samples were collected in the respective containers, they were transported to the laboratory using pneumatic chutes for Group-A samples and manual carry for Group-B samples. Analysis of transportation time using the new collection method (Group-A) when compared with the current method of practice (Group-B) was done. The incidence of spillage was also monitored. Results: A significant improvement was noticed in the transportation process and spill incidence with closed collection devices through the pneumatic chute. Conclusion: To conclude, the implementation of pneumatic chute compatible closed collection tubes for urine improves the transportation and processing time, eliminates the manual carry of urine samples, eliminates the incidences of leakage and spillage, reduces errors and reduces the exposure of urine to healthcare workers, thereby leading to significant improvement in patient care, patient experience and staff satisfaction. [ABSTRACT FROM AUTHOR]

Volume 41 of the journal Contemporary Economic Policy, published in 2023, contained 37 articles on various topics in economics. The journal received 196 manuscripts for review, with an acceptance rate of 13%. The refereeing process helped improve the quality of accepted manuscripts, but finding willing referees was a challenge. The journal had a low response rate from referees, impacting turnaround time. The average time to first decision was 69 days. The journal's impact factor increased to 1.7, and an Outstanding Review Service Award was introduced to recognize exceptional referees. Starting with Volume 42, the journal will be published online-only to reduce environmental impact, and its social media presence has been expanded. [Extracted from the article]

Comprehensive biomarker testing for patients with non–small cell lung cancer is critical for selecting appropriate targeted therapy or immunotherapy. Ensuring timely ordering, processing, and reporting is key to optimizing patient outcomes. However, various factors can prevent or delay patients from being offered the option of treatment selection based on comprehensive biomarker testing. These factors include problems with access to testing, tissue adequacy, turnaround time, and health insurance coverage and billing practices. Turnaround time depends on several logistical and tissue handling factors, which involve institutional policies, processes, resources, testing methodology, and testing algorithms that vary across different practices. In this article, the authors identify key factors that prolong biomarker testing turnaround time, propose strategies to reduce it, and present a process map to aid physicians and key organizational stakeholders in improving testing efficiency. [ABSTRACT FROM AUTHOR]

Background Hypothesis/Objectives Animals Materials and Methods Results Conclusions and Clinical Relevance Bacterial identification and antimicrobial susceptibility testing is an important step in timely therapeutic decisions for canine superficial bacterial folliculitis (SBF), commonly caused by Staphylococcus pseudintermedius. Next‐generation sequencing (NGS) offers the appeal of potentially expedited results with complete detection of bacterial organisms and associated resistance genes compared to culture. Limited studies exist comparing the two methodologies for clinical samples.To compare and contrast genotypic and phenotypic methods for bacterial identification and antimicrobial susceptibility from cases of canine SBF.Twenty‐four client‐owned dogs with lesions consistent with SBF were enrolled.A sterile culturette swab was used to sample dogs with SBF lesions. The swab was rinsed in 0.9 mL of sterile phosphate‐buffered saline and vortexed to create a homogenous solution. Two swabs for NGS laboratories (Labs) and one swab for culture (Culture Lab) were randomly sampled from this solution and submitted for bacterial identification and antimicrobial susceptibility.No statistical difference regarding turnaround time for NGS Labs compared to Culture Lab was found. NGS Lab 1 identified more organisms than NGS Lab 2 and Culture Lab, which were both statistically significant. There was no statistical difference in detection frequency for Staphylococcus spp. among all laboratories. There was poor agreement for the presence of meticillin resistance and most antimicrobials among all laboratories.Utilisation of NGS as a replacement for traditional culture when sampling canine SBF lesions is not supported at this time. [ABSTRACT FROM AUTHOR]

Introduction: Comprehensive genome profiling (CGP) has revolutionized healthcare by offering personalized medicine opportunities. However, its real‐world utility and impact remain incompletely understood. This study examined the extent to which CGP leads to genomically matched therapy and its effectiveness. Methods: We analyzed data from advanced solid tumor patients who underwent CGP panel between December 2019 and May 2023 at the Osaka International Cancer Institute. Patient demographics, specimen details, and expert panel assessments were collected. Turnaround time (TAT) and genomically matched therapy outcomes were analyzed. Gene alterations and their co‐occurrence patterns were also assessed. Results: Among 1437 patients, 1096 results were available for analysis. The median TAT was 63 [28–182] days. There were 667 (60.9%) cases wherein recommended clinical trials were presented and there were 12 (1.1%) cases that could be enrolled in the trial and 25 (2.3%) cases that could lead to therapies under insurance reimbursement. The median progression free survival of the trial treatment was 1.58 months (95% CI: 0.66–4.37) in clinical trials and 3.66 months (95% CI: 2.14–7.13) in treatment under insurance. Pathologic germline variants were confirmed in 15 patients (1.3%). Co‐alteration of CDKN2A, CDKN2B, and MTAP was significantly observed in overall population. Conclusion: The effectiveness of the genomically matched therapy based on the CGP panel was unsatisfactory. Expansion of clinical trials and utilization of remote clinical trials are required to ensure that the results of the CGP panel can be fully returned to patients. [ABSTRACT FROM AUTHOR]

AbstractObjectiveMethodsResultsConclusionsAccurate and rapid identification of causative pathogens is essential to guide the clinical management of lower respiratory tract infections (LRTIs). Here we conducted a single-centre prospective study in 284 patients suspected of lower respiratory tract infections to evaluate the utility of a nucleic acid test based on highly multiplexed polymerase chain reaction (PCR) and CRISPR-Cas12a.We determined the analytical and diagnostic performance of the CRISPR assay using a combination of reference standards, including conventional microbiological tests (CMTs), metagenomic Next-Generation Sequencing (mNGS), and clinical adjudication by a panel of experts on infectious diseases and microbiology.The CRISPR assay showed a higher detection rate (63.0%) than conventional microbiological tests (38.4%) and was lower than metagenomic Next-Generation Sequencing (72.9%). In detecting polymicrobial infections, the positivity rate of the CRISPR assay (19.4%) was higher than conventional microbiological tests (3.5%) and lower than metagenomic Next-Generation Sequencing (28.9%). The overall diagnostic sensitivity of the CRISPR assay (67.8%) was higher than conventional microbiological tests (41.8%), and lower than metagenomic Next-Generation Sequencing (93.2%).Considering the low cost, ease of operation, short turnaround time, and broad range of pathogens detected in a single test, the CRISPR assay has the potential to be implemented as a screening tool for the aetiological diagnosis of lower respiratory tract infections patients, especially in cases where atypical bacteria or coinfections are suspected. [ABSTRACT FROM AUTHOR]

Background : Metagenomics is a powerful approach for the detection of unknown and novel pathogens. Workflows based on Illumina short-read sequencing are becoming established in diagnostic laboratories. However, high sequencing depth requirements, long turnaround times, and limited sensitivity hinder broader adoption. We investigated whether we could overcome these limitations using protocols based on untargeted sequencing with Oxford Nanopore Technologies (ONT), which offers real-time data acquisition and analysis, or a targeted panel approach, which allows the selective sequencing of known pathogens and could improve sensitivity. Methods: We evaluated detection of viruses with readily available untargeted metagenomic workflows using Illumina and ONT, and an Illumina-based enrichment approach using the Twist Bioscience Comprehensive Viral Research Panel (CVRP), which targets 3153 viruses. We tested samples consisting of a dilution series of a six-virus mock community in a human DNA/RNA background, designed to resemble clinical specimens with low microbial abundance and high host content. Protocols were designed to retain the host transcriptome, since this could help confirm the absence of infectious agents. We further compared the performance of commonly used taxonomic classifiers. Results: Capture with the Twist CVRP increased sensitivity by at least 10–100-fold over untargeted sequencing, making it suitable for the detection of low viral loads (60 genome copies per ml (gc/ml)), but additional methods may be needed in a diagnostic setting to detect untargeted organisms. While untargeted ONT had good sensitivity at high viral loads (60,000 gc/ml), at lower viral loads (600–6000 gc/ml), longer and more costly sequencing runs would be required to achieve sensitivities comparable to the untargeted Illumina protocol. Untargeted ONT provided better specificity than untargeted Illumina sequencing. However, the application of robust thresholds standardized results between taxonomic classifiers. Host gene expression analysis is optimal with untargeted Illumina sequencing but possible with both the CVRP and ONT. Conclusions: Metagenomics has the potential to become standard-of-care in diagnostics and is a powerful tool for the discovery of emerging pathogens. Untargeted Illumina and ONT metagenomics and capture with the Twist CVRP have different advantages with respect to sensitivity, specificity, turnaround time and cost, and the optimal method will depend on the clinical context. [ABSTRACT FROM AUTHOR]

Antimicrobial susceptibility testing (AST) is a core function of the clinical microbiology laboratory and is critical to the management of patients with bloodstream infections (BSIs) to facilitate optimal antibiotic therapy selection. Recent technological advances have resulted in several rapid methods for determining susceptibility direct from positive blood culture that can provide turnaround times in under 8 h, which is considerably shorter than conventional culture-based methods. As diagnostic results do not directly produce a medical intervention, actionability is a primary determinant of the effect these technologies have on antibiotic use and ultimately patient outcomes. Randomized controlled trials and observational studies consistently show that rapid AST significantly reduces time to results and improves antimicrobial therapy for patients with BSI across various methods, patient populations and organisms. To date, the clinical impact of rapid AST has been demonstrated in some observational studies, but randomized controlled trials have not been sufficiently powered to validate many of these findings. This article reviews various metrics that have been described in the literature to measure the impact of rapid AST on actionability, antibiotic exposure and patient outcomes, as well as highlighting how implementation and workflow processes can affect these metrics. [ABSTRACT FROM AUTHOR]

Background Bloodstream infections are linked to heightened morbidity and mortality rates. The consequences of delayed antibiotic treatment can be detrimental. Effective management of bacteraemia hinges on rapid antimicrobial susceptibility testing. Objectives This retrospective study examined the influence of the VITEK® REVEAL™ Rapid AST system on positive blood culture (PBC) management in a French tertiary hospital. Materials and methods Between November 2021 and March 2022, 79 Gram-negative monomicrobial PBC cases underwent testing with both VITEK®REVEAL™ and VITEK®2 systems. Results The study found that VITEK®REVEAL™ yielded better results than the standard of care, significantly shortening the time to result (7.0 h compared to 9.6 h) as well as the turnaround time (15 h compared to 31.1 h) when applied for all isolates. Conclusions This study implies that the use of VITEK®REVEAL™ enables swift adaptations of antibiotic treatment strategies. By considerably minimizing the turnaround time, healthcare professionals can promptly make necessary adjustments to therapeutic regimens. Notably, these findings underscore the potential of VITEK®REVEAL™ in expediting appropriate antibiotic interventions, even in less ideal conditions. Further studies in varied laboratory contexts are required to validate these encouraging outcomes. [ABSTRACT FROM AUTHOR]

Background Development of rapid bacterial identification from blood cultures has been an area of intense study in diagnostic microbiology. Shortened turnaround time coupled with antimicrobial stewardship interventions have been shown to improve patient outcomes and decrease healthcare-associated costs. Objectives We report the validation of a short incubation method for Gram-positive and Gram-negative bacterial identification utilizing MALDI-TOF MS without additional instrumentation, processing or cost compared with current practice. Methods Prospective, observational, single-centre study in a quaternary care academic hospital encompassing 376 blood cultures subjected to bacterial identification after short incubation periods of 3–4 and 6–8 h. Results There was 97.5% species-level identification agreement with tests undertaken after 3–4 h incubation with 83.6% isolates identified, and 99.7% species-level identification agreement after 6–8 h incubation with 96.7% isolates identified. Conclusions The short incubation method provides a rapid MALDI-TOF MS bacterial identification method, reducing turnaround time by 10–18 h compared with standard practice without additional cost, processing or instrumentation. [ABSTRACT FROM AUTHOR]

Summary Imagine if we could simultaneously predict spatial protein expression in tissues from their routine Hematoxylin and Eosin (H&E) stained images, and create tissue images given protein expression profiles thus enabling virtual simulations of how protein expression alterations impact histology in complex diseases like cancer. Such an approach could lead to more informed diagnostic and therapeutic decisions for precision medicine at lower costs and shorter turnaround times, more detailed insights into underlying disease pathology as well as improvement in predictive and generative performance. In this study, we investigate the intricate correlation between protein expressions obtained from Hyperion mass cytometry and histopathological microstructures in conventional H&E stained glioblastoma (GBM) samples, unveiling morphological patterns and cellular-level spatial alterations associated with protein expression changes. To model these complex relationships, we propose a novel generative-predictive framework called Ouroboros for producing H&E images from protein expressions and simultaneously predicting protein expressions from H&E images. Our comprehensive sample-independent validation over 9920 tissue spots from 4 GBM samples encompassing visual image analysis, quantitative analysis, subspace alignment and perturbation experiments shows that the proposed generative-predictive approach offers significant improvements in predicting protein expression from images in comparison to baseline methods as well as accurate generation of virtual GBM sample images. This proof of concept study can contribute to advancing our understanding of histological responses to protein expression perturbations and lays the foundations for further developments in this area. Availability and implementation Implementation and associated data for the proposed approach are available at the URL: https://github.com/Srijay/Ouroboros. [ABSTRACT FROM AUTHOR]

A nurse-led standardized pre-authorization process was implemented to reduce decision turnaround times to subsequently reduce costs and improve access to care. Nurses should lead Quadruple Aim initiatives because of their expertise and unique positioning within health care systems. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to determine autoverification rules for routine glycated hemoglobin (HbA1c) analysis based on high-performance liquid chromatography (HPLC) principle. Laboratory information system (LIS) and Bio-Rad D-100 Advisor software (Bio-Rad, Hercules, USA) with graphics recognition function were carriers for the autoverification system. Materials and methods: A total of 105,126 HbA1c results, including 98,249 HbA1c matching fast plasma glucose (FPG) results of real-world data from May 2019 to June 2020, were collected to determine autoverification rules including flags, delta checks, reporting limits, and logical rules. The validation database was composed of 48,045 HbA1c results and 41,083 matching FPG results. Autoverification passing rate and the reduction of turnaround time (TAT) were evaluated. Results: Four autoverification systems (A, B, C, D) were established by two types of delta check rules, 28 flags, one reporting limits, and two kinds of logical rules. The autoverification passing rates were 80.6%, 78.8%, 83.7%, and 81.3%, and the average time saved in TAT were 117.5 min, 116.7 min, 121.1 min, and 121.7 min, respectively. Conclusions: Autoverification system C was the optimal one. Application of distribution of FPG corresponding to HbA1c groups had better performance as logical rules. Established HbA1c autoverifcation system shortened the auditing report time and improved work efficiency. [ABSTRACT FROM AUTHOR]

Background Point-of-care (PoC) hepatitis B virus (HBV) DNA viral load (VL) assays represent an alternative to laboratory-based standard-of-care (SoC) VL assays to accelerate diagnosis and treatment. We evaluated the impact of using PoC versus SoC approaches on the uptake of VL testing, treatment, and turnaround times from testing to treatment across the HBV care cascade. Methods We searched 5 databases, 6 conference websites, and contacted manufacturers for unpublished reports, for articles with or without a comparator (SoC VL testing), and had data on the uptake of VL testing, treatment, or turnaround times between hepatitis B surface antigen (HBsAg) testing, VL testing, and treatment in the cascade. We performed a random-effects meta-analysis on rates of VL testing and treatment initiation. Results Six studies, composing 9 arms, were included. Three PoC arms reported less than 1 day between screening for HBsAg positivity and VL testing, and the other one (2 arms) reported it between 7 and 11 days. Five arms reported the time to available VL test results (<1 day). Three studies reported 1–8 days between VL testing results and treatment initiation. Two studies reported the turnaround times between a positive HBsAg screening and treatment initiation (the same day and 27 days). Overall, 84.1% of those with HBsAg positivity were tested for DNA VL and 88.3% of eligible people initiated treatment. Conclusions HBV PoC DNA testing appears to be associated with a turnaround time of <1 day for receipt of VL results and appears associated with high rates of DNA testing and initiation of treatment among those eligible. Clinical Trials Registration PROSPERO CRD42023398440. [ABSTRACT FROM AUTHOR]

Current malaria diagnostic methods require blood collection, which may be associated with pain and the risk of transmitting blood-borne pathogens, and often create poor compliance when repeated sampling is needed. This study determined the potential use of non-invasive methods (saliva and urine specimens) as alternative sample sources for the diagnosis of malaria infection using real-time polymerase Chain Reaction (qPCR) among children below five years in Nnewi, Anambra State, Nigeria. Biomarkers (18S rRNA) were captured and concentrated from saliva and urine samples using a magnetic bead-based method. DNA recovered from the saliva and urine samples was amplified using qPCR. The results revealed that, out of the 552 participants recruited in this study, the malaria prevalence based on blood microscopy was 55.1%. The prevalence of malaria among children based on the qPCR of saliva specimens was 343 (62.1%), out of which 301 (87.7%) were true positives (TP) and 42 (12.3%) were false positives (FP) when compared with microscopy. Moreover, the prevalence of malaria among children based on qPCR of urine specimens was 269 (48.7%), of which 237 (88.1%) were true positive (TP) and 32 (11.9%) were false positive (FP). When the qPCR method was compared to thick blood film-microscopy as the reference standard, saliva qPCR had a sensitivity of 98.7%, specificity of 80.0%, positive predictive value (PPV) of 87.2%, and negative predictive value (NPV) of 97.8%; urine qPCR had a sensitivity of 88.1%, specificity of 84.3%, PPV of 88.5%, and NPV of 83.8%. Saliva and urine samples are therefore promising non-invasive approaches for malaria diagnosis, and their qPCR has a sensitivity comparable to that of blood microscopy, despite the limitations of cost and turnaround time. [ABSTRACT FROM AUTHOR]

Introduction: Therapeutic decisions in early breast cancer are based on clinico-pathological features which are subject to intra- and inter-observer variability. This single-center decision impact study aimed to evaluate the effects of the Prosigna assay on physicians' adjuvant treatment choices. Methods: Between 09/2017 and 02/2018, formalin-fixed tumor samples from 52 newly diagnosed, postmenopausal, hormone receptor-positive, HER2-negative breast cancer (T1–T2; pN0-N1a) patients were analyzed. Pre-test clinical judgements and Prosigna test results were compared. Results: The mean age was 59 (42–77). Invasive ductal carcinoma (79.2%), grade 2 (52.8%) and T1c-N0 tumors (43.4%) were represented. There was 40.4% discordance between the pre- and post-test risk of recurrences. No significant change was observed in the clinical intermediate risk category, while there was a net reclassification of low-risk patients into a high Prosigna recurrence risk group. In addition, clinically determined intrinsic subtypes were 34.6% discordant with the Prosigna results, which is largely driven by the reclassification of the luminal A tumors into the Prosigna-assessed luminal B group. Before the Prosigna test, endocrine treatment was the primary choice in 20 patients (39.2%), and chemotherapy was recommended to 31 patients (60.8%). Overall, the Prosigna assay led to a change in treatment choice for one patient. Conclusions: Although conventional risk assessment methods are relatively inexpensive with shorter turnaround times, their accuracy and value for risk reduction are suboptimal. According to our results, the Prosigna assay was found to be a relevant tool for the clinical decision making process. Long-term follow-up of these patients will elucidate the potential benefits of using multigene molecular tests as biomarkers for treatment. [ABSTRACT FROM AUTHOR]

Managing neonatal sepsis is challenging due to nonspecific clinical signs, hematological markers with poor accuracy, and a lengthy turnaround time for the identification of microorganisms. Delaying the initiation of antibiotics in truly infected infants can lead to severe morbidity and mortality. Therefore, decisions regarding empiric antibiotic treatment are risk stratified, which exposes many uninfected infants to antibiotics. This causes gut microbiota perturbation, unnecessary hospital admissions, and the generation of multi-resistant organisms. High-speed diagnostic assays could expedite discontinuation or avert the initiation of antibiotics in uninfected infants. This study will evaluate the diagnostic performance of molecular culture (MC), a rapid broad-range PCR-based bacterial profiling technique, for diagnosing neonatal sepsis in infants below 90 days old. A multi-center prospective observational cohort study will include infants evaluated for early and late-onset sepsis. Routine evaluation for suspected sepsis includes microbiological cultures of blood. Additionally, blood for MC will be collected. For early-onset sepsis, umbilical cord blood may be used alternatively. Primary outcome is the agreement between MC and conventional blood culture results. Secondary outcome is the agreement of both assays with clinical sepsis using four different, commonly used definitions. Faster diagnostic pathways for sepsis may reduce antibiotic exposure time. Broad-range molecular assays may identify pathogens undetectable by conventional methods. Employment of umbilical cord blood samples for early-onset sepsis diagnosis can resolve challenges in collecting adequate blood volume and could further expedite treatment decisions. [ABSTRACT FROM AUTHOR]

'Ramping' is a commonly used term in contemporary Australian healthcare. It is also a part of the public and political zeitgeist. However, its precise definition varies among sources. In the published literature, there are distinctions between related terms, such as 'entry overload' and 'Patient Off Stretcher Time Delay'. How ramping is defined and how it came to be defined have significance for policies and procedures relating to the described phenomenon. Through examination of the history of the term, insights are obtained into the underlying issues contributing to ramping and, accordingly, associated possible solutions. [ABSTRACT FROM AUTHOR]

Chinese hamster ovary (CHO) cells are the preferred system for expression of therapeutic proteins and the majority of all biotherapeutics are being expressed by these cell lines. CHO expression systems are readily scalable, resistant to human adventitious agents, and have desirable post‐translational modifications, such as glycosylation. Regardless, drug development as a whole is a very costly, complicated, and time‐consuming process. Therefore, any improvements that result in reducing timelines are valuable and can provide patients with life‐saving drugs earlier. Here we report an effective method (termed SPEED‐MODE, herein) to speed up the Cell line Development (CLD) process in a targeted integration (TI) CHO CLD system. Our findings show that (1) earlier single cell cloning (SCC) of transfection pools, (2) speeding up initial titer screening turnaround time, (3) starting suspension adaptation of cultures sooner, and (4) maximizing the time CHO cultures spend in the exponential growth phase can reduce CLD timelines from ~4 to ~3 months. Interestingly, SPEED‐MODE timelines closely match the theoretical minimum timeline for CHO CLD assuming that CHO cell division is the rate limiting factor. Clones obtained from SPEED‐MODE CLD yielded comparable titer and product quality to those obtained via a standard CLD process. Hence, SPEED‐MODE CLD is advantageous for manufacturing biotherapeutics in an industrial setting as it can significantly reduce CLD timelines without compromising titer or product quality. [ABSTRACT FROM AUTHOR]

The diagnosis of Clostridioides difficile infection (CDI) in the pediatric population is complicated by the high prevalence of asymptomatic colonization, particularly in infants. Many laboratory diagnostic methods are available, but there continues to be controversy over the optimal laboratory testing approach to diagnose CDI in children. We evaluated commonly used C. difficile diagnostic commercial tests in our pediatric hospital population at Sidra Medicine in Doha, Qatar. Between June and December 2023, 374 consecutive stool samples from pediatric patients aged 0–18 years old were tested using: Techlab C. diff Quik Chek Complete, Cepheid GeneXpert C. difficile, QIAstat-Dx Gastrointestinal Panel, and culture using CHROMagar C. difficile. The results of these tests as standalone methods or in four different testing algorithms were compared to a composite reference method on the basis of turnaround time, ease of use, cost, and performance characteristics including specificity, sensitivity, negative predictive value, and positive predictive value. Our study showed variability in test performance of the different available assays in diagnosing CDI. In our population, a testing algorithm starting with Cepheid GeneXpert C. difficile PCR assay or QIAstat-Dx Gastrointestinal panel as a screening test followed by toxin immunoassay for positive samples using the Techlab C. diff Quik Chek Complete kit showed the best performance (100% specificity and 100% positive predictive value) when combined with clinical review of the patient to assess risk factors for CDI, clinical presentation, and alternative causes of diarrhea. [ABSTRACT FROM AUTHOR]

Abstract Background The clinical utility of whole genome sequencing (WGS) in paediatric cancer has been demonstrated in recent years. WGS has been routinely available in the National Health Service (NHS) England for all children with cancer in England since 2021, but its uptake has been variable geographically. To explore the underlying barriers to routine use of WGS in this population across England and more widely in the United Kingdom (UK) and the Republic of Ireland (ROI), a one-day workshop was held in Cambridge, United Kingdom in October 2022. Methods Following a series of talks, delegates participated in open, round-table discussions to outline local and broader challenges limiting routine WGS for diagnostic work-up for children with cancer in their Principal Treatment Centres (PTCs) and Genomic Laboratory Hubs (GLHs). Within smaller groups, delegates answered structured questions regarding clinical capability, education and training needs, and workforce competence and requirements. Data was recorded, centrally collated, and analysed following the event using thematic analysis. Results Sixty participants attended the workshop with broad representation from the 20 PTCs across the UK and ROI and the seven GLHs in England. All healthcare professionals involved in the WGS pathway were represented, including paediatric oncologists, clinical geneticists, clinical scientists, and histopathologists. The main themes highlighted by the group in ensuring equitable access to WGS identified were: lack of knowledge equity between NHS trusts, with a perception of WGS being for research only; and perception of lack of financial support for the clinical process surrounding WGS, including lack of time to take informed consent from patients. The latter also included limited trained staff available for data interpretation, affecting the turnaround time for reporting. Finally, the need for an integrated digital pathway to order, track, and return data to clinicians was highlighted. Conclusion At the workshop, the general motivation for including WGS in the diagnostic work up for children with cancer was high throughout the UK, however a perceived lack of resources and education opportunities limit the widespread use of this commissioned assay. This workshop has led to some recommendations to increase access to WGS in this population in England and more widely in the devolved national of the UK and the ROI.

BACKGROUND: Teleradiology has become an important tool in emergency medicine, particularly in the interpretation of emergency ultrasonography. In emergency situations, where time is essential, rapid diagnosis and treatment can mean the difference between life and death. Teleradiology is an innovative alternative to augment the staffing and fill the gaps of onsite radiology personnel in emergency departments or during off-hours. AIM: To assess the effectiveness/impact of teleradiology in emergency ultrasound interpretation. MATERIALS AND METHODS: A retrospective study was performed in a cohort of 33,616 patients from 86 hospitals across the USA between January and December 2022. The study involved radiological interpretations of 37,253 ultrasound images acquired in the emergency setting by American Board Certified Radiologists empaneled by a teleradiology service provider, headquartered in Bangalore, India. RESULTS: The proposed telehealth model provided timely and quality reporting of 37,253 scans of patients with a mean turnaround time of 35.71 min (95% confidence interval 35.50–35.91). CONCLUSION: This study demonstrates that a structured telesonography program with defined protocols for image capture, transmission, and clinical communication can allow for successful immediate reporting of ultrasound data in the emergency care setting.

Introduction: Bloodstream infection is a major cause of mortality and morbidity worldwide. Timely reporting of blood culture results is of utmost importance for better patient outcomes. The recently introduced Rapid Antimicrobial Susceptibility Testing (RAST) method is poised to profoundly influence clinical outcomes. Aim: To compare the results of RAST with Standard Antimicrobial Susceptibility Testing (SAST) and evaluate the impact of RAST reporting on the clinical management of septicaemia patients. Materials and Methods: This prospective, observational study was conducted in the Department of Microbiology, Government Medical College, Kurnool, Andhra Pradesh, India from May 2021 to September 2022. All positive blood culture bottles with only a single morphotype in gram staining were further processed using the RAST method, followed by conventional identification and SAST. Categorical agreement and disagreement between the RAST and SAST results were compared, along with the difference in the time at which results were available. Results: Out of a total of 1,146 blood cultures received, 228 were flagged as positive. A total of 514 isolate and antimicrobial agent combinations were evaluated, of which 496 (96.5%) showed categorical agreement. Only 18 (3.5%) showed categorical disagreement, with the majority being Major Errors (ME) (1.56%), followed by Very Major Errors (VME) (0.97%) and minor Errors (mE) (0.97%). Conclusion: RAST results demonstrated strong concurrence with SAST results. RAST is affordable, fast, and flexible and can potentially lead to a considerably shortened time for AST results to reach the bedside of the patient. This enables rapid modifications and adjustments in antibiotic therapy, including both escalation and de-escalation.

Timing cues such as interaural time differences (ITDs) and temporal pitch are pivotal for sound localization and source segregation, but their perception is degraded in cochlear-implant (CI) listeners as compared to normal-hearing listeners. In multi-electrode stimulation, intra-aural channel interactions between electrodes are assumed to be an important factor limiting access to those cues. The monaural asynchrony of stimulation timing across electrodes is assumed to mediate the amount of these interactions. This study investigated the effect of the monaural temporal electrode asynchrony (mTEA) between two electrodes, applied similarly in both ears, on ITD-based left/right discrimination sensitivity in five CI listeners, using pulse trains with 100 pulses per second and per electrode. Forward-masked spatial tuning curves were measured at both ears to find electrode separations evoking controlled degrees of across-electrode masking. For electrode separations smaller than 3 mm, results showed an effect of mTEA. Patterns were u/v-shaped, consistent with an explanation in terms of the effective pulse rate that appears to be subject to the well-known rate limitation in electric hearing. For separations larger than 7 mm, no mTEA effects were observed. A comparison to monaural rate-pitch discrimination in a separate set of listeners and in a matched setup showed no systematic differences between percepts. Overall, an important role of the mTEA in both binaural and monaural dual-electrode stimulation is consistent with a monaural pulse-rate limitation whose effect is mediated by channel interactions. Future CI stimulation strategies aiming at improved timing-cue encoding should minimize the stimulation delay between nearby electrodes that need to be stimulated successively. [ABSTRACT FROM AUTHOR]

The increasing prevalence of gut colonization with CTX-M extended-spectrum β-lactamase- and/or DHA plasmid-mediated AmpC-producing Escherichia coli is a concern. Here, we evaluate Nanopore-shotgun metagenomic sequencing (Nanopore-SMS) latest V14 chemistry to detect blaCTX-M and blaDHA genes from healthy stools. We test 25 paired samples characterized with culture-based methods (native and pre-enriched). Antimicrobial resistant genes (ARGs) are detected from reads and meta-assembled genomes (MAGs) to determine their associated genetic environments (AGEs). Sensitivity and specificity of native Nanopore-SMS are 61.1% and 100%, compared to 81.5% and 75% for pre-enriched Nanopore-SMS, respectively. Native Nanopore-SMS identifies only one sample with an AGE, whereas pre-enriched Nanopore-SMS recognizes 9/18 plasmids and 5/9 E. coli chromosomes. Pre-enriched Nanopore-SMS identifies more ARGs than native Nanopore-SMS (p < 0.001). Notably, blaCTX-Ms and blaDHAs AGEs (plasmid and chromosomes) are identified within 1 hour of sequencing. Furthermore, microbiota analyses show that pre-enriched Nanopore-SMS results in more E. coli classified reads (47% vs. 3.1%), higher differential abundance (5.69 log2 fold) and lower Shannon diversity index (p < 0.0001). Nanopore-SMS has the potential to be used for intestinal colonization screening. However, sample pre-enrichment is necessary to increase sensitivity. Further computational improvements are needed to reduce the turnaround time for clinical applications. In this work, authors employ Nanopore-based shotgun metagenomic sequencing for the screening of antimicrobial resistance genes (blaCTX-M/blaDHA) in human stool samples. [ABSTRACT FROM AUTHOR]

Cloud computing is a popular, flexible, scalable, and cost-effective technology in the modern world that provides on-demand services dynamically. The dynamic execution of user requests and resource-sharing facilities require proper task scheduling among the available virtual machines, which is a significant issue and plays a crucial role in developing an optimal cloud computing environment. Round Robin is a prevalent scheduling algorithm for fair distribution of resources with a balanced contribution in minimized response time and turnaround time. This paper introduced a new enhanced round-robin approach for task scheduling in cloud computing systems. The proposed algorithm generates and keeps updating a dynamic quantum time for process execution, considering the available number of process in the system and their burst length. Since our method dynamically runs processes, it is appropriate for a real-time environment like cloud computing. The notable part of this approach is the capability of scheduling tasks with asymmetric distribution of burst time, avoiding the convoy effect. The experimental result indicates that the proposed algorithm has outperformed the existing improved round-robin task scheduling approaches in terms of minimized average waiting time, average turnaround time, and number of context switches. Comparing the method against five other enhanced round robin approaches, it reduced average waiting times by 15.77% and context switching by 20.68% on average. After executing the experiment and comparative study, it can be concluded that the proposed enhanced round-robin scheduling algorithm is optimal, acceptable, and relatively better suited for cloud computing environments. [ABSTRACT FROM AUTHOR]

Inflammatory bowel disease (IBD) is characterized by chronic inflammation of the gastrointestinal (GI) tract. Fecal calprotectin (fCAL) is a noninvasive laboratory test used in the diagnosis and monitoring of IBDs such as Crohn's disease and ulcerative colitis. The fCAL send-out test that our facility has been offering so far uses an ELISA-based method. In the current study, we sought to validate the performance of a Buhlmann fCAL turbo assay in an automated Abbott Alinity C analyzer (AFCAL) in our core laboratory. Five-day imprecision studies showed good performance for both within-run (5.3%) and between-day (2.5%) measurements. The reportable range was verified as 30–20,000 µg/g. Deming regression and Bland–Altman analysis indicated a strong correlation of r = 0.99 with a low, acceptable bias of 1.8% for AFCAL relative to the predicate Buhlmann fCAL ELISA results. AFCAL's clinical performance was determined retrospectively in 62 patients with ICD codes for IBD. Overall, the implementation of AFCAL in our routine clinical testing has improved our turnaround time, reduced the cost per test, and significantly increased our clinician satisfaction. [ABSTRACT FROM AUTHOR]