Reduce Turnaround Time Research Articles

IRB stipulations and protocol complexity: An opportunity for collaboration to reduce turnaround times

IRB stipulations and protocol complexity: An opportunity for collaboration to reduce turnaround times

Performance evaluation of 4-day versus 5-day blood cultures using the BD BACTEC FX system

Background: Blood culture (BC) systems have evolved to increase sensitivity and reduce turnaround times. This study compared the performance of a 4-day versus a 5-day BC incubation period using the BD BACTEC™ FX (Becton, Dickinson and Company, USA). Methods: A total of 37,379 consecutive sets of BC were evaluated over a 3-month period in a 2,700-bed tertiary care hospital. Positive BC results were reviewed to assess time-to-positivity (TTP) and species identification of the isolates. The BCs were performed in pairs of vials, utilizing either BD BACTEC Plus Aerobic/F or Peds Plus/F with BD BACTEC Lytic Anaerobic media. Results: A total of 14,899 episodes, averaging 2.51 sets per episode, were analyzed. Of these, 1,398 (9.38%) were positive, yielding 1,465 isolates. TTP (hours) were < 12 in 48.87%, 12-24 in 31.40%, 24-48 in 13.38%, 48-72 in 3.28%, 72-96 in 1.43%, and >96 in 1.64%. The two most prevalent organisms, Escherichia coli and Klebsiella spp. were detected within 12 hours in 88.75% and 78.90%, respectively. The respective median TTP (T50) values for E. coli, Klebsiella spp., Enterococcus faecalis/E. faecium, and Staphylococcus aureus were 9.24, 9.60, 13.75, and 14.20. T50 values for these species were significantly shorter in anaerobic bottles than in aerobic bottles. Of 24 BCs with TTP > 96, only 4 containing anaerobic bacteria or molds were f irst detected after 96 hours. Conclusion: A 4-day incubation has demonstrated excellent sensitivity. However, a 5-day incubation may be beneficial for hospitals caring for patients at high risk for infections with slow-growing fungi or fastidious bacteria.

The impact of laboratory automation on efficiency and accuracy in healthcare settings

Automated sample processing systems, such as handlers, have played a role in expediting specimen handling, especially during emergencies. Additionally, automated analyzers have contributed to increased testing efficiency by enabling high throughput screening and quicker access to information. This article explores how the use of automated technology in laboratories has greatly improved efficiency and accuracy in healthcare settings. By examining the integration of automated systems for processing samples and conducting tests this review highlights the impact automation has had on outcomes. One notable benefit is reduced turnaround times, streamlined workflows, and enhanced precision in diagnostic testing. The incorporation of laboratory information management systems (LIMS) has further improved efficiency through data integration and real-time monitoring. Accuracy is an aspect of processes, and automated systems meticulously adhere to predefined protocols, resulting in reduced error rates and consistently reliable results. The introduction of intelligence (AI) has enhanced accuracy, particularly in image analysis within the pathology and radiology fields. Effective clinical management of laboratory automation entails technology selection planning for implementation and ongoing monitoring. Interoperability between systems, continuous education on advancements, and efficient workforce management are all crucial components for successful implementation. Despite challenges faced along the way, adopting laboratory automation is essential for optimizing laboratories' workflows while delivering timely information. The review consistently affirms laboratory automation's valid influence in improving efficiency and accuracy within healthcare environments.

Streamlined instrument-free lysis for the detection of Candida auris

The continued spread of Candida auris in healthcare facilities has increased the demand for widely available screening to aid in containment and inform treatment options. Current methods of detection can be unreliable and require bulky and expensive instruments to lyse and identify fungal pathogens. Here, we present a quick, low-cost, instrument-free method for lysis of C. auris suitable for streamlined sample processing with polymerase chain reaction (PCR) detection. Chemical, thermal, and bead beating lysis techniques were evaluated for lysis performance and compatibility with nucleic acid extraction and downstream PCR reactions. Using only 10 s of manual shaking with glass beads, this method demonstrated a limit of detection (LOD) of C. auris at 500 colony forming units per mL, a 20-fold improvement compared to the LOD without manual shaking, and a 60-fold reduction in time compared to common fungal lysis kits, all while maintaining repeatability and reproducibility across multiple users. This work highlights a simple method for increasing sensitivity and reducing turnaround time of PCR-based C. auris detection and exhibits promise for integration into point-of-care platforms towards real-time triage of colonized patients.

Optimization of a rapid method for screening drugs in blood by liquid chromatography tandem mass spectrometry.

In the recent years, liquid chromatography with tandem mass spectrometry has gained popularity in laboratories. This technique has a higher specificity, detects different analytes from a single specimen, measures analytes in distinct matrices, and substantially reduce analytical interference, with respect to immunoassay. The processing and preparation of biological samples are crucial in chromatography. Interferences in blood testing are usually caused by the presence of phospholipids and proteins. The main objective of this study was to improve analytical processes for drug screening by LC-MS/MS using a novel blood sample preparation method based on protein precipitation and removal of phospholipids. An evaluation was performed of a new method for the preparation of blood samples based on protein precipitation and removal of phospholipids by LC-Q-q-LIT. Limit of detection, limit of quantification and measurement range were determined for 56 molecules. The results of 11 cases were compared with those obtained using standard blood collection methods and instruments. The novel blood preparation and testing method based on LC-Q-q-LIT, a more sensitive technique, has demonstrated to yield comparable results to traditional methods. In addition, this new technique reduces turnaround time and costs.

Blockchain-Powered Incentive System for JIT Arrival Operations and Decarbonization in Maritime Shipping

Efficiency and sustainability are undisputedly the most critical objectives for modern ports. Current exercises for port services still lack performance profiling for arriving vessels regarding their arrival punctuality and compliance with port resource schedule for Just-in-time (JIT) service, as well as their efforts contributing towards less emission through reduced turnaround time within port. As a result, a performance-based incentive is missing. Bringing in the incentive component may facilitate the objectives of achieving both port efficiency and sustainability. Blockchain technology, owning to its intrinsic features like immutability, traceability, governance and provenance, and in-built tokens (for most public chain platforms), allow for the establishment of system solutions to record key performance indicators (KPIs) and distribute incentives to good performers. This paper is the first to propose a blockchain-based system to incentivize JIT and green operations in ports. The platform system design and operating mechanisms are elaborated in detail, and a prototype system has been implemented based on the Solana blockchain to demonstrate the core features. The current system’s potential is substantial, considering the industry’s increasing awareness about its environmental footprint. Continuous developments can be facilitated by connecting to market-based measures such as carbon pricing and emission trading in the maritime sector.

Characterization of add-on testing before and after automation at a core laboratory

ObjectivesAdd-on testing refers to the process that occurs in clinical laboratories when clinicians request that additional tests be performed on a previously analysed specimen. This is a common but inefficient procedure, highly time-consuming, especially at core laboratories and could be optimised by automating these procedures. The aims of this study are: 1) To describe patterns of add-on testing at a core laboratory at a tertiary hospital, 2) To evaluate turnaround time (TAT) before and after automation of the pre-, post- and analytical phases. MethodsRetrospective, observational study conducted at the biochemistry area of a core laboratory of all add-on orders received in two different months (pre-automation and post-automation). ResultsA total of 2464 add-on orders were analysed, representing around 5 % of total requests. Most orders were for either one (>50 %) or two (≈20 %) tests. Most orders were received during the week (from Monday to Friday), particularly during the morning shift (>50 %). More than 50 % of requests were made by the Emergency Department. The two most common add-on parameters were C-reactive protein and N-terminal pro-brain natriuretic peptide. After automation, the median TAT decreased by 42.3 % (from 52 to 22 min). The largest decreases in TAT were observed for routine samples (58.89 %) and fully automated analyses (56.86 %). ConclusionsAutomation of our core laboratory substantially reduced turnaround time for add-on testing, indicating an increase in efficiency. Automation eliminated several manual steps in the process, leading to a mean reduction of 15 work hours per day (more than 2 full-time equivalents).

EMPLOYEE PERFORMANCE IN AN EFFORT TO IMPROVE QUALITY AND EFFICIENCY IN PPKS MARIHAT

The aim and benefit of the research as a result of the internship carried out by the author is so that PPKS Marihat can understand how employee performance can be improved to achieve increased quality and efficiency in PPKS operations. The research method used in this research is qualitative research. The questionnaire used in this research is an open questionnaire where the answers are filled in by employees divided into 10 people so that they get in-depth information. The sample data source used was purposive sampling. The results of this research show that employees who show better performance tend to provide services that are more responsive, accurate and in line with customer needs. High-performing employees also tend to be able to complete tasks more efficiently, reduce turnaround time, and minimize waste of resources.

Intelligent Cloudlet Scheduling for Optimized Execution Time in Cloud Computing Environments

Cloud computing has become a cornerstone of modern IT infrastructure, offering scalable and flexible resources. However, efficient resource management, particularly cloudlet scheduling, presents a significant challenge due to its NP-hard nature. This paper introduces a novel heuristic-based cloudlet scheduling algorithm aimed at minimizing execution time and improving load balancing in cloud computing environments. We detail the development and implementation of the algorithm, along with a simulation setup using the CloudSim toolkit to evaluate its performance against existing methods. Results from extensive simulations demonstrate that the proposed algorithm consistently reduces turnaround times, thus optimizing resource allocation. The findings suggest that our approach can significantly impact cloud computing efficiency, paving the way for improved service provider offerings and user satisfaction. The implications of these advancements are discussed, alongside potential directions for future research in dynamic cloud environments.

Prediction of methicillin-resistant Staphylococcus aureus and carbapenem-resistant Klebsiella pneumoniae from flagged blood cultures by combining rapid Sepsityper MALDI-TOF mass spectrometry with machine learning

This study investigated combination of the Rapid Sepsityper Kit and a machine learning (ML)-based matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) approach for rapid prediction of methicillin-resistant Staphylococcus aureus (MRSA) and carbapenem-resistant Klebsiella pneumoniae (CRKP) from positive blood culture bottles. The study involved 461 patients with monomicrobial bloodstream infections. Species identification was performed using the conventional MALDI-TOF MS Biotyper system and the Rapid Sepsityper protocol. The data underwent preprocessing steps, and ML models were trained using preprocessed MALDI-TOF data and corresponding labels. The interpretability of the model was enhanced using SHapely Additive exPlanations values to identify significant features. In total, 44 S. aureus isolates comprising 406 MALDI-TOF MS files and 126 K. pneumoniae isolates comprising 1249 MALDI-TOF MS files were evaluated. This study demonstrated the feasibility of predicting MRSA among S. aureus and CRKP among K. pneumoniae isolates using MALDI-TOF MS and Sepsityper. Accuracy, area under the receiver operating characteristic curve, and F1 score for MRSA/methicillin-susceptible S. aureus were 0.875, 0.898 and 0.904, respectively; for CRKP/carbapenem-susceptible K. pneumoniae, these values were 0.766, 0.828 and 0.795, respectively. In conclusion, the novel ML-based MALDI-TOF MS approach enables rapid identification of MRSA and CRKP from flagged blood cultures within 1 h. This enables earlier initiation of targeted antimicrobial therapy, reducing deaths due to sepsis. The favourable performance and reduced turnaround time of this method suggest its potential as a rapid detection strategy in clinical microbiology laboratories, ultimately improving patient outcomes.

The transition from gel separatory serum tubes to lithium heparin gel tubes in the clinical laboratory

Aims: To assess the viability of replacing serum samples with plasma samples in various clinical chemistry and immunoassay tests and to examine the implications of turnaround time (TAT) and sample quality during the transition process.
 Methods: We compared the results of 27 paired clinical chemistry and 13 immunoassay tests from samples obtained using gel separator serum and gel separator lithium heparinized plasma (LIH) tubes. We used regression analysis, bias values, and Bland-Altman plots to compare the performance of serum and LIH tubes in various clinical chemistry and immunoassay tests. We collected and evaluated sample aspiration errors, hemolysis index values, and TAT data from the laboratory information system before and after switching to plasma in our study.
 Results: Most tests showed no significant difference between the serum and LIH. However, for some analytes, total error (TE) values exceeded the total allowable error (TEa) limits derived from the biological variation database. Notably, insulin TE value did not exceed TEa, but it consumed near all its error budget. Consequently, we determined the alternative allowable error limits for some tests and found that plasma tubes could be used instead of serum tubes for most tests, except for lactate dehydrogenase (LDH). Plasma tubes improved the sample quality, reduced the incidence of aspiration errors, and decreased TAT in the emergency laboratory. We observed significant reductions in TAT after switching to plasma tubes.
 Conclusion: Our study showed that LIH tubes can replace serum tubes in most clinical chemistry and immunoassay tests. Using LIH tubes in clinical laboratories can improve healthcare quality and reduce the workload of the laboratory staff.

A-135 Improving Cell Count Turnaround Times With the GloCyte® Automated Cell Counter for CSF: A Retrospective Study at MercyOne Des Moines Medical Center

Abstract Background Accurate, STAT cerebrospinal fluid (CSF) cell counts are critical in the diagnosis of meningitis, malignancy, demyelinating disease, and hemorrhage. Due to historical limitations with the linearity of automated analyzers, CSF cell counts have traditionally been performed manually with a hemocytometer and the aid of a brightfield optical microscope. Manual cell counting is time-consuming, subjective due to reliance on human interpretation, and requires a high degree of skill. This poses significant challenges for clinical laboratories of all sizes facing unprecedented med tech shortages. The purpose of this study was to evaluate the impact of implementing the GloCyte Automated Cell Counter for CSF, an FDA-cleared device with linearity down to 0 cells/µL, on result turnaround times. Methods Result turnaround time data for CSF specimens processed in the hematology lab at MercyOne Des Moines Medical Center, a 600-bed hospital in Des Moines, Iowa, was analyzed in a retrospective study of two cell counting methods- (1) manual cell counting using a Neubauer-Improved hemocytometer and (2) GloCyte, a benchtop cell counting device that uses fluorescence technology and highly specific reagents to automate RBC and TNC cell counts in less than 5 min. Turnaround times for 227 CSF specimens counted manually during an approximately six-month period prior to the implementation of GloCyte (January 2, 2017 to June 29, 2017) were compared to those for 133 specimens analyzed on GloCyte over a similar duration (January 4, 2021 to June 30, 2021). In this study, turnaround times were defined as the time between specimen arrival in the lab and result verification. Correlation between the methods was previously established in the MercyOne Des Moines Medical Center laboratory. Results The data demonstrated a significant, 16–30-minute improvement in turnaround times with GloCyte compared to the manual hemocytometer method. Median turnaround times, analyzed to adjust for add-ons that resulted in longer turnaround times pre- and post-GloCyte implementation, were 1:38h for specimens counted manually vs 1:08 h for specimens analyzed on GloCyte. The average turnaround time for the 227 CSF specimens counted manually was 2:03 h compared to 1:46 h for the 133 samples analyzed on GloCyte. The MercyOne Des Moines Medical Center laboratory processed 456 CSF cell counts in 2022, equating to a reduction in turnaround time of 122–228 h annually with the implementation of GloCyte. Conclusion This study demonstrates that GloCyte can be implemented to significantly improve turnaround times for CSF cell counts. The MercyOne Des Moines Medical Center laboratory realized several benefits from the reduction in turnaround times- GloCyte has (1) freed up significant tech time for other tasks, (2) standardized CSF cell counting to mitigate tech to tech variability, (3) increased lab staff satisfaction and decreased stress levels, and (3) increased physician satisfaction. For MercyOne Des Moines Medical Center’s sister site, MercyOne West Des Moines Medical Center, a 146-bed hospital that infrequently performs CSF cell counts, GloCyte has provided peace of mind in performing cell counts accurately with techs of all skill levels.

B-014 Impact of Centrifugation Time Reduction in Laboratory Automation System

Abstract Background The centrifugation of specimens is an important preanalytical process which will be impact the most on turnaround time of the laboratory results. To verify the automation systems, we tested different combinations of tube and centrifugation settings to determine the most efficient for routine chemistry procedure. The outcomes of each combination were then compared to the benchmark to find out the best setting to reduce turnaround time for laboratory results. Methods In this study, we evaluated a total of 40 leftover blood samples that were collected on 4 mL plastic Vacutainer® (Becton Dickinson) lithium heparin tubes and 2 mL plastic Vacuette® (Greiner bio-one) lithium heparin tubes. All tubes were centrifuged on Abbott Automation GLP systems. The first set of samples was centrifuged according to the manufacturer’s guideline (10 min at 1300 × g, room temperature for Vacutainer® tubes and 10 min at 2200 × g, room temperature for Vacuette® tubes). The second set was centrifuged 7 min at 2700 × g, room temperature. And the third set was centrifuged 5 min at 2700 × g, room temperature. Then, analyzed all samples with 22 routine chemistry parameters on Alinity ci analyzers. The allowable total error and correlation coefficient (R) were used to determine the significance of the differences between 3 protocols of the centrifugation time. Results The study showed that the centrifugation times of 7 min and 5 min were not significantly different from the manufacturer’s protocol (10 min) after testing with 22 routine chemistry parameters (albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, direct bilirubin, total bilirubin, calcium, chloride, cholesterol, creatinine, low-density lipoprotein-cholesterol, iron, potassium, lactate dehydrogenase, sodium, phosphorus, total protein, triglycerides, unsaturated iron-binding capacity, high-density lipoprotein-cholesterol, urea nitrogen and uric acid) in both 4 mL plastic Vacutainer® lithium heparin tubes and 2 mL plastic Vacuette® lithium heparin tubes. Overall, the results of the study indicate that shorter centrifugation times of 7 min and 5 min at 2700 × g able to use for routine chemistry. Conclusion The study concluded that the centrifugation time did not affect the analytical results of 22 routine chemistry parameters. This suggests that shorter centrifugation times able to use with no impact on accuracy or reliability. The results of the study will support laboratory to have efficiency improvements by shorten the turnaround time on the results release.

Corrected QT Interval (QTc) Diagnostic App for the Oncological Routine: Development Study.

Numerous antineoplastic drugs such as chemotherapeutics have cardiotoxic side effects and can lead to long QT syndrome (LQTS). When diagnosed and treated in time, the potentially fatal outcomes of LQTS can be prevented. Therefore, regular electrocardiogram (ECG) assessments are critical to ensure patient safety. However, these assessments are associated with patient discomfort and require timely support of the attending oncologist by a cardiologist. This study aimed to examine whether this approach can be made more efficient and comfortable by a smartphone app (QTc Tracker), supporting single-lead ECG records on site and transferring to a tele-cardiologist for an immediate diagnosis. To evaluate the QTc Tracker, it was implemented in 54 cancer centers in Germany. In total, 266 corrected QT interval (QTc) diagnoses of 122 patients were recorded. Moreover, a questionnaire on routine ECG workflow, turnaround time, and satisfaction (1=best, 6=worst) was answered by the centers before and after the implementation of the QTc Tracker. Compared to the routine ECG workflow, the QTc Tracker enabled a substantial turnaround time reduction of 98% (mean 2.67, 95% CI 1.72-2.67 h) and even further time efficiency in combination with a cardiologic on-call service (mean 12.10, 95% CI 5.67-18.67 min). Additionally, nurses and patients reported higher satisfaction when using the QTc Tracker. In particular, patients' satisfaction sharply improved from 2.59 (95% CI 2.41-2.88) for the routine ECG workflow to 1.25 (95% CI 0.99-1.51) for the QTc Tracker workflow. These results reveal a significant improvement regarding reduced turnaround time and increased user satisfaction. Best patient care might be guaranteed as the exposure of patients with an uncontrolled risk of QTc prolongations can be avoided by using the fast and easy QTc Tracker. In particular, as regular side-effect monitoring, the QTc Tracker app promises more convenience for patients and their physicians. Finally, future studies are needed to empirically test the usability and validity of such mobile ECG assessment methods. ClinicalTrials.gov NCT04055493; https://classic.clinicaltrials.gov/ct2/show/NCT04055493.

Rapid Identification and Antimicrobial Susceptibility Testing of Gram Positive Bacteria by Direct Inoculation from Positive Blood Culture Bottles

Abstract Background Rapid identification of the causative agent for sepsis and determination of its susceptibility profile by direct inoculation of the biochemical and susceptibility testing media with the blood-broth mixtures from signal positive bottles might help reducing the time needed for provision of results compared to the standard isolated-colony based method and hence would help the rapid initiation of effective and targeted antimicrobial therapy and reduce the bacteremia-related morbidity and mortality Aim of the Work To validate the direct inoculation method as a rapid method for the identification of Gram-positive bacteremic isolates and determination of their antimicrobial susceptibility profile by comparing its results to that of the standard isolate-based method routinely used in our laboratories. Patients and Methods This study included a total of 100 positive blood culture bottles submitted to the Main Microbiology laboratory for identification and antimicrobial susceptibility testing via disk diffusion method directly from blood culture bottles and according to standard isolate-based identification method. Results There was a 100% categorical agreement between the results of the direct (primary) biochemical identification method and those of the standard isolate-based identification method. As regard AST the overall categorical agreement between both methods was 96.9%, the minor error rate was 0.8% and the major error rate was 2.3%. Conclusion Rapid Identification and Antimicrobial Susceptibility Testing of Gram-positive Bacteria is a time saving method and can help in reducing turnaround time to obtain AST results.

LABNET

The LabNet project represents a transformative initiative aimed at modernizing laboratory testing through the strategic integration of cutting-edge technologies. By implementing the innovative Laboratory at Home system, driven by the dynamic MERN stack (MongoDB, Express.js, React, Node.js), this project has successfully streamlined the entire laboratory workflow, resulting in enhanced efficiency, accuracy, and accessibility. The transition from traditional paper-based methods to a digitized platform has significantly reduced turnaround time, leading to timely delivery of critical test results to healthcare providers and patients. The seamless integration of laboratory instruments further amplifies system efficiency, automating data capture and minimizing errors. With a steadfast focus on patient outcomes, the LabNet project facilitates real-time communication among laboratory staff, healthcare providers, and patients, ultimately empowering informed decision-making and contributing to elevated healthcare services. This project embodies a revolutionary shift in laboratory management, embracing the power of digitization and automation to provide precise, timely results, and holds the potential to redefine industry standards while enhancing patient satisfaction.

Validation study of 6 dye-based SF25™ PCR amplification kit

Ever since the inception of STR-based forensic DNA analysis for human identification and DNA profiling, the approach developed continuously. Most of these developments are pertaining to achieve the set of best polymorphic loci for analysis, high inhibitor tolerance capability, and increase in sensitivity, reduction in turnaround time, and cost-effectiveness. On the similar line, the SF25™ PCR amplification kit, a 6 fluorescent dye-chemistry based autosomal STR kit was developed, which analyses 25 STR loci viz., FAM fluorescent dye-labelled D3S1358, D13S317, D7S820, D16S539, D1S1656, and Penta E; HEX fluorescent dye-labelled TPOX, TH01, D2S1338, CSF1PO, and Penta D; SUM fluorescent dye-labelled D19S433, vWA, D21S11, D18S51, and D6S1043; LYN fluorescent dye-labelled Amelogenin, D8S1179, D5S818, D12S391, and FGA; PUR fluorescent dye-labelled D22S1045, Y-indel; D2S441 and D10S1248. The developmental validation of the SF25™ PCR Amplification reagents were carried out in this study to analyze its specificity, sensitivity, and concordance. This multiplex kit showed higher sensitivity with 125 pg of DNA template generating a complete profile (with 100% allele call). Out of 316 samples, 32samples showed aberrant triallelic pattern/aberrant heterozygous pattern at D16S539 locus. The possible discrepant homozygous condition at locus D1S1656 might be due to the invasion of alleles at D1S1656 locus present adjacent to D16S539 locus. Such invasion resulted due to the shortening of the allelic bin size at the D1S1656 locus. The allelic ladder of the SF25™ PCR amplification kit reveals the allelic range of D1S1656 from 11 to 19.3 which can be interpreted according to the casework as deemed by the end-users for their samples.

A label-free electrochemical biosensor for the detection of alpha-thalassemia 1 (SEA deletion) carriers using screen-printed carbon electrodes

A label-free electrochemical DNA biosensor based on electrochemical impedance spectroscopy (EIS) biosensor has been extensively developed for diagnosing human genetic diseases. However, its application has been limited to simulated target DNA. The aim of this study was to develop an EIS biosensor that can identify carriers of alpha (α)-thalassemia 1 with Southeast Asia (SEA) deletion. The biosensor was coupled with screen-printed carbon electrodes (SPCEs) and Hoechst 33,258 dye. To determine the optimal conditions and cutoff criteria, we evaluated forty samples with known DNA genotypes. Our findings suggested that the cutoff value for identifying α-thalassemia 1 (SEA deletion) carriers was more than 26.84 kΩ of negative imaginary impedance (-Z″) and 48.83 kΩ of charge transfer resistance (Rct). The sensitivity of the developed EIS biosensor was comparable to that of conventional gel electrophoresis, with no cross-reactivity observed in α-thalassemia 1 (THAI deletion), α-thalassemia 2 (3.7 deletion), α-thalassemia 2 (4.2 deletion), and beta (β)-thalassemia carriers. The diagnostic potential of the developed EIS biosensor was evaluated using 81 clinical blood samples, demonstrating 100% sensitivity, 88.2% specificity, 83.3% positive predictive value (PPV), 100% negative predictive value (NPV) and 92.6% accuracy for Rct measurement. The developed EIS biosensor presents an attractive screening method for the detecting α-thalassemia 1 (SEA deletion) carriers due to its simplicity, cost-effectiveness, and 45-fold reduction in turnaround time compared to conventional gel electrophoresis. Consequently, the identification of α-thalassemia 1 (SEA deletion) carrier through this approach represents the most effective strategy for the management and prevention of the most severe form of thalassemia.

Application of Agile and Simulation Approaches for the Maximal Benefits of Reduced Turnaround Time from the Point of Care Testing

This paper uses simulation to explore improvement opportunities in the orthopaedic care process. Secondly, this study used a combination of simulation and agile strategies to explore agile operational plans that can be adopted to maximize the benefits of reduced turnaround time. Data used for this study was collected by observing the entire orthopaedic care process. A total of 635 observations were obtained, with 179 out of these observations undergoing the whole care process. The actual collected patient data were compared with the simulation output to validate the developed simulation. Different scenarios were developed to test operational plans for the maximal benefit of reduced turnaround time. Deployment of point-of-care platforms reduced turnaround time for sample tests. Flexibility was introduced as an agile operational plan to ensure the maximal benefit of the reduced turnaround time. The effect of flexibility on the orthopaedic care process was significant. The simulation results showed a significant decrease in patient waiting time by 86%. This study was limited to orthopaedic patients. Studies focusing on other clinical settings are encouraged. This study recommends using agile operations practices to maximize the benefit of reduced turnaround time in healthcare processes.
 Keywords: Point of care, Turnaround time, Agile and simulation

Direct detection of drug-resistant Mycobacterium tuberculosis using targeted next generation sequencing.

Mycobacterium tuberculosis complex (MTBC) infections are treated with combinations of antibiotics; however, these regimens are not as efficacious against multidrug and extensively drug resistant MTBC. Phenotypic (growth-based) drug susceptibility testing on slow growing bacteria like MTBC requires many weeks to months to complete, whereas sequencing-based approaches can predict drug resistance (DR) with reduced turnaround time. We sought to develop a multiplexed, targeted next generation sequencing (tNGS) assay that can predict DR and can be performed directly on clinical respiratory specimens. A multiplex PCR was designed to amplify a group of thirteen full-length genes and promoter regions with mutations known to be involved in resistance to first- and second-line MTBC drugs. Long-read amplicon libraries were sequenced with Oxford Nanopore Technologies platforms and high-confidence resistance mutations were identified in real-time using an in-house developed bioinformatics pipeline. Sensitivity, specificity, reproducibility, and accuracy of the tNGS assay was assessed as part of a clinical validation study. In total, tNGS was performed on 72 primary specimens and 55 MTBC-positive cultures and results were compared to clinical whole genome sequencing (WGS) performed on paired patient cultures. Complete or partial susceptibility profiles were generated from 82% of smear positive primary specimens and the resistance mutations identified by tNGS were 100% concordant with WGS. In addition to performing tNGS on primary clinical samples, this assay can be used to sequence MTBC cultures mixed with other mycobacterial species that would not yield WGS results. The assay can be effectively implemented in a clinical/diagnostic laboratory with a two to three day turnaround time and, even if batched weekly, tNGS results are available on average 15 days earlier than culture-derived WGS results. This study demonstrates that tNGS can reliably predict MTBC drug resistance directly from clinical specimens or cultures and provide critical information in a timely manner for the appropriate treatment of patients with DR tuberculosis.