Laboratory Implementation Research Articles

Verification of the Performance of the Panbio COVID-19 Ag Rapid Test Device for Implementation in the Clinical Laboratory

Objectives: The Panbio COVID-19 Ag Rapid Test Device (Panbio COVID-19 Ag, Abbott Rapid Diagnostics) is a lateral flow immunochromatographic assay targeting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleoprotein in nasopharyngeal specimens for the diagnosis of coronavirus disease 2019 (COVID-19). This study aimed to verify the performance of the Panbio COVID-19 Ag for implementation in clinical laboratories. Methods: Sixty nasopharyngeal swab specimens (30 positive and 30 negative) dipped in transport medium, and COVID-19 was confirmed using real-time RT-PCR using Allplex SARS-CoV-2 assay (Seegene), were tested using the Panbio COVID-19 Ag. Reproducibility was evaluated using positive and negative control materials. Sensitivity and specificity were calculated based on the results of real-time RT-PCR as the standard test method. Results: Reproducibility was confirmed by the consistent results of repeated tests of the quality control materials. The overall sensitivity and specificity of Panbio COVID-19 Ag were 50.0% and 100.0%, respectively. Panbio COVID-19 Ag demonstrated high sensitivity (88.2%) in analyzing the detection limit cycle threshold (Ct) value of 26.67 provided by the manufacturer as a positive criterion, and the sensitivity was 100.0% for the positive criterion of Ct values <25, although it was less sensitive for Ct ≥25. Conclusion: Considering the high sensitivity for positive samples with Ct values <25 and the rapid turnaround of results, Panbio COVID-19 Ag can be used in clinical laboratories to diagnose COVID-19 in limited settings.

Test Performance and Potential Clinical Utility of the GenMark Dx ePlex Blood Culture Identification Gram-Negative Panel.

The test performance and potential clinical utility of the ePlex blood culture identification Gram-negative (BCID-GN) panel was evaluated relative to matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry on bacterial isolates and conventional antimicrobial susceptibility testing. The majority (106/108, 98.1%) of GN bacteria identified by MALDI were on the BCID-GN panel, and valid tests (107/108, 99.1%) yielded results on average 26.7 h earlier. For all valid tests with on-panel organisms, the positive percent agreement was 102/105 (97.2%) with 3 false negatives and the negative percent agreement was 105/105. Chart review (n = 98) showed that in conjunction with Gram stain results, negative pan-Gram-positive (GP) markers provided the opportunity to discontinue GP antibiotic coverage in 63/98 (64.3%) cases on average 26.2 h earlier. Only 8/12 (66.7%) Enterobacterales isolates with resistance to third-generation cephalosporins harbored the CTX-M gene. In contrast, 8/8 CTX-M+ samples yielded a resistant isolate. Detection of 1 Stenotrophomonas maltophilia (18 h), 1 OXA23/48+ Acinetobacter baumannii (52.4 h), and 3 CTX-M+ Enterobacterales isolates on ineffective treatment (47.1 h) and 1 on suboptimal therapy (72.6 h) would have additionally enabled early antimicrobial optimization in 6/98 (6.1%) patients. IMPORTANCE The GenMark Dx ePlex rapid blood culture diagnostic system enables earlier time to identification of antimicrobial-resistant Gram-negative bacteria causing bloodstream infections. Its ability to rule out Gram-positive bacteria enabled early discontinuation of unnecessary antibiotics in 63/98 (64.3%) cases on average 26.2 h earlier. Detection of bacteria harboring the CTX-M gene as well as early identification of highly resistant bacteria such as Stenotrophomonas maltophilia and Acinetobacter baumannii enabled optimization of ineffective therapy in 6/98 (6.1%) patients. Its implementation in clinical microbiology laboratories optimizes therapy and improves patient care.

Foam EOR as an Optimization Technique for Gas EOR: A Comprehensive Review of Laboratory and Field Implementations

Foam-enhanced oil recovery (EOR) is poised to become one of the most promising tertiary recovery techniques to keep up with the continuously increasing global energy demands. Due to their low sensitivity to gravity and permeability heterogeneities that improve sweep efficiency, foams are the preferred injection fluids over water or gas. Although foam injection has been used in the field to improve oil recovery and control gas mobility, its success is still hindered by several conceptual and operational challenges with regard to its stability and foamability under reservoir conditions. This can be attributed to the insufficient attention given to the mechanisms underlying foam generation and stability at the microscopic level in many studies. For a deeper understanding, this study reviews the most pertinent published works on foam-EOR. The major objective is to provide a broad basis for subsequent laboratory and field applications of foam-EOR. In this work, we highlighted foam classification and characterization, as well as the crucial factors impacting foam formation, stability, and oil recovery. Additionally, the principal mechanisms of foam generation are thoroughly explained. Finally, the most recent developments in foam generation and stability improvement are discussed. Foam-EOR is comprehensively reviewed in this work, with an emphasis on both theoretical and practical applications.

Structural testing of concrete walls on-edge with combined axial and out-of-plane loading

Full-scale testing of structural components can be time consuming and difficult. The design of full-scale slender concrete walls is highly influenced and controlled by second-order and out-of-plane bending loads. Previous experiments on out-plane bending of slender walls and insulated walls have been performed with bending in the direction of gravity (with or against). Additionally, most of the research considering out-of-plane bending does not include an axial load and suffers from inaccurate results due to not simulating the actual loading and constraining conditions or safety issues. This testing method was developed expressly for the determination of slender wall behavior in insulated concrete panels and verified on solid slender walls, which are well understood. The testing setup presented has the following advantages•Reduces the risk of cracking panel prior to testing and provides safe and rapid testing.•Offers ease of implementation in labs with height restrictions, given sufficient floor space.•Integrates axial and lateral uniform loading.

Laboratory Results Release to Patients under the 21st Century Cures Act: The Eight Stakeholders Who Should Care.

A major aim of the 21st Century Cures Act is to support patients' access to their electronic health data and to prevent information blocking practices by health care organizations and health information technology developers. Prior to the Cures Act, significant variation existed in patient access to laboratory test results, key pieces of health data which enable timely self-management and engagement in care. Although many health care systems began releasing test results immediately through patient portals because of the Cures Act, implementation remains challenging due to variations in state regulations around electronic results release, local interpretations of allowable exceptions to Cures information blocking, concerns about privacy of sensitive laboratory results, and technological limitations. This paper outlines the eight stakeholder groups involved in implementation of electronic laboratory result release to patients and describes recommendations for these groups to consider in achieving the Cures Act goals to support a patient's access to their health information and control of their health care.

Virtual Training Laboratory for Primary Impedance Metrology

This article presents the concept and some aspects of the physical implementation of a virtual training laboratory (VTL) in the field of primary impedance metrology. The creation of a VTL provides a novel method of disseminating metrological knowledge and expertise in a practical way and at a low cost. It will expose new users to the live experience of operating a digital impedance bridge thus helping to encourage the uptake of this novel and useful impedance measurement technology. The VTL was developed as part of the EMPIR projects VersICal 17RPT04, A versatile electrical impedance calibration laboratory based on digital impedance bridges, and GIQS 18SIB07, Graphene impedance quantum standard.

Digital pathology implementation in a private laboratory: The CEDAP experience

IntroductionThe transition to digital pathology has been carried out by several laboratories across the globe, with some cases described in Portugal. In this article, we describe the transition to digital pathology in a high-volume private laboratory, considering the main challenges and opportunities. Material and methodsOur process started in 2020, with laboratory workflow adaptation and we are currently using a high-capacity scanner (Aperio GT450DX) to digitize slides at 20×. The visualization system, Aperio eSlide Manager WebViewer, is integrated into the Laboratory System. The validation process followed the Royal College of Pathologists Guidelines. ResultsRegarding validation, the first phase detected an error rate of 6.8%, mostly due to digitization errors. Phase optimization and collaboration with technical services led to improvements in this process. In the second validation phase, most of the slides had the desired quality for evaluation, with only an error rate of 0.6%, corrected with a new scan. The interpathologist correlation had a total agreement rate of 96.87% and 3.13% partial agreement. ConclusionThe implementation and validation of digital pathology was a success, being ready for prime time. The total integration of all laboratory systems and the acquisition of new equipment will maximize their use, especially with the application of artificial intelligence algorithms.

METHODOLOGY FOR TEACHING LABORATORY CLASSES IN PHYSICS THROUGH THE STEM METHOD

STEM (Science, Technology, Engineering, Mathematics) is designed to explore what information is available to mechanical engineering students in higher education institutions and what work is being done there. Nowadays, modern teaching methods are used in educational institutions, and one of such methods is the STEM method. Based on global experience, we know that this method is an interdisciplinary approach used to provide students with a broad and deep education in the sciences. The widespread use of information and communication technologies in the field of science education has led to the emergence of a new type of educational experiment - a virtual experiment. This is considered a form of virtual simulation of STEM technologies. The implementation of virtual laboratories using computer programs that simulate physical processes virtually on a computer and allow changing its operating conditions and parameters is a type of STEM method. Such a program creates a unique situation for the implementation of interactive learning. We reviewed scientific literature published in peer-reviewed, high-ranking journals on the development of problem-solving abilities in STEM-rich physics teaching. Based on STEM education, mechanical engineering students were given stages of teaching specific content topics related to curriculum concepts. In order to increase the effectiveness of teaching the STEM method in laboratory classes of the Faculty of Mechanics, an article devoted to this issue discusses ways to use interactive modeling PhET, Algodoo - a digital programming language for 2D physical modeling, computer modeling "Open Physics". programs. One of the main principles of STEM education is to teach future physicists to acquire industrial experience and methodologically sophisticated research methods. The second important issue is the development of industrial business, that is, access to new ideas in response to production problems. It can be seen that the results obtained during the study of the STEM method of teaching in laboratory classes at the Department of Mechanics show great interest in providing students with teaching aids. The information obtained as a result of the study is recommended for use in higher and secondary educational organizations, and these results are the basis for new directions of research in the field of physics education.

Profile of Acute Encephalitis Syndrome Patients from South India.

Encephalitis is a major public health problem worldwide that causes huge emotional and economic loss to humanity. Encephalitis, being a serious illness, affects people of all ages. The aim is to describe the sociodemographic, clinical, etiological, and neuroimaging profile among 101 acute encephalitis syndrome (AES) patients visiting a tertiary neuro-specialty care hospital in India. Record review of medical records of all patients attending neurology emergency and outpatient services at NIMHANS Hospital, diagnosed with AES in 2019, was conducted. Data were collected using standardized data collection forms for all cases in the study. Descriptive analyses (mean and standard deviation for continuous variables and proportions for categorical variables) were conducted. The Chi-square test/Fisher's exact test was used for the comparison of independent groups for categorical variables, and t-test for comparing means for continuous variables. About 42.6% of AES patients had viral etiology, while in 57.4%, etiology was not ascertained. Common presenting symptoms were fever (96%), altered sensorium (64.4%), seizures (70.3%), headache (42.6%), and vomiting (27.7%). Herpes simplex was the most common (21.8%) identified viral encephalitis, followed by chikungunya (5%), arboviruses (chikungunya and dengue) (4%), Japanese encephalitis (4%), rabies (3%), dengue (1%), and varicella virus (1%). About 40% of AES patients showed cerebrospinal fluid pleocytosis (44%), increased protein (39.6%), abnormal computed tomography brain (44.6%), and magnetic resonance imaging abnormalities (41.6%). The study highlights the need to ascertain etiology and importance of evidence-based management of AES patients. A better understanding of opportunities and limitations in the management and implementation of standard laboratory and diagnostic algorithms can favor better diagnosis and management of AES.

Clinical Decision Support systems: A step forward in establishing the clinical laboratory as a decision maker hub - A CDS system protocol implementation in the clinical laboratory

BackgroundNew tools for health information technology have been developed in recent times, such as Clinical Decision Support (CDS) systems, which are any digital solutions designed to help healthcare professionals when making clinical decisions. The study aimed to show how we have adopted a CDS system in the San Juan de Alicante Clinical Laboratory and facilitate the implementation of our protocol in other clinical laboratories. We have user experience and the motivation to improve healthcare tools. The improvement, measurement, and monitoring of interventions and laboratory tests has been our motto for years. Materials and methodsA descriptive research was conducted. All stages in the design of the project are as follows: 1. Set up a multidisciplinary workgroup. 2. Review patients’ data. 3. Identify relevant data from main sources. 4. Design the likely outcomes. 5. Define a complete integration scenario. 6. Monitor and track the impact. To set up this protocol, two new software systems were implemented in our laboratory: AlinIQ CDS v8.2 as Rule Engine, and AlinIQ AIP Integrated Platform v1.6 as Business Intelligence (BI) tool. ResultsOur protocol shows the workflow and actions that can be done with a CDS system and also how it could be integrated with other monitoring systems, as well as some examples of KPIs and their outcomes. ConclusionsCDS could be a great strategic asset for clinical laboratories to improve the integration of care, optimize the use of laboratory tests, and add more clinical value to physicians in the interpretation of results.

Effect of Night Shift Work in Clinical Laboratories on Pediatric Complete Blood Count Results.

There has been much research into the impact of shift systems on clinicians and nurses, but little research into quality control in clinical laboratories. This topic focuses on assessing the impact of shift systems on clinical laboratory scientists. A total of 34,955 CBCs from pediatric patients who visited the hospital during night-time hours over a period of three years were selected for analysis. The quality of routine blood tests was evaluated using four indica-tors: red blood cell count, white blood cell count, platelet count, and hemoglobin levels. The effects of gender, years of experience, and length of the night shift on test results were evaluated separately for each clinical laboratory scientist. The results showed that the gender and years of experience of the clinical laboratory scientists did not affect the CBC results. However, a significant impact was observed as the number of hours worked on night shifts increased. The findings of this study suggest that the night shift schedule of clinical laboratory scientists can have an impact on the accuracy of pediatric CBCs. It is essential for healthcare institutions to consider the length of night shifts for clinical laboratory scientists and implement measures to minimize the impact on test results.

‘Consociatio vita minabatur procursus’: Citrobacter freundii outbreak causing periculosus neonatal septicaemia in neonatal intensive care unit of tertiary care hospital

Abstract Background: Citrobacter freundii is a common cause of neonatal intensive care unit (NICU) outbreaks, causing high morbidity and mortality as a hospital-acquired pathogen. This is the first study from our geographic region, which makes it of utmost importance for spreading awareness about this unusual pathogen amongst healthcare settings. Aim: Investigating an outbreak caused by C. freundii in the NICU of a tertiary care hospital. Settings and Design: During the month of May 2023, an outbreak of C. freundii causing neonatal septicaemia was suspected in the NICU of a tertiary care hospital in Western Uttar Pradesh. The outbreak was investigated and surveillance conducted by the hospital infection control (HIC) team, to find a source of the infection by root cause analysis (RCA), to study clinical profiles and outcomes, to determine their antimicrobial susceptibility pattern, to take corrective action preventive action (CAPA). Materials and Methods: A total of 132 blood samples were tested for blood culture and sensitivity using the BD FX40 system. Positive flagged bottles were processed for Gram stain and sub-cultured on 5% sheep blood agar and MacConkey’s agar media plates. Final bacterial identification and antibiotic susceptibility were done with an automated BD-Phoenix M-50 system. Results: C. freundii with similar antimicrobial susceptibility was identified in seven neonates, contributing to a major percentage of neonatal blood culture positivity of 13.7%, out of a total positivity rate of 38.63%. The mortality rate of this outbreak was 28.57%. The HIC team investigates this outbreak for CAPA and RCA. On environmental surveillance, C. freundii was isolated from infant incubators, dressing trolleys, and laryngoscope blades of the NICU. Discussion: C. freundii association in Blood culture from critical areas patients is life-threatening ‘Consociatio Vita Minabatur Procursus’. Direct access to the bloodstream causing neonatal septicaemia in a short time is a concern for its potential severity, making it as ‘Periculosus Pathogen’. Laboratory automation and implementation of strict infection control strategies in critical areas can improve clinical outcomes and prevent future outbreaks.

Implementation of NPIVL to Improve Critical Thinking Skills of Pre-Service Physics Teacher

This study aimed to describe the critical thinking skills of pre-service physics teacher through the implementation of the Nuclear Physics Inquiry Virtual Laboratory (NPIVL) program. This study used a quantitative pre-experimental study with one group pretest-posttest design involving 14 pre-service physics teachers at one of universities in Banjarmasin, South Kalimantan. The research sample was taken using purposive sampling. The instrument used in this study was a test of critical thinking skills with 25 essay type questions. The questions were compiled based on five indicators of critical thinking skills, namely elementary clarification, basic support, inference, advanced clarification, and strategy and tactics. Data were analyzed using quantitative descriptive. Based on the results of the study, it was found that pre-service physics teachers’ critical thinking skills had a normalized N-gain of 0.33 in the medium category. The percentage of the increase in critical thinking skills indicators was varied, from the largest were basic support, elementary clarification, inference, advanced clarification, and the smallest was strategy and tactics. Based on these findings it can be concluded that the implementation of the NPIVL program can improve the thinking skills of pre-servive physics teacher.

Social Media Labs in the Social Education Degree: Exploring Digital Competences of University Students

Social media labs, as spaces for experimentation, have recently become one of the main mechanisms for innovation. The role of universities, with degrees focused on subjects linked to social innovation, can be a fundamental factor in social development. It is essential to transform traditional centres into spaces for dialogue, into creative ecosystems, simultaneously dedicated to reflection and debate, research and production, training, and socialisation. Within this framework, we carried out ethnographic research on the implementation of a social media laboratory developed with social education students during the last two academic years at the faculty of education in Palencia. The results provide evidence of the development by university students in some skills related to creativity, reflection, and debate, as well as various digital skills. In line with the existing literature, we show how the social media laboratory enables the acquisition of knowledge situated in the social reality of the environment that is of great use to future social educators, as well as some of its limitations in these processes of experimentation and social innovation.

The Use of Virtual Reality Technology in Intelligent Transportation Systems Education

Simulation-based education is a critical component of Intelligent Transportation Systems (ITS) education. This study discusses the experimental success of using Virtual Reality (VR) technology in simulation-based ITS education, which was found to improve the quality of education while increasing immersion and motivation. The study documents the application of VR technology to a microscopic simulation model within the ITS curriculum. Furthermore, the study also proposes using a standardized methodology to capture and evaluate students’ subjective experiences. The findings of the study are discussed, along with potential ways to improve the planned VR technology implementation in the ITS laboratory.

Profiling oocytes with neural networks from images and mechanical data

The success rate of assisted reproductive technologies could be greatly improved by selectively choosing egg cells (oocytes) with the greatest chance of fertilization. The goal of mechanical profiling is, thus, to improve predictive oocyte selection by isolating the mechanical properties of oocytes and correlating them to their reproductive potential. The restrictions on experimental platforms, however – including minimal invasiveness and practicality in laboratory implementation – greatly limits the data that can be acquired from a single oocyte. In this study, we perform indentation studies on human oocytes and characterize the mechanical properties of the zona pellucida, the outer layer of the oocyte. We obtain excellent fitting with our physical model when indenting with a flat surface and clearly illustrate localized shear-thinning behavior of the zona pellucida, which has not been previously reported. We conclude by outlining a promising methodology for isolating the mechanical properties of the cytoplasm using neural networks and optical images taken during indentation.

Designing A Science Lesson: Developing Pre-service Teachers' Lesson Planning Skills Based on Real-life Context-based Approach

In this study, it was aimed to support pre-service primary and science teachers’ ability to implement real-life context-based course design in the 5E Model and to use current science education approaches in lesson designs. For this purpose, action research, one of the qualitative research types, was adopted. 13 pre-service primary and science teachers participated in the research. The data of the study were obtained from pre-post measurements, lesson plans developed by the pre-service teachers and observations made by the researchers as participant observers. The data were analyzed with descriptive and content analysis methods. The preliminary results show that pre-service teachers could not use basic teaching approaches such as the real-life contextual approach, nature of science,
 scientific reasoning, STEM activities, Web 2.0 tools, laboratory implementations. At the end of the trainings, pre-service teachers’ competencies in preparing a science lesson plan based on context-based science teaching and in accordance with the current and basic science education paradigm increased significantly. This study supported the pre-service teachers’ science self-efficacy for introducing current practices related to science teaching during their undergraduate education to become classroom and science teachers and to gain skills on how to reflect these practices in lesson plans. The findings indicate that there is a need for practical training in teacher training due to field studies in Turkey, and that pre-service teachers should adopt the 21st century science teaching approach.

Determination of tryptamine analogs in whole blood by 96-well electromembrane extraction and UHPLC-MS/MS

Tryptamines are a class of new psychoactive substances relevant for analysis in forensic laboratories. Tryptamine analogs are diverse in structure and chemical properties, and prone to display instability. This puts high demands on sample preparation, especially from complex matrices such as whole blood. In the present paper, a prototype 96-well electromembrane extraction (EME) device was employed for the simultaneous extraction of 20 tryptamines from whole blood prior to UHPLC-MS/MS analysis. For the EME procedure, spiked whole blood diluted 3-fold with 1% ascorbic acid in 25 mM formic acid was extracted for 60 min across a supported liquid membrane (SLM) containing 5% bis(2-ethylhexyl) ether (DEHP) in 2-nitrophenyloctylether (NPOE) into an acceptor solution containing 1% ascorbic acid in 25 mM formic acid. The method was validated for 16 of the tryptamines in the range 5-500 nM according to SWGTOX guidelines and the analytes displayed limits of detection from >0.15 nM to 0.75 nM. An AGREEprep analysis was performed to evaluate method greenness with a final greenness score of 0.76. 96-well EME offered fast, efficient and green extraction of tryptamines from whole blood, demonstrating good potential for implementation in forensic laboratories when commercial devices will become available.

Analytical Validation of the Quanterix Neurofilament Light Chain (NfL) Advantage Assay in Plasma

AbstractBackgroundNeurofilament light chain (NfL) is an emerging blood‐based biomarker useful for assessing neuro‐axonal injury in several neurological conditions. Plasma NfL concentrations reflect the extent of axonal damage, making it a general marker of neurodegenerative disease progression. This study evaluates the analytical performance characteristics of the Quanterix NfL Advantage method in EDTA‐plasma.MethodThe assay was performed per manufacturer’s instructions on the Quanterix Simoa HD‐X Analyzer. Analytical validation included analyte stability, imprecision, lower limit of quantification (LLOQ), analytical measurement range (AMR), accuracy, and interferences. One‐sided reference intervals were established using quantile regression methods among 1100 cognitive normal individuals, age 20 to 95 years without known chronic kidney disease, stroke, or myocardial infarction.ResultNfL was stable in plasma three days ambient, seven days refrigerate, 90 days frozen (‐20C), and over 3 freeze/thaw cycles. Intra and inter‐assay imprecision, expressed as % coefficient of variation (%CV), ranged from 3.4 – 6.0% and 5.9 – 11.6% respectively. The LLOQ was evaluated using patient plasma pools at concentrations of 1.7 and 3.6 pg/mL. %CVs were 16.8% and 9.7% respectively, and the LLOQ was set at 3.0 pg/mL. Accuracy was assessed by spiking 5 plasma samples with NfL calibratoran 87% average recovery (range 81‐94%) was observed. The AMR of 3.0 – 1500 pg/mL was verified with a regression slope of 0.93 and r2 > 0.99. Additionally, plasma admixtures covering the AMR showed acceptable linear response (slope of 1.02 and r² >0.99). The assay was not affected by icterus to 100 mg/dL, lipemia to 1000 mg/dL, hemolysis to 1000 mg/dL at NfL concentrations >30 pg/mL or to 200 mg/dL at NfL concentrations ≤30 pg/mL. NfL increased with age but did not differ by sex. The data supported age‐based reference intervals broken down into 10‐year intervals. The 97.5th percentile limits were: 20s: ≤8.4 pg/mL, 30s: ≤11.4 pg/mL, 40s: ≤15.4 pg/mL, 50s: ≤20.8 pg/mL, 60s: ≤28.0 pg/mL, 70s: ≤37.9 pg/mL, 80+: ≤51.2 pg/mL.ConclusionThe analytical performance characteristics of the plasma Quanterix NfL advantage assay were deemed acceptable for clinical laboratory implementation. The establishment of NfL reference intervals will aid in the clinical interpretation of patient plasma NfL concentrations.

Validation of a fully automated lab developed test for plasma phospho‐tau 181 levels for Alzheimer’s disease diagnosis

AbstractBackgroundThe potential usefulness of plasma phosphorylated tau (pTau) measurements for identifying individuals likely to be on the Alzheimer’s disease (AD) continuum is evident from recent literature. Here we report the validation of an immunoassay for measurement of pTau181 in human plasma that will aid in the evaluation of Alzheimer’s pathology in cases presenting with mild cognitive impairment.MethodThe Simoa pTau‐181 assay is a fully automated 2‐step digital sandwich immunoassay that utilizes paramagnetic beads with capture antibodies and biotinylated detector antibodies. Digital detection is achieved using Simoa discs via SβG (Streptavidin‐ß‐galactosidase) and RGP (Resorufin‐β‐D‐galactopyranoside) amplification of specific pTau181 immune complexes. Harmonization to the Simoa pTau‐181 method described by Karikari et al (Mol Psychiatry. 2021;26(2):429‐442) using 80 samples, establishes commutability with published results from ADNI cohorts. Analytical validation on HD‐X instrument followed CLSI guidelines. Thirty‐four AD cases from the Amsterdam Dementia Cohort (age 66 ± 8 years) diagnosed according to the NIA‐AA diagnostic AD criteria and had a CSF biomarker‐confirmed AD diagnosis, 36 age‐ and sex‐matched (age 66 ± 8 years) cognitively healthy controls from the Dutch Brain Research Registry were included for clinical validation of this LDT.ResultThe limits of detection (LoD) and quantification (LoQ) were 0.056 pg/mL and 0.276, respectively. Repeatability and reproducibility across 3 reagent lots using samples across the measuring range were 4.25% (95%CI:2.84‐5.65), 9.42% (95% CI: 4.46‐14.37) respectively. Linearity was demonstrated per CLSI EP06‐A, as ≤15% deviation at all dilutions. Cross reactivity against full length unphosphorylated‐Tau441 and synthetic peptides for pTau231 and pTau217 epitopes was below LoQ. ROC analysis resulted in a high AUC (area under the curve) of 0.897 (95% CI 0.825 to 0.969). Applying the cut‐offs described in Karikari1 (17.7 pg/mL) for this cohort resulted in a sensitivity of 94%, specificity of 72%.ConclusionThis test demonstrated acceptable analytical performance for CLIA laboratory implementation. High AUC of 0.897 to discriminate AD from non‐AD cases helps both rule‐in or rule‐out scenarios, and further allows for setting of cut‐off values that not only take the pretest probability, impact on screening algorithm, treatment protocols into consideration but also the costs incurred by misdiagnosis.