Factors of a physician quality improvement leadership coalition that influence physician behaviour: a mixed methods study.

BACKGROUND: A coalition (Strategic Clinical Improvement Committee), with a mandate to promote physician quality improvement (QI) involvement, identified hospital laboratory test overuse as a priority. The coalition developed and supported the spread of a multicomponent initiative about reducing repetitive laboratory testing and blood urea nitrogen (BUN) ordering across one Canadian province. This study's purpose was to identify coalition factors enabling medicine and emergency department (ED) physicians to lead, participate and influence appropriate BUN test ordering. METHODS: Using sequential explanatory mixed methods, intervention components were grouped as person focused or system focused. Quantitative phase/analyses included: monthly total and average of the BUN test for six hospitals (medicine programme and two EDs) were compared pre initiative and post initiative; a cost avoidance calculation and an interrupted time series analysis were performed (participants were divided into two groups: high (>50%) and low (<50%) BUN test reduction based on these findings). Qualitative phase/analyses included: structured virtual interviews with 12 physicians/participants; a content analysis aligned to the Theoretical Domains Framework and the Behaviour Change Wheel. Quotes from participants representing high and low groups were integrated into a joint display. RESULTS: Monthly BUN test ordering was significantly reduced in 5 of 6 participating hospital medicine programmes and in both EDs (33% to 76%), resulting in monthly cost avoidance (CAN$900-CAN$7285). Physicians had similar perceptions of the coalition's characteristics enabling their QI involvement and the factors influencing BUN test reduction. CONCLUSIONS: To enable physician confidence to lead and participate, the coalition used the following: a simply designed QI initiative, partnership with a coalition physician leader and/or member; credibility and mentorship; support personnel; QI education and hands-on training; minimal physician effort; and no clinical workflow disruption. Implementing person-focused and system-focused intervention components, and communication from a trusted local physician-who shared data, physician QI initiative role/contribution and responsibility, best practices, and past project successes-were factors influencing appropriate BUN test ordering.

New Translational Trends in Personalized Medicine: Autologous Peripheral Blood Stem Cells and Plasma for COVID-19 Patient.

The COVID-19 pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), still remains a severe threat. At the time of writing this paper, the second infectious wave has caused more than 280,000 deaths all over the world. Italy was one of the first countries involved, with more than 200,000 people reported as infected and 30,000 deaths. There are no specific treatments for COVID-19 and the vaccine still remains somehow inconclusive. The world health community is trying to define and share therapeutic protocols in early and advanced clinical stages. However, numbers remain critical with a serious disease rate of 14%, ending with sepsis, acute respiratory distress syndrome (ARDS), multiple organ failure (MOF) and vascular and thromboembolic findings. The mortality rate was estimated within 2-3%, and more than double that for individuals over 65 years old; almost one patient in three dies in the Intensive Care Unit (ICU). Efforts for effective solutions are underway with multiple lines of investigations, and health authorities have reported success treating infected patients with donated plasma from survivors of the illness, the proposed benefit being protective antibodies formed by the survivors. Plasma transfusion, blood and stem cells, either autologous or allograft transplantation, are not novel therapies, and in this short paper, we propose therapeutic autologous plasma and peripheral blood stem cells as a possible treatment for fulminant COVID-19 infection.

A Computational Approach in the Diagnostic Process of COVID-19: The Missing Link between the Laboratory and Emergency Department.

BACKGROUND: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the COVID-19 pandemic and so it is crucial the right evaluation of viral infection. According to the Centers for Disease Control and Prevention (CDC), the Real-Time Reverse Transcription PCR (RT-PCR) in respiratory samples is the gold standard for confirming the disease. However, it has practical limitations as time-consuming procedures and a high rate of false-negative results. We aim to assess the accuracy of COVID-19 classifiers based on Arificial Intelligence (AI) and statistical classification methods adapted on blood tests and other information routinely collected at the Emergency Departments (EDs). METHODS: Patients admitted to the ED of Careggi Hospital from April 7th-30th 2020 with pre-specified features of suspected COVID-19 were enrolled. Physicians prospectively dichotomized them as COVID-19 likely/unlikely case, based on clinical features and bedside imaging support. Considering the limits of each method to identify a case of COVID-19, further evaluation was performed after an independent clinical review of 30-day follow-up data. Using this as a gold standard, several classifiers were implemented: Logistic Regression (LR), Quadratic Discriminant Analysis (QDA), Random Forest (RF), Support Vector Machine (SVM), Neural Networks (NN), K-nearest neighbor (K-NN), Naive Bayes (NB). RESULTS: Most of the classifiers show a ROC >0.80 on both internal and external validation samples but the best results are obtained applying RF, LR and NN. The performance from the external validation sustains the proof of concept to use such mathematical models fast, robust and efficient for a first identification of COVID-19 positive patients. These tools may constitute both a bedside support while waiting for RT-PCR results, and a tool to point to a deeper investigation, by identifying which patients are more likely to develop into positive cases within 7 days. CONCLUSIONS: Considering the obtained results and with a rapidly changing virus, we believe that data processing automated procedures may provide a valid support to the physicians facing the decision to classify a patient as a COVID-19 case or not.

Direct-to-consumer laboratory testing (DTCT): challenges and implications for specialists in laboratory medicine.

In vitro diagnostics (IVD) testing is a powerful tool for medical diagnosis, and patients' safety is guaranteed by a complex system of personnel qualification of the specialist in laboratory medicine, of process control, and legal restrictions in healthcare, most of them under national regulation. Direct-to-consumer laboratory testing (DTCT) is testing ordered by the consumer and performed either by the consumer at home or analysis of self-collected samples in a laboratory. However, since DTCT are not always subject to effective competent authority oversight, DTCT may pose risks to lay persons using and relying on it for healthcare decision-making. Laboratory medicine specialists should be very cautious when new DTCTs are introduced. As qualified professionals, they should feel obliged to warn and educate patients and the public about the risks of inappropriate and harmful DTCT.

Central role of laboratory medicine in public health and patient care.

Clinical laboratories play a vital role in the healthcare system. Objective medical data provided by clinical laboratories supports approximately 60-70% of clinical decisions, however, evidence supporting this claim is poorly documented and laboratories still lack visibility, despite their indisputable impact on patient care and public health. The International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Outcome Studies in Laboratory Medicine (TF-OSLM) was recently developed to support directed research evaluating the role of laboratory medicine on clinical outcomes. Establishing and documenting this evidence is key to enhance visibility of the field in the eye of the public and other healthcare professionals together with optimizing patient outcomes and health care system operations. In this review, we discuss four areas that exemplify the contribution of laboratory medicine directly to patient care. This includes high-sensitivity cardiac troponin (hs-cTn) and N-terminal pro-B-type natriuretic peptide/B-type natriuretic peptides (NT-proBNP/BNP) for the diagnosis and prognosis of myocardial infarction and heart failure, respectively, and procalcitonin for the management of sepsis and antibiotic stewardship. Emerging markers of traumatic brain injury and the role of laboratory medicine in the fight against the COVID-19 pandemic are discussed along with an introduction to plans of IFCC TF-OSLM.

Positivization time of a COVID-19 rapid antigen self-test predicts SARS-CoV-2 viral load: a proof of concept.

OBJECTIVES: This proof of concept study was aimed to validate the hypothesis that the time of positivization of SARS-CoV-2 self-performed rapid diagnostic tests (RDTs) may reflect the actual viral load in the specimen. METHODS: A SARS-CoV-2 positive sample with high viral load was diluted and concomitantly assayed with molecular assay (Xpert Xpress SARS-CoV-2) and RDT (COVID-VIRO ALL IN RDT). The (mean cycle threshold; Ct) values and RDT positivization times of these dilutions were plotted and interpolated by calculating the best fit. The parameters of this equation were then used for converting the positivization times into RDT-estimated SARS-CoV-2 Ct values in routine patient samples. RESULTS: The best fit between measured and RDT-estimated Ct values could be achieved with a 2-degree polynomial curve. The RDT-estimated Ct values exhibited high correlation (r=0.996) and excellent Deming fit (y=1.01 × x - 0.18) with measured Ct values. In 30 consecutive patients with positive RDT test, the correlation between RDT positivization time and measured Ct value was r=0.522 (p=0.003). The correlation of RDT-estimated and measured Ct values slightly improved to 0.577 (Deming fit: y=0.44 × x + 11.08), displaying a negligible bias (1.0; 95% CI, -0.2 to 2.2; p=0.105). Concordance of RDT-estimated and measured Ct values at the <20 cut-off was 80%, with 0.84 sensitivity and 0.73 specificity. CONCLUSIONS: This proof of concept study demonstrates the potential feasibility of using RDTs for garnering information on viral load in patients with acute SARS-CoV-2 infection.

Do Circulating Histones Represent the Missing Link among COVID-19 Infection and Multiorgan Injuries, Microvascular Coagulopathy and Systemic Hyperinflammation?

Several studies shed light on the interplay among inflammation, thrombosis, multi-organ failures and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Increasing levels of both free and/or circulating histones have been associated to coronavirus disease 2019 (COVID-19), enhancing the risk of heart attack and stroke with coagulopathy and systemic hyperinflammation. In this view, by considering both the biological and clinical rationale, circulating histones may be relevant as diagnostic biomarkers for stratifying COVID-19 patients at higher risk for viral sepsis, and as predictive laboratory medicine tool for targeted therapies.

Diagnostic and Therapeutic Potential for HNP-1, HBD-1 and HBD-4 in Pregnant Women with COVID-19.

Pregnancy is characterized by significant immunological changes and a cytokine profile, as well as vitamin deficiencies that can cause problems for the correct development of a fetus. Defensins are small antimicrobial peptides that are part of the innate immune system and are involved in several biological activities. Following that, this study aims to compare the levels of various cytokines and to investigate the role of defensins between pregnant women with confirmed COVID-19 infection and pregnant women without any defined risk factor. TNF-α, TGF-ß, IL-2 and IL-10, ß-defensins, have been evaluated by gene expression in our population. At the same time, by ELISA assay IL-6, IL-8, defensin alpha 1, defensin beta 1 and defensin beta 4 have been measured. The data obtained show that mothers affected by COVID-19 have an increase in pro-inflammatory factors (TNF-α, TGF-ß, IL-2, IL-6, IL-8) compared to controls; this increase could generate a sort of "protection of the fetus" from virus attacks. Contemporarily, we have an increase in the anti-inflammatory cytokine IL-10 and an increase in AMPs, which highlights how the mother's body is responding to the viral attack. These results allow us to hypothesize a mechanism of "trafficking" of antimicrobial peptides from the mother to the fetus that would help the fetus to protect itself from the infection in progress.

Clinical performance of Fujirebio Lumipulse G SARSCoV- 2 Ag chemiluminescent immunoassay.

We evaluated the performance of Fujirebio Lumipulse G SARS-CoV-2 Ag chemiluminescent immunoassay. A nasopharyngeal swab was collected from 160 subjects and assayed simultaneously with Fujirebio Lumipulse G SARS-CoV-2 Ag and Altona Diagnostics RealStar SARS-CoV-2 RT-PCR assays. Using 0.60 pg/mL diagnostic threshold, Fujirebio Lumipulse G SARS-CoV-2 Ag displayed 0.88 area under the curve, 0.88 sensitivity and 0.75 specificity compared to molecular testing. The area under the curve increased to 1.00 after excluding samples with low viral load (i.e., cycle threshold values between 25-37). Thus, this chemiluminescent immunoassay could be used for rapid identification of many subjects with high nasopharyngeal SARS-CoV-2 viral load.

COVID-19 in pregnancy: underestimated risk

The almost relentless worldwide diffusion of severe acute respiratory syndrome coronavirus (SARS-CoV-2) is deeply engaging the minds of many scientists, clinicians and laboratory professionals, who struggle to identify the possible short- and long-term consequences of coronavirus disease 2019 (COVID-19) in the general population, as well as in specific cohorts of individuals, who may display peculiar features of infection. Pregnant women represent one of these categories, since the biological implications of SARS-CoV-2 infection extend far beyond those caused to the mother, involving also the fetus. Several lines of evidence now attest that although mother-to-child SARS-CoV-2 transmission is relatively rare (<2% of all pregnancies), the consequences on maternal-fetal-neonatal interface of COVID-19 can be very serious. To this end, some important questions raise, such as "is COVID-19 a risk factor for complications in pregnancy?", "which laboratory tests are more predictable of unfavorable pregnancy outcomes?", "how efficacious is COVID-19 vaccination in pregnancy?" and, last but not least, "what evidence supports laboratory monitoring of COVID-19 vaccination immunogenicity in pregnancy?". In this opinion paper, we will attempt to provide an overview of the current biological, clinical and laboratory evidence of SARS-CoV-2 infection in pregnancy, trying also to provide reliable answers to the aforementioned questions. Copyright © 2022 Biomedia. All rights reserved.

Association between viral load and positivization time of a SARS-CoV-2 rapid antigen test in routine nasopharyngeal specimens.

Background: Rapid SARS-CoV-2 antigen tests are potentially useful tools for screening carriers with high viral load. This study was aimed to assess the potential association between viral load and positivization time of a manual SARS-CoV-2 commercial antigen test in routine nasopharyngeal specimens. Methods: In a sample of subjects undergoing routine diagnostic testing, SARS-CoV-2 positivity of nasopharyngeal samples was assayed with both molecular (Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit) and antigenic (Roche SARS-CoV-2 Rapid Antigen Test) tests. Positivization time of rapid antigen test was correlated and compared with viral load expressed as mean of SARS-CoV2 E/S genes cycle threshold (Ct) values. Results: The study sample consisted of 106 patients (median age 48 years, 55 women) with positive results of rapid SARS-CoV-2 antigen testing. A highly significant Spearman's correlation was found between mean SARSCoV-2 E/S genes Ct values and positivization time of manual antigen test (r= 0.70; p<0.001). The positivization time of rapid SARS-CoV-2 antigen test displayed an area under the curve of 0.82 (95%CI, 0.74-0.89) for predicting nasopharyngeal samples with high viral load (i.e., mean Ct <20). A positivization time cut-off of 32 SEC had 94.9% sensitivity and 58.2% specificity for detecting specimens with high viral load. The overall agreement between mean Ct value <20 and positivization time <32 SEC was 70.8%. Conclusions: Positivization time of rapid SARS-CoV-2 antigen tests may provide easy and rapid information on viral load, thus making this type of manual assay potentially suitable for quick and reliable detection and isolation of supercarriers.

Simple signature/countersignature shared-accountability quality improvement initiative to improve reliability of blood sample collection: an essential clinical task.

BACKGROUND: Timely lab results are important to clinical decision-making and hospital flow. However, at our institution, unreliable blood sample collection for patients with central venous access jeopardised this outcome and created staff dissatisfaction. METHODS: A multidisciplinary team of nurses including a specialist clinical nurse leader (CNL), the hospital intravenous team and quality improvement (QI) consultants aimed to achieve >80% blood sample collection reliability among patients with central venous access by employing a simple signature/countersignature form coupled with audit-feedback and behavioural economics strategies. The form was piloted on one 25-bed unit. Data were collected for 60 weeks and interpreted per standard run chart rules. RESULTS: Blood sample collection reliability exceeded the 80% goal by week 22. The practice was sustained on the pilot unit and spread successfully to other wards despite significant operational threats including the COVID-19 pandemic. CONCLUSIONS: At our institution, a simple signature/countersignature form supplemented by audit-feedback and behavioural economics strategies led to sustained practice change among staff. The pairing of CNL to QI consultant enhanced change potency and durability.

Cultivating Clinical Clarity through Computer Vision: A Current Perspective on Whole Slide Imaging and Artificial Intelligence.

Diagnostic devices, methodological approaches, and traditional constructs of clinical pathology practice, cultivated throughout centuries, have transformed radically in the wake of explosive technological growth and other, e.g., environmental, catalysts of change. Ushered into the fray of modern laboratory medicine are digital imaging devices and machine-learning (ML) software fashioned to mitigate challenges, e.g., practitioner shortage while preparing clinicians for emerging interconnectivity of environments and diagnostic information in the era of big data. As computer vision shapes new constructs for the modern world and intertwines with clinical medicine, cultivating clarity of our new terrain through examining the trajectory and current scope of computational pathology and its pertinence to clinical practice is vital. Through review of numerous studies, we find developmental efforts for ML migrating from research to standardized clinical frameworks while overcoming obstacles that have formerly curtailed adoption of these tools, e.g., generalizability, data availability, and user-friendly accessibility. Groundbreaking validatory efforts have facilitated the clinical deployment of ML tools demonstrating the capacity to effectively aid in distinguishing tumor subtype and grade, classify early vs. advanced cancer stages, and assist in quality control and primary diagnosis applications. Case studies have demonstrated the benefits of streamlined, digitized workflows for practitioners alleviated by decreased burdens.

The Significance of External Quality Assessment Schemes for Molecular Testing in Clinical Laboratories.

External quality assessment (EQA) schemes are a tool for clinical laboratories to evaluate and manage the quality of laboratory practice with the support of an independent party (i.e., an EQA provider). Depending on the context, there are different types of EQA schemes available, as well as various EQA providers, each with its own field of expertise. In this review, an overview of the general requirements for EQA schemes and EQA providers based on international guidelines is provided. The clinical and scientific value of these kinds of schemes for clinical laboratories, clinicians and patients are highlighted, in addition to the support EQA can provide to other types of laboratories, e.g., laboratories affiliated to biotech companies. Finally, recent developments and challenges in laboratory medicine and quality management, for example, the introduction of artificial intelligence in the laboratory and the shift to a more individual-approach instead of a laboratory-focused approach, are discussed. EQA schemes should represent current laboratory practice as much as possible, which poses the need for EQA providers to introduce latest laboratory innovations in their schemes and to apply up-to-date guidelines. By incorporating these state-of-the-art techniques, EQA aims to contribute to continuous learning.

Virtual Pathology Education in Medical Schools Worldwide during the COVID-19 Pandemic: Advantages, Challenges Faced, and Perspectives.

The COVID-19 pandemic shifted pathology education in medical schools worldwide towards online delivery. To achieve this goal, various innovative platforms were used by pathology educators and medical students, facilitating both synchronous and asynchronous learning. The aim of this study was to review the published evidence regarding remote pathology teaching at the medical school level during this period, present our own experience, and provide some perspectives regarding the best mode of pathology teaching post-pandemic. Among its advantages, virtual pathology education was considered among students and educators as convenient, flexible, and engaging, while learning outcomes were met and students' academic performance was in general satisfactory. However, several challenges were faced. For instance, suboptimal internet connection compromised the flow of classes and was even associated with a lower academic performance. The lack of hands-on laboratory activities, such as operating the light microscope and tissue grossing, and the reduced student interactions among themselves and their instructors, were also pointed out as significant drawbacks of remote pathology education. Whereas online education has multiple advantages, experiencing the physical university environment, in-person interactions and teamwork, exposure to the "hidden curriculum", and hands-on activities are vital for medical school education and future student development. In conclusion, the implementation of a blended approach in pathology education-where online and face-to-face sessions are jointly used to promote students' engagement, interaction with their instructors and peers, and learning-could be the most optimal approach to pathology teaching in medical schools post-pandemic.

The Role of Biomarkers in Hospitalized COVID-19 Patients With Systemic Manifestations.

The following article aims to review COVID-19 biomarkers used in hospital practice. It is apparent that COVID-19 is not simply a pulmonary disease but has systemic manifestations. For this reason, biomarkers must be used in the management of diagnosed patients to provide holistic care. Patients with COVID-19 have been shown to have pulmonary, hepatobiliary, cardiovascular, neurologic, and renal injury, along with coagulopathy and a distinct cytokine storm. Biomarkers can effectively inform clinicians of systemic organ injury due to COVID-19. Furthermore, biomarkers can be used in predictive models for severe COVID-19 in admitted patients. The utility of doing so is to allow for risk stratification and utilization of proper treatment protocols. In addition, COVID-19 biomarkers in the pediatric population are discussed, specifically in predicting Multisystem Inflammatory Syndrome. Ultimately, biomarkers can be used as predictive tools to allow clinicians to identify and adequately manage patients at increased risk for worse outcomes from COVID-19. Both literature review and anecdotal evidence has shown that severe COVID-19 is a systemic disease, and understanding associated biomarkers are crucial for hospitalized patients' proper clinical decision-making. For example, the cytokine storm releases inflammatory markers in different organ systems such as the pulmonary, hepatobiliary, hematological, cardiac, neurological, and renal systems. This review summarizes the latest research of COVID-19 that can help inform healthcare professionals how to better mitigate morbidity and mortality associated with this disease and provides information about certain systemic biomarkers that can be incorporated into hospital practice to provide more comprehensive care for hospitalized COIVD-19 patients.

Isolation of SARS-CoV-2 in Viral Cell Culture in Immunocompromised Patients With Persistently Positive RT-PCR Results.

Immunocompromised adults can have prolonged acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive RT-PCR results, long after the initial diagnosis of coronavirus disease 2019 (COVID-19). This study aimed to determine if SARS-CoV-2 virus can be recovered in viral cell culture from immunocompromised adults with persistently positive SARS-CoV-2 RT-PCR tests. We obtained 20 remnant SARS-CoV-2 PCR positive nasopharyngeal swabs from 20 immunocompromised adults with a positive RT-PCR test ≥14 days after the initial positive test. The patients' 2nd test samples underwent SARS-CoV-2 antigen testing, and culture with Vero-hACE2-TMPRSS2 cells. Viral RNA and cultivable virus were recovered from the cultured cells after qRT-PCR and plaque assays. Of 20 patients, 10 (50%) had a solid organ transplant and 5 (25%) had a hematologic malignancy. For most patients, RT-PCR Ct values increased over time. There were 2 patients with positive viral cell cultures; one patient had chronic lymphocytic leukemia treated with venetoclax and obinutuzumab who had a low viral titer of 27 PFU/mL. The second patient had marginal zone lymphoma treated with bendamustine and rituximab who had a high viral titer of 2 x 106 PFU/mL. Most samples collected ≥7 days after an initial positive SARS-CoV-2 RT-PCR had negative viral cell cultures. The 2 patients with positive viral cell cultures had hematologic malignancies treated with chemotherapy and B cell depleting therapy. One patient had a high concentration titer of cultivable virus. Further data are needed to determine risk factors for persistent viral shedding and methods to prevent SARS-CoV-2 transmission from immunocompromised hosts.

Early prediction of COVID-19-associated acute kidney injury: Are serum NGAL and serum Cystatin C levels better than serum creatinine?

BACKGROUND: Coronavirus disease-2019 (COVID-19) is associated with a high risk of acute kidney injury (AKI), often requiring renal replacement therapy (RRT). Serum Cystatin C (sCysC) and serum Neutrophil Gelatinase-Associated Lipocalin (sNGAL) are emerging biomarkers for kidney injury, and were suggested to be superior to serum creatinine (sCr) in several clinical settings. Moreover, elevated sCysC is associated with disease severity and mortality in COVID-19. We aimed to assess the utility of sCysC and sNGAL for predicting COVID-19-associated AKI, need for RRT, and need for intensive care unit (ICU) admission, when measured at presentation to the emergency department (ED). METHODS: Patients presenting to the ED with laboratory-confirmed COVID-19 were included. The primary outcome was development of COVID-19-associated AKI, while the secondary outcomes were need for RRT and ICU admission. RESULTS: Among 52 COVID-19 patients, 22 (42.3%) developed AKI with 8/22 (36.4%) requiring RRT. Both sCr and sCysC demonstrated excellent performance for predicting AKI (AUC, 0.86 and 0.87, respectively) and need for RRT (AUC, 0.94 and 0.95, respectively). sNGAL displayed acceptable performance for predicting AKI (AUC, 0.81) and need for RRT (AUC, 0.87). CONCLUSIONS: SCr and sCysC measured at ED presentation are both highly accurate predictors of AKI and need for RRT, whereas sNGAL demonstrated adequate diagnostic performance. While sCyC was previously shown to be superior to sCr as a diagnostic biomarker of kidney injury in certain etiologies, our findings demonstrate that sCr is comparable to sCyC in the context of predicting COVID-19-associated AKI. Given the high sensitivity of these biomarkers for predicting the need for RRT, and as sCysC is associated with mortality in COVID-19 patients, we recommend their measurement for enabling risk stratification and early intervention.

Clinical performance of the Roche Elecsys SARS-CoV-2 antigen fully automated electrochemiluminescence immunoassay.

OBJECTIVE: We assessed the clinical performance of novel Roche Elecsys SARS-CoV-2 Antigen fully automated electrochemiluminescence immunoassay (ECLIA). DESIGN AND METHODS: We tested 160 subjects, 110 (68.8%), with positive molecular test for SARS-CoV-2 infection in nasopharyngeal samples, with Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit and Roche Elecsys SARS-CoV-2 Antigen. RESULTS: Highly significant correlation was found between Elecsys SARS-CoV-2 Antigen ECLIA and cycle threshold (Ct) values of SARS-CoV-2 S and E genes (both r = -0.91; p < 0.001). The area under the curve (AUC), sensitivity and specificity of Elecsys SARS-CoV-2 Antigen ECLIA were 0.83, 0.43 and 1.00 in all samples, 0.99, 0.87 and 0.99 in those with both Ct values < 30, as well as 1.00, 1.00 and 0.89 in samples with both Ct values < 25. CONCLUSION: Roche Elecsys SARS-CoV-2 Antigen ECLIA may be a surrogate of molecular testing for identification of super-spreaders.

Promotion to Top-Tier Journal and Development Strategy of the Annals of Laboratory Medicine for Strengthening its Leadership in the Medical Laboratory Technology Category: A Bibliometric Study.

BACKGROUND: A bibliometric analysis of the Annals of Laboratory Medicine (ALM) was performed to understand its position in the medical laboratory technology category and to suggest a developmental strategy. METHODS: Journal metrics, including the number of articles by publication type, country of authors, total citations, 2-year impact factor, country of cited authors, journals citing ALM, and Hirsch-index, were obtained from the Journal Citation Report and Web of Science Core Collection. Target data included ALM content in the Web of Science from January 1, 2012, to October 5, 2021. Bibliometric analysis was performed using Biblioshiny. RESULTS: The impact factor increased from 1.481 in 2013 to 3.464 in 2020. Authors belonging to the USA, China, and Korea cited ALM articles the most. Plos One, Scientific Reports, and Frontiers in Microbiology most frequently cited ALM, besides ALM itself. The Hirsch-index was 34. The co-occurrence network of Keyword Plus indicated four clusters: diagnosis, identification, prevalence, and risk. The conceptual structure map of Keyword Plus based on multiple correspondence analysis showed two clusters: bacterial susceptibility at the bench and clinical courses. The co-citation network showed that ALM was in the cluster of the New England Journal of Medicine, The Lancet, JAMA, and the Annals of Internal Medicine. The collaboration network showed that Korean authors collaborated mainly with authors from the USA, Germany, and Italy. CONCLUSIONS: The journal's promotion to an international top-tier journal has been successful. "Principles of transparency and best practice in scholarly publishing" and a preprint policy are yet to be added.