Clinical Investigation of Flat Pack Toric Contact Lenses and Wearer Attitudes to Environmental Impact.

OBJECTIVES: To investigate the performance of a novel flat pack toric daily disposable contact lens compared with traditionally packaged toric lenses in a randomized, crossover study. Environmental attitudes to contact lens wear were also explored. METHODS: Habitual contact lens wearers were recruited to wear a hioxifilcon A (Miru 1 day Flat Pack Toric, Menicon, Nagoya, Japan) test lens and a control lens: either nelfilcon A (Dailies AquaComfort Plus, Alcon, Geneva, Switzerland) or etafilcon A (1-Day Acuvue Moist, Johnson & Johnson, New Brunswick, NJ). Objective lens performance was assessed at fitting, and participants wore lenses in a randomized order for three consecutive days. Subjective measures of lens performance (comfort, vision, and handling) were then assessed by a questionnaire, with further questions on overall lens preference and environmental perceptions. RESULTS: Objective measures of lens fit were similar for the test and control lenses, except for distance VA which was better with the control lenses ( P <0.05; difference of two logMAR letters). End of day comfort was greater with the test lens, but this did not reach significance. Both lenses demonstrated similar scores for overall satisfaction. 87.5% of participants indicated the environmental impact of contact lenses to be important/extremely important to them, with 100% of participants identifying the flat pack packaging as having a smaller environmental impact. CONCLUSION: Overall, the lenses used in the study performed to similar levels. Environmental credentials are important to contact lens wearers, which may contribute to overall lens preference.

Validation of the Thermo Scientific™ SureTect™ Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus PCR Assay for the Detection of Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus in Seafood Matrixes: AOAC Performance Tested MethodsSM 022301.

BACKGROUND: The Thermo Scientific™ SureTect™ Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus PCR Assay method is a real-time PCR method for the multiplex detection of Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus in seafood. OBJECTIVE: The Thermo Scientific SureTect Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus Assay was evaluated for AOAC Performance Tested MethodsSM certification. METHOD: Inclusivity/exclusivity, matrix, product consistency/stability, and robustness studies were conducted to assess the method's performance. For the matrix study, the method was validated using the Applied Biosystems™ QuantStudio™ 5 Real-Time PCR Food Safety Instrument and the Applied Biosystems™ 7500 Fast Real-Time PCR Food Safety Instrument against the U.S. Food and Drug Administration Bacteriological Analytical Manual, Chapter 9 (2004), Vibrio and ISO 21872-1:2017 Microbiology of the food chain-Horizontal method for the determination of Vibrio spp.-Part 1: Detection of potentially enteropathogenic Vibrio parahaemolyticus, Vibrio cholerae, and Vibrio vulnificus reference methods. RESULTS: Matrix studies showed equivalent or superior performance of the candidate method compared to the reference method and, overall, no difference between presumptive and confirmed results, except for one matrix due to high background flora. The inclusivity/exclusivity study correctly identified/excluded all strains analyzed. Robustness testing showed no statistically significant differences in assay performance under varied test conditions. Product consistency and stability studies demonstrated no statistically significant differences between assay lots with different expiration dates. CONCLUSIONS: The data presented show that the assay constitutes a rapid and reliable workflow for the detection of V. cholerae, V. parahaemolyticus, and V. vulnificus in seafood matrixes. HIGHLIGHTS: The SureTect PCR Assay method allows for fast, reliable detection of stipulated strains in seafood matrixes with results obtained in as little as 80 min post-enrichment.

Towards a standardised cross-sectoral data access agreement template for research: a core set of principles for data access within trusted research environments.

Introduction: Trusted Research Environments (TREs) are secure computing environments that provide access to data for approved researchers to use in studies that can save and improve lives. TREs rely on Data Access Agreements (DAAs) to bind researchers and their organisations to the terms and conditions of accessing the infrastructure and data use. However, DAAs can be overly lengthy, complex, and can contain outdated terms from historical data sharing agreements for physical exchange of data. This is often cited as a cause of significant delays to legal review and research projects starting. Objectives: The aim was to develop a standardised DAA optimised for data science in TREs across the UK and framed around the 'Five Safes framework' for trustworthy data use. The DAA is underpinned by principles of data access in TREs, the development of which is described in this paper. Methods: The Pan-UK Data Governance Steering Group of the UK Health Data Research Alliance led the development of a core set of data access principles. This was informed by a benchmarking exercise of DAAs used by established TREs and consultation with public members and stakeholders. Results: We have defined a core set of principles for TRE data access that can be mapped to a common set of DAA terms for UK-based TREs. Flexibility will be ensured by including terms specific to TREs or specific data/data owners in customisable annexes. Public views obtained through public involvement and engagement (PIE) activities are also reported. Conclusions: These principles provide the foundation for a standardised UK TRE DAA template, designed to support the growing ecosystem of TREs. By providing a familiar structure and terms, this template aims to build trust among data owners and the UK public and to provide clarity to researchers on their obligations to protect the data. Widespread adoption is intended to accelerate health data research by enabling faster approval of projects, ultimately enabling more timely and effective research.

Evaluation of the Thermo Scientific SureTectTM Listeria Species PCR Assay in a Broad Range of Foods and Selected Environmental Surfaces: Pre-Collaborative and Collaborative Study, First Action 2021.06.

BACKGROUND: The Thermo Scientific SureTect™ Listeria species PCR assay utilizes SolarisTM reagents for performing PCR for the rapid and specific detection of Listeria species in a broad range of foods and selected environmental surfaces. OBJECTIVE: To demonstrate reproducibility of the Thermo Scientific SureTect Listeria species PCR assay in a collaborative study using a challenging matrix, full-fat cottage cheese (25 g), to extend the scope of the method. METHODS: In the collaborative study, the candidate method was compared to the US Food and Drug Administration/Bacteriological Analytical Manual (FDA/BAM) Ch. 10 Listeria reference method. The candidate method used two PCR thermocyclers, the Applied Biosystems QuantStudio™ 5 Real-Time PCR instrument (QS5) and the Applied Biosystems 7500 Fast Real-Time PCR instrument (7500 Fast). The candidate method included its own confirmation procedure. Eighteen participants from 10 laboratories located within the United States and Europe were solicited for the collaborative study, with 12 participants submitting valid data. Statistical analysis was conducted according to the probability of detection (POD) statistical model. In addition, in order to extend the scope of the method, seven matrix studies were performed comparing the candidate method to the FDA/BAM reference method. One of these matrixes was also compared to the ISO 11290-1:2017 Microbiology of the food chain-Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp.-Part 1: Detection method reference method. RESULTS: In the collaborative study, the difference in laboratory results indicates equivalence between the candidate method and reference method for the matrix evaluated and the method demonstrated acceptable inter-laboratory reproducibility as determined in the collaborative evaluation. The two PCR instruments used in the study performed equivalently. All presumptive positives were confirmed via the alternative confirmation procedure. In the pre-collaborative studies, the results showed comparable performances between the candidate method and the reference method for all matrixes tested. CONCLUSION: Based on the data generated, the method demonstrated acceptable inter-laboratory reproducibility data and statistical analysis. HIGHLIGHTS: Due to the COVID-19 pandemic, some participants had to be trained remotely. Additionally, 25 g full-fat cottage cheese is known to be a challenging matrix to test. No unusual cross-contamination, or false-positive/negative data was reported, highlighting the ease of use, reproducibility, and robustness of the candidate method.

Comparison of Outcomes of In-Centre Haemodialysis Patients between the 1st and 2nd COVID-19 Outbreak in England, Wales, and Northern Ireland: A UK Renal Registry Analysis.

INTRODUCTION: This retrospective cohort study compares in-centre haemodialysis (ICHD) patients' outcomes between the 1st and 2nd waves of the COVID-19 pandemic in England, Wales, and Northern Ireland. METHODS: All people aged ≥18 years receiving ICHD at 31 December 2019, who were still alive and not in receipt of a kidney transplant at 1 March and who had a positive polymerase chain reaction test for SARS-CoV-2 between 1 March 2020 and 31 January 2021, were included. The COVID-19 infections were split into two "waves": wave 1 from March to August 2020 and wave 2 from September 2020 to January 2021. Cumulative incidence of COVID-19, multivariable Cox models for risk of positivity, median, and 95% credible interval of reproduction number in dialysis units were calculated separately for wave 1 and wave 2. Survival and hazard ratios for mortality were described with age- and sex-adjusted Kaplan-Meier plots and multivariable Cox proportional models. RESULTS: 4,408 ICHD patients had COVID-19 during the study period. Unadjusted survival at 28 days was similar in both waves (wave 1 75.6% [95% confidence interval [CI]: 73.7-77.5], wave 2 76.3% [95% CI 74.3-78.2]), but death occurred more rapidly after detected infection in wave 1. Long vintage treatment and not being on the transplant waiting list were associated with higher mortality in both waves. CONCLUSIONS: Risk of death of patients on ICHD treatment with COVID-19 remained unchanged between the first and second outbreaks. This highlights that this vulnerable patient group needs to be prioritized for interventions to prevent severe COVID-19, including vaccination, and the implementation of measures to reduce the risk of transmission alone is not sufficient.

Evaluation of the Thermo ScientificTM SureTectTMListeria monocytogenes PCR Assay in a Broad Range of Foods and Selected Environmental Surfaces: Pre-Collaborative and Collaborative Study, First Action 2021.05.

BACKGROUND: The Thermo Scientific™ SureTect™ Listeria monocytogenes PCR Assay uses Solaris reagents for performing PCR for the rapid and specific detection of Listeria monocytogenes in a broad range of foods and selected environmental surfaces. OBJECTIVE: To demonstrate reproducibility of the SureTect Listeria monocytogenes PCR Assay in a collaborative study using a challenging matrix, full-fat cottage cheese (25 g). To extend the scope of the method. METHOD: In the collaborative study, the candidate method was compared to the United States Food and Drug Administration/Bacteriological Analytical Manual (FDA/BAM) Chapter 10 Listeria reference method. The candidate method used two PCR thermocyclers, the Applied Biosystems™ QuantStudio™ 5 Real-Time PCR instrument (QS5) and the Applied Biosystems 7500 Fast Real-Time PCR instrument (7500 Fast). Eighteen participants from 10 laboratories located within the United States and Europe were solicited for the collaborative study, with 12 participants submitting valid data. Three levels of contamination were evaluated for each matrix. Statistical analysis was conducted according to the probability of detection (POD) statistical model. In addition, to extend the scope, six matrix studies were performed comparing the candidate method to the FDA/BAM reference method. One of these matrixes was also compared to the ISO 11290-1:2017 Microbiology of the Food Chain-Horizontal Method for the Detection and Enumeration of Listeria monocytogenes and of Listeria spp.-Part 1: Detection Method Reference Method. RESULTS: In the collaborative study, the difference in laboratory results indicates equivalence between the candidate method and reference method for the matrix evaluated, and the method demonstrated acceptable inter-laboratory reproducibility as determined in the collaborative evaluation. The two PCR instruments used in the study performed equivalently. All presumptive positives were confirmed via the alternative confirmation procedure. In the pre-collaborative studies, the results showed comparable performances between the candidate method and the reference method for all matrixes tested. CONCLUSIONS: Based on the data generated, the method demonstrated acceptable inter-laboratory reproducibility data and statistical analysis. HIGHLIGHTS: Due to the COVID-19 pandemic, some participants had to be trained remotely. Additionally, 25 g full-fat cottage cheese is known to be a challenging matrix to test. No unusual cross-contamination or false positive/negative data were reported, highlighting the ease of use, reproducibility, and robustness of the method.

Increasing trends in hemodialysis and living donor kidney transplantation for children and young people in the United Kingdom.

BACKGROUND: The UK Renal Registry is responsible for the national collection and reporting of data on all children receiving long-term kidney replacement therapy [KRT], including kidney transplantation. METHODS: All 13 UK pediatric nephrology centers contributed to providing individual patient data from the pediatric population incident to and prevalent to KRT as per the date 31 December 2018. Data for children aged 16-<18 years were presented separately as some were managed under adult care settings with different methods of data collection. Demographics and biochemical data, including kidney function and prevalence of cardiovascular risk factors [hypertension, hypercholesterolemia, BMI] were reported. RESULTS: Eight hundred and twenty-six children (65.4 per million age-related population [pmarp]) and 199 young people (139.4pmarp) in the United Kingdom were prevalent to KRT on 31 December 2018. Overall, the incidence of KRT during 2018 was 9.1 pmarp and 12.6 pmarp in children and young people, respectively. Congenital anomalies of the kidney and urinary tract (CAKUT) were the most prevalent primary diagnoses (52%). Living and deceased donor transplantation was the most common treatment modality (78%). Patients on dialysis had lower age standardized mean height and weight ranges recorded in comparison to transplant patients [median height z score -1.8 vs. -1.1]. 73.1% patients had one or more cardiovascular disease risk factors. CONCLUSIONS: This study highlights increasing prevalence of hemodialysis and living donor transplantation as modalities for KRT. Of those incident to KRT, the highest patient survival was seen among 8-12 years and lowest <2 years. Moreover, there was a demographic shift from Caucasian toward Asian/other ethnicity and from CAKUT to other primary kidney diseases.

Evaluation of the Thermo Scientific SureTect Salmonella Species PCR Assay in a Broad Range of Foods and Select Environmental Surfaces: Pre-Collaborative and Collaborative Study: First Action 2021.02.

BACKGROUND: The Thermo Scientific™ SureTect™ Salmonella species PCR Assay utilizes Solaris™ reagents for performing PCR for the rapid and specific detection of Salmonella species in a broad range of foods and select environmental surfaces. OBJECTIVE: The aims were to demonstrate the reproducibility of the Thermo Scientific SureTect Salmonella species PCR Assay in a collaborative study using a challenging matrix, cocoa powder, and to extend the scope of the method. METHOD: In the collaborative study, the candidate method was compared to the US Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) Chapter 5 Salmonella reference method. The candidate method used two PCR thermocyclers, the Applied Biosystems™ QuantStudio™ 5 Real-Time PCR instrument (QS5) and the Applied Biosystems 7500 Fast Real-Time PCR instrument (7500 Fast). Fourteen participants from nine laboratories located within the United States and Europe were solicited for the collaborative study, with 12 participants submitting valid data. Three levels of contamination were evaluated for each matrix. Statistical analysis was conducted according to the probability of detection statistical model. In addition, 11 matrix studies were performed comparing the candidate method to the FDA/BAM Chapter 5 or US Department of Agriculture, Food Safety and Inspection Service, Microbiology Laboratory Guidebook 4.10 Isolation and Identification of Salmonella from Meat, Poultry, Pasteurized Egg, and Siluriformes (Fish) Products and Carcass and Environmental Sponges reference method. Nine of these matrices were also compared to the EN ISO 6579-1:2017/Amd.1:2020(E) Microbiology of the food chain-Horizontal method for the detection, enumeration and serotyping of Salmonella-Part 1: Detection of Salmonella spp.-AMENDMENT 1: Broader range of incubation temperatures, amendment to the status of Annex D, and correction of the composition of MSRV and SC reference method. RESULTS: In the collaborative study, the difference in laboratory results indicates equivalence between the candidate method and reference method for the matrix evaluated, and the method demonstrated acceptable interlaboratory reproducibility as determined in the collaborative evaluation. False-positive and false-negative rates were determined for the matrix and produced values of <2%. The two PCR thermocyclers (QS5, 7500 Fast) performed equivalently. There were no result differences between candidate method confirmations and reference method confirmations. In the pre-collaborative matrix extension, the results from the matrix studies showed a comparable performance between the candidate method and the tested reference methods. CONCLUSIONS: Based on the data generated, the method demonstrated acceptable interlaboratory reproducibility data and statistical analysis. HIGHLIGHTS: Due to the COVID-19 pandemic, some participants had to be trained remotely. Additionally, 375 g cocoa powder is known to be a challenging matrix for PCR methods. No unusual cross-contamination or false-positive/negative was reported, highlighting the ease of use, reproducibility, and robustness of the method.

Ectopic vortex veins and varices in Donnai Barrow syndrome.

BACKGROUND: Donnai Barrow Syndrome (DBS) is a rare, multi-system autosomal recessively inherited disorder of relevance to ophthalmologists. To aim to describe the ocular phenotype using multimodal imaging for two cases of genetically confirmed DBS and compare against the published phenotype. MATERIALS AND METHODS: Retrospective case series of two unrelated patients with DBS and review of the literature. Both cases were referred to our tertiary unit for laser prophylaxis against retinal detachment. RESULTS: There was extreme high myopia greater than 20 dioptres without rhegmatogenous retinal detachment (RRD). Anterior segment features included iris transillumination and ciliary body hypoplasia. Posterior segment changes included previously described changes of optic nerve hypoplasia and a strikingly abnormal appearance of the fundus consisting of multiple bilateral giant posterior vortex veins (PVV). The mouse model shows a similar phenotype. CONCLUSIONS: Ectopic vortex veins of the choroid expand the phenotype of DBS and can be helpful in distinguishing the differential diagnosis of high myopia in children. Posterior vortex veins have been described in adult high myopia as acquired but our cases suggest that they could be congenital. Orbital manipulation and hypotony during surgery should be avoided to minimise complications. The evidence to recommend prophylactic laser retinopexy in these cases is inconclusive, and overall we recommend that conservative management should be considered using wide-angle retinal imaging in the clinic.

Causes of Death and End-of-Life Care in Patients With Intracranial High-Grade Gliomas: A Retrospective Observational Study.

BACKGROUND AND OBJECTIVES: To understand patterns of care and circumstances surrounding end of life in patients with intracranial gliomas. METHODS: We retrospectively analyzed end-of-life circumstances in patients with intracranial high-grade gliomas at Columbia University Irving Medical Center who died from January 2014 to February 2019, including cause of death, location of death, and implementation of comfort measures and resuscitative efforts. RESULTS: There were 152 patients (95 men, 57 women; median age at death 61.5 years, range 24-87 years) who died from January 2014 to February 2019 with adequate data surrounding end-of-life circumstances. Clinical tumor progression (n = 117, 77.0%) was the most common cause of death, with all patients transitioned to comfort measures. Other causes included, but were not limited to, infection (19, 12.5%); intratumoral hemorrhage (5, 3.3%); seizures (8, 5.3%); cerebral edema (4, 2.6%); pulmonary embolism (4, 2.6%); autonomic failure (2, 1.3%); and hemorrhagic shock (2, 1.3%). Multiple mortal events were identified in 10 (8.5%). Seventy-three patients (48.0%) died at home with hospice. Other locations were inpatient hospice (40, 26.3%); acute care hospital (34, 22.4%), including 27 (17.8%) with and 7 (4.6%) without comfort measures; skilled nursing facility (4, 3.3%), including 3 (2.0%) with and 1 (0.7%) without comfort measures; or religious facility (1, 0.7%) with comfort measures. Acute cardiac or pulmonary resuscitation was performed in 20 patients (13.2%). DISCUSSION: Clinical tumor progression was the most common (77.0%) cause of death, followed by infection (12.5%). Hospice or comfort measures were ultimately implemented in 94.7% of patients, although resuscitation was performed in 13.2%. Improved understanding of circumstances surrounding death, frequency of use of hospice services, and frequency of resuscitative efforts in patients with gliomas may allow physicians to more accurately discuss end-of-life expectations with patients and caregivers, facilitating informed care planning.

Validation of the Thermo Scientific SureTect™ Escherichia coli O157:H7 and STEC Screening PCR Assay and SureTect™ Escherichia coli STEC Identification PCR Assay for the Detection of Escherichia coli O157:H7 and the Escherichia coli STEC Serotypes (O26, O45, O103, O111, O121, O145) from Fresh Raw Spinach, Fresh Baby Leaves, Fresh Cut Tomatoes, Frozen Raw Beef, Raw Beef Trim, and Beef Carcass Sponges: AOAC Performance Tested MethodSM 012102.

BACKGROUND: The Thermo Scientific SureTect™ Escherichia coli O157:H7 and STEC Screening PCR Assay and SureTect Escherichia coli STEC Identification PCR Assay are real-time PCR kits for the rapid detection of E. coli O157:H7 and non-E. coli O157 Shiga toxin-producing E. coli (STEC) serotypes (O26, O45, O103, O111, O121, O145) from fresh raw spinach, fresh baby leaves, fresh cut tomatoes, frozen raw beef, raw beef trim, and beef carcass sponges. OBJECTIVE: Both assays were evaluated for AOAC®Performance Tested MethodsSM certification. METHODS: Detection and confirmation inclusivity/exclusivity, matrix, product consistency and stability, and robustness studies were conducted. In the matrix studies, the candidate method was validated against United States and international reference methods for STEC serotypes. RESULTS: Matrix studies showed no statistically significant differences between the candidate and reference method results when analyzed by probability of detection. For each inclusivity/exclusivity study, all inclusivity strains and no exclusivity strains were detected by either kit. Robustness testing demonstrated that the identification assay performed reliably despite method deviations; however, although not statistically significant, the screening assay performance was impacted. Product consistency and stability testing demonstrated no statistically significant differences between kit lots and storage time points. CONCLUSION: The data presented show that both assays constitute a rapid and reliable workflow for the detection and confirmation of E. coli O157:H7 and stipulated non-E. coli O157:H7 STEC serotypes from the tested matrixes. HIGHLIGHTS: Results are obtained in 80 min post-enrichment with both assays run simultaneously, allowing for the detection and confirmation of STEC within a single workflow.

Validation of the Thermo Scientific™ SureTect™Staphylococcus aureus PCR Assay for the Detection of Staphylococcus aureus in Dairy Matrixes: AOAC Performance Tested MethodSM 052101.

BACKGROUND: The Thermo Scientific™ SureTect™Staphylococcus aureus PCR Assay is a real-time PCR assay for the detection of Staphylococcus aureus in dairy samples. OBJECTIVE: The Thermo Scientific SureTect Staphylococcus aureus PCR Assay was evaluated for AOAC Performance Tested MethodSM certification. METHODS: Inclusivity/exclusivity, matrix studies, product consistency and stability, and robustness testing were conducted to assess the method's performance. For the matrix study, the method was validated on the Applied Biosystems™ QuantStudio™ 5 Real-Time PCR instrument and the Applied Biosystems 7500 Fast Real-Time PCR instrument against the ISO 6888-3:2003 Microbiology of food and animal feeding stuffs-Horizontal method for the enumeration of coagulase-positive staphylococci (Staphylococcus aureus and other species)-Part 3: Detection and MPN technique for low numbers, and the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) Ch. 12, Staphylococcus aureus, 2016, reference methods. RESULTS: Matrix studies showed no statistically significant differences between the candidate and reference methods or between presumptive and confirmed results. The inclusivity/exclusivity study correctly identified/excluded all strains analyzed. Robustness testing showed no statistically significant difference in assay performance after set method parameter deviations, and product consistency and stability studies demonstrated no statistically significant differences in performance between kit lots at different expiration points. CONCLUSION: The data presented show that the assay is a rapid and reliable workflow for the detection of S. aureus from dairy matrixes. HIGHLIGHTS: The PCR assay allows for fast, reliable detection of S. aureus in dairy matrixes with results obtained in as little as 80 min post enrichment.

Validation of the Thermo Scientific SureTect™ Campylobacter jejuni, C. coli, and C. lari PCR Kit for the Detection of Campylobacter jejuni, C. coli, and C. lari in Raw Poultry and Ready-to-Cook Poultry Products: AOAC Performance Tested MethodSM 012101.

BACKGROUND: The Thermo Scientific SureTect™ Campylobacter jejuni, C. coli, and C. lari PCR Kit is a real-time PCR assay for the detection and differentiation of C. jejuni, C. coli, and C. lari from raw poultry, ready-to-cook poultry products, and environmental samples. OBJECTIVE: The Thermo Scientific SureTect Campylobacter jejuni, C. coli, and C. lari PCR Kit was evaluated for AOAC®Performance Tested MethodsSM certification. METHODS: Inclusivity/exclusivity, matrix studies, product consistency and stability, and robustness testing were conducted to assess the method's performance. In the matrix studies, the method was validated against United States and international reference methods for Campylobacter detection. RESULTS: There were no statistically significant differences found in the matrix studies between the candidate and reference methods when analyzed by probability of detection. All 52 inclusivity strains and none of the 51 exclusivity strains tested were detected by the assay. Robustness testing demonstrated that the assay gave reliable performance with specific method deviations outside of the recommended parameters, and the real-time stability testing demonstrated that there were no statistically significant differences between kit lots, validating the stated shelf life of the kit. CONCLUSION: The data presented support the product claims that the Thermo Scientific SureTect Campylobacter jejuni, C. coli, and C. lari PCR assay is suitable for the detection and differentiation of C. jejuni, C. coli, and C. lari from raw poultry, ready-to-cook poultry products, and environmental samples. HIGHLIGHTS: Presumptive results can be obtained in as little as 23 h. Microaerophilic incubators are not required for enrichment.

Outcomes of patients with COVID-19 on kidney replacement therapy: a comparison among modalities in England.

BACKGROUND: Chronic kidney disease is a recognized risk factor of poor outcomes from coronavirus disease 2019 (COVID-19). METHODS: This retrospective cohort study used the UK Renal Registry database of people on kidney replacement therapy (KRT) at the end of 2019 in England and who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) between 1 March 2020 and 31 August 2020 to analyse the incidence and outcomes of COVID-19 among different KRT modalities. Comparisons with 2015-2019 mortality data were used to estimate excess deaths. RESULTS: A total of 2783 individuals on KRT tested positive for SARS-CoV-2. Patients from more-deprived areas {most deprived versus least deprived hazard ratio [HR] 1.20 [95% confidence interval (CI) 1.04-1.39]} and those with diabetes compared with those without [HR 1.51 (95% CI 1.39-1.64)] were more likely to test positive. Approximately 25% of in-centre haemodialysis and transplanted patients died within 28 days of testing positive compared with 36% of those on home therapies. Mortality was higher in those ≥80 years of age compared with those 60-79 years [odds ratio (OR) 1.71 (95% CI 1.34-2.19)] and much lower in those listed for transplantation compared with those not listed [OR 0.56 (95% CI 0.40-0.80)]. Overall, excess mortality in 2020 for people on KRT was 36% higher than the 2015-2019 average. Excess deaths peaked in April 2020 at the height of the pandemic and were characterized by wide ethnic and regional disparities. CONCLUSIONS: The impact of COVID-19 on the English KRT population highlights their extreme vulnerability and emphasizes the need to protect and prioritize this group for vaccination. COVID-19 has widened underlying inequalities in people with kidney disease, making interventions that address health inequalities a priority.

Acute kidney injury identification for pharmacoepidemiologic studies: Use of laboratory electronic acute kidney injury alerts versus electronic health records in Hospital Episode Statistics.

PURPOSE: A laboratory-based acute kidney injury (AKI) electronic-alert (e-alert) system, with e-alerts sent to the UK Renal Registry (UKRR) and collated in a master patient index (MPI), has recently been implemented in England. The aim of this study was to determine the degree of correspondence between the UKRR-MPI and AKI International Classification Disease-10 (ICD-10) N17 coding in Hospital Episode Statistics (HES) and whether hospital N17 coding correlated with 30-day mortality and emergency re-admission after AKI. METHODS: AKI e-alerts in people aged ≥18 years, collated in the UKRR-MPI during 2017, were linked to HES data to identify a hospitalised AKI population. Multivariable logistic regression was used to analyse associations between absence/presence of N17 codes and clinicodemographic features. Correlation of the percentage coded with N17 and 30-day mortality and emergency re-admission after AKI were calculated at hospital level. RESULTS: In 2017, there were 301 540 adult episodes of hospitalised AKI in England. AKI severity was positively associated with coding in HES, with a high degree of inter-hospital variability-AKI stage 1 mean of 48.2% [SD 14.0], versus AKI stage 3 mean of 83.3% [SD 7.3]. N17 coding in HES depended on demographic features, especially age (18-29 years vs. ≥85 years OR 0.22, 95% CI 0.21-0.23), as well as sex and ethnicity. There was no evidence of association between the proportion of episodes coded for AKI with short-term AKI outcomes. CONCLUSION: Coding of AKI in HES is influenced by many factors that result in an underestimation of AKI. Using e-alerts to triangulate the true incidence of AKI could provide a better understanding of the factors that affect hospital coding, potentially leading to improved coding, patient care and pharmacoepidemiologic research.

Validation of the Thermo Scientific™ SARS-CoV-2 RT-PCR Detection Workflow for the Detection of SARS-CoV-2 from Stainless-Steel Environmental Surface Swabs: AOAC Performance Tested MethodSM 012103.

BACKGROUND: The Thermo Scientific™ SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) Detection Workflow, packaged with Applied Biosystems™ TaqMan™ 2019-nCoV Assay Kit v1 targets three different SARS-CoV-2 genomic regions in a single RT-PCR reaction. OBJECTIVE: To validate the Thermo Scientific SARS-CoV-2 RT-PCR Workflow, for the detection of SARS-CoV-2 virus on stainless-steel surfaces as part of the AOAC Performance Tested MethodSM Emergency Response Validation program. METHOD: The Applied Biosystems TaqMan 2019-nCoV Assay Kit v1, as part of the Thermo Scientific SARS-CoV-2 RT-PCR Workflow, was evaluated for specificity using in silico analysis of 15 764 SARS-CoV-2 sequences and 65 exclusivity organisms. The Thermo Scientific SARS-CoV-2 RT-PCR Workflow was evaluated in an unpaired study for one environmental surface (stainless steel) and compared to the U.S. Centers for Disease Control and Prevention 2019-Novel Coronavirus RT-PCR Diagnostic Panel, Instructions for Use (Revision 4, Effective 6/12/2020). RESULTS: In silico analysis showed that, of the 15 756 target SARS-CoV-2 genomes analyzed, 99% of the strains/isolates are perfectly matched to at least two of the three assays, and more than 90% have 100% homology to all three assays (ORF1ab, N-gene, S-gene) in the SARS-CoV-2 Kit. None of the 65 non-target strain genomes analyzed showed matching sequences. In the matrix study, the Thermo Scientific SARS-CoV-2 workflow showed comparable detection to the centers of disease control and prevention (CDC) method. CONCLUSIONS: The Thermo Scientific SARS-CoV-2 RT-PCR Workflow is an effective procedure for detection of RNA from SARS-CoV-2 virus from stainless steel. HIGHLIGHTS: The workflow provides equivalent performance results with the two tested RNA extraction platforms and the two tested RT-PCR instruments.

Sociodemographic features and mortality of individuals on haemodialysis treatment who test positive for SARS-CoV-2: A UK Renal Registry data analysis.

Kidney disease is a recognised risk factor for poor COVID-19 outcomes. Up to 30 June 2020, the UK Renal Registry (UKRR) collected data for 2,385 in-centre haemodialysis (ICHD) patients with COVID-19 in England and Wales. Overall unadjusted survival at 1 week after date of positive COVID-19 test was 87.5% (95% CI 86.1-88.8%); mortality increased with age, treatment vintage and there was borderline evidence of Asian ethnicity (HR 1.16, 95% CI 0.94-1.44) being associated with higher mortality. Compared to the general population, the relative risk of mortality for ICHD patients with COVID-19 was 45.4 and highest in younger adults. This retrospective cohort study based on UKRR data supports efforts to protect this vulnerable patient group.

The Challenges of Using UK Renal Registry Data to Audit the Care of Patients with Diabetes on Renal Replacement Therapy.

INTRODUCTION: Diabetes is a major cause of CKD and of mortality in patients on renal replacement therapy (RRT). Auditing the care of patients with diabetes on RRT against published guidelines relies on robust data collection. OBJECTIVE: This article assesses the completeness of data items collected by the UK Renal Registry (UKRR) that are required to audit the care of patients with diabetes on RRT. METHODS: The UKRR receives data on all patients receiving RRT in the UK. Patients with diabetes, diabetes type, and method of renal diagnosis were identified from primary renal disease (PRD) codes and comorbidity data for patients commencing RRT at one of the 57 renal centres in England and Wales between 2010 and 2016. The completeness of demographic and clinical data (blood pressure, cholesterol, glycated haemoglobin [HbA1c], and smoking status) was assessed for the first year of RRT. RESULTS: Ninety-three per cent of all patients on RRT irrespective of diagnosis had a PRD code, but only 28/57 renal centres had comorbidity data completeness ≥70%; 34.9% of patients with diabetic nephropathy (DN) had type 1 diabetes, but this varied between centres (9.2-100%). Overall, 4.2% of DN diagnoses were by biopsy. Data completeness in the first year of RRT for cardiovascular risk factors ranged between 50.0 and 80.0%, with HbA1c data completeness being 63.0%. Of 57 centres, 20 had HbA1c data for ≥70% of patients in the first year of RRT. CONCLUSIONS: There is persistent variation between renal centres in the completeness of data collected on patients with diabetes on RRT, impacting on the ability to undertake robust audit. Data linkages and expanded data permissions could see registry data play a key role in ongoing audit and research into patients with diabetes and CKD, provided adequate data can be collected.