Assessing the comparability of cycle threshold values derived from five external quality assessment rounds for omicron nucleic acid testing.

BACKGROUND: A variety of open-system real-time reverse transcriptase polymerase chain reaction (RT-PCR) assays for several acute respiratory syndrome coronavirus 2 are currently in use. This study aimed to ensure the quality of omicron nucleic acid testing and to assess the comparability of cycle threshold (Ct) values derived from RT-PCR. METHODS: Five external quality assessment (EQA) rounds using the omicron virus-like particles were organized between February 2022 and June 2022. RESULTS: A total of 1401 qualitative EQA reports have been collected. The overall positive percentage agreement was 99.72%, the negative percentage agreement was 99.75%, and the percent agreement was 99.73%. This study observed a significant variance in Ct values derived from different test systems. There was a wide heterogeneity in PCR efficiency among different RT-PCR kits and inter-laboratories. CONCLUSION: There was strong concordance among laboratories performing qualitative omicron nucleic acid testing. Ct values from qualitative RT-PCR tests should not be used for clinical or epidemiological decision-making to avoid the potential for misinterpretation of the results.

The impact of earnings volatility, environmental uncertainty and COVID-19 pandemic on accounting comparability in an emerging economy

Purpose: The present study investigated the impact of earnings volatility and environmental uncertainty on accounting comparability in an emerging economy and the moderating role of COVID-19 pandemic for the companies listed on Tehran Stock Exchange (TSE). Design/methodology/approach: The data about 181 companies during 2014–2021 were examined. In this study, accounting comparability was predicted for the firms' accounting systems and the coefficient estimates were calculated. The present study used the coefficient of variation of sales to capture sales volatility as the primary environmental uncertainty measure. Findings: The results showed that both the earnings volatility and environmental uncertainty have a significant negative effect on accounting comparability, and that COVID-19 significantly increases the negative impact of earnings volatility and environmental uncertainty on accounting comparability. The hypothesis testing based on robust, GLS, GMM, GLM, OLS regressions and t+1 test confirmed these results. Originality/value: The present study aimed to develop knowledge-providing benefits for companies about the accounting comparability and managing more efficient decisions. The present findings help investors to understand and evaluate the performance of firms more accurately especially in earnings volatility and environmental uncertainty conditions and in the wake of a pandemic crisis such as COVID-19. © 2023, Emerald Publishing Limited.

A CHO stable pool production platform for rapid clinical development of trimeric SARS-CoV-2 spike subunit vaccine antigens.

Protein expression from stably transfected Chinese hamster ovary (CHO) clones is an established but time-consuming method for manufacturing therapeutic recombinant proteins. The use of faster, alternative approaches, such as non-clonal stable pools, has been restricted due to lower productivity and longstanding regulatory guidelines. Recently, the performance of stable pools has improved dramatically, making them a viable option for quickly producing drug substance for GLP-toxicology and early-phase clinical trials in scenarios such as pandemics that demand rapid production timelines. Compared to stable CHO clones which can take several months to generate and characterize, stable pool development can be completed in only a few weeks. Here, we compared the productivity and product quality of trimeric SARS-CoV-2 spike protein ectodomains produced from stable CHO pools or clones. Using a set of biophysical and biochemical assays we show that product quality is very similar and that CHO pools demonstrate sufficient productivity to generate vaccine candidates for early clinical trials. Based on these data, we propose that regulatory guidelines should be updated to permit production of early clinical trial material from CHO pools to enable more rapid and cost-effective clinical evaluation of potentially life-saving vaccines.

Evaluation and comparison of four quantitative SARS-CoV-2 serological assays in COVID-19 patients and immunized healthy individuals, cancer patients, and patients with immunosuppressive therapy.

BACKGROUND: Semi-quantitative and quantitative immunoassays are the most commonly used methodology to evaluate immunity post immunization. OBJECTIVES: To compare four quantitative SARS-CoV-2 serological assays in COVID-19 patients and immunized healthy individuals, cancer patients, and patients with immunosuppressive therapy. STUDY DESIGN: 210 serological samples from COVID-19 infection and vaccination cohorts were used to create a serological sample repository. Serological methods from four manufacturers, namely Euroimmun, Roche, Abbott, and DiaSorin, were evaluated for quantitative, semi-quantitative, and qualitative antibody measurements. All four methods measure IgG antibodies against the SARS-CoV-2 spike receptor-binding domain and report the results in Binding Antibody Unit/mL (BAU/mL). A Total Error Allowable (TEa) of ±25% was chosen as the criteria to determine whether two methods are clinically equivalent quantitatively. Semi-quantitative results (titers) were derived using numeric antibody concentration divided by the cut-off value for each method. RESULTS: All paired quantitative comparisons demonstrated unacceptable performance. With ±25% as TEa, the best agreement was 74 (35.2% out of 210 samples) between Euroimmun and DiaSorin, whereas the lowest agreement was 11 (5.2% out of 210 samples) between Euroimmun and Roche. Antibody titers amongst all four methods were significantly different (p < 0.001). The highest titer difference from the same sample is between Roche and DiaSorin with a 1392-fold difference. On qualitative comparison, none of the paired comparison showed acceptable comparison (p < 0.001). CONCLUSIONS: Poor correlation exists between four evaluated assays, quantitatively, semi-quantitatively, and qualitatively. Further harmonization of assays is required to achieve comparable measurements.

New development: The development of standardized charts of accounts in public sector accounting

IMPACTCharts of Accounts (CoAs) in the public sector are important to control accounting records. They support the preparation of accurate and reliable financial statements and consolidated reporting. Standardized CoAs at the national level are desirable but specificities of different public sector areas must be considered, as well as harmonization with budget and Government Finance Statistics (GFS) classifications. Having broad international guidance for each country to develop its own CoA, while fostering public sector financial reporting harmonization, would allow for improved comparability of fiscal effects during difficult periods, such as the Covid 19 pandemic.This article addresses the development of standardized Charts of Accounts (CoAs) in public sector accounting and reporting. In particular, it focuses on matters concerning the role CoAs have, or should have, at a national level, their main technicalities and the expected impact of using them as a bookkeeping instrument on the accuracy of accounting records and, ultimately, on the reliability and usability of the financial information for different purposes. Empirical evidence is provided from a survey to representatives of accounting international and national (Belgium, Brazil, Estonia and Portugal) standard-setters and preparers.

Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines.

This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of vaccines and therapies in response to the COVID-19 pandemic. It integrates these experiences with the outcomes from the collaborative work between industry and regulators in recent years on innovative science- and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development are discussed and various approaches to facilitate accelerated development and global supply are collated for consideration. Relevant regulatory aspects are reviewed, including the role of Emergency Use/Conditional Marketing Authorizations, the dialogue between sponsors and agencies to facilitate early decision-making and alignment, and the value of improving reliance/collaborative assessment and increased collaboration between regulatory authorities to reduce differences in global regulatory requirements. Five areas are highlighted for particular consideration in the implementation of strategies for the quality-related aspects of accelerated development and supply: (1) the substantial need to advance reliance or collaborative assessment; (2) the need for early decision making and streamlined engagement between industry and regulatory authorities on CMC matters; (3) the need to further facilitate 'post-approval' changes; (4) fully exploiting prior and platform knowledge; and (5) review and potential revision of legal frameworks. The recommendations in this publication are intended to contribute to the discussion on approaches that can result in earlier and greater access to high-quality pandemic vaccines and therapies for patients worldwide but could also be useful in general for innovative medicines addressing unmet medical needs.

Multi-element protocol on IR experiments stability: Application to the TREC-COVID test collection

The evaluation of information retrieval systems is performed using test collections. The classical Cranfield evaluation paradigm is defined on one fixed corpus of documents and topics. Following this paradigm, several systems can only be compared over the same test collections (documents, topics, assessments). In this work, we explore in a systematic way the impact of similarity of test collections on the comparability of the experiments: characterizing the minimal changes between the collections upon which the performance of IR system evaluated can be compared. To do that, we create pair instances of sub-test collections from one reference collection with controlled overlapping elements, and we compare the Ranking of Systems (RoS) of a defined list of IR systems. We can then compute the probability that the RoS are the same across the sub-test collections. We experiment with our framework proposed on the TREC-COVID collections, and two of our findings show that: a) the ranking of systems, according to the MaP, is very stable even for overlaps smaller than 10% for documents, relevance assessments and positive relevance assessments sub-collections, and b) stability is not ensured for MaP, Rprec, Bpref and ndcg evaluation measures even when considering large overlap for the topics. © 2022 Copyright for this paper by its authors. Use permitted under Creative Commons License Attribution 4.0 International (CC BY 4.0).

Accountability and assessment in U.S. education: let’s not allow another crisis go to waste!

State education systems in the U.S. experienced major disruptions due to the COVID-19 pandemic. Results from assessments administered during, and at the conclusion of, the 2020-21 school year indicate substantial ‘unfinished learning’, with the losses generally greater among disadvantaged and marginalized students. States’ assessment systems are strongly tilted toward meeting Federal accountability requirements, especially state-wide comparability of end-of year test results, which severely limits innovation. The two-year pause in accountability due to the pandemic presents an opportunity to radically rethink school accountability, allowing states greater flexibility in developing creative interventions and more balanced assessment systems to better support student learning. A new trade-off between comparability and local flexibility is long overdue, especially given the poor record of the current system in promoting learning and closing achievement gaps. We offer some examples of how the trade-off can be accomplished and the potential benefits that would ensue. [ FROM AUTHOR] Copyright of Assessment in Education: Principles, Policy & Practice is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Students who prefer face-to-face tests outperform their online peers in organic chemistry

To test the hypothesis that students who complete remote online tests experience an 'online grade penalty', we compared performance outcomes of second-year students who elected to complete exams online to those who completed face-to-face, paper-based tests in an organic chemistry course. We pursued the following research questions: (RQ1) Are there performance gaps between students who elect to take online tests and those who take face-to-face tests? (RQ2) Do these two groups differ with respect to other affective or incoming performance attributes? How do these attributes relate to performance overall? (RQ3) How does performance differ between students who reported equal in-class engagement but selected different testing modes? (RQ4) Why do students prefer one testing mode over the other? We found that students who elected to take online tests consistently underperformed relative to those who took face-to-face tests. While we observed no difference between the two student groups with respect to their intrinsic goal orientation and incoming academic preparation, students who preferred face-to-face tests perceived chemistry as more valuable than students who preferred to complete exams online. We observed a positive correlation between performance outcomes and all affective factors. Among students who reported similar levels of in-class engagement, online testers underperformed relative to face-to-face testers. Open-ended responses revealed online testers were avoiding exposure to illness/COVID-19 and preferred the convenience of staying at home;the most common responses from face-to-face testers included the ability to perform and focus better in the classroom, and increased comfort or decreased stress they perceived while taking exams.

Quality comparability assessment of a SARS-CoV-2-neutralizing antibody across transient, mini-pool-derived and single-clone CHO cells.

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has triggered a serious public health crisis worldwide, and considering the novelty of the disease, preventative and therapeutic measures alike are urgently needed. To accelerate such efforts, the development of JS016, a neutralizing monoclonal antibody directed against the SARS-CoV-2 spike protein, was expedited from a typical 12- to 18-month period to a 4-month period. During this process, transient Chinese hamster ovary cell lines are used to support preclinical, investigational new drug-enabling toxicology research, and early Chemistry, Manufacturing and Controls development; mini-pool materials to supply Phase 1 clinical trials; and a single-clone working cell bank for late-stage and pivotal clinical trials were successively adopted. Moreover, key process performance and product quality investigations using a series of orthogonal and state-of-the-art techniques were conducted to demonstrate the comparability of products manufactured using these three processes, and the results indicated that, despite observed variations in process performance, the primary and high-order structures, purity and impurity profiles, biological and immunological functions, and degradation behaviors under stress conditions were largely comparable. The study suggests that, in particular situations, this strategy can be adopted to accelerate the development of therapeutic biopharmaceuticals and their access to patients.

Psychotherapy by Telephone or Internet in Austria and Germany Which CBT Psychotherapists Rate It more Comparable to Face-to-Face Psychotherapy in Personal Contact and Have more Positive Actual Experiences Compared to Previous Expectations?

Objectives: COVID-19 has led to changes in the provision in mental health services. The current study investigated influencing factors on: (i) the comparability of psychotherapy via internet/telephone with psychotherapy in face-to-face contact as well as (ii) the actual experience with psychotherapy via internet/telephone compared to respective prior expectations in CBT therapists. Methods: A quantitative cross-sectional study was conducted in the form of an online survey. The research samples, registered cognitive-behavioral therapy (CBT) psychotherapists in Austria and Germany, were contacted by e-mail. Results: One hundred and ninety CBT therapists were analyzed in this study. The total number of patients treated via telephone/internet is a decisive factor for the subjective evaluation of the comparability of psychotherapy via telephone/internet and psychotherapy in personal contact. This factor also influences the extent (positive/negative) of the assessment of the actual experience with psychotherapy via internet/telephone compared to previous expectations. Neither age nor gender were associated with comparability of psychotherapy via internet/telephone with psychotherapy in face-to-face contact or the actual experience with psychotherapy via internet/telephone compared to respective prior expectations. Conclusions: Implications of the results are that attitudes towards remote psychotherapy might be increased in CBT therapists when they treat more patients remotely and experiences with remote psychotherapies should be included in psychotherapy training.