Rapid Test Research Articles

Risk-based ultrasound probe quality assurance - a single center proof-of-concept study.

Ultrasound probe quality assurance is an underserved and underregulated area in medical imaging. While several testing methods exist, their availability and adoption remains varied, and the frequency of testing is often insufficient. Here we aimed to conduct a user-driven simple and rapid probe quality testing approach and to evaluate its rationale.Testing was based on physical examination of probe integrity (all probes) and in-air reverberation check (for curvilinear and linear array probes), findings, as well as probe age were registered. Prior to assessment, probes were divided into a high-risk vs. a low-risk category, based on the perceived risk of probe damage as a result of the typical application (e.g., non-invasive vs. interventional, inpatient vs. point-of-care).17.4% of the low-risk and 31.4% of high-risk probes demonstrated physical wear or damage. Reverberation artifacts were significantly more frequent (68%) in the high-risk category vs. the low-risk one (29.4%). Probes with either physical or reverberation faults were significantly older on average.The simple, rapid investigational technique uncovered an alarming percentage of probe damage or faults. It also identified immediately solvable technical issues (e.g., poor cable contact mimicking dropout). High-risk probe usage resulted in an increased rate of reverberation errors and physical damage. Risk-based, frequent rapid observational testing of ultrasound probes could substantially improve both diagnostic quality and patient safety.

Active case detection using bi-valent malaria rapid diagnostic test in nontransmission season impacts upcoming malaria transmission

Active case detection using bi-valent malaria rapid diagnostic test in nontransmission season impacts upcoming malaria transmission

First Seroprevalence Study of Feline Leukemia and Feline Immunodeficiency Infections Among Cats in Algiers (Algeria) and Associated Risk Factors

Feline leukemia and feline immunodeficiency virus infections are two widespread diseases that affect the health of domestic cats all over the world. In Algeria, despite the existence of a large population of cats, there are no published data regarding the epidemiological status of feline retroviruses. Therefore, the objective of the present study was to estimate the seroprevalence of FIV and FeLV infections in cats in Algiers and to assess the main factors associated with the infection. A cross-sectional study was conducted in which 71 cats were sampled from several private veterinary clinics, and their obtained sera were tested using an immunochromatography analysis (SNAP Duo FIV/FeLV Test; Virbac Laboratories, France). The seroprevalence was about 32.39% and 22.53% for FIV and FeLV, respectively. Overall, 11.26% were positive for both infections. The present study showed that FIV seropositivity was associated with a younger age and health status (p < 0.05), while FeLV seropositivity was associated with the sex, reproductive status, housing, age, and health status of the cats. This preliminary study, which utilized rapid tests, provides important initial data revealing a relatively high prevalence of retroviruses in cats in Algeria. The results underscore the urgent need for implementing both preventive and management measures to control the spread of these retrovirus diseases. However, to enhance the reliability of future findings, it is essential to expand the sample size and incorporate reference diagnostic methods.

Codesigning a Digital Type 2 Diabetes Risk Communication Tool in Singapore: Qualitative Participatory Action Research Approach.

Diabetes is a serious public health concern worldwide. Despite public health efforts encouraging early screening and improving knowledge of effective interventions for those at increased risk of type 2 diabetes (T2D), the incorporation of preventative behaviors into an individual's daily life remains suboptimal. Successfully and accurately increasing risk perception has been demonstrated to increase behavioral intention. The study aims to codesign a T2D risk communication tool by engaging public participants to (1) identify key characteristics that contribute to an effective risk communication tool and (2) test and iterate to develop a culturally sensitive and meaningful risk communication tool that can motivate T2D preventative behaviors. We adopted a novel methodology, "Patient and Public Involvement (PPI) Hawkers," where we approached patrons at hawker centers and public eateries frequented by all local residents to evaluate and test 3 prototypes for the tool. The three prototypes were (1) "Diabetes Onset"-estimated age of diabetes onset of T2D based on one's risk factors, (2) "Relative Risk"-the relative risk of T2D is presented in a 1-10 scale indicating where one's risk score lie in relation to others, and (3) "Metabolic Age"-the median age of the risk category based on one's risk factors, presented to be compared against their chronological age. We gathered reactions and feedback through rapid testing and iteration to understand which risk result presentation would be received the best. All the collected data were revisited and analyzed using an inductive thematic analysis to identify the key characteristics contributing to an effective risk communication tool. We engaged with 112 participants (female: n=59, 56%) across 6 hawker centers. The key characteristics that were important to participants emerged in four main themes: (1) appeal and user experience, in terms of format and readability; (2) trust and validity of the institution providing the tool and the accuracy of the risk result; (3) threat appraisal: salience of risk information, which influenced their risk perception; and (4) coping appraisal: facilitators for behavior change, which impacted their intention for implementing T2D preventative behaviors. The predictive nature of the prototype entitled "Diabetes Onset" was poorly received and removed after the first iteration. The Relative Risk prototype was valued for being straightforward but feared to be boring. The Metabolic Age prototype was anticipated to be more motivating for behavior change, but there were some concerns that the terminology may not be understood by everyone. Participants were divided on which of the 2 prototypes, "Metabolic Age" or "Relative Risk," they would favor adopting. Further testing is now required to determine which prototype will be more effective in motivating behavior change. This study's insights on the design process and valued characteristics of a risk communication tool will inform future development of such interventions.

Bridging the "know-do" gap to improve active case finding for tuberculosis in India: A qualitative exploration into national tuberculosis elimination program staffs' perspectives.

In 2022, India's national tuberculosis (TB) elimination program (NTEP) commissioned a national level evaluation of active case finding (ACF) for TB to guide evidence-based strategic planning. As part of this evaluation, based on secondary data analysis we observed that the quality of ACF was suboptimal in 2021. Hence, this study aimed to understand the enablers, barriers, and suggested solutions to improve ACF for TB in India from NTEP staff (provider) perspective. This was a descriptive qualitative study involving key informant interviews from six districts and eight states, conducted between February and August 2023. We purposively selected key state- district- and sub-district-level program managers and implementers who were experienced and vocal. The interviews were audio recorded and transcribed verbatim by research interns and investigators. Two investigators independently did manual descriptive thematic analysis, and a third investigator resolved inconsistencies. The themes and categories emerged by collating together the results of the coding process. A total of 34 key informant interviews were conducted and of these, four were repeat interviews. Adequate budgets for ACF including incentives, performance review mechanism, engagement of all stakeholders, adopting a community friendly approach, use of rapid diagnostic tests and digitalization were the perceived enablers. In some states ACF was implemented in general population (not restricted to high-risk population) following directives at state level. There were limited mechanisms to ensure ACF quality indicators were met before disbursing incentives and cross-verification of the aggregate ACF care cascade numbers that were reported in Ni-kshay (electronic TB information management system under NTEP). In addition to the state and district level implementers having limited understanding of concepts around ACF (quality indicators, number needed to screen and yield), we also inferred the presence of a 'know-do' gap for many activities under ACF. The suggested solutions were around capacity building and quality improvement strategies. The existing national ACF guidance should be revised to emphasize capacity building, need to carry out ACF in high-risk (not general) population, quality control-linked incentives, and regular implementation monitoring of the activities. This should contribute towards better coverage and improved quality translating into better ACF outcomes.

Diagnostic Accuracy of a Rapid Antigen Detection Test for Group A Streptococcus in Children With Pleural Empyema.

Diagnostic Accuracy of a Rapid Antigen Detection Test for Group A Streptococcus in Children With Pleural Empyema.

Compact and simple antenna inspection testing range for 5G smartphones

Abstract Over-the-air antenna performance evaluation in the millimeter-wave band often relies on compact antenna test range systems, which require large reflectors and a substantial measurement range volume. Such setups are impractical for rapid testing in space-constrained environments such as antenna fault diagnosis in smartphone manufacturing facilities. This paper presents a novel design methodology for highly compact antenna inspection testing range utilizing offset parabolic reflectors specifically designed for 5G smartphones. The proposed design system employs three small offset parabolic reflectors configured to account for beam tilting caused by smartphone back covers, eliminating the need to physically reposition the smartphone during testing. By directing electromagnetic fields toward a fixed receiver antenna from multiple angles corresponding to different antenna module positions, the system streamlines the test procedure, significantly reducing measurement time and measurement range volume. The proposed antenna inspection testing range provides a cost-effective and efficient solution for 5G antenna fault diagnosis in manufacturing facilities, ensuring rapid and reliable inspection while minimizing space requirements on the production line.

Retrospective analysis of a large-scale cholera outbreak in Sudan

Background: Cholera outbreak is a significant public health threat in some parts of Sudan. In 2023, there was a large-scale outbreak in Gadarif State. Aim: To analyse the 2023 cholera outbreak in Sudan and recommend prevention and control measures for the future. Methods: In this retrospective study we conducted an epidemiological analysis of data from suspected and confirmed cholera cases, aged ≥ 2 years, from 138 health centres in Gadarif State, Sudan. Results: A total of 1997 cholera cases were confirmed using rapid diagnostic test between 25 August and 17 December 2023. Most patients (99.2%) had severe watery diarrhoea, and vomiting was reported in over 73% of cases. Dehydration rates were similar for men and women (≈55–60%), average attack rate was 6.7 per 10 000 population. The attack rate varied by locality but not by gender across all age groups. The outbreak lasted 20 weeks and claimed 46 lives, giving a case fatality ratio of 2.6%. Public misconception about water chlorination substantially hindered control efforts. Conclusion: The prolonged period of the outbreak and the high case fatality ratio highlight the need for better laboratory and epidemiologic surveillance as well as better preparedness and response for future outbreaks, along with educational activities to address myths and misconceptions.

Prevalence of asymptomatic parasitaemia among household members of children under seasonal malaria chemoprevention coverage and comparison of the performance of standard rapid diagnostic tests versus ultrasensitive RDT for the detection of asymptomatic parasitaemia in Nanoro, Burkina Faso.

Asymptomatic carriers of Plasmodium falciparum represent important parasite reservoirs maintaining malaria transmission in the community. This study aimed on the one hand to screen the other household members living with children under seasonal malaria chemoprevention (SMC) coverage in order to determine the level of malaria infection in this population and on the other hand to determine the appropriate type of rapid diagnostic test (RDT) for this screening to detect these asymptomatic carriers in the community. During the 2022 SMC campaign (July to October), a cross-sectional survey was carried out in 745 participants who were screened by ultrasensitive rapid diagnostic test (usRDT), standard rapid diagnostic test (rRDT) and microscopy. Out of them, 395 had microscopy results available and were included in the data analysis. The prevalence of asymptomatic carriers of asexual forms of Plasmodium falciparum was 26.58% (105/395) while sexual forms were found in 5.32% (21/395) of the study population. Children from 5 to 15 years had the highest prevalence of P. falciparum asexual forms 35.76% (59/165) compared with older participants. Malaria positivity rate for rRDT and usRDT was 29.40% (219/745) and 40.49% (305/745) respectively. The usRDT had a higher sensitivity than the rRDT (72.38% (95% CI 62.8-80.66) vs. 60.95% (95% CI 50.94-70.33)). In terms of specificity, rRDT had a higher specificity 82.41% (95% CI 77.53-86.62) versus 69.66% (95% CI 64.01-74.89) for usRDT. This study reports a high prevalence of parasite carriers in household members of children under SMC coverage in Nanoro, Burkina Faso. In conclusion, usRDT seems more appropriate for strategies based on detection and treatment of parasite carriers within the community.

Emerging public health strategies in malaria control: innovations and implications.

Malaria remains a significant global health challenge, particularly in regions with limited resources and tropical climates. Despite extensive efforts, the disease continues to cause significant morbidity and mortality, with ~229 million cases and 409000 deaths reported in 2020. However, recent years have seen promising advancements in public health strategies aimed at malaria control and elimination. Technological advancements have played a crucial role in improving malaria control efforts. Genomic surveillance techniques enable the monitoring of malaria parasite populations, aiding in the detection of drug resistance and informing targeted interventions. Additionally, innovative diagnostic technologies, such as rapid diagnostic tests (RDTs) and molecular assays, have enhanced the speed and accuracy of malaria diagnosis, facilitated prompt treatment and reduced transmission. These tools are instrumental in achieving the WHO goals of reducing malaria cases and deaths by at least 90% by 2030. Novel vector control methods offer innovative approaches to reduce malaria transmission. Insecticide-treated nets (ITNs) and indoor residual spraying (IRS) remain foundational strategies, with advancements including the development of next-generation insecticides and long-lasting insecticidal nets (LLINs). Furthermore, genetic modification of mosquitoes, such as gene drive technology, holds promise for reducing mosquito populations and interrupting malaria transmission. These vector control innovations complement other strategies, contributing to comprehensive malaria control efforts aimed at achieving sustainable disease reduction and eventual elimination.

Diagnostic utility of rapid antigen testing as point-of-care test for influenza and other respiratory viruses in patients with acute respiratory illness

This study investigates the prevalence and clinical characteristics of respiratory viruses among patients with acute respiratory illness (ARI) in a low-resource setting, using a rapid antigen test as a point-of-care test (POCT). We included 343 patients presenting with ARI symptoms at an outpatient pulmonary clinic from December 2023 to April 2024. Nasopharyngeal swabs were tested for SARS-CoV-2, influenza A/B, respiratory syncytial virus, and adenovirus using POCT. The overall prevalence of respiratory viruses was 21.2%, with influenza A being the most common (11.4%). Shorter duration of symptoms and lower lymphocyte counts were associated with higher influenza positivity. Patients who tested positive for influenza received significantly more antiviral therapy (98.1% vs. 39.4%, p<0.001) and less antibiotic therapy (1.9% vs. 28.5%, p<0.001) compared to those who tested negative. The study highlights the utility of rapid antigen testing in enhancing antiviral and antibiotic stewardship, thereby improving clinical decision-making and patient outcomes in resource-limited settings.

Detection and isolation of Leishmania infantum from natural infected dog in Türkiye

Some clinical signs such as cachexia, alopecia, exfoliative dermatitis, hair loss, and swollen lymph nodes were observed in a one-year-old crossbred male dog living in a rural area of Kirikkale province, Türkiye, was presented to the veterinary clinic by its owner. Anaemia, leucopenia, hyperglobulinemia, and bilirubinemia were detected. Seropositivity was detected using Leishmania IgG/IgM Rapid Test. The amastigote forms of the parasite were observed in the lymph node aspirates. Viable promastigotes were observed in the samples obtained from the Novy-MacNeal-Nicolle medium (NNN) tubes. The parasite DNA was extracted from the promastigotes produced in the NNN medium using a DNA extraction kit according to the manufacturer's instructions. The specific bands indicating the gene regions of L. infantum (350 bp and 730 bp for HSP20 and HSP70, respectively) were observed. Additionally, BLASTn analysis revealed 100 % similarity with GenBank-deposited L. infantum sequences. The sequences were submitted to GenBank (Accession numbers: OR806945 and OR806946). According to the author's knowledge, it is the first dog isolate deposited in the collection of the Microbiology Reference Laboratories and Biological Products Department, General Directorate of Public Health, Ministry of Health, Ankara, Türkiye. The isolate (TR_L. infantum CanL-1_damla) has been preserved by cryopreservation at −150 °C for further studies.

The quick screening of binding compounds and proteins for drug discovery and pharmacological research

In drug discovery and pharmacological research, early identification of target molecules for compounds with pharmacological effects is crucial. However, this process often requires significant effort and can be rate-limiting, thereby slowing down research progress. This paper introduces a simplified and rapid method for quick screening of binding compounds or proteins. Utilizing Affinity Selection Mass Spectrometry (ASMS), this technique efficiently detects compound-target binding through size-exclusion chromatography and mass spectrometry. ASMS offers high sensitivity and specificity, making it ideal for accurate identification of binding interactions. We have further enhanced ASMS to handle membrane proteins without solubilization, creating Binder Selection Technology (BST). BST allows screening against both soluble and challenging membrane proteins such as GPCRs and SLC transporters. By using cell membrane fractions or organelle fractions with high target molecule expression, BST efficiently identifies potential binding compounds. This innovative method constructs a comprehensive database of binding compounds for various targets, facilitating rapid hypothesis testing and pharmacological evaluation. Additionally, BST screens 17,000 proteins, including membrane proteins, using wheat germ cell-free and animal cell expression systems. This approach allows exploration of binding interactions without labeling compounds or immobilizing proteins, preserving their native state. BST is powerful for identifying targets of compounds with known pharmacological effects but unknown targets in animal or cell-based assays. By utilizing BST, researchers can overcome bottlenecks in early drug discovery, significantly enhancing research speed and success rates. This method represents a major advancement, providing an efficient and effective way to identify and validate target molecules in drug discovery.

Adsorbability of a Wide Range of Per- and Polyfluoroalkyl Substances on Granular Activated Carbon, Ion Exchange Resin, and Surface Modified Clay

The increased detection of understudied per- and polyfluoroalkyl substances (PFAS) in environmental matrices has highlighted the need to evaluate the treatability of a wide-range of PFAS by sorption-based processes. This study investigated the efficacy of three commercial adsorbents (i.e., granular activated carbon (GAC), surface modified clay (SMC), and anionic exchange resin (AER)) for the removal of a wide range of cationic, zwitterionic, and anionic PFAS from an aqueous film forming foam (AFFF)-impacted groundwater employing rapid small-scale column tests (RSSCTs) coupled with high resolution mass spectrometry (HRMS) and suspect screening analysis (SQ). AER exhibited later breakthrough times for the majority of anionic and zwitterionic PFAS compared to SMC and GAC. However, both AER and SMC exhibited negligible removal of cationic PFAS presumably due to the reliance of these adsorbents on electrostatic interactions and the counteraction of hydrophobic forces caused by the repulsion between cationic PFAS and positively charged surfaces of AER and SMC. GAC, being a non-selective adsorbent, was largely unaffected by the ionic charge of the evaluated PFAS with molecular structure having a bigger impact on adsorbability. The detection of a variety of PFAS classes in the investigated AFFF-impacted groundwater enabled assessment of the relative impact of chemical structure on adsorptive removal of PFAS. Chain-length dependent adsorption was observed across all investigated anionic and zwitterionic PFAS classes. The PFAS structures possessing hydroxyl and/or methyl functional groups exhibited later breakthrough times compared to their homologues lacking these functional groups and cyclic/unsaturated structures were removed less efficiently compared to their linear/saturated homologues. In the case of perfluoroalkyl acid (PFAA)-derivative structures, hydrogen-substituted classes (i.e., H-PFAAs) were removed more efficiency than PFAAs while keto-substituted structures (i.e., K-PFSA) and pentahydrido-fluoroalkane sulfates (PeH-FAOS) exhibited lower adsorbability compared to PFAAs for all adsorbents. Oxa-PFAAs (O-PFSA; isomer class of PFA-OS) on the other hand demonstrated higher adsorbability compared to PFAAs in the case of AER-like adsorbents, while this trend was reversed for GAC.

Development of a concentration method for simple and sensitive detection of SARS-CoV-2 in saliva using a magnetic nanoparticle kit

BackgroundWhen diagnosing viral infections in humans and animals, the presence of virus in a sample in trace amounts that are below the analytical sensitivity of the detection system may cause false negative results and inaccurate diagnosis. We previously reported the development of a simple virion concentration technique using 12ml large-volume samples that can dramatically improve diagnostic sensitivity by increasing analytical sensitivity by 100-fold over conventional methods. The present study was conducted to further improve the simplicity and versatility of this method. We constructed a simple and highly sensitive method for the detection of SARS-CoV-2 in human saliva after concentration using a magnetic nanoparticle conjugated with polyethylene glycol (PEG). ResultsPerformance of the method was evaluated by comparing a combination of automated nucleic acid extraction and RT-qPCR or triplex RT-LAM detection in a spiked sample of 20ml saliva collected from healthy humans. The method theoretically achieved 300-fold concentration of spiked SARS-CoV-2 in saliva, enabling 10- to 1000-fold higher analytical sensitivity for detection compared to conventional RNA extraction methods. ConclusionsThis newly developed method allows for easy and reliable concentration of the virion in less than 60min, improving the analytical sensitivity of the SARS-CoV-2 test. Further, the method allows for easy and reliable enrichment of the virus in less than 60min, improving the analytical sensitivity of the SARS-CoV-2 test. This method is easily used for highly sensitive virus detection from a variety of human oral fluid samples and may also be applied to rapid and labor-saving screening tests by pooling a large number of samples.

Effects of Na2SiO3/NaOH ratio in alkali activator on the microstructure, strength and chloride ingress in fly ash and GGBS based alkali activated concrete

In this study, the impact of alkaline solutions composed of various Na2SiO3/NaOH ratio and NaOH molarity on the strength, chloride ingress and chloride binding capacity of fly ash (FA) and ground granulated blast furnace slag (GGBS) based alkali activated concrete (AAC) was investigated. The microstructural properties of alkali activated binders (AAB) composites was also studied to understand its influence on the chloride permeability of AAC. Chloride permeability of concrete was tested by using the rapid chloride penetration test (RCPT) and by immersing concrete in NaCl solution (ASTM C1556). The compressive strength, chloride ingress and chloride binding capacity of AAC was compared with Portland cement-based concrete (OPC). Results showed that higher Na2O/SiO2 ratio in alkaline solutions resulted in a weak microstructure with, low strength and high chloride ingress. Concrete activated by alkaline solutions with Na2O/SiO2 molar ratio =1 (+3), exhibited greater compressive strength and resistance to chloride ion penetration. The increase of SiO2 concentration in alkaline solution greatly reduces the binding capacity of AAC while the bound chlorides increased with the NaOH molarity. No chemical chloride binding was observed in AAC but for OPC concrete, calcium salts formed in the microstructure after immersion in NaCl solution. Compared to OPC concrete, AAC showed superior performance in terms of strength and chloride diffusion making it a potential candidate for application in marine structures.

Convalescent plasma therapy for COVID-19 – Donor selection strategies and establishment of a plasma bank

BackgroundEarly in the COVID-19 pandemic, convalescent plasma (CP) emerged as a potentially effective treatment neutralising SARS-CoV-2. Early CP therapy with high neutralising antibody (NAb) titre may benefit COVID-19 outpatients and, in sufficient quantities even some hospitalised patients. This study details the process of setting up a CP bank, containing high- and low-titre CP for a clinical trial. Study design and methodsWe identified 18–65-year-old convalescents with SARS-CoV-2 NAb titres of ≥1:40 in microneutralisation test (MNT). Following eligibility pre-screening, the Finnish Red Cross Blood Service (FRCBS) determined suitability as CP donors. ResultsOf the 6466 COVID-19 convalescents contacted, 1481 provided serum, with 851 (57.5 %) exhibiting NAb titres ≥1:40. Participation barriers included reluctance, advanced age and, for women, insufficient body size. Of the volunteers, 125 were evaluated at FRCBS, with major exclusions for HLA antibodies (42 women), interferon antibodies (five men), and NAb titres waning below 1:20 (16 participants). Finally, 70 underwent plasmapheresis, resulting in 50 suitable CP donors (0.8 % of initial contacts and 3.4 % of those tested for NAb). DiscussionThe process of setting up a CP bank proved challenging. Excessive laboratory workloads during a pandemic hamper their ability to conduct MNT, underscoring the need for rapid screening tests. Only a small proportion of our convalescents exhibited high-titre CP, this fraction declining over time because of waning immunity. Strict plasmapheresis criteria further constrained donor eligibility. Establishing a plasma bank requires meticulous planning to maximize efficiency. Detailed insights from current experiences may prove critical in future pandemics before other remedies and vaccines become available.

An Update on Recent Clinical Trial Data in Bloodstream Infection

Bloodstream infections (BSIs) remain a significant source of morbidity and mortality globally, exacerbated by an ageing population and rising antimicrobial resistance (AMR). This review offers an updated evaluation of randomized clinical trials (RCTs) in BSI management from 2018 onwards, focusing on the evolving landscape of diagnostics and treatment. New rapid diagnostic technologies and shorter antimicrobial courses have transformed clinical practice, reducing the time to appropriate therapy and hospital stays. Several RCTs demonstrated that rapid phenotypic and genotypic tests shorten the time to optimal therapy, especially when paired with antimicrobial stewardship. Ongoing trials are investigating novel antimicrobial regimens and the safety of early oral switch strategies, particularly for Gram-positive and Gram-negative BSIs. Recent RCTs on Staphylococcus aureus BSI (SAB) and multidrug-resistant Gram-negative bacteria highlight advances in treatment but emphasize the need for further study into the efficacy of combination therapies and the utility of rapid diagnostics in different healthcare settings. The review also explores challenges in trail design, with adaptive and pragmatic appropriates improving the efficacy of clinical trials. Finally, this paper identifies gaps in the research, including the need for further investigation into oral step-down therapy, optimal durations, and the role of rapid diagnostics in resource-limited settings.

A New Test for Evaluating the Psychological Impact of COVID-19 in Nurses

Introduction During the COVID-19 pandemic, many health care workers were involved and suffered significant physical and psychological strain, and nursing was one of the main players. Clearly and objectively establishing the psychological impact on nurses during the pandemic is necessary for long-term recovery and to be prepared for new outbreaks in the future. Aim The aims of this study were to evaluate the perceived impact on nurses at risk of psychological stress at work during a major health care crisis and determine the psychological impact and its influencing factors. Methods An online questionnaire was designed and distributed between April 9 and April 19, 2020, in Spain. The comprehensive self-conducted questionnaire included demographic information and the Psychological Stress and Adaptation at work Score. For the analysis, descriptive statistics, logistic regressions, and receiver operating characteristic curves were determined. Results A total of 825 nurses (33% working in intensive care units and emergency departments) answered the questionnaire. A logistic regression analysis revealed that nurses with higher psychological stress scores experienced more physical overload (P = .02), higher psychological overload (P &lt; .01), poor teamwork (P = .02), more distress due to new circumstances (P &lt; .01), more personal impact of how society responded to COVID-19 (P &lt; .01), anticipation of negative future consequences (P &lt; .01), and worse balance between family and work (P &lt; .01). The area under the curve for the cutoff point of Psychological Stress and Adaptation at work Score 40 was 0.82 (95% confidence interval, 0.79-0.91), with 70% sensitivity and 81% specificity. The positive predictive value was 72%, and the negative predictive value was 80%. Conclusion Psychological Stress and Adaptation at work Score is a rapid and accurate test for evaluating the psychological well-being of health care staff that can be used when crisis prevents the use of conventional stress diagnosis methods. Higher psychological impact was observed in nurses who worked in the intensive care unit and in the hospital ward.

A randomized, placebo-controlled first-in-human study of oral TQS-168 in healthy volunteers: Assessment of safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect.

TQS-168, a first-in-class small-molecule inducer of peroxisome proliferator-activated receptor gamma coactivator 1-alpha gene expression, is in development for the treatment of amyotrophic lateral sclerosis. A single-ascending-dose (SAD) and multiple-ascending-dose (MAD) study of TQS-168 was carried out in healthy male subjects to investigate safety, tolerability, pharmacokinetics (PK), food effect, and preliminary pharmacodynamic effects (PD). Since solubility enhancement could be beneficial, assessment of three formulations was incorporated into the study using an integrated rapid manufacturing and clinical testing approach. Dosing in the SAD part was initiated with a crystalline methylcellulose (MC) suspension, and then spray-dried dispersion (SDD) and hot-melt extrusion (HME) suspensions were evaluated. The HME and SDD formulations showed two and fourfold higher exposure than the MC suspension, respectively, and the SDD formulation was selected for progression to subsequent SAD and MAD cohorts, in which there was further investigation of the food effect on exposure in addition to assessments of safety, tolerability, PK, and PD. Cmax and AUC plasma exposures of TQS-168 were supra-proportional at higher doses, irrespective of formulation. Median Tmax for TQS-168 occurred between 0.5 and 4.0 h post-dose and occurred later with higher doses. Geometric mean half-lives (T1/2) for TQS-168 were independent of formulation and food, ranging from 3.2 to 10.5 h following single doses and 4.1 to 7.3 h following multiple doses. Food blunted TQS-168 Cmax but had minimal impact on AUC. TQS-168 was considered to be safe and generally well tolerated following single and multiple oral doses. The SDD formulation was selected for future patient studies.