The impact of COVID-19 on routine patient care from a laboratory perspective

Background. Globally, few studies have examined the effect of the COVID-19 pandemic on routine patient care and follow-up.Objectives. To evaluate the effect of the COVID-19 response on biochemical test requests received from outpatient departments (OPDs) and peripheral clinics serviced by the National Health Laboratory Service Chemical Pathology Laboratory at Tygerberg Hospital, Cape Town, South Africa (SA). Request volumes were used as a measure of the routine care of patients, as clinical information was not readily available.Methods. A retrospective audit was conducted. The numbers of requests received from OPDs and peripheral clinics for creatinine, glycated haemoglobin (HbA1c), lipid profiles, thyroid-stimulating hormone (TSH), free thyroxine, free tri-iodothyronine (fT3), serum and urine protein electrophoresis, serum free light chains and neonatal total serum bilirubin were obtained from 1 March to 30 June for 2017, 2018, 2019 and 2020.Results. The biggest impact was seen on lipids, creatinine, HbA1c, TSH and fT3. The percentage reduction between 1 March and 30 June 2019 and between 1 March and 30 June 2020 was 59% for lipids, 64% for creatinine and HbA1c, 80% for TSH and 81% for fT3. There was a noteworthy decrease in overall analyte testing from March to April 2020, coinciding with initiation of level 5 lockdown. Although an increase in testing was observed during June 2020, the number of requests was still lower than in June 2019.Conclusions. This study, focusing on the short-term consequences of the SA response to the COVID-19 pandemic, found that routine follow-up of patients with communicable and non-communicable diseases was affected. Future studies are necessary to evaluate the long-term consequences of the pandemic for these patient groups.

Hypertriglyceridaemia in adolescents may have serious complications

Acute pancreatitis is an often-overlooked cause of acute abdominal pain in children and adolescents. Severe hypertriglyceridaemia is an important cause of recurrent acute pancreatitis. Monogenic causes of hypertriglyceridaemia, such as familial chylomicronaemia caused by lipoprotein lipase deficiency, are more frequently encountered in children and adolescents, but remain rare. Polygenic hypertriglyceridaemia is more common, but may require a precipitant before manifesting. With the global increase in obesity and type 2 diabetes, secondary causes of hypertriglyceridaemia in children and adolescents are increasing. We report two cases of severe hypertriglyceridaemia and pancreatitis in adolescent females. Hypertriglyceridaemia improved markedly with restriction of dietary fat. An inhibitor to lipoprotein lipase was found to be the cause in one patient, while in the other limited genetic investigation excluded chylomicronaemia owing to deficiency of lipoprotein lipase, its activators and processing proteins

Управление рисками безопасного использования высокоавтоматизированных транспортных средств в мегаполисе: системно-правовой анализ

The article presents the results of a scientific study of current issues of risk management associated with ensuring safe operation of unmanned vehicles, obtained by the authors as a result of implementation of the second stage of a scientific project supported by the Russian Science Foundation. The conclusions presented in the article are based on the results of a study of legal and organisational problems of ensuring the safe use of unmanned vehicles in a metropolis, carried out during the first stage of the project.The study confirmed the authors’ assumption that solving the problem of ensuring the safe use of unmanned vehicles is possible based on scientific research into the risks arising during their operation. It is substantiated that identification, differentiation, monitoring of risks determined by appearance of unmanned vehicles on highways is a necessary condition for development of a scientifically based system of legal measures of general and private prevention, including measures of legal liability for relevant offenses, based on categorisation of risks and threats of violation of mandatory requirements adopted to ensure transport safety and traffic management using this type of vehicle.The fundamental provisions are analysed and comprehended underlying the application of the risk­based approach in homogeneous and single-type social relations.В статье представлены результаты научного исследования актуальных вопросов управления рисками, связанными с обеспечением безопасной эксплуатации беспилотных автомобилей, полученные авторами в результатах реализации второго этапа научного проекта, поддержанного Российским научным фондом. Выводы, представленные в статье, основываются на результатах исследования правовых и организационных проблем обеспечения безопасного использования беспилотных автомобилей в условиях мегаполиса, осуществленного в период первого этапа проекта.В ходе исследования подтвердилось предположение авторов, что решение задачи обеспечения безопасного использования беспилотных автомобилей возможно на основе научного исследования рисков, возникающих при их эксплуатации. Обосновывается, что выявление, дифференциация, мониторинг рисков, детерминированных появлением на автомобильных дорогах беспилотных автомобилей, является необходимым условием для выработки научно обоснованной системы правовых мер общей и частной превенции, включающей меры юридической ответственности за соответствующие правонарушения, основанной на категорировании рисков и угроз нарушения обязательных требований, устанавливаемых в целях обеспечения безопасности на транспорте и организации дорожного движения с использованием такого рода транспортных средств.Проанализированы принципиальные положения, заложенные в основу применения риск-ориентированного подхода воднородных и одновидовых общественных отношениях

Правовые и технологические аспекты внедрения контракта жизненного цикла в пассажирском комплексе дальнего следования

The analysis and the experience gained in shaping contractual relations in the LCC format, both on the part of foreign companies and in the domestic market, have resulted in the conclusion that it is beneficial for the customer to conclude LCC. Ultimately, the costs are reduced by about 10-15 % compared to the traditional form of contractual relations (separate contracts for manufacturing and, respectively, service maintenance). LCC is also advantageous since it eliminates the need to search for and subsequently contract the contractors at the stage of operation.When concluding LCC contract, both purchase and subsequent maintenance of rolling stock can be carried out through a concession agreement in compliance with legislation regulating the procurement procedure. When purchasing, it is necessary to be guided by the requirements of federal law in terms of mandatory tender procedures and selection of potential suppliers.The analysis of existing models for formation of contractual relations for maintenance of rolling stock under the LCC contract has shown that it is advisable to consider the possibility of extending it to newly manufactured passenger rolling stock used in long­distance passenger transportation. Целью настоящей публикации является рассмотре­ние и оценка внедрения обслуживания и ремонта пасса­жирского подвижного состава на основе заключения до­говорных отношений по контракту жизненного цикла (КЖЦ).По результатам проведённого анализа и полученного опыта формирования договорных отношений в формате КЖЦ как со стороны зарубежных компаний, так и на отече­ственном рынке установлено, что заказчику выгодно их заключение. Расходы, в конечном итоге, снижаются пример­но на 10—15 % в сравнении с традиционной формой заключе­ния договорных отношений (отдельный договор на изготов­ление и сервисное обслуживание). Существенным преимуще­ством является также то, что использование такого рода соглашений исключают необходимость поиска и последую­щего заключения договоров с исполнителями на этапе экс­плуатации.При заключении контрактов КЖЦ закупка и заключение до­говора на последующее сервисное обслуживание подвижного со­става могут быть осуществлены на основе концессионного соглашения в соответствии с требованиями законодательства о закупке. При закупке необходимо руководствоваться требова­ниями федерального закона в части обязательного проведения конкурсных процедур и отбора потенциальных поставщиков.На основании анализа существующих моделей форми­рования договорных отношений по обслуживанию подвижно­го состава по контракту КЖЦ целесообразно рассматри­вать возможность его распространения на вновь изготав­ливаемый пассажирский подвижной состав, используемый в дальнем сообщении.

High pleural fluid adenosine deaminase levels: A valuable tool for rapid diagnosis of pleural TB in a middle-income country with a high TB/HIV burden

Background. South Africa has the highest burden of tuberculosis (TB) in the World Health Organization (WHO) African region. Using traditional TB diagnostic tools, the diagnosis of pleural TB (PTB) is highly unrewarding. Elevated levels of pleural fluid adenosine deaminase (FADA) have been shown to be useful in the diagnosis of PTB; however, similar levels may be found in some other medical conditions leading to misdiagnosis. Following queries from clinicians concerning the likely high false-positive (FP) rate of FADA from our laboratory, we performed a retrospective audit of all high FADA results generated over a 12-month period.Objectives. To determine the positive predictive value (PPV) of FADA, the frequent causes of FPs in our laboratory and the demographic characteristics of tuberculous pleural effusions (TPEs) and non-tuberculous pleural effusions (NTPEs).Methods. High FADA results generated in the past year were extracted with corresponding TB culture results, fluid cell count, cytology/ histology results, radiology reports and HIV results. Hospital records were reviewed for the final diagnosis in each case. Diagnosis of PTB was based on the WHO case definition of TB.Results. A total of 159 results were reviewed: 133 (83.6%) were TPE, hence FADA had a PPV of 83.6%. Neoplasm was the most common cause of an FP in 13/26 (50%) NTPEs. While TPE was more common than NTPE in younger people, both groups had an equal gender distribution.Conclusion. FADA had a high PPV for PTB in our laboratory. We recommend its continued use as a rapid and reliable diagnostic tool for PTB.

Electrophoresis test prevalence, requesting patterns, yield and related bone marrow biopsy findings at a South African tertiary hospital: A 5-year retrospective audit

Background. Studies of electrophoresis testing (serum protein electrophoresis (SPE), urine protein electrophoresis (UPE), immunofixation electrophoresis (IFE)) in a South African (SA) pathology laboratory setting are limited.Objectives. To evaluate the prevalence, testing pattern and yield of electrophoresis tests performed over a 5-year period in a tertiary academic laboratory and to relate these findings to bone marrow biopsy findings in a few selected cases.Methods. This was a retrospective audit of all SPE, UPE and IFE tests performed on new and follow-up adult patients (aged ≥18 years) from 2010 to 2015, using data from the Tygerberg Academic Hospital (Cape Town, SA) National Health Laboratory Service hospital information system database. A subgroup analysis of all patients with negative serum (SIFE) and/or urine immunofixation (UIFE) tests who had concurrent bone marrow biopsies close to the time of IFE testing was also performed.Results. A total of 5 086 SPE tests were performed (44.3% were follow-up tests, and of these patients 13.8% had SIFE tests); 1 299 UPE tests were performed (23.3% were follow-up tests, and of these patients 33.6% had UIFE tests). The mean ages of patients who had SIFE and UIFE tests were 59 years (standard deviation (SD) 14.2) and 60 years (SD 15), respectively. The female-to-male ratio was 1.1:1 for both SIFE and UIFE. The negative test yields for SIFE and UIFE were 31.3% and 52.1%, respectively. Bone marrow biopsy findings for patients with negative SIFE tests identified 8 out of the 20 biopsies (40.0%) as positive for myeloma.Conclusion. This audit provides baseline data on the prevalence of test requests, their source and the yield of electrophoresis testing in our laboratory. An increasing trend in SIFE and UIFE was evident

Проблемные вопросы правового регулирования использования автомобилей с автоматизированной системой вождения

In the context of a fundamental change in the fundamental approaches to building a traffic management system, traditionally based on establishing the driver’s duty to ensure constant control over the traffic situation and, accordingly, presuming his responsibility for harm caused by a source of increased danger, the problem of legal regulation of the use of highly automated vehicles equipped with an automated driving system that does not provide for participation of the driver in the dynamic control of the car becomes not only relevant in theoretical, but also especially significant from practical aspects.The objective of the comprehensive study being conducted by the authors was to identify and visualise key groups of problems of legal regulation of the operation of cars with an automated driving system, to formulate proposals for their solution as part of a subsequent systemic legal study. This article is devoted to the results of consideration of the first block of the identified issues.Using the methods of the system-legal approach, formal-logical and formal-dogmatic analysis, the authors have identified the most problematic issues of legalising the terminology used in positive law and scientific sources. In particular, options for identifying the essential features of highly automated cars are proposed with the purpose to further legislatively determine the cars that should be classified as highly automated, to reveal which software and hardware complex can be considered an automated driving system, etc.Based on the results of solving the scientific problem, which consists in determining the directions for adapting the legislation governing the requirements for safety of vehicles and the procedure for their admission to operation for the needs of the widespread introduction of highly automated vehicles, the research can be carried out in two directions at the same time: to develop upper-level, essential requirements to safety and to develop specific, purely technical requirements for automated driving systems, as well as to develop a methodology for testing them.As a part of the taxonomic analysis carried out by the authors to determine, on a fundamentally new basis, the range of rights and obligations of the participants in the relations under the study, it is proposed to highlight the problem of distinguishing between situations in which the driver needs to take an active part in driving a car from situations in which he is not required to be actively involved. into this process.When considering issues of liability for harm caused by a car with an automated driving system, the article focuses on the need to solve the problem of balancing the responsibility of the car owner and the manufacturer, which can be facilitated by the application of methods of comparative legal analysis.В условиях коренного изменения принципиальных подходов к построению системы организации дорожного движения, традиционно основанной на установлении обязанности водителя обеспечивать постоянный контроль за дорожной обстановкой и, соответственно, презюмировании его ответственности за вред, причинённый источником повышенной опасности, проблема правового регулирования применения высокоавтоматизированных транспортных средств, оснащённых автоматизированной системой вождения, не предусматривающей участия водителя в динамическом управлении автомобилем, становится не только актуальной в теоретическом, но и особо значимой в практическом аспектах.Целями ведущегося авторами комплексного исследования стали выявление и визуализация ключевых групп проблем правового обеспечения использования автомобилей с автоматизированной системой вождения, формулирование предложений по их решению в рамках последующего системно-правового исследования. В данной публикации приведены результаты рассмотрения первого блока обозначенных вопросов.С использованием методик системно-правового подхода, формальнологического и формально-догматического анализа авторами определены наиболее проблемные вопросы легализации терминологии, используемой в позитивном праве и научных источниках. В частности, предложены варианты выявления сущностных признаков высокоавтоматизированных автомобилей в интересах последующего законодательного определения того, какие автомобили должны быть отнесены к высокоавтоматизированным, какой программно-аппаратный комплекс может считаться автоматизированной системой вождения и т.п.По результатам решения научной задачи, состоящей в определении направлений адаптации законодательства, регулирующего требования к безопасности транспортных средств и процедуру их допуска к эксплуатации к потребностям широкого внедрения высокоавтоматизированных автомобилей, авторами сделан вывод, что данная работа может вестись в двух направлениях одновременно: по разработке верхнеуровневых, сущностных требований к безопасности и по выработке точечных, сугубо технических требований к автоматизированным системам вождения, а также по разработке методологии их испытаний.В рамках осуществления таксономического анализа, осуществлённого авторами в целях определения круга прав и обязанностей участников исследуемых отношений предлагается особо выделить проблему разграничения ситуаций, в которых водителю необходимо принимать активное участие в управлении автомобилем, от ситуаций, в которых от него не требуется активного вовлечения в этот процесс.При рассмотрении вопросов ответственности за вред, причинённый автомобилем с автоматизированной системой вождения, делается акцент на необходимость решения проблемы баланса ответственности владельца автомобиля и изготовителя, чему может способствовать применение методов компаративно-правового анализа

Prognostic value of biochemical parameters among severe COVID-19 patients admitted to an intensive care unit of a tertiary hospital in South Africa

Background: Data on biochemical markers and their association with mortality rates in patients with severe coronavirus disease 2019 (COVID-19) admitted to intensive care units (ICUs) in sub-Saharan Africa are scarce. An evaluation of baseline routine biochemical parameters was performed in COVID-19 patients admitted to the ICU, in order to identify prognostic biomarkers. Methods: Demographic, clinical, and laboratory data were collected prospectively from patients with PCR-confirmed COVID-19 admitted to the adult ICU of a tertiary hospital in Cape Town, South Africa, between October 2020 and February 2021. Robust Poisson regression methods and the receiver operating characteristic (ROC) curve were used to explore the association of biochemical parameters with severity and mortality. Results: A total of 82 patients (median age 53.8 years, interquartile range 46.4–59.7 years) were enrolled, of whom 55 (67%) were female and 27 (33%) were male. The median duration of ICU stay was 10 days (interquartile range 5–14 days); 54/82 patients died (66% case fatality rate). Baseline lactate dehydrogenase (LDH) (adjusted relative risk 1.002, 95% confidence interval 1.0004–1.004; P = 0.016) and N-terminal pro B-type natriuretic peptide (NT-proBNP) (adjusted relative risk 1.0004, 95% confidence interval 1.0001–1.0007; P = 0.014) were both found to be independent risk factors of a poor prognosis, with optimal cut-off values of 449.5 U/l (sensitivity 100%, specificity 43%) and 551 pg/ml (sensitivity 49%, specificity 86%), respectively. Conclusions: LDH and NT-proBNP appear to be promising predictors of a poor prognosis in COVID-19 patients in the ICU. Studies with a larger sample size are required to confirm the validity of this combination of biomarkers

Haematological predictors of poor outcome among COVID-19 patients admitted to an intensive care unit of a tertiary hospital in South Africa

BACKGROUND: Studies from Asia, Europe and the USA indicate that widely available haematological parameters could be used to determine the clinical severity of Coronavirus disease 2019 (COVID-19) and predict management outcome. There is limited data from Africa on their usefulness in patients admitted to Intensive Care Units (ICUs). We performed an evaluation of baseline haematological parameters as prognostic biomarkers in ICU COVID-19 patients. METHODS: Demographic, clinical and laboratory data were collected prospectively on patients with confirmed COVID-19, admitted to the adult ICU in a tertiary hospital in Cape Town, South Africa, between March 2020 and February 2021. Robust Poisson regression methods and receiver operating characteristic (ROC) curves were used to explore the association of haematological parameters with COVID-19 severity and mortality. RESULTS: A total of 490 patients (median age 54.1 years) were included, of whom 237 (48%) were female. The median duration of ICU stay was 6 days and 309/490 (63%) patients died. Raised neutrophil count and neutrophil/lymphocyte ratio (NLR) were associated with worse outcome. Independent risk factors associated with mortality were age (ARR 1.01, 95%CI 1.0–1.02; p = 0.002); female sex (ARR 1.23, 95%CI 1.05–1.42; p = 0.008) and D-dimer levels (ARR 1.01, 95%CI 1.002–1.03; p = 0.016). CONCLUSIONS: Our study showed that raised neutrophil count, NLR and D-dimer at the time of ICU admission were associated with higher mortality. Contrary to what has previously been reported, our study revealed females admitted to the ICU had a higher risk of mortality

Diagnostic Accuracy of Adenosine Deaminase and Lymphocyte Proportion in Pleural Fluid for Tuberculous Pleurisy in Different Prevalence Scenarios

BACKGROUND: Tuberculous pleural effusion (TPE) is a paucibacillary manifestation of tuberculosis, so isolation of Mycobacterium tuberculosis is difficult, biomarkers being an alternative for diagnosis. Adenosine deaminase (ADA) is the most cost-effective pleural fluid marker and is routinely used in high prevalence settings, whereas its value is questioned in areas with low prevalence. The lymphocyte proportion (LP) is known to increase the specificity of ADA for this diagnosis. We analyse the diagnostic usefulness of ADA alone and the combination of ADA ≥ 40 U/l (ADA(40)) and LP ≥ 50% (LP(50)) in three different prevalence scenarios over 11 years in our area. MATERIALS AND METHODS: Biochemistry, cytology and microbiology studies from 472 consecutive pleural fluid samples were retrospectively analyzed. ADA and differential cell count were determined in all samples. We established three different prevalence periods, based on percentage of pleural effusion cases diagnosed as tuberculosis: 1998-2000 (31.3%), 2001-2004 (11.8%), and 2005-2008 (7.4%). ROC curves, dispersion diagrams and pre/post-test probability graphs were produced. TPE accounted for 73 episodes (mean prevalence: 15.5%). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for ADA(40) were 89%, 92.7%, 69.2% and 97.9%, respectively. For ADA(40)+LP(50) the specificity and PPV increased (98.3% and 90%) with hardly any decrease in the sensitivity or NPV (86.3% and 97.5%). No relevant differences were observed between the three study periods. CONCLUSIONS/SIGNIFICANCE: ADA remains useful for the diagnosis of TPE even in low-to-intermediate prevalence scenarios when combined with the lymphocyte proportion