Séroprevalenční studie jsou významným nástrojem umožňujícím zjistit, jaká část populace již byla infikována (např. SARS-CoV-2). Bez těchto informací je pro státní instituce velmi obtížné přijímat správná protiepidemická opatření. Na jaře 2020 proběhla v jižních Čechách, v okresech Strakonice a Písek, středně velká séroprevalenční studie. Vyšetřeno bylo celkem 2011 lidí, a to ve skupině dobrovolníků z řad veřejnosti a vybraných profesních skupin. Stanovení protilátek IgA a IgG proti koronaviru bylo provedeno metodou ELISA Euroimmun. Zjistili jsme, že v květnu 2020 mělo protilátky proti koronaviru 2,9 % obyvatel okresu Strakonice a 1,9 % obyvatel okresu Písek. Na jednu osobu s pozitivním testem PCR tedy připadlo dalších nejméně 50 osob s protilátkami proti koronaviru. Při provádění séroprevalenčních studií je potřeba řešit 3 základní problémy. Je nutné dobře studii naplánovat a promyslet, jaké varianty výsledků lze očekávat. Také vybrat kvalitní testy známých parametrů, které umožnují kvalifikovaně odhadnout podíl falešně pozitivních a falešně negativních výsledků. V neposlední řadě musíme umět data rozumně vyhodnotit a vyvodit z nich správné závěry a zobecnění. Na konkrétním případě séroprevalenční studie z Jihočeského kraje dále ukazujeme, jak správně řešit případné komplikace, které mohou nastat při takto rozsáhlém testování.
Seroprevalence studies represent a very important tool to find out what fraction of population has already met with the new type of coronavirus (e.g. SARS-CoV-2). Without these data, it is almost impossible for the state authorities to manage the epidemic and adopt rational measures. This article brings the results of a medium-sized seroprevalence study which was carried out in the spring of 2020 in South Bohemia. In the Strakonice and Písek regions, the ELISA method was used to test the prevalence of IgA and IgG antibodies in 2011 subjects, volunteers from general public and selected professions working in areas with a higher exposure to the infection. The study showed that already in May 2020, 2.9% of inhabitants of the Strakonice region and 1.9% of inhabitants of the Písek region had antibodies against the coronavirus. These numbers imply that for each PCR positive person, there were at least fifty others who had probably already undergone the infection. The article points out three types of problems that might occur in such a study. First, the study must be planned correctly, and possible outcomes must be pre-assessed. Second, an appropriate test must be selected with known parameters. This enables us to correctly estimate the share of false positive and false negative results. Third, the data must be evaluated in a reasonable way and correct inference must be performed. We offer a set of recommendations how to manage these issues and how to solve problems that inevitably arise in such a large-scale testing.
- MeSH
- COVID-19 * MeSH
- ELISA MeSH
- imunoglobulin A krev MeSH
- imunoglobulin G krev MeSH
- lidé MeSH
- polymerázová řetězová reakce MeSH
- protilátky virové krev MeSH
- SARS-CoV-2 MeSH
- senzitivita a specificita MeSH
- séroepidemiologické studie * MeSH
- sérologické testování na COVID-19 MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
Releasing of metals from joint replacements represents one of the current topics of modern orthopedics. Determination of metals can contribute to understanding of patient's exposure to the metals and could be used as potential biomarker to detect the failure of joint replacements. This review focuses on materials used in production of joint replacements and their release into the human body. It provides an overview of the most frequently used sample preparation procedures, instrumental techniques including elemental speciation analysis, and the previously reported concentration levels of released metals in various clinical matrices, such as blood, serum, joint fluid or tissues. Quality of results, as a non-negligible part of analytical procedure, is also discussed.
- MeSH
- kovy * analýza krev moč škodlivé účinky MeSH
- lidé MeSH
- protézy kloubů * škodlivé účinky MeSH
- selhání protézy MeSH
- spektrální analýza metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- MeSH
- COVID-19 epidemiologie MeSH
- koronavirové infekce epidemiologie MeSH
- Publikační typ
- populární práce MeSH
- rozhovory MeSH
- MeSH
- COVID-19 diagnóza imunologie MeSH
- epidemie statistika a číselné údaje MeSH
- interpretace statistických dat MeSH
- klinické laboratorní techniky MeSH
- koronavirové infekce diagnóza imunologie MeSH
- lidé MeSH
- protilátky virové MeSH
- statistika jako téma MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- populární práce MeSH
- rozhovory MeSH
Pharmaceutical products as well as active pharmaceutical ingredients (APIs) are checked for levels of elemental contaminants to guarantee medicines administration will not involve the consumption of level of contaminants greater than their maximum admissible intake. However, the conformity decision is affected by the measurement uncertainty function of analytical steps performance, used standards quality and how measurement performance is assessed during method validation. When an ingredient is considered conform, since the measured concentration is lower than the maximum limit, the risk of a false acceptance depends on how close the measured concentration is from the limit and on the measurement uncertainty. The analytical methods used for pharmaceutical analysis should be validated by ICH and USP recommendations, in order to prove measurements are fit for purpose. The validation must also be economically feasible and have an acceptable duration. This work discusses how to evaluate the uncertainty of elemental analysis in pharmaceutical ingredients from data collected during the validation of the analytical method by following ICH guidelines and USP chapters. A top-down uncertainty evaluation based on results from the analysis of a model API intermediate, with the native analyte after spiking at three concentration levels, where analyses are performed by two analysts in two different days, is presented. The impact of the correlation of some uncertainty components of collected results on the uncertainty evaluation is discussed and considered in the calculations. The developed measurement model was checked by a cross-validation procedure where some validation data was randomly removed and used for an independent model control. The developed uncertainty evaluation methodology was successfully applied to the analysis of Pd in a model API intermediate by ICP-MS after a micro-wave assisted acid digestion, where the risk of a false acceptance of the pharmaceuticals is determined. The measurement performance data and used spreadsheet are made available as Supplementary Material.
- MeSH
- kontaminace léku MeSH
- léčivé přípravky * MeSH
- nejistota MeSH
- referenční standardy MeSH
- spektrální analýza MeSH
- Publikační typ
- časopisecké články MeSH
This prospective study examined the content of metals released from total joint arthroplasty into joint fluid, whole blood and periprosthetic tissues. We determined the levels of Ti, V, Nb, Co, Cr, and Mo, using inductively coupled plasma mass spectrometry, in samples from patients who underwent reoperation of total hip or knee arthroplasty. All of the patients (n = 117) included in the study had either metal on polyethylene or ceramic on polyethylene-bearing pairs. First, our results conclusively showed that the majority of released metals were deposited in periprosthetic tissues. In this context, the bloodstream turned out to be an ineffective biomarker of the effects occurring in local tissues. Second, there was a clear time-dependent nature of metallic accumulation. Based on our extensive dataset, we found significantly elevated levels of the released metals in joint fluid and periprosthetic tissues originating from loosened implants compared to stable ones, as well as recognizable differences between the groups with stable implants and aseptic loosening. Finally, it was proved that the concentrations of metals decreased dependent on the distance of the tissue from the implant. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 107B: 454-462, 2019.
- MeSH
- dospělí MeSH
- kovy farmakokinetika MeSH
- kyčelní protézy škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- náhrada kyčelního kloubu * MeSH
- prospektivní studie MeSH
- protézy kolene škodlivé účinky MeSH
- selhání protézy škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- synoviální tekutina metabolismus MeSH
- totální endoprotéza kolene * MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
A common Authentication and Authorisation Infrastructure (AAI) that would allow single sign-on to services has been identified as a key enabler for European bioinformatics. ELIXIR AAI is an ELIXIR service portfolio for authenticating researchers to ELIXIR services and assisting these services on user privileges during research usage. It relieves the scientific service providers from managing the user identities and authorisation themselves, enables the researcher to have a single set of credentials to all ELIXIR services and supports meeting the requirements imposed by the data protection laws. ELIXIR AAI was launched in late 2016 and is part of the ELIXIR Compute platform portfolio. By the end of 2017 the number of users reached 1000, while the number of relying scientific services was 36. This paper presents the requirements and design of the ELIXIR AAI and the policies related to its use, and how it can be used for serving some example services, such as document management, social media, data discovery, human data access, cloud compute and training services.
- MeSH
- biomedicínský výzkum metody MeSH
- lidé MeSH
- software * MeSH
- systémy řízení databází * MeSH
- uživatelské rozhraní počítače MeSH
- výpočetní biologie metody MeSH
- výzkumní pracovníci MeSH
- zabezpečení počítačových systémů * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
