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The aim of this study was to describe the effectiveness of the vaccines (Tozinameran and Sputnik V), administered on a convenience sample of healthcare workers, and also to describe the relationship between the levels of neutralizing antibodies (NAbs) and the type of vaccine used, as well as their association with incident cases during follow-up. more...

Background: Diabetic nephropathy (DN) is a leading cause of end-stage renal disease. Progressive damage and decline in the number of podocytes often occur in the early stages of DN. Thus, nephrin as a podocyte-specific protein may be regarded as a potential biomarker of early detection of DN. The aim of this study is to determine whether urinary nephrin is an earlier marker in DN than microalbuminuria and to test the significance of urinary nephrin as a marker for early detection of DN. Methods: Our cross-sectional study included 90 patients with type 2 diabetes mellitus (T2DM), 30 patients with diagnosed DN and 60 patients without diagnosed DN. As a control group, we used 30 healthy subjects. All patients with T2DM were classified into three subgroups according to urinary microalbumin/creatinine ratio (UMCR): normoalbuminuric, microalbuminuric and macroalbuminuric patients. Nephrin in urine was measured by immunoenzyme assay, microalbumin with turbidimetric and creatinine with the photometric method. In blood sera, we measured a few standard biochemical parameters. Results: Nephrinuria was found to be present in 100% of patients with T2DM and macroalbuminuria, in 88% with microalbuminuria, as well as 82% of patients with T2DM and normoalbuminuria. A concentration of urinary nephrin was significantly increased in all groups of subjects with T2DM compared to the control group (p more...

Laboratories in the Republic of North Macedonia are subject to many national requirements. Each laboratory should deliver quality laboratory service for patients in accordance to national regulations and requirements. The International Organization for Standardization (ISO), has developed quality systems to assess specific aspects of health services. A majority of laboratories rely on International Quality Standards known as ISO/IEC/17025 for all types of testing and calibrating laboratories and more specifically ISO 15189 for medical laboratories. These standards are quite comprehensive and often very resource-intensive. Medical laboratories were early leaders in efforts to minimize medical errors and improve patient safety. A quality management system (QMS) is a vehicle to deliver a quality service. The importance of quality in the functioning of health care laboratories is well recognized globally. The poor quality of laboratory results can lead to inappropriate interventions, adversely affect the credibility of the laboratory and may also invite legal action. It is, hence, essential to develop and implement a policy on quality in health laboratories. The QMS defines the organizational structure, responsibilities, policies, procedures, standards and resources required. What is needed is a roadmap for quality that ensures that each laboratory makes its best contribution to patient care and safety.The laboratory quality system essentials are:Organization;Facilities;Personnel; Equipment; Purchasing and inventory. The work quality system essentials are: Process control;Documents and records and Information management. The measurement quality system essentials are:Occurrence management; Assessments: external and internal; Customer service and Process improvement. An important relationship between quality activities that should be designed and supported by laboratory management and the technical activities that produce laboratory results for patient care should exist.Different laboratories are at different levels of quality development and hence a flexible step-wise approach has to been followed.Laboratories not implementing a good quality management system are guaranteed that there will be many errors and problems occurring that may go undetected. Implementing a quality management system may not guarantee an error-free laboratory, but it does yield a high-quality laboratory that detects errors and prevents them from recurring. Identification of a national focal point for laboratories, along with a well-defined national laboratory policy is essential. It is suggested that subsequent to the development of minimum national standards, countries should strive to make these mandatory. Implementation of international standards can be undertaken subsequently through up gradation of national standards. [ABSTRACT FROM AUTHOR] more...

One of the main aspects of laboratory quality improvement is participation in external quality assessment schemes (EQAS), proficiency testing (PT) or interlaboratory comparisons (ILC). According to the requirements of the standard ISO EN 15189:2012, participation in EQAS is mandatory for each accredited laboratory. Accreditation is a formal recognition of eligibility to perform certain set of activities. National accreditation body (NAB) can monitor technical competence of the lab through participation in EQAS. Aim of the study: Assessment of the results of participation in EQAS for Biochemical Analyses Laboratory (BAL). Material and methods: BAL, within the Institute of Medical and Experimental Biochemistry, Medical Faculty- Skopje, is a medical laboratory accredited according to the International Standard MKC ISO EN 15189:2013. BAL participates in EQAS organized by Instand eV, Dusseldorf, Germany, since 2011. We analyze results of EQA after every survey. Institute for accreditation of the Republic of North Macedonia is NAB. As accredited laboratory, BAL has an obligation to fulfill two documents: plan for participation in EQAS/PT/ILC and review of participation (documents OB 05-18-2 and OB 05-18) and to present them to the lead assessor and technical assessor on annual basis during the on-site assessment of the laboratory. Results: Our laboratory participates in surveys for: haematology (differential blood count) and clinical chemistry (conventional analyses). Performance in the last 8 years varied by panel. Testing samples from each panel are sent to the BAL 3-4 times/year. There is variation in performance, with a best annual average performance in 2016 and 2017. Acceptancce criteria is +/- 2SD. Except for haematology, annual performances for enrolled panels varied from year to year, indicating some difficulty in maintaining consistency in quality. The main challenges of the EQAS program observed between 2011 to 2019 were funding, sourcing, and safe transportation of quality panels to our laboratory. All these failures in the last years have helped us to significantly improve our overall quality of laboratory practices. Corrective and preventive actions are issued for outlying EQA results. By directing corrective measures at root causes, we had realized that the likelihood of problem recurrence was minimized. Key benefit of participation in EQAS is improvement of the laboratory performance through: discovering of sources of error; systematic errors; demonstration of effectiveness of changes; common understanding of method differences; discovery of method sensitivities, etc. Conclusions: We therefore recommend all laboratories to participate in the EQAS program. Successful performance in an EQA programme reflects the effectiveness of the laboratory’s quality management. EQA is important for improvement of the laboratory quality management system, as it is a measure of laboratory performance. [ABSTRACT FROM AUTHOR] more...

An EC50 database was established to assess the acute toxicity of 16 PESTANAL pesticide standards and of seven pesticide commercial formulations using a Vibrio fischeri bioluminescence method. Half maximal effective concentration (EC50) is defined as the concentration of pollutant (in this case, pesticide) destroying 50% of the bacteria population and causing 50% bioluminescence inhibition, after a specified exposure time. Linear curves of bioluminescence inhibition versus pesticide concentration and EC50 values were obtained for exposure times (t) of 5 or 15 min for these pesticides. The EC50 values ranged from 6.90 × 10−4 to 0.83 mg/ml (t = 5 min), and from 9.00 × 10−4 to 0.37 mg/ml (t = 15 min) for pesticide standards, plus from 0.0077 to 0.74 mg/ml (t = 5 min), and from 0.0076 and 0.57 mg/ml (t = 15 min) for pesticide commercial formulations. The EC50 database allowed classification of the pesticides under study into three categories according to their toxicity: very toxic, toxic and moderately toxic. These results demonstrated that the establishment of an EC50 database and of linear curves of bioluminescence inhibition versus the pesticide concentration resulted in very important and irreplaceable tools to estimate the global and individual toxicity of pesticides present in environmental samples. [ABSTRACT FROM AUTHOR] more...

Copyright of Macedonian Pharmaceutical Bulletin / Makedonsko Farmacevtski Bilten is the property of Macedonian Pharmaceutical Association 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 abstract 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 abstract. (Copyright applies to all Abstracts.) more...

The EN ISO 15189:2022 standard, titled “Medical laboratories – Requirements for quality and competence,” is a significant update to the regulations for medical laboratories. The revised standard was published on December 6, 2022, replacing both EN ISO 15189:2012 and EN ISO 22870:2016. Key objectives of the revision include: 1. Alignment with ISO/IEC 17025:2017, 2. Removal of unintended prescription, 3. Focus on patient interest and safety, 4. Minimization of new requirements, and 5. Improved clarity of text. Dedicating to harmonizing accreditation processes across Europe the EFLM Committee on Accreditation and ISO/CEN standards (C: A/ISO) has produced this guidance document to assist the laboratory medicine community in understanding and implementing the criteria of the EN ISO 15189 revision. Two main objectives of the guidance in educating both laboratories and accreditation bodies with their assessors as well as other stakeholders in laboratory medicine were agreed on. Firstly, to clarify the relevant changes covering all paragraphs of the standard and secondly to make an impact analysis on previous C: A/ISO guidance documents. [ABSTRACT FROM AUTHOR] more...

Hypertensive nephropathy (HN) is characterized by kidney damage due to chronic high blood pressure. Podocytes play a crucial role in the pathogenesis of HN, thus, nephrin could be important in the early diagnosis of HN. The aim of the study was to investigate the association of urinary nephrin (u-nephrin) levels with clinical and laboratory characteristics in patients with HN and to test diagnostic relevance of u-nephrin as an early biomarker of HN. In this cross-sectional study, 114 subjects were recruited, 84 patients with chronic hypertension (CH) and 30 healthy controls. All patients with CH were classified according to the urinary microalbumin/creatinine ratio (UM/CR) and according to the chronic kidney disease (CKD) stage. Urine samples were collected to estimate the u-nephrin level by ELISA and to determine UM/CR. Blood samples were used for biochemical analyses. We found elevated u-nephrin in 78.3% of normoalbuminuric subjects with CH. The levels of u-nephrin increased gradually with the stage of CKD. ROC curve plotted for u-nephrin showed 89.7% sensitivity and 88.8% specificity, while UM/CR showed a sensitivity of 44.8% and specificity of 86.1% to detect HN in the early stage. It is concluded that u-nephrin can be useful as an early biomarker of HN., (Sestre Milosrdnice University Hospital.) more...

An EC 50 database was established to assess the acute toxicity of 16 PESTANAL pesticide standards and of seven pesticide commercial formulations using a Vibrio fischeri bioluminescence method. Half maximal effective concentration (EC 50 ) is defined as the concentration of pollutant (in this case, pesticide) destroying 50% of the bacteria population and causing 50% bioluminescence inhibition, after a specified exposure time. Linear curves of bioluminescence inhibition versus pesticide concentration and EC 50 values were obtained for exposure times (t) of 5 or 15 min for these pesticides. The EC 50 values ranged from 6.90 × 10 -4 to 0.83 mg/ml (t = 5 min), and from 9.00 × 10 -4 to 0.37 mg/ml (t = 15 min) for pesticide standards, plus from 0.0077 to 0.74 mg/ml (t = 5 min), and from 0.0076 and 0.57 mg/ml (t = 15 min) for pesticide commercial formulations. The EC 50 database allowed classification of the pesticides under study into three categories according to their toxicity: very toxic, toxic and moderately toxic. These results demonstrated that the establishment of an EC 50 database and of linear curves of bioluminescence inhibition versus the pesticide concentration resulted in very important and irreplaceable tools to estimate the global and individual toxicity of pesticides present in environmental samples., (© 2019 John Wiley & Sons, Ltd.) more...

A key to effective treatment of cardiovascular disease is to understand the body's complex lipoprotein transport system. Reverse cholesterol transport (RCT) is the process of cholesterol movement from the extrahepatic tissues back to the liver. Lipoproteins containing apoA-I [highdensity lipoprotein (HDL)] are key mediators in RCT, whereas non-high-density lipoproteins (non-HDL, lipoproteins containing apoB) are involved in the lipid delivery pathway. HDL particles are heterogeneous; they differ in proportion of proteins and lipids, size, shape, and charge. HDL heterogeneity is the result of the activity of several factors that assemble and remodel HDL particles in plasma: ATP-binding cassette transporter A1 (ABCA1), lecithin cholesterol acyltransferase (LCAT), cholesteryl ester transfer protein (CETP), hepatic lipase (HL), phospholipid transfer protein (PLTP), endothelial lipase (EL), and scavenger receptor class B type I (SR-BI). The RCT pathway consists of the following steps: 1. Cholesterol efflux from peripheral tissues to plasma, 2. LCAT-mediated esterification of cholesterol and remodeling of HDL particles, 3. direct pathway of HDL cholesterol delivery to the liver, and 4. indirect pathway of HDL cholesterol delivery to the liver via CETP-mediated transfer There are several established strategies for raising HDL cholesterol in humans, such as lifestyle changes; use of drugs including fibrates, statins, and niacin; and new therapeutic approaches. The therapeutic approaches include CETP inhibition, peroxisome proliferator-activated receptor (PPAR) agonists, synthetic farnesoid X receptor agonists, and gene therapy. Results of clinical trials should be awaited before further clinical management of atherosclerotic cardiovascular disease. more...

Background: Chronic infections in CHD are due to one or both of the organisms Chlamydia pneumoniae and Helicobacter pylori., Aim: To examine the association between serum markers of Chlamydia pneumoniae and Helicobacter pylori infection and markers of myocardial damage. in patients with acute coronary syndrome (ACS), with chronic coronary artery disease (CAD) and in-control group., Material and Methods: Sera were taken from a total of 153 subjects. Subjects were divided in three groups: 64 patients with ACS; 53 patients with CAD and a group of 35 conditionally healthy individuals. Analysis of patients' sera for IgG antibodies to H. pylori and markers for myocardial damage was done on the Immulite system. The presence of specific IgG and IgA antibodies to C. pneumoniae was determined with MIF, Sero FIA (Savyon Diagnostics, Israel). Statistical analysis of data was done using the statistical program SPSS (Statistical Package for Social Sciences), version 13., Results and Discussion: There was a high significant difference in troponin levels between the three groups of subjects (p=0.0000). Levels of creatine kinase isoenzyme (CK-MB) were highest in the ACS group (500.0 ng/mL). There was a statistically significant difference between CG subjects and ACS patients due to more frequent detection of antichlamydial IgA antibodies in patients with acute coronary syndrome. Positive serum immune response for Helicobacter pylori was 17 (53.1%) and 29 (80.6%), respectively., Conclusion: Increased IgA antibody titers for C. Pneumoniae, increased CRP values as well as classic markers of myocardial damage are risk factors for coronary events. more...