scholarly journals Procedures for Validation of Diagnostic Methods in Clinical Laboratory Accredited by ISO 15189

10.5772/19762 ◽  
2011 ◽  
Author(s):  
Silvia Izquierdo ◽  
Francisco A. Bernabeu Andreu
Keyword(s):  
Clinical Laboratory ◽  
Diagnostic Methods ◽  
Iso 15189

LUPUS NEPHRITE WITH FAST - PROGRESSING CURRENT: CASE REPORT

Vestnik ◽  
2021 ◽  
pp. 143-146
Author(s):  
Б.Г. Султанова ◽  
С.Б. Бодесова ◽  
А.Т. Ибрашева ◽  
Б.С. Мусабаев ◽  
Д.Ш. Бетирова ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Case Report ◽  
Lupus Erythematosus ◽  
Clinical Laboratory ◽  
Rapidly Progressive Glomerulonephritis ◽  
Diagnostic Methods ◽  
Symptomatic Therapy ◽  
Systemic Lupus ◽  
Current Case ◽  
Complex Therapy

В статье описан «неклассический» случай, редко встречающаяся форма заболевания системной красной волчанкой без типичного поражения кожи с проявлением быстропрогрессирующего гломерулонефрита, с поражением тазобедренного сустава, выраженным болевым синдромом у юноши. С применением новых инновационных методов диагностики (непрямая иммунофлюоресценция на анализаторе AKLIDES), что позволило провести своевременно комплексную терапию включая в себя патогенетическую, эфферентную (гемодиализ, плазмаферез), тем самым получен хороший клинический эффект. This article describes a non- racial case of systemic lupus erythematosus with the manifestation of a rapidly progressive glomerulonephritis, hip joint lesion, a pronounced painful syndrom, without dermal manifestations. By the use of new diagnostic methods (immunofluorescence), timely complex therapy: pathogenetic, efferent therapy, symptomatic therapy, it is possible to obtain a fairly good clinical - laboratory- instrumental result.

Organization of the work of the medical laboratory service in accordance with the requirements of the standard GOST ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence»

2020 ◽  
pp. 15-22
Author(s):  
Elena Vitalievna Perminova
Keyword(s):  
Clinical Laboratory ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Iso 15189 ◽  
Laboratory Service ◽  
Medical Laboratories

Clinical laboratory diagnostics is a medical specialty, which is based on in vitro diagnostic studies of biomaterial obtained from an individual. At the present stage, there are three main types of organization of the laboratory research process — a laboratory service as part of a medical and preventive institution, a centralized laboratory where biomaterials are delivered for research from various healthcare institutions, as well as mobile laboratories that allow conducting the research directly at the patient’s bedside. This discipline involves the use of a wide variety of diagnostic research methods and the use of a huge number of specific techniques. Their list should include carrying out hematological, microbiological, virological, immunological, serological, parasitic, and biochemical studies. Also, when organizing laboratory diagnostic activities, a number of other studies (cytological, histological, toxicological, genetic, molecular biological, etc.) are provided. A laboratory report is formulated after obtaining clinical data and comparing them with the obtained test results. The quality of laboratory tests is ensured through the systematic implementation of internal laboratory control, as well as participation in a national program for external quality assessment. The activities of the clinical diagnostic laboratory should be organized in accordance with the requirements of the standard GOST R ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence», which is based on the provisions of two more fundamental standards — ISO 9001 and ISO 17025, and adds a number of special requirements related to medical laboratories.

scholarly journals Audit of Reporting Errors in Biochemistry Section of NABL Accredited Laboratory in a Tertiary Care Teaching Hospital

2021 ◽  
Vol 9 (1) ◽  
pp. 37-42
Author(s):  
Gayatri C. Gawade ◽  
Meghana K. Padwal ◽  
Shyam Gaisamudre ◽  
Abdulrahaman A. Momin
Keyword(s):  
Clinical Laboratory ◽  
Tertiary Care ◽  
Continuous Training ◽  
Iso 15189 ◽  
Laboratory Staff ◽  
Root Cause ◽  
Great Hope ◽  
Causes Of Errors ◽  
Information Management Systems ◽  
Accredited Laboratory

Background: In the modern era of tremendous automation in analytical processes, reporting errors have been reduced significantly. Therefore, the focus has been shifted to identifying the extra analytical causes of errors in the laboratory. Objectives: This study aimed to audit major clinical decisions affecting quality indicators (i.e., reporting errors and error prevention) by adhering to ISO 15189 (2012) and National Accreditation Board for Testing and Calibration Laboratories (NABL) (112) requirements. Methods: The records of the reporting errors were maintained from the biochemistry section of the central clinical laboratory (CCL) and analyzed based on the aim of this study. Then, the root cause analysis was performed, and the data was collected and audited from November 2015 to July 2020. Results: The total number of reporting errors between the mentioned periods were 132, with an incidence of 1 error per 384 processed samples on the day of observing the reporting error. In general, 22 (16.67%), 16 (12.12%), and 94 (71.21%) cases were pre-analytical, analytical, and post-analytical errors, respectively. The incidence of the post-analytical error was noted to be more since they were all typographical errors. Conclusion: Overall, transcriptional or typographical errors were found to be the main causes of reporting errors. In our clinical laboratory, we are attempting to minimize these errors by pre-validating the results by senior technicians and faculty prior to the typing and approval. These avoidable errors can be minimized by the continuous training of laboratory staff. Up-gradation to automated data collection information management systems are of great hope for preventing such errors.

Algorithm of Screening and Monitoring of Hypertension in Rural Outpatient Clinics: the Realities of Practice Through the Prism of the Recommendations

2016 ◽  
pp. 88-93
Author(s):  
Khrystyna Symchych ◽  
Liubomyr Glushko ◽  
Serhii Fedorov ◽  
Irena Kozlova ◽  
Viktoriia Rudnyk ◽  
...  
Keyword(s):  
Sensitivity And Specificity ◽  
Outpatient Clinic ◽  
Clinical Laboratory ◽  
Blood Pressure Measurement ◽  
Ankle Brachial Index ◽  
High Sensitivity ◽  
Home Blood Pressure ◽  
Diagnostic Methods ◽  
Vascular Pathology ◽  
Continuous Control

The objective: of the study was a comparative analysis and identify the informativeness of diagnostic methods available in conditions of rural outpatient clinic and formulate the algorithm of screening and monitoring of hypertension in the practice of family doctors. Patients and methods: The study involved 62 patients with hypertension of the second-degree severity. In the first group diagnosis of AH was performed by the methods available in conditions of rural outpatient clinic, in the second group the reference methods were used. The clinical laboratory tests and instrumental examination were made. Informativeness of the methods available in conditions of rural outpatient clinic was defined on base of data of sensitivity, specificity and positive predictive value. Results. Home blood pressure measurement in terms of rural family medicine is the most justified because of the low cost of the survey, the possibility of continuous control of hypertension, the relative autonomy of the patient and results with data DMAT is approximate, high rates of sensitivity and specificity. Use ECG criteria for their relatively high sensitivity and specificity of the method proves informative and justifies its use in the village for early diagnosis of heart damage in patients with hypertension. Definition of ankle brachial index is informative, non-invasive, affordable method to detect the presence of vascular pathology, to evaluate dynamics during treatment. Determination of MAU is an affordable quality marker of kidney damage in hypertension, with high sensitivity and specificity. For a more accurate diagnosis be to calculate glomerular filtration rate. Lipid metabolism at clinic should be determined by the level of total cholesterol. Carbohydrate metabolism enough to carry on fasting glucose and glucose1tolerant test. Conclusion. It is proved the simple in performance, the cheap and routine methods that are used widely can to inform about cardiovascular risk and to determine the prognosis of illness in patients with hypertension.

Multicenter performance evaluation of the MultiDrugQuant assay kit.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e21140-e21140
Author(s):  
Peter Krajcsi ◽  
Katalin Tauber Jakab ◽  
Sandor Barath ◽  
Edit Gyimesi ◽  
Zsuzsanna Hevessy ◽  
...  
Keyword(s):  
Multidrug Resistance ◽  
Mononuclear Cells ◽  
Fluorescent Dyes ◽  
Clinical Laboratory ◽  
Diagnostic Methods ◽  
Cytotoxic Agents ◽  
Efflux Transporters ◽  
Target Cells ◽  
Functional Assay ◽  
Fluorescent Intensity

e21140 Background: Multidrug resistance is the most frequent type of resistance to anticancer chemotherapy, which usually results from the overexpression of efflux transporters, such as the MDR1, MRP1 and BCRP. Unfortunatelly, neither the genetic polymorphisms nor the mRNA/protein expression levels correlate closely with the functional activity. On the other hand, although the functional methods separately gave promising results, standardization and reproducibility of these tests failed to conform with values required from routine diagnostic methods. MultiDrugQuant (MDQ) kit was developed as an improved functional assay system, which can measure the multidrug resistance activity of the three, clinically most relevant efflux transporters using flow cytometry in living tumor cells. The present study aimed to carry out the laboratory validation and to evaluate the performance of the MDQ-kit. Methods: Validation of the kit was carried out according to the standards of the Clinical Laboratory Standards Institute in three university centres. Mononuclear cells were separated using Ficoll gradient and tested at 2-5×106/ml within 6 hours after specimen collection. Activities of the multidrug transporters were calculated from the difference between the mean fluorescent intensity of cells w/o the specific inhibitors, respectively. Inaccuracy and comparative measurements were carried out using cell lines with low and high activity of the transporters. Results on different flow cytometers were compared using CD45 CD19 or CD3 monoclonal antibodies for gating the population of interest. Results: The assay proved to be specific and robust at various concentrations of the fluorescent dyes (10-100 % of the original) or inhibitors (50-150 % of the original). Both intraassay and interassay reproducibilities were <5 %. Multidrug resistance activity values determined on different flow cytometers were comparable and eligible. Conclusions: The MDQ assay provides quantitative results on the activity of the MDR1, MRP1 and BCRP in the target cells, which might be used to predict the resistance of these cells to particular cytotoxic agents. Recently, the MDQ-kit has been registered for in vitro diagnostic use in the EU.

scholarly journals RADIAL DIGNOSTICS OF LIQUID FOCAL LIVER FORMATIONS WITH THEIR IDENTIFICATION OF A COMMUNICATIONS WITH THE INTRAHEPATIC BILIARY DUCTS

2021 ◽  
pp. 40-45
Author(s):  
I. P. Vakulenko ◽  
V. V. Khatsko ◽  
O. Ye. Kuzmenko ◽  
V. N. Voytyuk ◽  
V. M. Fominov ◽  
...  
Keyword(s):  
Differential Diagnosis ◽  
Clinical Laboratory ◽  
Early Stage ◽  
Diagnostic Methods ◽  
Laboratory Methods ◽  
The Past ◽  
Intrahepatic Bile Ducts ◽  
Biliary Ducts ◽  
Cyst Hydatid ◽  
Difficult Cases

Summary. The aim of the study is to improve radiological diagnosis and differential diagnosis of fluid focal formations of the liver and their communication with the intrahepatic bile ducts. Materials and methods. The article presents the results of radial diagnostics of drained liquid focal liver formations (non-parasitic cyst, hydatid cyst, abscess) in 182 patients over the past 8 years. Clinical laboratory methods, sonography, computer tomography, magnetic resonance imaging, laparoscopy, cytological and bacteriological examination of liquid from a cyst or liver abscess (in various combinations), statistical methods were used for the diagnostics. Results and discussion. 5 modified diagnostic methods have been applied, which made it possible to improve its accuracy and, at an early stage, to identify the communication of liquid formation with the intrahepatic biliary ducts. The characteristic radial criteria that correspond to various liquid focal liver formations are given. Conclusions. The use of a combination of imaging methods (MSCT, MRT, et al.) is necessary in difficult cases for the detection and differential diagnosis of fluid focal formations of the liver.

scholarly journals Hemorrhagic colitis syndrome in children: the etiological structure in the infectious diseases clinic

2021 ◽  
Vol 20 (4) ◽  
pp. 22-27
Author(s):  
O. V. Molochkova ◽  
O. B. Kovalev ◽  
O. V. Shamsheva ◽  
A. A. Sakharova ◽  
N. V. Sokolova ◽  
...  
Keyword(s):  
Infectious Diseases ◽  
Clinical Laboratory ◽  
Relative Number ◽  
Severe Form ◽  
Diagnostic Methods ◽  
Hemorrhagic Colitis ◽  
Laboratory Diagnostics ◽  
Bowel Diseases ◽  
Mesenteric Adenitis ◽  
Inflammatory Bowel

The range of differential diagnostic search in the development of hemorrhagic colitis (hemocolitis) is wide enough and includes infectious and non-infectious factors. Purpose: clinical, laboratory and etiological analysis of bacterial diarrhea occurring with hemorrhagic colitis in the infectious diseases department.Materials and methods: a retrospective study of 141 case histories of those hospitalized in the infectious diseases department of the2 Children's City Clinical Hospital No. 9 named after G.N. Speransky of Moscow in 2019—2021 patients with clinical picture of hemocolitis. Hemocolitis was determined on the basis of macroscopic and microscopic signs (in scatology — mucus, leukocytes, erythrocytes) signs. All patients underwent routine laboratory examinations. The etiology was verified using modern methods of laboratory diagnostics (bacteriological analysis of feces, Latex test, ICA, ELISA, PCR, IHR).Results. There were 137 patients with infectious hemocolitis. Inflammatory bowel disease was diagnosed in 3 children, anus fissure — in 1 child. Young children under 3 years of age prevailed (77%). The etiology of infectious hemocolitis was deciphered in 47 patients (34%). Salmonellosis (36%) and shigellosis (36%) prevailed. Campylobacteriosis, clostridiosis-dificile and klebsiellosis accounted for 11%, 9% and 6% of cases, respectively. Yersiniosis was detected in 1 child at the age of 5 months. The severe form was found in 5.8% of cases, in most cases with shigellosis. Symptoms of intoxication and febrile fever were expressed in all patients, vomiting — in 28.5%, abdominal pain — in 94%, mesenteric adenitis on ultrasound — in 15%, diarrhea with a frequency of more than 5 times a day — in 84%, dehydration — in 64%, intercurrent diseases (ARVI, pneumonia) — in 41.3% of cases. Inflammatory changes in infectious hemocolitis were manifested by an increase in C-reactive protein in 71% (23.91 ± 24.17 mg/l), leukocytosis — in 69% (11.58 ± 3.52 х103 / μl), thrombocytosis — in 26%, an increase in the relative number of stab neutrophils in the general blood test in 78% of cases (10.95 ± 0.4%).Conclusions. Differential diagnostic search in the development of hemocolitis should include modern diagnostic methods, if necessary, additional instrumental studies and specialist consultations to exclude inflammatory bowel diseases.

scholarly journals DIAGNÓSTICO DE ESTÁNDARES DE CALIDAD INTERNACIONALES EN LABORATORIOS DE DOCENCIA DE UNA UNIVERSIDAD ECUATORIANA

2021 ◽  
Vol 6 (5) ◽  
pp. 4
Author(s):  
Ronny Rodríguez Pincay ◽  
William Lino Villacreses ◽  
Nereida Valero Cedeño ◽  
Alfonso Jamil Cedillo Balcázar
Keyword(s):  
Clinical Laboratory ◽  
Cross Sectional Study ◽  
System Quality ◽  
Cross Sectional ◽  
Iso 15189 ◽  
Teaching Laboratory ◽  
Palabras Clave ◽  
A Site ◽  
And Control ◽  
Teaching Site

Introducción: El Laboratorio de Docencia es un sitio donde el estudiante puede acceder a ella en su proceso de aprendizaje, al igual que el Laboratorio Clínico, están ligados a normas que se deben de cumplir para poder funcionar como sitio de enseñanza, un sistema de gestión de calidad son actividades coordinas para dirigir y controlar una organización con respecto a la calidad, están definidas por la Organización Internacional de Normalización (ISO), los indicadores estándar son aplicados de manera internacional y adaptables a cualquier tipo de laboratorio. Objetivo: diagnosticar los estándares de calidad internacionales en laboratorios de docencia una universidad ecuatoriana. Métodos: diseño de estudio descriptivo y analítico de corte transversal, se utilizaron fuentes bibliográficas basadas en fuentes primarias, secundarias y terciarias, el universo total fue de 4 laboratorios de docencia; para la recolección de información de utilizaron dos instrumentos validados por la OPS/HSP/HSE y el MSP del Ecuador. Resultados: Se encontró que, del total de indicadores de la primera encuesta, el 52,6% equivalente a 20 parámetros se cumplen, mientras que el 47,4% (n:18) no lo hace; en la segunda encuesta el 53,3% (n:16) cumple con lo requerido, mientras que el 46,7% (n:14) no lo hace. Conclusiones: los indicadores estándares son importantes a la hora de la pedagogía en los laboratorios de docencia de la Carrera de Laboratorio Clínico de la UNESUM. Palabras clave: Gestión de la calidad, Normas ISO 15189, Laboratorio de Docencia, Calidad   ABSTRACT Introduction: The Teaching Laboratory is a site where the student can access it in their learning process, like the Clinical Laboratory, they are linked to standards that must be met in order to function as a teaching site, a management system Quality are coordinated activities to direct and control an organization with respect to quality, they are defined by the International Organization for Standardization (ISO), the standard indicators are applied internationally and adaptable to any type of laboratory. Objective: diagnose international quality standards in teaching laboratories an Ecuadorian university. Methods: descriptive and analytical cross-sectional study design, bibliographic sources based on primary, secondary and tertiary sources were used, the total universe was 4 teaching laboratories; Two instruments validated by PAHO / HSP / HSE and the MSP of Ecuador were used to collect information. Results: It was found that, of the total of indicators from the first survey, 52.6% equivalent to 20 parameters are met, while 47.4% (n:18) do not; in the second survey, 53.3% (n: 16) met the requirements, while 46.7% (n:14) did not. Conclusions: the standard indicators are important when it comes to pedagogy in the teaching laboratories of the Clinical Laboratory Career of UNESUM. Keywords: Quality management, ISO 15189 Standards, Teaching Laboratory, Quality

scholarly journals Agranulocytosis in Felty’s syndrome: a case from clinical practice

2018 ◽  
Vol 99 (5) ◽  
pp. 833-835
Author(s):  
A A Tulichev ◽  
E O Efremova
Keyword(s):  
Rheumatic Diseases ◽  
Successful Treatment ◽  
Clinical Presentation ◽  
Clinical Laboratory ◽  
Correct Diagnosis ◽  
Diagnostic Methods ◽  
Felty's Syndrome ◽  
Treatment And Prevention ◽  
Felty’S Syndrome ◽  
Hematological Manifestations

Differential diagnosis of articular syndrome is one of the leading issues of primary medical sanitary care. Timely and correct diagnosis of rheumatic diseases made by an internist in an out-patient setting is a cornerstone of successful treatment and prevention of possible complications. The masks of clinical course, subtle symptoms, as well as pathomorphosis of the disease make the accurate diagnosis difficult to establish. Among rheumatic diseases more and more often isolated hematological manifestations are observed on the onset of the disease. Among them the leading place is taken by Felty’s syndrome. Being a form of seropositive rheumatoid arthritis, it is often associated with cytopenia. The aim of the article is to draw attention to the problem of timely diagnosis of Felty’s syndrome. The presented clinical case of Felty’s syndrome with agranulocytosis was based on clinical, laboratory, instrumental data obtained on examination of a patient. The features of the course, diagnostic methods and treatment methods of the pathology are discussed. The treatment efficacy of corticosteroids and cytostatics, similarities in clinical presentation and course of the syndrome with lymphoproliferative diseases and liver cirrhosis are presented. According to the obtained data a conclusion was made about the need for early diagnosis and complex examination in case of Felty’s syndrome for successful treatment of the nosology.

scholarly journals On possibility of using routine biochemical techniques for research of alternative biological human liquids

2020 ◽  
Vol 4 (35) ◽  
pp. 54-57
Author(s):  
S. I. Murskiy
Keyword(s):  
Russian Federation ◽  
Clinical Laboratory ◽  
Biological Fluid ◽  
Biological Fluids ◽  
Reproductive Age ◽  
Laboratory Research ◽  
Iso 15189 ◽  
Biochemical Analyzer ◽  
Automatic Biochemical Analyzer ◽  
The Russian Federation

Biochemical studies of alternative human biological fluids are not common in laboratory practice due to the lack of validation methods. The aim of the study was to validatе on semen plasma routine biochemical research methods using an automatic biochemical analyzer. The studies were carried out on a Cobas Integra 400 plus automatic biochemical analyzer (Roche, Switzerland) using original Roche reagents (Switzerland). Materials for the study were 30 samples of semen plasma obtained from clinically healthy men of reproductive age. Planning and organization of validation activities were carried out in accordance with GOST ISO 15189–2015. The functional characteristics of the methods were determined in accordance with Order 45 of the Ministry of Health of the Russian Federation «On a system of measures to improve the quality of clinical laboratory research in healthcare facilities of the Russian Federation», and protocols of the CLSI Institute of Clinical Laboratory Standards (USA). It was possible to establish acceptable levels of linearity, precision and specificity for 31 of the 33 analytes studied. Also, the necessary dilution for 12 analytes was established empirically. Establishing the analytical reliability of biochemical methods for studying semen plasma opens up new possibilities for studying the metabolic characteristics of this biological fluid, and therefore expands the range of possibilities for its use as an object of laboratory research.

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