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1.
Rev Bras Epidemiol ; 22Suppl 02(Suppl 02): E190004.SUPL.2, 2019.
Artigo em Português, Inglês | MEDLINE | ID: mdl-31596375

RESUMO

INTRODUCTION: This article aims at describing the National Health Survey (Pesquisa Nacional de Saúde- PNS) methodology of collecting laboratory exams data. METHODOLOGY: A subsample of 25% of the census tracts was selected, according to the stratification of the PNS sample, with a probability inversely proportional to the difficulty of collection. The collection of blood and urine was done in the households by a laboratory agent, among residents selected for individual interview. Due to the difficulties found in the field work, the sample did not reach the minimum expected number in some strata, and a post-stratification procedure was proposed for the data analysis. RESULTS: The collection of biospecimens was performed in 8,952 individuals. Laboratory tests were: glycated hemoglobin; total cholesterol; LDL cholesterol; HDL cholesterol; serology for dengue; red blood cell count (erythrogram) and white series count (leukogram); high performance liquid chromatography (HPLC) for diagnosis of hemoglobinopathies; creatinine. Theexcretion of potassium, salt and sodium and creatinine was estimated in the urine. The database of laboratory exams was weighed and made publicly available on the Oswaldo Cruz Foundation's PNS website and can be accessed without prior authorization. CONCLUSION: The total subsample of laboratory exams is of great value, since it allowed us to establish national reference parameters adequate to sociodemographic and geographic characteristics of the Brazilian population, providing relevant and complementary information for the analysis of the health situation of Brazil.


Assuntos
Técnicas de Laboratório Clínico/métodos , Coleta de Dados/métodos , Bases de Dados Factuais , Inquéritos Epidemiológicos/métodos , Adolescente , Adulto , Coleta de Amostras Sanguíneas/métodos , Brasil , Colesterol/sangue , Cromatografia Líquida de Alta Pressão , Dengue/sangue , Contagem de Eritrócitos , Feminino , Humanos , Contagem de Leucócitos , Masculino , Pessoa de Meia-Idade , Coleta de Urina/métodos , Adulto Jovem
2.
Presse Med ; 48(7-8 Pt 1): 816-824, 2019.
Artigo em Francês | MEDLINE | ID: mdl-31439443

RESUMO

Diagnosis of mature B cell malignancies is highly multidisciplinary. Biological tools provide diagnostic, prognostic and theranostic information. Biological hematology allows considering mature B cell diseases from two perspectives : cellular and molecular approaches. Cytomorphology and flow cytometry are tools from cell hematology. Conventional cytogenetics, FISH and molecular biology are tools from molecular hematology. NGS is a new technique that could dramatically change diagnostic and therapeutic management of B cell malignancies in the near future. Integration of clinical, pathological and biological data allows for personalized management of these diseases.


Assuntos
Técnicas de Laboratório Clínico/métodos , Leucemia de Células B/diagnóstico , Linfoma de Células B/diagnóstico , Integração de Sistemas , Hibridização Genômica Comparativa/métodos , Citodiagnóstico/métodos , Análise Citogenética/métodos , Análise Mutacional de DNA/métodos , Sequenciamento de Nucleotídeos em Larga Escala/métodos , Humanos , Imunofenotipagem/métodos , Hibridização in Situ Fluorescente/métodos , Leucemia de Células B/genética , Leucemia de Células B/patologia , Linfoma de Células B/genética , Linfoma de Células B/patologia , Técnicas de Diagnóstico Molecular/métodos , Imagem Multimodal/métodos , Imagem Multimodal/tendências
3.
Nature ; 572(7767): 116-119, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31367026

RESUMO

The early prediction of deterioration could have an important role in supporting healthcare professionals, as an estimated 11% of deaths in hospital follow a failure to promptly recognize and treat deteriorating patients1. To achieve this goal requires predictions of patient risk that are continuously updated and accurate, and delivered at an individual level with sufficient context and enough time to act. Here we develop a deep learning approach for the continuous risk prediction of future deterioration in patients, building on recent work that models adverse events from electronic health records2-17 and using acute kidney injury-a common and potentially life-threatening condition18-as an exemplar. Our model was developed on a large, longitudinal dataset of electronic health records that cover diverse clinical environments, comprising 703,782 adult patients across 172 inpatient and 1,062 outpatient sites. Our model predicts 55.8% of all inpatient episodes of acute kidney injury, and 90.2% of all acute kidney injuries that required subsequent administration of dialysis, with a lead time of up to 48 h and a ratio of 2 false alerts for every true alert. In addition to predicting future acute kidney injury, our model provides confidence assessments and a list of the clinical features that are most salient to each prediction, alongside predicted future trajectories for clinically relevant blood tests9. Although the recognition and prompt treatment of acute kidney injury is known to be challenging, our approach may offer opportunities for identifying patients at risk within a time window that enables early treatment.


Assuntos
Lesão Renal Aguda/diagnóstico , Técnicas de Laboratório Clínico/métodos , Lesão Renal Aguda/complicações , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Simulação por Computador , Conjuntos de Dados como Assunto , Reações Falso-Positivas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doença Pulmonar Obstrutiva Crônica/complicações , Curva ROC , Medição de Risco , Incerteza , Adulto Jovem
4.
Rev Assoc Med Bras (1992) ; 65(6): 745-754, 2019 Jul 22.
Artigo em Inglês | MEDLINE | ID: mdl-31340297

RESUMO

The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.


Assuntos
Técnicas de Laboratório Clínico/normas , Doenças Sexualmente Transmissíveis/diagnóstico , Brasil , Tomada de Decisão Clínica , Técnicas de Laboratório Clínico/métodos , Humanos , Fatores de Risco , Sensibilidade e Especificidade
5.
Rev Chilena Infectol ; 36(2): 145-166, 2019 Apr.
Artigo em Espanhol | MEDLINE | ID: mdl-31344152

RESUMO

The confrontation of the differential and etiological diagnosis of the infectious diseases of cancer patients, including hematopoietic stem cells transplant (HSCT) recipients, must correspond to an informed, timely decision that directly affects medical behavior that determines a better survival and quality of life for patients. The main goal of this work was to contribute to the management of these patients developing a useful tool for the clinician to make these decisions. For that, infections were grouped by compromised systems, differentiating the possible etiological agents in bacteria, viruses, fungi and parasites, highlighting the relevant diagnostic tests, mentioning the recommended techniques together with the optimal sample type for proper processing. In addition, under each group of techniques we added the item "level of requirement" to suggest what, in the opinion of the authors and the existing evidence, must be mandatory to have at local level or can be derivable to another laboratory.


Assuntos
Infecção Hospitalar/diagnóstico , Infecção Hospitalar/microbiologia , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Laboratórios Hospitalares/normas , Neoplasias/complicações , Biópsia/normas , Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Infecção Hospitalar/terapia , Exposição Ambiental/efeitos adversos , Humanos , Imunocompetência , Neoplasias/terapia
6.
Lakartidningen ; 1162019 Apr 02.
Artigo em Sueco | MEDLINE | ID: mdl-31192386

RESUMO

The aim of automated reflex testing is to achieve more rational and cost-effective use of laboratory investigations in clinical practice. In order to make use of this cost-effectiveness, the new tests should have a short implementation phase and clear objective goals. To accomplish an equal health care, the usage of new tests should have minimal variations between different primary health care units. We started a new model in Ostergotland County regarding clinical usage of new tests by active follow-up in two levels, both primary health care unit level and individual physician level, during the implementation phase. This study shows that active follow-up and feedback resulted in both shorter implementation phase and minimal variation between different primary health care units.


Assuntos
Técnicas de Laboratório Clínico/normas , Testes Diagnósticos de Rotina/normas , Ácido Metilmalônico/análise , Tireotropina/análise , Vitamina B 12/análise , Técnicas de Laboratório Clínico/métodos , Testes Diagnósticos de Rotina/métodos , Humanos , Modelos Teóricos , Atenção Primária à Saúde , Suécia
7.
S Afr Med J ; 109(4): 223-226, 2019 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-31084685

RESUMO

BACKGROUND: Spotted fever rickettsiosis, also known as tick bite fever (TBF), is a common infectious disease in South Africa (SA). Although the diagnosis of TBF is often based on clinical grounds only, laboratory testing is important to confirm the diagnosis and can contribute to case management in the light of a myriad of differential diagnoses, and in complicated cases. OBJECTIVES: To report on the availability and scope of laboratory tests for investigating suspected cases of TBF in SA, and the outcome of an inter-laboratory comparison (ILC) conducted for serological tests. METHODS: A self-administered questionnaire was circulated to major pathology laboratories in SA to determine what TBF tests they offered for TBF investigation. In addition, a clinical panel was provided to willing laboratories in order to perform an ILC of the serological tests. RESULTS: Serological tests for TBF were available from five laboratories serving both the private and state medical sectors in SA. There was no standardised testing platform or result interpretation across the different laboratories. Polymerase chain reaction (PCR) tests were less frequently available, and not available to state-operated facilities. The outcome of the ILC indicated varied performance and interpretation of serological results for TBF. CONCLUSIONS: Laboratory investigation for TBF is routinely and widely available in SA. Both serological and PCR-based methods were varied, and the lack of standardisation and interpretation of tests needs to be addressed to improve the overall quality of TBF diagnosis in SA. The utility of ILC to identify problem areas in serological testing for TBF is highlighted, and laboratories in SA are encouraged to use it to improve the quality of testing.


Assuntos
Serviços de Laboratório Clínico/estatística & dados numéricos , Técnicas de Laboratório Clínico/estatística & dados numéricos , Recursos em Saúde/estatística & dados numéricos , Acesso aos Serviços de Saúde/estatística & dados numéricos , Laboratórios/estatística & dados numéricos , Rickettsiose do Grupo da Febre Maculosa/diagnóstico , Benchmarking , Biomarcadores/sangue , Serviços de Laboratório Clínico/normas , Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Diagnóstico Diferencial , Recursos em Saúde/normas , Acesso aos Serviços de Saúde/normas , Humanos , Laboratórios/normas , Garantia da Qualidade dos Cuidados de Saúde , Melhoria de Qualidade , África do Sul , Rickettsiose do Grupo da Febre Maculosa/sangue
8.
Asian Pac J Cancer Prev ; 20(5): 1525-1529, 2019 May 25.
Artigo em Inglês | MEDLINE | ID: mdl-31128058

RESUMO

Background: Accurate diagnosis of Helicobacter pylori (H. pylori) infection plays an important role in further effective treatment. Rapid urine test (RAPIRUN) is a test developed for qualitative detection of urine H. Pylori antibody and use for determine the sensitivity, specificity and accuracy. However, the test needs validation in Thai population before using in clinical practice. Objective: This study aimed to compare performance of different diagnostic tests on H. pylori detection in Thai population. Methods: Total of 94 patients with dyspepsia who referred to Thammasat University Hospital, Pathumthani, Thailand, between December 2012 and April 2013 were enrolled in this study. All patients underwent gastroscopy. Then, 3 biopsies at antrum were taken for H. pylori diagnosis. including rapid urease test (Pronto Dry, Eisai, Thailand), H. pylori culture, and histopathology. Urine samples were also collected at the same time for rapid urine test (RAPIRUN H. pylori Antibody, Otsuka Pharmaceutical Co., Ltd.). Patients were diagnosed with H. pylori-positive if their culture or rapid urease tests plus histopathology yielded positive results. Results: Total of 29 patients (30.9%) were infected with H. pylori. Prevalence of H. pylori infection by rapid urease test, histopathology, culture and rapid urine test were 25.5%, 28.7%, 29.8%, and 32.9% respectively. We observed that rapid urease test, histopathology, culture, and rapid urine test had sensitivity of 82.8%, 93.1%, 93.1% and 86.2%; specificity of 100%, 100%, 100%, and 90.8%; and accuracy of 95.7%, 97.9%, 97.9%, and 89.4%, respectively. Conclusion: Rapid urine test (RAPIRUN) provided a reliable result for diagnosis of H. pylori infection. Furthermore, this rapid urine test demonstrated high accuracy, reliable, safe handle and easy to use. We suggested rapid urine test for diagnosis of H. pylori infection in Thai population since we found it less invasive and with higher reliable efficacy.


Assuntos
Técnicas de Laboratório Clínico/métodos , Infecções por Helicobacter/diagnóstico , Infecções por Helicobacter/urina , Helicobacter pylori/isolamento & purificação , Urina/microbiologia , Adulto , Anticorpos Antibacterianos/urina , Biópsia/métodos , Dispepsia/microbiologia , Dispepsia/urina , Feminino , Gastroscopia/métodos , Infecções por Helicobacter/microbiologia , Humanos , Masculino , Kit de Reagentes para Diagnóstico/microbiologia , Sensibilidade e Especificidade , Tailândia , Urease/urina
9.
Medicine (Baltimore) ; 98(18): e15513, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31045842

RESUMO

INTRODUCTION: Over the last few decades, the concepts of minimally invasive surgery and enhanced recovery after surgery (ERAS) protocols have been introduced into the field of total joint arthroplasty (TJA), and tranexamic acid (TXA) has been widely used in TJA. Modern-day surgical techniques and perioperative care pathways of TJA have experienced unexpected improvements. Recently, the necessity of the practice of ordering routine postoperative laboratory tests for patients undergoing primary TJA has been challenged, especially in the context of implementation of ERAS protocols in TJA. These studies have consistently suggested that routine postoperative laboratory tests are not necessary in modern-day primary, unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA), and laboratory tests after surgery should only be obtained for patients with risk factors. However, it remains unclear whether routine postoperative laboratory tests after THA and TKA remains justified in the Chinese patient population. Therefore, we developed this study to address this issue. METHODS AND ANALYSIS: This retrospective cohort study will include adult patients who underwent primary unilateral THA or TKA and received multimodal perioperative care pathways according to ERAS protocols. The following patient data will be collected from the electronic medical record system: patients' demographics, preoperative and postoperative laboratory values, operation time, intraoperative blood loss, TXA use, tourniquet use, postoperative length of stay, and any medical intervention directly related to abnormal laboratory values. The main study outcomes are the incidence of acute anemia requiring transfusion and incidence of hypoalbuminemia requiring albumin supplementation. The secondary outcomes are the rates of acute kidney injury, incidence of abnormal serum sodium level, incidence of abnormal serum potassium level, and incidence of abnormal serum calcium level. These clinical data will be analyzed to determine the incidence of abnormal postoperative laboratory values following primary unilateral THA and TKA; to clarify the frequency of any medical intervention directly related to abnormal postoperative laboratory values; and to identify risk factors that predispose patients to have abnormal postoperative laboratory results. STUDY REGISTRATION: Chinese Clinical Trial Registry (http://www.chictr.org.cn): ChiCTR1900020690.


Assuntos
Artroplastia de Quadril/reabilitação , Artroplastia do Joelho/reabilitação , Técnicas de Laboratório Clínico/normas , Cuidados Pós-Operatórios/normas , Complicações Pós-Operatórias/diagnóstico , Adulto , Anemia/diagnóstico , Anemia/epidemiologia , Anemia/etiologia , Antifibrinolíticos/uso terapêutico , Artroplastia de Quadril/estatística & dados numéricos , Artroplastia do Joelho/estatística & dados numéricos , Técnicas de Laboratório Clínico/métodos , Protocolos Clínicos/normas , Feminino , Humanos , Hipoalbuminemia/diagnóstico , Hipoalbuminemia/epidemiologia , Hipoalbuminemia/etiologia , Incidência , Masculino , Pessoa de Meia-Idade , Cuidados Pós-Operatórios/métodos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Período Pós-Operatório , Projetos de Pesquisa , Estudos Retrospectivos , Fatores de Risco , Ácido Tranexâmico/uso terapêutico
10.
Int J STD AIDS ; 30(4): 411-414, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30931826

RESUMO

The aim of this study is to compare the performance of the BD MAX™ Vaginal Panel (Becton, Dickinson and company, Franklin Lakes, NJ, USA) in the diagnosis of bacterial vaginosis (BV), candidiasis and trichomoniasis with current standard tests in a UK specialist sexual health service. Women with abnormal vaginal discharge attending the service who had not used douches or vaginal treatment in the preceding 48 hours had two vulvovaginal swabs taken: one for Chlamydia and gonorrhoea nucleic acid amplification test (NAAT) and one for testing on the BD MAX™ Vaginal Panel on the BD MAX System. Speculum examination was then performed and vaginal swabs taken for vaginal pH, and microscopy of vaginal secretions: Gram stain for Candida and BV using the Hay-Ison score and wet-mount for clue cells and Trichomonas vaginalis (TV). Forty-six (23.6%) women were negative for all three infections on the Vaginal Panel. Ninety-three were positive for BV (47.7%), 70 (35.9%) for Candida and 9 (4.6%) had TV detected. Thirty-six women tested positive for both BV and Candida on the BD MAX™. The investigational test sensitivity for all Candida species was 86.4% with a specificity of 86.0% and for BV the sensitivity was 94.4% with a specificity of 79%. The sensitivity for BV was good but specificity is lower than previously described and may reflect the high rates of sexually transmitted infections in this population which potentially altered the vaginal microbiome. The lower specificity and sensitivity for Candida is not unexpected as a high proportion of women are colonised with Candida, and in all cases other pathogens were found to account for their symptoms. NAATs do not provide the immediate results available from in-clinic microscopy but were easy to perform and process and offer benefits over the traditional "high vaginal swab" performed in primary care and other settings where immediate microscopy is unavailable.


Assuntos
Candida/isolamento & purificação , Candidíase Vulvovaginal/diagnóstico , Técnicas de Laboratório Clínico/métodos , Vaginite por Trichomonas/diagnóstico , Trichomonas vaginalis/isolamento & purificação , Vagina/microbiologia , Descarga Vaginal/etiologia , Adolescente , Adulto , Candidíase Vulvovaginal/microbiologia , Técnicas de Laboratório Clínico/normas , Feminino , Violeta Genciana , Humanos , Técnicas de Amplificação de Ácido Nucleico , Fenazinas , Sensibilidade e Especificidade , Saúde Sexual , Vaginite por Trichomonas/microbiologia , Reino Unido , Vaginose Bacteriana/diagnóstico , Vaginose Bacteriana/microbiologia
11.
Mem Inst Oswaldo Cruz ; 114: e180478, 2019 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-30942278

RESUMO

The population of Brazil is currently characterised by many individuals harbouring low-intensity Schistosoma mansoni infections. The Kato-Katz technique is the diagnostic method recommended by the World Health Organization (WHO) to assess these infections, but this method is not sensitive enough in the context of low egg excretion. In this regard, potential alternatives are being employed to overcome the limits of the Kato-Katz technique. In the present review, we evaluated the performance of parasitological and immunological approaches adopted in Brazilian areas. Currently, the diagnostic choices involve a combination of strategies, including the utilisation of antibody methods to screen individuals and then subsequent confirmation of positive cases by intensive parasitological investigations.


Assuntos
Anticorpos Anti-Helmínticos/análise , Antígenos de Helmintos/análise , Técnicas de Laboratório Clínico/métodos , Fezes/parasitologia , Schistosoma mansoni , Esquistossomose mansoni/diagnóstico , Animais , Brasil/epidemiologia , Doenças Endêmicas , Humanos , Técnicas Imunoenzimáticas , Contagem de Ovos de Parasitas , Schistosoma mansoni/imunologia , Schistosoma mansoni/isolamento & purificação , Esquistossomose mansoni/epidemiologia , Sensibilidade e Especificidade , Índice de Gravidade de Doença
12.
Clin Lab ; 65(4)2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30969069

RESUMO

BACKGROUND: Escherichia coli is the most common pathogenic bacteria that frequently causes life-threatening opportunistic human infections, diarrhea, and septicemia in immunocompromised hosts. METHODS: This study aimed to establish a loop-mediated isothermal amplification (LAMP) method for the rapid and sensitive detection of a hypothetical protein from an E. coli-specific gene (GenBank ID: 13702648). The gene was obtained through local and online BLAST, and specific primers were designed for this gene. Reaction conditions were optimized at 65ºC for 30 minutes and 80ºC for 2 minutes, whereas the reaction system contained 5.2 mM Mg2+, 8 U of Bst 2.0 DNA polymerase, 1.4 mM deoxyribonucleotide, and 0.2 and 1.6 µM of the outer and inner primers, respectively. The LAMP method was evaluated using 240 strains of E. coli and 150 strains of non-E. coli. RESULTS: Positive reactions were observed on all 240 strains of E. coli while all non-E. coli strains were negative. Plasmids with the specific gene and mice blood with E. coli were used for sensitivity analysis. The detection limit of LAMP was 100 bacterium/reaction. CONCLUSIONS: Results showed that the LAMP targeted to the hypothetical protein (GenBank ID: 13702648) is a fast, specific, sensitive, inexpensive, and suitable method for the detection of E. coli.


Assuntos
Técnicas de Laboratório Clínico/métodos , Escherichia coli/genética , Técnicas de Amplificação de Ácido Nucleico , Animais , Primers do DNA/genética , Diarreia/microbiologia , Humanos , Hospedeiro Imunocomprometido , Limite de Detecção , Camundongos , Plasmídeos/genética , Reação em Cadeia da Polimerase , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
13.
Clin Lab ; 65(4)2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30969071

RESUMO

BACKGROUND: Cardiac troponin I (TnI) is one of the most crucial biomarkers for the management of acute coronary syndrome. However, the TnI values can vary when using commercial TnI assays from different vendors. We assessed the feasibility of TnI harmonization using plasma and serum samples. METHODS: Leftover plasma and serum samples were collected from patients and stored for further analysis (n = 200). TnI measurements were performed using 3 different analyzers. The TnI values for plasma and serum were compared, and the mathematical recalibration was performed using the mean of 3 values from each analyzer as a reference value. The number of biased cases was counted before and after recalibration. RESULTS: The final analysis was performed in a total of 140 plasma and serum samples, and constant and/or proportional differences for each analyzer were observed. Mathematical recalibration of the TnI values resulted in improved correlation to the reference values. The number of TnI values that were remote from the reference values decreased after recalibration. The effects were more evident for serum samples. CONCLUSIONS: In this study, we reassured the possibility of TnI harmonization among 3 different immunoassays using plasma and serum samples. It is important to note the differences between sample types during TnI harmonization.


Assuntos
Biomarcadores/sangue , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/métodos , Imunoensaio/normas , Plasma , Soro , Troponina I/sangue , Síndrome Coronariana Aguda/sangue , Calibragem , Humanos , Modelos Teóricos , Infarto do Miocárdio/sangue , Valores de Referência , Troponina T/sangue
14.
Ann Biol Clin (Paris) ; 77(2): 131-154, 2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30998194

RESUMO

This document provides a joint recommendation for venous blood sampling of the European federation of clinical chemistry and laboratory medicine (EFLM) Working Group for preanalytical phase (WG-PRE) and Latin American working group for preanalytical phase (WG-PRE-LATAM) of the Latin America confederation of clinical biochemistry (COLABIOCLI). It offers guidance on the requirements for ensuring that blood collection is a safe and patient-centered procedure and provides practical guidance on how to successfully overcome potential barriers and obstacles to its widespread implementation. The target audience for this recommendation are healthcare staff members directly involved in blood collection. This recommendation applies to the use of a closed blood collection system and does not provide guidance for the blood collection with an open needle and syringe and catheter collections. Moreover, this document neither addresses patient consent, test ordering, sample handling and transport nor collection from children and unconscious patients. The recommended procedure is based on the best available evidence. Each step was graded using a system that scores the quality of the evidence and the strength of the recommendation. The process of grading was done at several face-to-face meetings involving the same mixture of stakeholders stated previously. The main parts of this recommendation are: 1) Pre-sampling procedures, 2) Sampling procedure, 3) Post-sampling procedures and 4) Implementation. A first draft of the recommendation was circulated to EFLM members for public consultation. WG-PRE-LATAM was also invited to comment the document. A revised version has been sent for voting on to all EFLM and COLABIOCLI members and has been officially endorsed by 33/40 EFLM and 21/21 COLABIOCLI members. We encourage professionals throughout Europe and Latin America to adopt and implement this recommendation to improve the quality of blood collection practices and increase patient and workers safety.


Assuntos
Coleta de Amostras Sanguíneas/normas , Química Clínica/normas , Técnicas de Laboratório Clínico/normas , Flebotomia/normas , Fase Pré-Analítica/normas , Adulto , Coleta de Amostras Sanguíneas/métodos , Química Clínica/organização & administração , Criança , Técnicas de Laboratório Clínico/métodos , Europa (Continente) , Humanos , América Latina , Flebotomia/métodos , Fase Pré-Analítica/métodos , Sociedades Médicas/organização & administração , Sociedades Médicas/normas , Manejo de Espécimes/métodos , Manejo de Espécimes/normas
15.
Clin Chim Acta ; 495: 129-138, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30935874

RESUMO

The Evaluation of measurement data - Guide to the Expression of Uncertainty in Measurement (GUM) provides the framework for evaluating measurement uncertainty. The preferred GUM approach for addressing bias assumes that all systematic errors are identified and corrected at an early stage in the measurement process. We review some procedures for treating uncorrected bias and its inclusion into an overall uncertainty statement. When bias and its uncertainty are recognised as metrological states independent of scatter in the test results, the uncertainty of the reference and uncertainty of the bias can be equated. The net standard uncertainty of a test result is the root-sum-square of the standard uncertainty of the bias and the standard uncertainty of measurements on the test. Since an incomplete and therefore potentially erroneous formula is often used for estimating bias standard uncertainty, we propose an alternative calculation. We next propose a graphical method using a simple algorithm that quantifies the discrepancy between the results of a test measurement and the corresponding reference value, in terms of the percentage overlap of two probability density functions. We propose that bias should be corrected wherever possible and we illustrate this approach using the graphical method. Even though this review is focused principally on analytical chemistry and medical laboratory applications, much of the discussion is applicable to all areas of metrology.


Assuntos
Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Viés , Análise de Dados , Humanos , Padrões de Referência
16.
J Med Microbiol ; 68(5): 741-747, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30990403

RESUMO

PURPOSE: Serological analysis is an essential tool for the diagnosis of pertussis or whooping cough, disease surveillance and the evaluation of vaccine effectiveness against Bordetella pertussis. Accurate measurement of anti-pertussis toxin (anti-PT) IgG antibody levels in sera is essential. These measurements are usually performed using immunological methods such as ELISA and multiplex immunoassays. However, there are a large number of different assay systems available, and therefore standardization and harmonization between the methods are needed to obtain comparable data. METHODOLOGY: In collaboration with ECDC, the EUPert-LabNet network has organized three External Quality Assessment (EQA) schemes (2010, 2012 and 2016), which initially identified the diverse range of techniques and reagents being used throughout Europe. This manuscript discusses the findings of each of the EQA rounds and their impact on the participating laboratories. RESULTS: The studies have shown an increasing number of laboratories (from 65% to 92%) using only the recommended coating antigen, purified PT, in immunoassays, as this allows exact quantification of serum anti-PT IgG and since PT is only produced by Bordetella pertussis this prevents cross-reactivity with other species. There has also been an increase in the numbers of laboratories (from 59% to 92%), including a WHO reference serum in their assays, which allows anti-PT IgG concentrations to be measured in International Units, thus enabling the comparison of results from different methods and laboratories. In addition, manufacturers have also considered these recommendations when they produce commercial ELISA kits. CONCLUSION: The three EQA rounds have resulted in greater harmonization in methods among different laboratories, showing a significant improvement of the ELISA methods used for serodiagnosis of pertussis.


Assuntos
Bordetella pertussis/imunologia , Ensaio de Imunoadsorção Enzimática/métodos , Colaboração Intersetorial , Coqueluche/diagnóstico , Anticorpos Antibacterianos/sangue , Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Ensaio de Imunoadsorção Enzimática/normas , Europa (Continente) , Humanos , Imunoensaio , Imunoglobulina G/sangue , Internacionalidade , Controle de Qualidade , Kit de Reagentes para Diagnóstico/normas , Testes Sorológicos/métodos , Coqueluche/imunologia
17.
Clin Chim Acta ; 493: 148-155, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30858092

RESUMO

BACKGROUND: Cerebral Creatine deficiency syndromes (CCDS) include three hereditary diseases affecting the metabolism of creatine (Cr): arginine glycine amidinotransferase deficiency, guanidinoacetate methyltransferase deficiency and disorders of creatine transporter. These pathologies cause a brain creatine deficiency responsible of non-specific neurological impairments with mental retardation. LC-MS/MS measurements of guanidinoacetic acid (GAA) and creatine in urine and plasma are an important screening test to identify the deficit. Analysis of this polar and basic molecules not hold on standard column requires a derivatization step to butyl-esters. To overcome this long and fastidious derivatization, an ion pairing (IP) method was chosen in this study. METHOD: IP method was validated using Comité francais d'accréditation (COFRAC) recommendations. Then, urine GAA and creatine of 15 patients with a CDS deficiency suspected were tested y LC-MS/MS using IP technique, and performances were assessed with reference laboratory method (butylation method). Moreover, references values were suggested y the study of 100 urines samples of healthy patients. RESULTS: The method developed provided a good accuracy and precision with intra and inter-day coefficients of variation (CVs) <15%. The curve was linear for the biological and pathological concentrations. The comparison with the reference method did not reveal any significant difference for analytical performances but showed a simplification of the preparation of samples. CONCLUSION: The use of IP technique that we have developed demonstrated a good correlation with the butylation method. Moreover, this new method not only allows a simplification of the technique, but also decreases in run time.


Assuntos
Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Creatina/urina , Glicina/análogos & derivados , Guanidinoacetato N-Metiltransferase/deficiência , Transtornos do Desenvolvimento da Linguagem/urina , Transtornos dos Movimentos/congênito , Cromatografia Líquida de Alta Pressão , Glicina/urina , Guanidinoacetato N-Metiltransferase/urina , Humanos , Transtornos do Desenvolvimento da Linguagem/diagnóstico , Transtornos dos Movimentos/diagnóstico , Transtornos dos Movimentos/urina , Espectrometria de Massas em Tandem
18.
Clin Chim Acta ; 495: 85-87, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30926278

RESUMO

We describe the validation and implementation of the new 5th generation high sensitivity Troponin T assay (Roche Diagnostics®). In addition to the assay improved sensitivity, the numerical values, reporting units, reference intervals, and critical limits are markedly different. We describe the use of clinical correlation as the basis for implementation and validation of the fifth-generation hs-TnT assay at a large teaching county hospital.


Assuntos
Técnicas de Laboratório Clínico/métodos , Hospitais de Condado , Hospitais de Ensino , Limite de Detecção , Troponina T/análise , Humanos
19.
Klin Lab Diagn ; 64(2): 117-121, 2019.
Artigo em Russo | MEDLINE | ID: mdl-30917254

RESUMO

According to the World Health Organization, every year about 1 million cases of purulent bacterial meningitis (PBM) are registered in the world, of which 200 thousand cases end in death. Bacterial meningitis is polyethiologic, which makes the task of determining the pathogen the main in the organization of epidemiological surveillance, treatment regimens, planning of preventive and anti-epidemic measures. The quality of laboratory diagnostics has a key influence on this. The true incidence of meningitis of different etiology can be altered at low-efficiency laboratory diagnostics. This work was carried out to assess the effectiveness of existing laboratory methods for the detection of PBM pathogens: Haemophilus influenzae, Streptococcus pneumoniae and Neisseria meningitidis; as a part of the programme on sentinel surveillance of invasive bacterial diseases (IBD) carried out by the WHO regional office for Europe in a number of countries in Europe (Ukraine, Belarus), Transcaucasia (Azerbaijan, Armenia, Georgia), Asia (Uzbekistan, Kyrgyzstan, Kazakhstan) in the period 2010-2017. 2893 samples of clinical material (CSF and blood) obtained from patients with the meningeal syndrome were studied by four diagnostic methods: cultural method, latex-agglutination test, immunochromatographic test (BinaxNOW), PCR (conventional and real-time), used to identify the following pathogens: Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae. When identifying the causative agents of BM, PCR more effective than culture method is 5 times in detecting N. meningitidis; 3 times in the detection of S. pneumoniae; 4 times the detection of H. influenzae b. Latex-agglutination test and immunochromatographic test allow to increase the identification of pathogens of BM for N. meningitidis - by 35.6%; S. pneumoniae - by 67%; H. influenzae b - by 19.2%, it is possible to set them in the field and at the epidpoint if necessary. When working with clinical material from patients diagnosed with GBM, it is advisable for bacteriological laboratories to complement the culture method of microbiological diagnosis of latex-agglutination test, immunochromatographic test or PCR.


Assuntos
Técnicas de Laboratório Clínico/métodos , Meningites Bacterianas/diagnóstico , Haemophilus influenzae/isolamento & purificação , Humanos , Neisseria meningitidis/isolamento & purificação , Vigilância de Evento Sentinela , Streptococcus pneumoniae/isolamento & purificação
20.
PLoS Negl Trop Dis ; 13(3): e0007257, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30883555

RESUMO

INTRODUCTION: In October 2017, a blood sample from a resident of Kween District, Eastern Uganda, tested positive for Marburg virus. Within 24 hour of confirmation, a rapid outbreak response was initiated. Here, we present results of epidemiological and laboratory investigations. METHODS: A district task force was activated consisting of specialised teams to conduct case finding, case management and isolation, contact listing and follow up, sample collection and testing, and community engagement. An ecological investigation was also carried out to identify the potential source of infection. Virus isolation and Next Generation sequencing were performed to identify the strain of Marburg virus. RESULTS: Seventy individuals (34 MVD suspected cases and 36 close contacts of confirmed cases) were epidemiologically investigated, with blood samples tested for MVD. Only four cases met the MVD case definition; one was categorized as a probable case while the other three were confirmed cases. A total of 299 contacts were identified; during follow- up, two were confirmed as MVD. Of the four confirmed and probable MVD cases, three died, yielding a case fatality rate of 75%. All four cases belonged to a single family and 50% (2/4) of the MVD cases were female. All confirmed cases had clinical symptoms of fever, vomiting, abdominal pain and bleeding from body orifices. Viral sequences indicated that the Marburg virus strain responsible for this outbreak was closely related to virus strains previously shown to be circulating in Uganda. CONCLUSION: This outbreak of MVD occurred as a family cluster with no additional transmission outside of the four related cases. Rapid case detection, prompt laboratory testing at the Uganda National VHF Reference Laboratory and presence of pre-trained, well-prepared national and district rapid response teams facilitated the containment and control of this outbreak within one month, preventing nationwide and global transmission of the disease.


Assuntos
Técnicas de Laboratório Clínico/métodos , Controle de Doenças Transmissíveis/métodos , Surtos de Doenças , Doença do Vírus de Marburg/epidemiologia , Doença do Vírus de Marburg/patologia , Marburgvirus/isolamento & purificação , Adulto , Animais , Análise por Conglomerados , Transmissão de Doença Infecciosa/prevenção & controle , Saúde da Família , Feminino , Sequenciamento de Nucleotídeos em Larga Escala , Humanos , Masculino , Doença do Vírus de Marburg/mortalidade , Pessoa de Meia-Idade , Mortalidade , Uganda/epidemiologia , Cultura de Vírus
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