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1.
Clin Chem Lab Med ; 61(10): 1708-1718, 2023 09 26.
Artigo em Inglês | MEDLINE | ID: mdl-37021544

RESUMO

OBJECTIVES: Knowledge of the stability of analytes in clinical specimens is a prerequisite for proper transport and preservation of samples to avoid laboratory errors. The new version of ISO 15189:2022 and the European directive 2017/746 increase the requirements on this topic for manufacturers and laboratories. Within the project to generate a stability database of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Preanalytical Phase (WG-PRE), the need to standardise and improve the quality of published stability studies has been detected, being a manifest deficit the absence of international guidelines for the performance of stability studies on clinical specimens. METHODS: These recommendations have been developed and summarised by consensus of the WG-PRE and are intended primarily to improve the quality of sample stability claims included in information for users provided by assay supplier companies, according to the requirements of the new European regulations and standards for accreditation. RESULTS: This document provides general recommendations for the performance of stability studies, oriented to the estimation of instability equations in the usual working conditions, allowing flexible adaptation of the maximum permissible error specifications to obtain stability limits adapted to the intended use. CONCLUSIONS: We present this recommendation based on the opinions of the EFLM WG-PRE group for the standardisation and improvement of stability studies, with the intention to improve the quality of the studies and the transferability of their results to laboratories.


Assuntos
Química Clínica , Fase Pré-Analítica , Humanos , Laboratórios , Padrões de Referência , Acreditação
2.
Clin Chem Lab Med ; 59(1): 59-69, 2020 07 25.
Artigo em Inglês | MEDLINE | ID: mdl-32710715

RESUMO

To ensure that clinical laboratories produce results that are both accurate and of clinical utility it is essential that only samples of adequate quality are analysed. Although various studies and databases assessing the stability of analytes in different settings do exist, guidance on how to perform and report stability studies is lacking. This results in studies that often do not report essential information, thus compromising transferability of the data. The aim of this manuscript is to describe the Checklist for Reporting Stability Studies (CRESS) against which future studies should be reported to ensure standardisation of reporting and easy assessment of transferability of studies to other healthcare settings. The EFLM WG-PRE (European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase) produced the CRESS checklist following a detailed literature review and extensive discussions resulting in consensus agreement. The checklist consists of 20 items covering all the aspects that should be considered when producing a report on a stability study including details of what should be included for each item and a rationale as to why. Adherence to the CRESS checklist will ensure that studies are reported in a transparent and replicable way. This will allow other laboratories to assess whether published data meet the stability criteria required in their own particular healthcare scenario. The EFLM WG-PRE encourage researchers and authors to use the CRESS checklist as a guide to planning stability studies and to produce standardised reporting of future stability studies.


Assuntos
Lista de Checagem , Publicações/normas , Relatório de Pesquisa/normas , Análise Química do Sangue/normas , Química Clínica/normas , Humanos , Fase Pré-Analítica/normas , Manejo de Espécimes/normas
3.
Clin Chem Lab Med ; 57(11): 1699-1711, 2019 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-31617690

RESUMO

Background Some clinical chemistry measurement methods are vulnerable to interference if hemolyzed serum samples are used. The aims of this study were: (1) to obtain updated information about how hemolysis affects clinical chemistry test results on different instrument platforms used in Nordic laboratories, and (2) to obtain data on how test results from hemolyzed samples are reported in Nordic laboratories. Methods Four identical samples containing different degrees of hemolysis were prepared and distributed to 145 laboratories in the Nordic countries. The laboratories were asked to measure the concentration of cell-free hemoglobin (Hb), together with 15 clinical chemistry analytes. In addition, the laboratories completed a questionnaire about how hemolyzed samples are handled and reported. Results Automated detection of hemolysis in all routine patient samples was used by 63% of laboratories, and 88% had written procedures on how to handle hemolyzed samples. The different instrument platforms measured comparable mean Hb concentrations in the four samples. For most analytes, hemolysis caused a homogenous degree of interference regardless of the instrument platform used, except for alkaline phosphatase (ALP), bilirubin (total) and creatine kinase (CK). The recommended cut-off points for rejection of a result varied substantially between the manufacturers. The laboratories differed in how they reported test results, even when they used the same type of instrument. Conclusions Most of the analytes were homogeneously affected by hemolysis, regardless of the instrument used. There is large variation, however, between the laboratories on how they report test results from hemolyzed samples, even when they use the same type of instrument.


Assuntos
Química Clínica/métodos , Testes Hematológicos/métodos , Hemólise/fisiologia , Humanos , Laboratórios , Doadores de Tecidos
4.
Clin Chem Lab Med ; 57(10): 1511-1521, 2019 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-31085743

RESUMO

Background Correct handling and storage of blood samples for coagulation tests are important to assure correct diagnosis and monitoring. The aim of this study was to assess the pre-analytical practices for routine coagulation testing in European laboratories. Methods In 2013-2014, European laboratories were invited to fill in a questionnaire addressing pre-analytical requirements regarding tube fill volume, citrate concentration, sample stability, centrifugation and storage conditions for routine coagulation testing (activated partial thromboplastin time [APTT], prothrombin time in seconds [PT-sec] and as international normalised ratio [PT-INR] and fibrinogen). Results A total of 662 laboratories from 28 different countries responded. The recommended 3.2% (105-109 mmol/L) citrate tubes are used by 74% of the laboratories. Tube fill volumes ≥90% were required by 73%-76% of the laboratories, depending upon the coagulation test and tube size. The variation in centrifugation force and duration was large (median 2500 g [10- and 90-percentiles 1500 and 4000] and 10 min [5 and 15], respectively). Large variations were also seen in the accepted storage time for different tests and sample materials, for example, for citrated blood at room temperature the accepted storage time ranged from 0.5-72 h and 0.5-189 h for PT-INR and fibrinogen, respectively. If the storage time or the tube fill requirements are not fulfilled, 72% and 84% of the respondents, respectively, would reject the samples. Conclusions There was a large variation in pre-analytical practices for routine coagulation testing in European laboratories, especially for centrifugation conditions and storage time requirements.


Assuntos
Testes de Coagulação Sanguínea/métodos , Coleta de Amostras Sanguíneas/métodos , Fase Pré-Analítica/métodos , Coagulação Sanguínea , Testes de Coagulação Sanguínea/normas , Coleta de Amostras Sanguíneas/normas , Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Testes Diagnósticos de Rotina/métodos , Testes Diagnósticos de Rotina/normas , Europa (Continente) , Fibrinogênio/análise , Humanos , Laboratórios , Fase Pré-Analítica/normas , Tempo de Protrombina/normas , Fatores de Tempo
5.
Clin Chem Lab Med ; 56(12): 2015-2038, 2018 11 27.
Artigo em Inglês | MEDLINE | ID: mdl-30004902

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 , Ciência de Laboratório Médico , Química Clínica , Europa (Continente) , Humanos , América Latina
6.
Clin Chem ; 62(9): 1255-63, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27384539

RESUMO

BACKGROUND: We undertook this study to evaluate method differences for 5 components analyzed by immunoassays, to explore whether the use of method-dependent reference intervals may compensate for method differences, and to investigate commutability of external quality assessment (EQA) materials. METHODS: Twenty fresh native single serum samples, a fresh native serum pool, Nordic Federation of Clinical Chemistry Reference Serum X (serum X) (serum pool), and 2 EQA materials were sent to 38 laboratories for measurement of cobalamin, folate, ferritin, free T4, and thyroid-stimulating hormone (TSH) by 5 different measurement procedures [Roche Cobas (n = 15), Roche Modular (n = 4), Abbott Architect (n = 8), Beckman Coulter Unicel (n = 2), and Siemens ADVIA Centaur (n = 9)]. The target value for each component was calculated based on the mean of method means or measured by a reference measurement procedure (free T4). Quality specifications were based on biological variation. Local reference intervals were reported from all laboratories. RESULTS: Method differences that exceeded acceptable bias were found for all components except folate. Free T4 differences from the uncommonly used reference measurement procedure were large. Reference intervals differed between measurement procedures but also within 1 measurement procedure. The serum X material was commutable for all components and measurement procedures, whereas the EQA materials were noncommutable in 13 of 50 occasions (5 components, 5 methods, 2 EQA materials). CONCLUSIONS: The bias between the measurement procedures was unacceptably large in 4/5 tested components. Traceability to reference materials as claimed by the manufacturers did not lead to acceptable harmonization. Adjustment of reference intervals in accordance with method differences and use of commutable EQA samples are not implemented commonly.


Assuntos
Ferritinas/sangue , Ácido Fólico/sangue , Imunoensaio/normas , Tireotropina/sangue , Vitamina B 12/sangue , Humanos , Garantia da Qualidade dos Cuidados de Saúde , Controle de Qualidade , Testes de Função Tireóidea
7.
Clin Chem Lab Med ; 54(7): 1141-5, 2016 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-26816400

RESUMO

Venous blood sampling (phlebotomy) is the most common invasive procedure performed in patient care. Guidelines on the correct practice of phlebotomy are available, including the H3-A6 guideline issued by the Clinical Laboratory Standards Institute (CLSI). As the quality of practices and procedures related to venous blood sample collection in European countries was unknown, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase conducted an observational study in 12 European countries. The study demonstrated that the level of compliance of phlebotomy procedures with the CLSI H3-A6 guideline was unacceptably low, and that patient identification and tube labelling are amongst the most critical steps in need of immediate attention and improvement. The process of patient identification and tube labelling is an essential safety barrier to prevent patient identity mix-up. Therefore, the EFLM Working Group aims to encourage and support worldwide harmonisation of patient identification and tube labelling procedures in order to reduce the risk of preanalytical errors and improve patient safety. With this Position paper we wish to raise awareness and provide recommendations for proper patient and sample identification procedures.


Assuntos
Coleta de Amostras Sanguíneas/normas , Técnicas de Laboratório Clínico/normas , Erros de Diagnóstico/prevenção & controle , Laboratórios Hospitalares/normas , Sistemas de Identificação de Pacientes/métodos , Controle de Qualidade , Coleta de Amostras Sanguíneas/métodos , Erros de Diagnóstico/estatística & dados numéricos , Humanos
8.
Clin Chem Lab Med ; 53(9): 1321-31, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25536667

RESUMO

BACKGROUND: An observational study was conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) to assess the level of compliance with the CLSI H3-A6 guidelines. METHODS: A structured checklist including 29 items was created to assess the compliance of European phlebotomy procedures with the CLSI H3-A6 guideline. A risk occurrence chart of individual phlebotomy steps was created from the observed error frequency and severity of harm of each guideline key issue. The severity of errors occurring during phlebotomy was graded using the risk occurrence chart. RESULTS: Twelve European countries participated with a median of 33 (18-36) audits per country, and a total of 336 audits. The median error rate for the total phlebotomy procedure was 26.9 % (10.6-43.8), indicating a low overall compliance with the recommended CLSI guideline. Patient identification and test tube labelling were identified as the key guideline issues with the highest combination of probability and potential risk of harm. Administrative staff did not adhere to patient identification procedures during phlebotomy, whereas physicians did not adhere to test tube labelling policy. CONCLUSIONS: The level of compliance of phlebotomy procedures with the CLSI H3-A6 guidelines in 12 European countries was found to be unacceptably low. The most critical steps in need of immediate attention in the investigated countries are patient identification and tube labelling.


Assuntos
Coleta de Amostras Sanguíneas/normas , Fidelidade a Diretrizes/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Sociedades Científicas/normas , Inquéritos e Questionários , Humanos , Flebotomia , Medição de Risco
9.
Clin Chem Lab Med ; 48(7): 963-72, 2010 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-20441473

RESUMO

Self-monitoring of blood glucose (SMBG) has been available for patients with diabetes for more than 30 years. Today, SMBG is an important component in diabetes management, helping patients achieve and maintain normal blood glucose concentrations. Implementation of SMBG as an effective glycaemic control tool requires that instruments have acceptable analytical quality, that the patients are educated in using them, and that actions are taken upon the results. This paper gives an overview of SMBG, including the history, clinical utility, principles of measurement and several aspects of analytical quality of SMBG. The latter comprises a standardised evaluation of SMBG performance, quality specifications as well as different approaches to monitor the quality of SMBG performance.


Assuntos
Automonitorização da Glicemia/normas , Glicemia/análise , Automonitorização da Glicemia/economia , Automonitorização da Glicemia/métodos , Humanos , Garantia da Qualidade dos Cuidados de Saúde , Controle de Qualidade
10.
Biochem Med (Zagreb) ; 29(2): 020704, 2019 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-31223258

RESUMO

INTRODUCTION: Compared to other activities of the testing process, the preanalytical phase is plagued by a lower degree of standardization, which makes it more vulnerable to errors. With the aim of providing guidelines and recommendations, the EFLM WG-PRE issued a survey across European medical laboratories, to gather information on local preanalytical practices. This is part one of two coherent articles, which covers all practices on monitoring preanalytical quality except haemolysis, icterus and lipemia (HIL). MATERIALS AND METHODS: An online survey, containing 39 questions dealing with a broad spectrum of preanalytical issues, was disseminated to EFLM member countries. The survey included questions on willingness of laboratories to engage in preanalytical issues. RESULTS: Overall, 1405 valid responses were received from 37 countries. 1265 (94%) responders declared to monitor preanalytical errors. Assessment, documentation and further use of this information varied widely among respondents and partially among countries. Many responders were interested in a preanalytical online platform, holding information on various aspects of the preanalytical phase (N = 1177; 87%), in a guideline for measurement and evaluation of preanalytical variables (N = 1235; 92%), and in preanalytical e-learning programs or webinars (N = 1125; 84%). Fewer responders were interested in, or already participating in, preanalytical EQA programs (N = 951; 71%). CONCLUSION: Although substantial heterogeneity was found across European laboratories on preanalytical phase monitoring, the interest in preanalytical issues was high. A large majority of participants indicated an interest in new guidelines regarding preanalytical variables and learning activities. This important data will be used by the WG-PRE for providing recommendations on the most critical issues.


Assuntos
Medicina Clínica , Fase Pré-Analítica , Inquéritos e Questionários , Química Clínica , Técnicas de Laboratório Clínico , Europa (Continente) , Humanos
11.
Biochem Med (Zagreb) ; 29(2): 020705, 2019 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-31223259

RESUMO

INTRODUCTION: No guideline currently exists on how to detect or document haemolysis, icterus or lipemia (HIL) in blood samples, nor on subsequent use of this information. The EFLM WG-PRE has performed a survey for assessing current practices of European laboratories in HIL monitoring. This second part of two coherent articles is focused on HIL. MATERIALS AND METHODS: An online survey, containing 39 questions on preanalytical issues, was disseminated among EFLM member countries. Seventeen questions exclusively focused on assessment, management and follow-up actions of HIL in routine blood samples. RESULTS: Overall, 1405 valid responses from 37 countries were received. A total of 1160 (86%) of all responders stating to analyse blood samples - monitored HIL. HIL was mostly checked in clinical chemistry samples and less frequently in those received for coagulation, therapeutic drug monitoring and serology/infectious disease testing. HIL detection by automatic HIL indices or visual inspection, along with haemolysis cut-offs definition, varied widely among responders. A quarter of responders performing automated HIL checks used internal quality controls. In haemolytic/icteric/lipemic samples, most responders (70%) only rejected HIL-sensitive parameters, whilst about 20% released all test results with general comments. Other responders did not analysed but rejected the entire sample, while some released all tests, without comments. Overall, 26% responders who monitored HIL were using this information for monitoring phlebotomy or sample transport quality. CONCLUSION: Strategies for monitoring and treating haemolytic, icteric or lipemic samples are quite heterogeneous in Europe. The WG-PRE will use these insights for developing and providing recommendations aimed at harmonizing strategies across Europe.


Assuntos
Medicina Clínica , Hemólise , Hiperlipidemias/sangue , Icterícia/sangue , Fase Pré-Analítica , Inquéritos e Questionários , Química Clínica , Técnicas de Laboratório Clínico , Europa (Continente) , Humanos
12.
Diabetes Technol Ther ; 10(6): 467-77, 2008 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-19049376

RESUMO

BACKGROUND: Instruments for self-monitoring of blood glucose (SMBG) should undergo a standardized evaluation including a user-test before being marketed. In this study the results from standardized evaluations of nine different SMBG instruments are presented, and the standardized evaluation is discussed. METHODS: Approximately 80 diabetes patients using three lots of test strips participated in each evaluation. Half of the patients were educated in how to use the meter, and the evaluations were carried out by both medical laboratory technologists (MLTs) and patients. Questionnaires were used to assess the user manual and the user-friendliness of the instrument. RESULTS: The imprecision obtained by the patients (coefficients of variation [CVs] of 3.2-8.1%) were generally higher compared to that by the MLT (CVs of 2.3-5.9%). Three of the nine instruments did not achieve the quality goal based on the recommendation in the International Organization for Standardization's ISO 15197 guideline in the hands of diabetes patients. The bias from the comparison method ranged from -10.4% to +3.2%. There were significant lot-to-lot variations and hematocrit effects for some of the instruments. Temperature difference between the instruments and the test strip caused deterioration of the quality in one instrument. The user-friendliness was in general acceptable. CONCLUSIONS: The quality of instruments for SMBG seems to have improved during recent years, although there are still analytical problems. A standardized evaluation protocol is necessary and should be regularly revised taking into account the development of new technology and the needs of the patients.


Assuntos
Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/normas , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Desenho de Equipamento , Humanos , Ciência de Laboratório Médico , Variações Dependentes do Observador , Educação de Pacientes como Assunto , Fitas Reagentes , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Inquéritos e Questionários
14.
Biochem Med (Zagreb) ; 24(1): 114-22, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24627720

RESUMO

In laboratory medicine, several studies have described the most frequent errors in the different phases of the total testing process, and a large proportion of these errors occur in the pre-analytical phase. Schemes for registration of errors and subsequent feedback to the participants have been conducted for decades concerning the analytical phase by External Quality Assessment (EQA) organizations operating in most countries. The aim of the paper is to present an overview of different types of EQA schemes for the pre-analytical phase, and give examples of some existing schemes. So far, very few EQA organizations have focused on the pre-analytical phase, and most EQA organizations do not offer pre-analytical EQA schemes (EQAS). It is more difficult to perform and standardize pre-analytical EQAS and also, accreditation bodies do not ask the laboratories for results from such schemes. However, some ongoing EQA programs for the pre-analytical phase do exist, and some examples are given in this paper. The methods used can be divided into three different types; collecting information about pre-analytical laboratory procedures, circulating real samples to collect information about interferences that might affect the measurement procedure, or register actual laboratory errors and relate these to quality indicators. These three types have different focus and different challenges regarding implementation, and a combination of the three is probably necessary to be able to detect and monitor the wide range of errors occurring in the pre-analytical phase.


Assuntos
Acreditação/normas , Laboratórios/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Controle de Qualidade , Acreditação/organização & administração , Humanos , Laboratórios/organização & administração , Garantia da Qualidade dos Cuidados de Saúde/organização & administração , Projetos de Pesquisa
15.
J Diabetes Sci Technol ; 3(1): 83-8, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-20046652

RESUMO

OBJECTIVE: Little attention has been given and few studies have been published focusing on how to optimize self-monitoring of blood glucose (SMBG) use to monitor daily therapy for persons with type 1 diabetes mellitus. This study was designed to evaluate the effect on glycated hemoglobin (A1C) of a structured intervention focused on SMBG in type 1 diabetes patients with insufficient metabolic control (A1C ≥8%) using a randomized clinical trial design. METHOD: One hundred fifty-nine outpatients with type 1 diabetes on multiple injection therapy with insulin and A1C ≥8% were recruited and randomized to one group receiving a focused, structured 9-month SMBG intervention (n=59) and another group receiving regular care based on guidelines (n=64). RESULTS: Glycated hemoglobin values (mean % ± standard deviation) at study start was similar: 8.65 ± 0.10 in the intervention group and 8.61 ± 0.09 in the control group. The two groups were comparable (age, gender, body mass index, complication rate, and treatment modality) at study start and had mean diabetes duration and SMBG experience of 19 and 20 years, respectively. At study end, there was decrease in A1C in the intervention group (p<.05), and the A1C was 0.6% lower compared with the control group (p<.05). No increase in the number of minor or major hypoglycemia episodes was observed in the intervention group during the study period. CONCLUSIONS: A simple, structured, focused SMBG intervention improved metabolic control in patients with longstanding diabetes type 1 and A1C ≥8%. The intervention was based on general recommendations, realistic in format, and can be applied in a regular outpatient setting.


Assuntos
Automonitorização da Glicemia/métodos , Diabetes Mellitus Tipo 1/sangue , Hemoglobinas Glicadas/metabolismo , Adulto , Feminino , Humanos , Masculino
16.
Clin Chem ; 52(7): 1311-7, 2006 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-16690732

RESUMO

BACKGROUND: The analytical quality of self-monitoring of blood glucose (SMBG) is not satisfactory, and the need for standardized control routines for SMBG has been underscored. The objective of this study was to investigate whether an external quality assessment scheme (EQAS) designed for office laboratories could improve the quality of SMBG measurements. METHODS: From October 2001 through March 2004, we conducted 6 glucose surveys for diabetes patients and coordinated them with an EQAS for office laboratories. Patients received 2 control samples by post twice a year. They measured each control sample in duplicate in accordance with written instructions, returned the results, and received an assessment of their analytical performance. Participants who got a poor evaluation were followed up by phone and were offered guidance. RESULTS: Participating in an EQA program over a period of 3 years decreased the percentage of poor results among diabetes patients significantly, from 11.2% to 1.9% in the first and last surveys, respectively. Between-participant CVs improved from 5.5% to 3.7% and were comparable to results from office laboratories. It was difficult to sort out factors contributing to quality improvement. CONCLUSIONS: Implementing a traditional EQAS among diabetes patients may improve the analytical quality of SMBG and could be convenient for motivated patients. Further evaluation of the clinical usefulness of implementing such a program is needed, however, and costs as well as limitations of current EQAS for glucose in general should be taken into account.


Assuntos
Automonitorização da Glicemia/normas , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 2/diagnóstico , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Controle de Qualidade , Padrões de Referência
17.
Clin Chem ; 51(9): 1632-6, 2005 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-16120948

RESUMO

BACKGROUND: External quality assessment schemes (EQAS) are conducted to evaluate user performance (participant assessment) and to assess different methods and instruments (method assessment). The quality of control materials is crucial to achieving these goals. Inconsistencies in between-lot variations detected by use of different control and sample materials may affect EQAS outcomes. METHODS: For the Accu-Chek Sensor, Precision Xtra, Ascensia Elite, and HemoCue 201 glucometers, 3 different lots of glucose strips were used with each instrument. Method assessment results from analysis of capillary blood and 3 control materials were used to calculate between-lot differences. A simulation study was performed to evaluate the effect of between-lot variation on participant assessment results. RESULTS: With the Precision Xtra, the results obtained with EQA control material mirrored those obtained with capillary blood, but for the other instruments, we found between-lot differences of as much as 1.3 mmol/L, which were substantially greater than those found with capillary blood and of clinical importance at decision limits. The simulation study showed an effect on participant assessment results related to the target values, with the percentage of poor results decreasing (38%, 10%, and 4%) with the use of common, method-specific, and lot-specific target values, respectively. CONCLUSIONS: Between-lot variation may influence participant EQA results for participant and method assessments. The clinical relevance of between-lot variation discovered in EQAS using noncommutable control materials should be examined by use of native blood samples.


Assuntos
Glicemia/análise , Glucose/normas , Diabetes Mellitus/diagnóstico , Humanos , Laboratórios/normas , Controle de Qualidade , Fitas Reagentes/normas , Padrões de Referência
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