RESUMO
BACKGROUND: Conducting HIV surveys in resource-limited settings is challenging because of logistics, limited availability of trained personnel, and complexity of testing. We described the procedures and systems deemed critical to ensure high-quality laboratory data in the population-based HIV impact assessments and large-scale household surveys. METHODS: Laboratory professionals were engaged in every stage of the surveys, including protocol development, site assessments, procurement, training, quality assurance, monitoring, analysis, and reporting writing. A tiered network of household, satellite laboratories, and central laboratories, accompanied with trainings, optimized process for blood specimen collection, storage, transport, and real-time monitoring of specimen quality, and test results at each level proved critical in maintaining specimen integrity and high-quality testing. A plausibility review of aggregate merged data was conducted to confirm associations between key variables as a final quality check for quality of laboratory results. RESULTS: Overall, we conducted a hands-on training for 3355 survey staff across 13 surveys, with 160-387 personnel trained per survey on biomarker processes. Extensive training and monitoring demonstrated that overall, 99% of specimens had adequate volume and 99.8% had no hemolysis, indicating high quality. We implemented quality control and proficiency testing for testing, resolved discrepancies, verified >300 Pima CD4 instruments, and monitored user errors. Aggregate data review for plausibility further confirmed the high quality of testing. CONCLUSIONS: Ongoing engagement of laboratory personnel to oversee processes at all levels of the surveys is critical for successful national surveys. High-quality population-based HIV impact assessments laboratory data ensured reliable results and demonstrated the impact of HIV programs in 13 countries.
Assuntos
Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , HIV-1 , Ensaio de Proficiência Laboratorial/normas , Países em Desenvolvimento , Monitoramento Epidemiológico , Inquéritos Epidemiológicos , Humanos , Pessoal de Laboratório/educação , Pessoal de Laboratório/normas , Controle de QualidadeRESUMO
BACKGROUND: The use of rapid diagnostic tests (RDTs) to diagnose malaria is common in sub-Saharan African laboratories, remote primary health facilities and in the community. Currently, there is a lack of reliable methods to ascertain health worker competency to accurately use RDTs in the testing and diagnosis of malaria. Dried tube specimens (DTS) have been shown to be a consistent and useful method for quality control of malaria RDTs; however, its application in National Quality Management programmes has been limited. METHODS: A Plasmodium falciparum strain was grown in culture and harvested to create DTS of varying parasite density (0, 100, 200, 500 and 1000 parasites/µL). Using the dried tube specimens as quality control material, a proficiency testing (PT) programme was carried out in 80 representative health centres in Togo. Health worker competency for performing malaria RDTs was assessed using five blinded DTS samples, and the DTS were tested in the same manner as a patient sample would be tested by multiple testers per health centre. RESULTS: All the DTS with 100 parasites/µl and 50% of DTS with 200 parasites/µl were classified as non-reactive during the pre-PT quality control step. Therefore, data from these parasite densities were not analysed as part of the PT dataset. PT scores across all 80 facilities and 235 testers was 100% for 0 parasites/µl, 63% for 500 parasites/µl and 93% for 1000 parasites/µl. Overall, 59% of the 80 healthcare centres that participated in the PT programme received a score of 80% or higher on a set of 0, 500 and 1000 parasites/ µl DTS samples. Sixty percent of health workers at these centres recorded correct test results for all three samples. CONCLUSIONS: The use of DTS for a malaria PT programme was the first of its kind ever conducted in Togo. The ease of use and stability of the DTS illustrates that this type of samples can be considered for the assessment of staff competency. The implementation of quality management systems, refresher training and expanded PT at remote testing facilities are essential elements to improve the quality of malaria diagnosis.
Assuntos
Antígenos de Protozoários/análise , Técnicas e Procedimentos Diagnósticos/estatística & dados numéricos , Instalações de Saúde , Mão de Obra em Saúde/normas , Ensaio de Proficiência Laboratorial/normas , Malária Falciparum/diagnóstico , Plasmodium falciparum/química , Humanos , Ensaio de Proficiência Laboratorial/métodos , Controle de Qualidade , Manejo de Espécimes , TogoRESUMO
Over the past decade, there has been an increase in the adoption of next generation sequencing (NGS) technologies for HIV drug resistance (HIVDR) testing. NGS far outweighs conventional Sanger sequencing as it has much higher throughput, lower cost when samples are batched and, most importantly, significantly higher sensitivities for variants present at low frequencies, which may have significant clinical implications. Despite the advantages of NGS, Sanger sequencing remains the gold standard for HIVDR testing, largely due to the lack of standardization of NGS-based HIVDR testing. One important aspect of standardization includes external quality assessment (EQA) strategies and programs. Current EQA for Sanger-based HIVDR testing includes proficiency testing where samples are sent to labs and the performance of the lab conducting such assays is evaluated. The current methods for Sanger-based EQA may not apply to NGS-based tests because of the fundamental differences in their technologies and outputs. Sanger-based genotyping reports drug resistance mutations (DRMs) data as dichotomous, whereas NGS-based HIVDR genotyping also reports DRMs as numerical data (percent abundance). Here we present an overview of the need to develop EQA for NGS-based HIVDR testing and some unique challenges that may be encountered.
Assuntos
Farmacorresistência Viral/genética , Infecções por HIV/virologia , HIV-1/genética , Sequenciamento de Nucleotídeos em Larga Escala/normas , Análise de Sequência de RNA/normas , Fármacos Anti-HIV/farmacologia , Fármacos Anti-HIV/uso terapêutico , Genótipo , Infecções por HIV/tratamento farmacológico , HIV-1/efeitos dos fármacos , Ensaio de Proficiência Laboratorial/normas , Mutação , Garantia da Qualidade dos Cuidados de SaúdeAssuntos
Análise Química do Sangue/normas , Hemoglobinas Glicadas/análise , Necessidades e Demandas de Serviços de Saúde , Laboratórios/legislação & jurisprudência , Ensaio de Proficiência Laboratorial , Legislação como Assunto , Análise Química do Sangue/métodos , Necessidades e Demandas de Serviços de Saúde/normas , Testes Hematológicos/métodos , Testes Hematológicos/normas , Humanos , Ensaio de Proficiência Laboratorial/legislação & jurisprudência , Ensaio de Proficiência Laboratorial/normas , Controle de Qualidade , Reprodutibilidade dos Testes , Estados UnidosRESUMO
BACKGROUND: The Clinical Pharmacology Quality Assurance (CPQA) program provides semiannual proficiency testing (PT) of antiretroviral analytes for 11 US and international clinical pharmacology laboratories (CPLs) to ensure interlaboratory comparability. In this article, we provide estimates of the main sources of variability and assess the accuracy of the algorithm for the assessment of performance. METHODS: Descriptive statistics are reported from 13 PT rounds from 2010 to 2016. Eight of the most common antiretroviral analytes were examined. Variance components analysis was used to rank the relative contributions of CPLs, antiretroviral analyte, and concentration category (low, medium, and high) to bias and variability using mixed models. Binary classification metrics of the PT assessment algorithm are calculated in comparison with a model using 95% prediction limits around estimated regression equations. RESULTS: CPLs provided 4109 reported concentrations of 65 unique samples for each of the 8 antiretroviral analytes across 13 PT rounds. Individual CPL accounted for the greatest amount of total variability (4.4%). Individual CPL and analyte combination (interaction) accounted for the greatest amount of bias (8.1%). Analyte alone accounted for 0.5% or less for total variability and bias. Overall, using a ±20% acceptance window around the final target, 97% of individual reported concentrations were scored acceptable, and 96% of antiretroviral/round scores were deemed satisfactory. Comparison with the regression model gave 100% sensitivity but only 34.47% specificity. Narrowing the acceptance window to ±15% improved specificity to 84.47% while maintaining a 99.17% sensitivity. CONCLUSIONS: The current CPQA PT scoring algorithm that use a ±20% acceptance window seems to suffer from a low specificity and may be too lenient. A stricter ±15% acceptance window would increase specificity and overall accuracy while lowering the overall pass rate by only 3%.
Assuntos
Antirretrovirais/uso terapêutico , Infecções por HIV/tratamento farmacológico , Ensaio de Proficiência Laboratorial/métodos , Ensaio de Proficiência Laboratorial/normas , Farmacologia Clínica/métodos , Farmacologia Clínica/normas , Serviços de Laboratório Clínico/normas , Humanos , Laboratórios/normas , Controle de QualidadeRESUMO
BACKGROUND: In this study, we tested to which extent possible between-center differences in standardized operating procedures (SOPs) for biobanking of cerebrospinal fluid (CSF) samples influence the homogeneity of the resulting aliquots and, consequently, the concentrations of the centrally analyzed selected Alzheimer's disease biomarkers. METHODS: Proficiency processing samples (PPSs), prepared by pooling of four individual CSF samples, were sent to 10 participating centers, which were asked to perform aliquoting of the PPSs into two secondary aliquots (SAs) under their local SOPs. The resulting SAs were shipped to the central laboratory, where the concentrations of amyloid beta (Aß) 1-42, pTau181, and albumin were measured in one run with validated routine analytical methods. Total variability of the concentrations, and its within-center and between-center components, were analyzed with hierarchical regression models. RESULTS: We observed neglectable variability in the concentrations of pTau181 and albumin across the centers and the aliquots. In contrast, the variability of the Aß1-42 concentrations was much larger (overall coefficient of variation 31%), with 28% of the between-laboratory component and 10% of the within-laboratory (i.e., between-aliquot) component. We identified duration of the preparation of the aliquots and the centrifugation force as two potential confounders influencing within-center variability and biomarker concentrations, respectively. CONCLUSIONS: Proficiency processing schemes provide objective evidence for the most critical preanalytical variables. Standardization of these variables may significantly enhance the quality of the collected biospecimens. Studies utilizing retrospective samples collected under different local SOPs need to consider such differences in the statistical evaluations of the data.
Assuntos
Doença de Alzheimer/líquido cefalorraquidiano , Peptídeos beta-Amiloides/líquido cefalorraquidiano , Ensaio de Proficiência Laboratorial/normas , Fragmentos de Peptídeos/líquido cefalorraquidiano , Albuminas/líquido cefalorraquidiano , Biomarcadores/líquido cefalorraquidiano , Humanos , Fosforilação , Reprodutibilidade dos Testes , Proteínas tau/líquido cefalorraquidiano , Proteínas tau/metabolismoRESUMO
BACKGROUND: The accuracy and trueness of results from a laboratory test, such as the HbA1c test, should not be taken for granted but must be checked continuously. A tool for this is the participation in external quality assessment (EQA) for all laboratories performing the HbA1c-test. An additional possibility to detect changes in trueness is to monitor variations in patient cohort mean or median values that is not explained by changes in treatment or selection of patients. METHODS: Results reported to an EQA scheme for HbA1c during 20 years have been extracted from Equalis database. The results are compared to current analytical performance specifications (APS) and to the mean HbA1c levels for the Swedish population of persons with type 2 diabetes. RESULTS: The accuracy of the HbA1c test has improved during the period. The hospital lab methods used in Sweden now fulfil APS agreed by professional organizations in Sweden. The accuracy for point-of-care tests (POCT) methods vary over time and fulfil APS for some periods. The bias found for some of the methods might explain changes seen in patient mean values for HbA1c in Sweden during the period 2007-2017. CONCLUSIONS: The global standardization of HbA1c has resulted in an improved comparability for HbA1c-results worldwide. But even small variation in trueness for the methods in use might have important impact on mean HbA1c values for cohorts of patients. When a systematic error is observed for a specific method it is therefore essential that manufacturers correct the method without delay.
Assuntos
Diabetes Mellitus Tipo 2/sangue , Hemoglobinas Glicadas/análise , Ensaio de Proficiência Laboratorial/métodos , Ensaio de Proficiência Laboratorial/normas , Humanos , SuéciaRESUMO
BACKGROUND: Tacrolimus is the most widely used immunosuppressant in solid organ transplant patients. The cytochrome P450 3A5 (CYP3A5) has been proved to be associated with tacrolimus dose requirement. Molecular detection for CYP3A5 genotyping is demanded for the optimization of treatments of tacrolimus. METHODS: To achieve the consistency and accuracy of the testing results, the Chinese National Center for Clinical Laboratories (NCCL) organized a national external quality assessment(EQA) program to evaluate the performance of laboratories providing CYP3A5 genotyping. Ten validated DNA samples covering the common genetic polymorphisms of CYP3A5 were delivered to 33 voluntary laboratories, and their detecting results and clinical written reports were evaluated. RESULTS: Thirty-three datasets were received. The corresponding analytical sensitivity was 95.9% (285/297 challenges; 95% confidence interval: 93.0%-97.9%), and the analytical specificity was 95.3% (346/363; 95% confidence interval: 92.6%-97.2%). Thirty of the participating laboratories correctly identified the CYP3A5 allele status for all EQA samples. Three laboratories made genotyping errors, and 2 of them failed to detect any of the homozygotes such as *1/*1 and *3/*3. Twenty-eight CYP3A5*3 tests reports were submitted, but many reports showed a shortage of essential information. No reports fulfilled all the consensus recommendations for pharmacogenetic test result reporting. CONCLUSION: The EQA program highlighted the necessity for an improvement in the accuracy of genotyping for some of the laboratories and a greater education on the reporting of CYP3A5 genotyping results.
Assuntos
Citocromo P-450 CYP3A/genética , Técnicas de Genotipagem/normas , Ensaio de Proficiência Laboratorial/normas , China , Genótipo , Técnicas de Genotipagem/métodos , Rejeição de Enxerto/tratamento farmacológico , Rejeição de Enxerto/prevenção & controle , Humanos , Imunossupressores/uso terapêutico , Ensaio de Proficiência Laboratorial/métodos , Transplante de Órgãos/efeitos adversos , Tacrolimo/uso terapêuticoRESUMO
OBJECTIVES: To assess the accuracy and costs of laboratory tests in Kampala, Uganda. METHODS: A random selection of 78 laboratories tested external quality assurance samples at market rates. There were 40 moderate- to high-complexity and 38 low-complexity laboratories. Four percent (3/78) of these laboratories were accredited and 94% (73/78) were private. The 40 moderate- to high-complexity laboratories performed malaria blood smear, urine human chorionic gonadotropin (hCG), human immunodeficiency virus (HIV), syphilis, glucose, and three-panel tests: CBC, liver function tests, and kidney function tests. The 38 low-complexity laboratories performed malaria blood smear, urine hCG, and syphilis testing only. Hematology, HIV, syphilis, and malarial proficiency testing samples were prepared by accredited laboratories in Kampala. All other samples were provided by the Royal College of Pathologists of Australia. RESULTS: 77.1% of all results were accurate (met target values). It varied widely by laboratory (50%-100%), test identity (malaria blood smear, 96%; serum urea nitrogen, 38%), and test type (quantitative: 66% [31%-89%], qualitative: 91% [68%-97%]). Test prices varied by up to 3,600%, and there was no correlation between test cost and accuracy (r2 = 0.02). CONCLUSIONS: There were large differences in accuracy and price across laboratories in Kampala. Price was not associated with quality.
Assuntos
Serviços de Laboratório Clínico/normas , Testes Diagnósticos de Rotina/normas , Laboratórios/normas , Ensaio de Proficiência Laboratorial/normas , Serviços de Laboratório Clínico/economia , Testes Diagnósticos de Rotina/economia , Custos de Cuidados de Saúde , Humanos , Laboratórios/economia , Ensaio de Proficiência Laboratorial/economia , Reprodutibilidade dos Testes , UgandaRESUMO
Quality in diagnostic testing represents a key target of laboratory medicine, for which an assurance around the quality of testing is expected from all involved in the process. Laboratories attempt to assure the quality of their testing by various processes, but especially by performance of internal quality control and external quality assessment (EQA). This is especially true for tests of hemostasis and coagulation. EQA in general provides information on test accuracy and on evaluation of long-term laboratory performance. EQA providers support laboratory performance by various means, including distribution of material for testing of analytes ("proficiency testing"), educational support through expert advice, distribution of publications or case series. Participation in EQA is often a laboratory accreditation requirement. This review aims to identify some of the strengths and weaknesses of EQA, and targets attempts towards harmonization of EQA practice, in order to achieve the best outcome for participant laboratories and, thus, for patients and their clinical care providers.
Assuntos
Hemostasia , Ensaio de Proficiência Laboratorial/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Coagulação Sanguínea , HumanosAssuntos
Betainfluenzavirus/isolamento & purificação , Vírus da Influenza A/isolamento & purificação , Ensaio de Proficiência Laboratorial/normas , Reação em Cadeia da Polimerase Via Transcriptase Reversa/normas , Organização Mundial da Saúde , Vírus da Influenza A Subtipo H1N1/isolamento & purificação , Virus da Influenza A Subtipo H5N1/isolamento & purificação , Subtipo H7N9 do Vírus da Influenza A/isolamento & purificação , Vírus da Influenza A/efeitos dos fármacos , Neuraminidase/antagonistas & inibidores , Avaliação de Programas e Projetos de Saúde , Controle de QualidadeRESUMO
BACKGROUND: Reports serve as a bridge between laboratories and clinicians, help synthesize an overwhelming amount of raw data into evidence-based medicine, and play a significant role in designing clinical treatments. In an effort to guarantee high-quality epidermal growth factor receptor (EGFR) gene mutation testing and reporting performance, the National Center for Clinical Laboratories launched a proficiency testing (PT) scheme reflecting clinical practices in China since 2014. This study focuses on the quality assessment of gene mutation reports. MATERIALS AND METHODS: Fifty-three laboratories that submitted reports in both 2014 and 2016 EGFR gene mutation PT schemes were selected for report analysis and comparison according to predefined evaluation criteria. RESULTS: The average score for reports from 2014 was 14 out of 30 points. The overall scores for reports from 2016 improved substantially, yielding an average score of 20 out of 30 points. Among the evaluation criteria, general items were well documented in the reports. However, items specific to molecular diagnosis were far from satisfactory, and some items were even missing. CONCLUSION: The quality assessment of clinical written reports from 2014 and 2016 demonstrates that substantial improvements have been made in overall reporting performance. However, not all statements pertaining to important elements met expectations. To continue education, repeated PT schemes need to be executed in a timely fashion to expose and address existing shortcomings in clinical reports. There remains ample room for improvement towards generating concise, comprehensive, and readable reports. IMPLICATIONS FOR PRACTICE: This article compares the quality of clinical gene mutation reports submitted in 2014 to those submitted in 2016 epidermal growth factor receptor proficiency testing schemes, exposes the existing shortcomings, and discusses ways to communicate results more effectively in the future. The findings demonstrate that notable progress was observed in the overall reporting performance. However, key points specific to molecular diagnosis were far from expectation, and some items were even missing. Standardization needs to be emphasized to improve the report format and content. This article provides a reference that laboratories can use to write concise, comprehensive, and readily accessible clinical reports.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Carcinoma Pulmonar de Células não Pequenas/genética , Ensaio de Proficiência Laboratorial/normas , Patologia Molecular/normas , Carcinoma Pulmonar de Células não Pequenas/patologia , China , Receptores ErbB/genética , Feminino , Humanos , Mutação , Garantia da Qualidade dos Cuidados de SaúdeRESUMO
INTRODUCTION: Proper standardization of laboratory testing requires assessment of performance after the tests are performed, known as the post-analytical phase. A nationwide external quality assessment (EQA) scheme implemented in Croatia in 2014 includes a questionnaire on post-analytical practices, and the present study examined laboratory responses in order to identify current post-analytical phase practices and identify areas for improvement. MATERIALS AND METHODS: In four EQA exercises between September 2014 and December 2015, 145-174 medical laboratories across Croatia were surveyed using the Module 11 questionnaire on the post-analytical phase of testing. Based on their responses, the laboratories were evaluated on four quality indicators: turnaround time (TAT), critical values, interpretative comments and procedures in the event of abnormal results. Results were presented as absolute numbers and percentages. RESULTS: Just over half of laboratories (56.3%) monitored TAT. Laboratories varied substantially in how they dealt with critical values. Most laboratories (65-97%) issued interpretative comments with test results. One third of medical laboratories (30.6-33.3%) issued abnormal test results without confirming them in additional testing. CONCLUSION: Our results suggest that the nationwide post-analytical EQA scheme launched in 2014 in Croatia has yet to be implemented to the full. To close the gaps between existing recommendations and laboratory practice, laboratory professionals should focus on ensuring that TAT is monitored and lists of critical values are established within laboratories. Professional bodies/institutions should focus on clarify and harmonized rules to standardized practices and applied for adding interpretative comments to laboratory test results and for dealing with abnormal test results.
Assuntos
Técnicas de Laboratório Clínico/normas , Erros de Diagnóstico/prevenção & controle , Ensaio de Proficiência Laboratorial/normas , Ciência de Laboratório Médico/normas , Patologia Clínica/normas , Garantia da Qualidade dos Cuidados de Saúde , Croácia , Humanos , Estudos Longitudinais , Controle de Qualidade , Estudos RetrospectivosRESUMO
BACKGROUND: Although tremendous efforts have been made to reduce rubella incidence, there are still 300 new cases of congenital rubella syndrome daily; thus, rubella infections remain one of the leading causes of preventable congenital birth defects. An effective surveillance system, which could be achieved and maintained by using an external quality assessment program, is critical for prevention and control of this disease. METHODS: Armored RNAs, which are noninfectious and RNase-resistant, were used for encapsulation of the E1 gene of rubella virus and for preparation of a 10-specimen panel for external quality assessment. Thirty-two laboratories across mainland China that used nucleic acid tests for rubella virus RNA detection were included in the external quality assessment program organized by the National Center for Clinical Laboratories of China. RESULTS: Different kinds of commercial kits were used by the laboratories for nucleic acid extraction and TaqMan real-time reverse-transcription PCR for rubella virus RNA detection; 99.2% sensitivity and 100% specificity were achieved in this external quality assessment program. CONCLUSIONS: Most of the participating laboratories obtained accurate results for rubella nucleic acid tests, thereby achieving the quality required for regional rubella and congenital rubella syndrome elimination.
Assuntos
Ensaio de Proficiência Laboratorial/normas , Indicadores de Qualidade em Assistência à Saúde/normas , RNA Viral/genética , Kit de Reagentes para Diagnóstico/normas , Reação em Cadeia da Polimerase em Tempo Real/normas , Reação em Cadeia da Polimerase Via Transcriptase Reversa/normas , Vírus da Rubéola/genética , Rubéola (Sarampo Alemão)/diagnóstico , China , Humanos , Variações Dependentes do Observador , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Rubéola (Sarampo Alemão)/virologiaRESUMO
Quantitative PCR (qPCR) is an important tool in pathogen detection. However, the use of different qPCR components, calibration materials and DNA extraction methods reduces comparability between laboratories, which can result in false diagnosis and discrepancies in patient care. The wider establishment of a metrological framework for nucleic acid tests could improve the degree of standardisation of pathogen detection and the quantification methods applied in the clinical context. To achieve this, accurate methods need to be developed and implemented as reference measurement procedures, and to facilitate characterisation of suitable certified reference materials. Digital PCR (dPCR) has already been used for pathogen quantification by analysing nucleic acids. Although dPCR has the potential to provide robust and accurate quantification of nucleic acids, further assessment of its actual performance characteristics is needed before it can be implemented in a metrological framework, and to allow adequate estimation of measurement uncertainties. Here, four laboratories demonstrated reproducibility (expanded measurement uncertainties below 15%) of dPCR for quantification of DNA from human cytomegalovirus, with no calibration to a common reference material. Using whole-virus material and extracted DNA, an intermediate precision (coefficients of variation below 25%) between three consecutive experiments was noted. Furthermore, discrepancies in estimated mean DNA copy number concentrations between laboratories were less than twofold, with DNA extraction as the main source of variability. These data demonstrate that dPCR offers a repeatable and reproducible method for quantification of viral DNA, and due to its satisfactory performance should be considered as candidate for reference methods for implementation in a metrological framework.
Assuntos
Infecções por Citomegalovirus/diagnóstico , Citomegalovirus/genética , DNA Viral/análise , Ensaio de Proficiência Laboratorial/normas , Reação em Cadeia da Polimerase em Tempo Real/métodos , Citomegalovirus/isolamento & purificação , Infecções por Citomegalovirus/genética , Infecções por Citomegalovirus/virologia , DNA Viral/genética , Humanos , Reprodutibilidade dos TestesRESUMO
CONTEXT: -Syphilis serology screening in laboratory practice is evolving. Traditionally, the syphilis screening algorithm begins with a nontreponemal immunoassay, which is manually performed by a laboratory technologist. In contrast, the reverse algorithm begins with a treponemal immunoassay, which can be automated. The Centers for Disease Control and Prevention has recognized both approaches, but little is known about the current state of laboratory practice, which could impact test utilization and interpretation. OBJECTIVE: -To assess the current state of laboratory practice for syphilis serologic screening. DESIGN: -In August 2015, a voluntary questionnaire was sent to the 2360 laboratories that subscribe to the College of American Pathologists syphilis serology proficiency survey. RESULTS: -Of the laboratories surveyed, 98% (2316 of 2360) returned the questionnaire, and about 83% (1911 of 2316) responded to at least some questions. Twenty-eight percent (378 of 1364) reported revision of their syphilis screening algorithm within the past 2 years, and 9% (170 of 1905) of laboratories anticipated changing their screening algorithm in the coming year. Sixty-three percent (1205 of 1911) reported using the traditional algorithm, 16% (304 of 1911) reported using the reverse algorithm, and 2.5% (47 of 1911) reported using both algorithms, whereas 9% (169 of 1911) reported not performing a reflex confirmation test. Of those performing the reverse algorithm, 74% (282 of 380) implemented a new testing platform when introducing the new algorithm. CONCLUSION: -The majority of laboratories still perform the traditional algorithm, but a significant minority have implemented the reverse-screening algorithm. Although the nontreponemal immunologic response typically wanes after cure and becomes undetectable, treponemal immunoassays typically remain positive for life, and it is important for laboratorians and clinicians to consider these assay differences when implementing, using, and interpreting serologic syphilis screening algorithms.
Assuntos
Algoritmos , Laboratórios/estatística & dados numéricos , Ensaio de Proficiência Laboratorial/estatística & dados numéricos , Inquéritos e Questionários , Sorodiagnóstico da Sífilis/estatística & dados numéricos , American Medical Association , Humanos , Laboratórios/normas , Ensaio de Proficiência Laboratorial/normas , Programas de Rastreamento/métodos , Programas de Rastreamento/normas , Programas de Rastreamento/estatística & dados numéricos , Patologistas , Patologia Clínica/organização & administração , Patologia Clínica/normas , Patologia Clínica/estatística & dados numéricos , Prevalência , Sensibilidade e Especificidade , Sífilis/diagnóstico , Sífilis/epidemiologia , Sorodiagnóstico da Sífilis/métodos , Sorodiagnóstico da Sífilis/normas , Estados Unidos/epidemiologiaRESUMO
Personalized medicine has gained increasing importance in clinical oncology, and several clinically important biomarkers are implemented in routine practice. In an effort to guarantee high quality of molecular testing in France, three subsequent external quality assessment rounds were organized at the initiative of the National Cancer Institute between 2012 and 2014. The schemes included clinically relevant biomarkers for metastatic colorectal (KRAS, NRAS, BRAF, PIK3CA, microsatellite instability) and non-small cell lung cancer (EGFR, KRAS, BRAF, PIK3CA, ERBB2), and they represent the first multigene/multicancer studies throughout Europe. In total, 56 laboratories coordinated by 28 regional molecular centers participated in the schemes. Laboratories received formalin-fixed, paraffin-embedded samples and were asked to use routine methods for molecular testing to predict patient response to targeted therapies. They were encouraged to return results within 14 calendar days after sample receipt. Both genotyping and reporting were evaluated separately. During the three external quality assessment rounds, mean genotype scores were all above the preset standard of 90% for all biomarkers. Participants were mainly challenged in case of rare insertions or deletions. Assessment of the written reports showed substantial progress between the external quality assessment schemes on multiple criteria. Several essential elements such as the clinical interpretation of test results and the reason for testing still require improvement by continued external quality assessment education.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/genética , Neoplasias Colorretais/genética , Ensaio de Proficiência Laboratorial/normas , Neoplasias Pulmonares/genética , Carcinoma Pulmonar de Células não Pequenas/patologia , Neoplasias Colorretais/patologia , França , Testes Genéticos/normas , Técnicas de Genotipagem/normas , Humanos , Neoplasias Pulmonares/patologia , Instabilidade de Microssatélites , Fatores de TempoRESUMO
In Japan, laboratory comparison, by means of proficiency testing or external quality assessment, has been conducted with separate programs on a nationwide basis, markedly contributing to quality improvement of clinical laboratory testing. However, from the standpoint of international standardization, there are issues to be addressed. Performance is evaluated once a year in each program, with time-consuming studies and different methods for data collection, analysis, and its assessment among programs, thus not leading to real-time monitoring and correction of the performance. Only the examination procedure of routine laboratory testing is focused on, while the entire process of the examination needs to be properly performed from the pre-examination down to the post-examination procedures. The development of proficiency testing for esoteric tests is needed, since both routine and esoteric ones have been provided by most medical laboratories, and a combination of them is used for decision-making in patient care. As molecular-genetic tests have been widely used, demand for the development of laboratory comparison programs has increased. In order to comprehensively evaluate the performance of laboratory, medical imaging and biophysical examination are also necessary. The overall performance of the medical laboratory must be assured along with the availability of proficiency testing or external quality assessment programs for each test to be performed, in order to contribute to optimal patient care.
Assuntos
Ensaio de Proficiência Laboratorial/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Testes Genéticos , Humanos , Controle de Qualidade , Reprodutibilidade dos TestesRESUMO
OBJECTIVES: Infliximab (IFX) and adalimumab (ADL) drug levels and anti-drug antibodies (ADA) are assessed using a variety of techniques, therefore, results cannot accurately be compared for clinical purposes. The aim of this study was to test two infliximab (IFX) and adalimumab (ADL) ELISA versions, for drug levels and ADA, to see whether they yield similar results. METHODS: ELISA versions [Promonitor® IFX R1 and R2 (V.1), Promonitor® IFX and Anti-IFX (V.2); Promonitor® ADL R1 and R2 (V.1), Promonitor® ADL and Anti-ADL (V.2) kits (Progenika Biopharma, Spain)] were used to measure drug levels and ADA in IFX (n=24) and ADL (n=24) rheumatoid arthritis-treated patients in three independent laboratories. Quantitative and qualitative agreements were evaluated using intraclass correlation coefficients (ICC), and Cohen's Kappa (κ) respectively. The Bland-Altman plots assessed differences between V.1 and V.2. RESULTS: Interlaboratory agreement (ICC/κ) with V.1 was poor for IFX (0.66/0.62) and ADL (0.69/0.52) drug levels; meanwhile, high agreement was found with V.2 for IFX (0.98/0.95) and ADL (0.094/1.00). Comparison between V.1 and V.2 in each laboratory resulted in systematically higher values in V.2 than in V.1 and poor agreement (ICC/κ ranges) for IFX (0.12-0.7/ 0.19-0.42) and ADL (0.69-0.89 /0.50-0.73). CONCLUSIONS: Qualitative measurements result in better agreement, as evidenced in our study. Greater agreement in V.2 compared with V.1 for IFX and ADL levels could be due to a better tune up. Further studies are required to standardise methods to establish therapeutic reference ranges.
Assuntos
Adalimumab/sangue , Antirreumáticos/sangue , Artrite Reumatoide/sangue , Monitoramento de Medicamentos/normas , Ensaio de Imunoadsorção Enzimática/normas , Infliximab/sangue , Ensaio de Proficiência Laboratorial/normas , Adalimumab/imunologia , Anticorpos/sangue , Antirreumáticos/imunologia , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/imunologia , Estudos Transversais , Humanos , Infliximab/imunologia , Variações Dependentes do Observador , Valor Preditivo dos Testes , Indicadores de Qualidade em Assistência à Saúde/normas , Reprodutibilidade dos Testes , Espanha , Resultado do TratamentoRESUMO
INTRODUCTION: We put forth our experiences of EQAS, analyzed the result discrepancies, reviewed the corrective actions and also put forth strategies for risk identification and prevention of potential errors in a medical laboratory. METHODS: For hematology, EQAS samples - blood, peripheral and reticulocyte smears - were received quarterly every year. All the blood samples were processed on HMX hematology analyzer by Beckman-Coulter. For clinical chemistry, lyophilized samples were received and were processed on Siemens Dimension Xpand and RXL analyzers. For microbiology, EQAS samples were received quarterly every year as lyophilized strains along with smears and serological samples. RESULTS: In hematology no outliers were noted for reticulocyte and peripheral smear examination. Only one outlier was noted for CBC. In clinical chemistry outliers (SDI ≥ 2) were noted in 7 samples (23 parameters) out of total 36 samples (756 parameters) processed. Thirteen of these parameters were analyzed as random errors, 3 as transcriptional errors and seven instances of systemic error were noted. In microbiology, one discrepancy was noted in isolate identification and in the grading of smears for AFB by Ziehl Neelsen stain. CONCLUSION: EQAS along with IQC is a very important tool for maintaining optimal quality of services.