O impacto da automação da fenotipagem eritrocitária estendida na rotina de um serviço de hemoterapia / The impact of automation of extended erythrocyte phenotyping in the routine of a blood transfusion center

Objetivos. Avaliar o impacto da automação na fenotipagem eritrocitária expandida e o nível de concordância dessa com a metodologia manual em amostras de doadores de sangue atendidos no hemocentro coordenador da Fundação HEMOPA no período de janeiro a dezembro de 2019. Material e Métodos. Foram analisadas 2.700 fenotipagens eritrocitárias realizadas por metodologia manual e automatizada através do equipamento IH500 da BioRad®. Os resultados foram testados quanto ao nível de concordância através do teste de Coeficiente Kappa. Resultados. Das amostras fenotipadas 98,6% (2.662/2.700) foram concordantes em ambas as metodologias e apenas 1,4% (38/2700) foram discordantes. Das 38 amostras discordantes 31,6% referiram-se ao fenótipo Lu(b); 15,8% ao fenótipo Lu(a); 13,1% ao fenótipo Fy(b); 7,9% aos fenótipos Le(b), E, c; 5,3% aos fenótipos N, S, s, Kp(a), P1; e 2,6% aos fenótipos M, Jk(a), Jk(b), Fy(a). Conclusões. O nível de concordância entre os dados obtidos através das técnicas de fenotipagem eritrocitária manual e automatizada foi de 98,6%. Já a implantação dessa metodologia teve um impacto positivo com o aumento em 1.649 amostras processadas a mais em relação ao mesmo período do ano anterior. [au]

Objective. Evaluate the impact of automation on expanded erythrocyte phenotyping and the level of agreement between it and the manual methodology in samples from blood donors treated at the blood center coordinating the Fundação HEMOPA from january to december 2019. Material and Methods. 2,700 erythrocyte phenotyping performed by manual and automated methodology using BioRad® IH500 equipment was analyzed. The results were tested for the level of agreement using the Kappa Coefficient test. Results. Of the phenotyped samples, 98,6% (2,662 / 2,700) were in agreement in both methodologies and only 1,4% (38/2700) were in disagreement. Of the 38 discordant samples, 31,6% referred to the Lu(b) phenotype; 15,8% to the Lu(a) phenotype; 13,1% to the Fy phenotype (b); 7,9% to Le(b), E, c phenotypes; 5,3% to N, S, s, Kp (a), P1 phenotypes; and 2,6% for phenotypes M, Jk(a), Jk(b), Fy(a). Conclusions. The level of agreement between data obtained through manual and automated erythrocyte phenotyping techniques was 98.6%. The implementation of this methodology had a positive impact, with an increase of 1,649 more processed samples compared to the same period of the previous year. [au]

Automated immature granulocyte count in patients of the intensive care unit with suspected infection / Contagem automatizada de granulócitos imaturos em pacientes de uma unidade de terapia intensiva com suspeita de infecção

ABSTRACT Introduction: Diagnosing infections in intensive care unit (ICU) patients is vital to provide appropriate therapies. Hematological analyzers perform automated immature granulocyte counts (IG) quickly and with no additional cost when compared to traditional microbiological cultures. Elevated IG is directly associated with infections and inflammation. Objectives: Evaluate IG as infection marker in adult inpatients at the ICU-Complexo Hospital de Clínicas da Universidade Federal do Paraná (CHC-UFPR), compared to cultures of biological materials (gold standard). Material And Methods: Samples of 200 adult inpatients at CHC-UFPR ICU with suspected infection were used. Absolute (IG#) and relative (IG%) counts were performed on the Sysmex XN-3000. Cultures and blood cultures were performed either manually or on Bactec FX. Diagnostic accuracy and agreement for IG# and IG% were evaluated. Results: The reference intervals (RI) obtained for IG# and IG% were 0.06 × 103/µl and 0.6%, respectively, with sensitivity for both of 74.4% and specificity of 25.3% for IG#, and 26.6% for IG%. The receiver operating characteristic (ROC) curve showed cut-off value of 0.33 × 103/µl for IG#, sensitivity of 28%, specificity of 82.3%, and area under the curve (AUC) of 0.521. For IG%, cut-off value was 1.35%, sensitivity 44.6%, specificity 64.6%, and AUC 0.532. CV < 3% increased specificity to 88%. Conclusion: RI of IG% and IG# showed high sensitivity and are useful in screening for infection in ICU patients. The CVs demonstrated by the ROC curves showed high specificity and are helpful on the exclusion of sepsis diagnosis in ICU patients. IG was shown to be useful for screening and confirmation of infection in ICU patients.

RESUMEN Introducción: Diagnosticar infecciones en pacientes de la unidad de cuidados intensivos (UCI) es de suma importancia para proporcionar el tratamiento adecuado. El contaje automatizado de granulocitos inmaduros (GI) en analizadores hematológicos es rápido y sin costes adicionales. La elevada tasa de GI está asociada a infecciones. Objetivos: Evaluar GI como indicador de infección en pacientes adultos de la UCI del Complexo Hospital de Clínicas da Universidade Federal do Paraná (CHC-UFPR) en comparación a culturas de materiales biológicos (estándar de oro). Material Y Métodos: Se analizaron muestras de 200 pacientes adultos con sospecha de infección de la UCI del CHC-UFPR. Los conteos automatizados de granulocitos inmaduros absolutos (GI#) e relativos (GI%) se realizaron en el Sysmex-XN-3000, y los cultivos y hemocultivos, manualmente o en el Baetec-FX. Se han evaluado precisión diagnóstica y concordancia para GI# y GI%. Resultados: Los rangos de referencia obtenidos para GI# y GI% fueron 0,06 × 103/µl y 0,6%, respectivamente, con sensibilidad para ambos de 74,4% y especificidad de 25,3% para IG# y 26,6% para IG%. La curva receiver operating characteristic (ROC) ha mostrado valor de corte de 0,33 × 103/µl para IG#, sensibilidad de 28%, especificidad de 82,3% y área bajo la curva (AUC) de 0,521. Para GI%, el valor de corte ha sido 135%, sensibilidad de 44,6%, especificidad de 64,6% y AUC de 0,532. Valores de corte de GI% < 3% aumentaron la especificidad para 88%. Conclusión: Rangos de referencia de GI% y GI# presentaron sensibilidad elevada y son útiles en el triaje de infecciones en pacientes de UCI. Los valores de corte enseñados por las curvas ROC presentaron alta especificidad, permitiendo la identificación adecuada de los pacientes sanos. GI se ha mostrado útil para triaje y confirmación de infección en pacientes de UCI.

RESUMO Introdução: Diagnosticar infecções em pacientes da unidade de terapia intensiva (UTI) é vital para implementar terapias apropriadas. A contagem automatizada de granulócitos imaturos (IG) em analisadores hematológicos é rápida e sem custos adicionais. A taxa de IG elevada está associada a infecções. Objetivos: Avaliar IG como indicador de infecção em pacientes adultos da UTI do Complexo Hospital de Clínicas da Universidade Federal do Paraná (CHC-UFPR) em comparação com culturas de materiais biológicos (padrão-ouro). Material E Métodos: Foram analisadas amostras de 200 pacientes adultos com suspeita de infecção da UTI do CHC-UFPR. As contagens automatizadas de granulócitos imaturos absolutas (IG#) e relativas (IG%) foram realizadas no Sysmex-XN-3000, e as culturas e as hemoculturas, manualmente ou no Bactec-FX. As características de desempenho de teste diagnóstico para IG# e IG% foram avaliadas. Resultados: Os intervalos de referência (IR) obtidos para IG# e IG% foram 0,06 × 103/µl e 0,6%, respectivamente, com sensibilidade para ambos de 74,4% e especificidade de 25,3% para IG# e 26,6% para IG%. A curva receiver operating characteristic (ROC) mostrou valor de corte de 0,33 × 103/µl para IG#, sensibilidade de 28%, especificidade de 82,3% e área sob a curva (AUC) de 0,521. Para IG%, o valor de corte foi de 1,35%, sensibilidade de 44,6%, especificidade de 64,6% e AUC de 0,532. Valores de corte de IG% < 3% aumentaram a especificidade para 88%. Conclusão: IRs de IG% e IG# apresentaram sensibilidade elevada e são úteis na triagem de infecção nos pacientes da UTI. Os VCs demonstrados pelas curvas ROC para IG% e IG# apresentaram elevada especificidade, sendo, portanto, úteis para exclusão de diagnóstico de sepse nos pacientes da UTI. IG mostrou-se útil para triagem e confirmação de infecção em pacientes de UTI.

Current state and future prospect of autoimmunity laboratory diagnosis / 中华检验医学杂志

Laboratory testing is of great value in the management of autoimmune disease. The results can help confirm a diagnosis, estimate disease severity, aid in assessing treatment effect. But the current autoimmunity laboratory system, including testing standards, quality control and supervision, does not match the national conditions well. As a result, the test reports are not mutual-recognized among laboratories. In the current background of precision medicine, with the advances of technology and the application of deep learning and artificial intelligence in the clinical laboratory field, the autoimmune laboratory has ushered in a new development trend of integration, automation and intelligence.

Harmonization study of results between biochemical analyzers Labmax 240® and Labmax 240 Premium® / Estudo de harmonização de resultados entre analisadores bioquímicos Labmax 240® e Labmax 240 Premium®

ABSTRACT Introduction: The harmonization of equipment is recommended in clinical laboratory practice aiming for the homogeneity of results when similar or equivalent analyzers are used to perform routine testing. Objectives: To conduct a study of equivalence between the biochemical analyzers Labmax 240® (E1) and Labmax 240 Premium® (E2) through the matching results and the statistical value analysis of dosages. Materials and methods: We evaluated tests with glucose, total cholesterol, triglycerides, uric acid, aspartate transaminase (AST), alanine transaminase (ALT) and lactate dehydrogenase (LDH), all with 40 repeated measurements, performed in both equipments. The Clinical and Laboratory Standards Institute (CLSI) EP09-3A protocol was used to conduct the comparison test between E1 and E2 equipment, with subsequent evaluation of the results for statistical analysis determining the Pearson correlation coefficient (r) and indexes comparison error with EP Evaluator® software. Results: Regarding the values of the Pearson correlation coefficient, all tests showed a strong correlation between equipment with r > 0.989, except for the dosage of LDH (r = 0.982). This dosage failed not because the value of r, but due to the values obtained in the error index being larger than the total errors index allowed. Discussion: Compared to clinical criteria, the results of the analyzers are approximately equal, but this control process must be done continuously in order to prevent and track random errors within the laboratory routine. Conclusion: The process of harmonization of multiple devices that perform the same laboratory parameters is essential for ensuring quality and reliability of laboratory results and should be standardized and included in routine clinical analysis laboratories.

RESUMO Introdução: No laboratório clínico, é recomendável a harmonização de equipamentos que visem à homogeneidade dos resultados, quando analisadores similares ou equivalentes são utilizados para desempenho da rotina de realização dos testes. Objetivos: Realizar um estudo de equivalência entre os analisadores bioquímicos Labmax 240® (E1) e Labmax 240 Premium® (E2). Materiais e métodos: Foram avaliados os testes glicose (GLI), colesterol total (COL), triglicerídeos (TRI), ácido úrico , aspartato aminotransferase (AST), alanina aminotransferase (ALT) e lactato desidrogenase (LDH), todos com 40 dosagens repetidas, realizadas em ambos os equipamentos. O protocolo do Clinical and Laboratory Standards Institute (CLSI) EP09-3A foi utilizado para conduzir o teste de comparação, com posterior avaliação dos resultados pela análise estatística no software EP Evaluator®, com determinação do coeficiente de correlação de Pearson (r) e comparação de índices de erro. Resultados: Em relação aos valores do coeficiente de correlação de Pearson, todos os testes apresentaram forte correlação entre os equipamentos, com r > 0,989, exceto para a dosagem de LDH (r = 0,982), que foi reprovada, não em função do valor de r, mas devido aos valores obtidos em relação ao índice de erro, o qual é maior do que os índices de erro total permitido. Discussão: Diante dos critérios clínicos, os resultados dos analisadores são aproximadamente iguais, porém esse controle do processo deve ser feito continuamente a fim de impedir e rastrear erros aleatórios dentro da rotina laboratorial. Conclusão: O processo de harmonização de múltiplos equipamentos que realizam os mesmos parâmetros laboratoriais é fundamental para a garantia da qualidade e da confiabilidade dos resultados laboratoriais, devendo ser padronizado e incluído na rotina dos laboratórios de análises clínicas.

Establishment and application of autoverification procedure for clinical chemistry test results / 中华检验医学杂志

Objective@#To develop autoverification rules to assistant the verification of biochemical results, based on laboratory information management system. @*Methods@#Designed six kinds of autoverification logic rules according to the guidelines of Clinical and Laboratory Standards Institute (CLSI) AUTO-10A and Accreditation Criteria for the Quality and Competence of Medical Laboratories(ISO15189: 2012), based on in-control of the Internal Quality Control. Those rules inculds: logic disorder rules, critical value rules, warning value rules, delta check rules, relevant contradictions rules, abnormal mode rules, etc. Those rules was setted up in laboratory information management system of Dian Diagnostics. From October 2016 to April 2017, The status of autoverification was checked according to the items and bar code, and compared with clinical diagnostic and manual review. @*Results@#The passing rate of autoverification is over 65% when counted according to tests and is 45% when counted according to sample code, the coincidence rate is 92% with clinical diagnosis.In passing results of autoverification, the coincidence rate is 97.48% to 100% when campared with manual verification, and in not-passing results, the coincidence rate is 82.98% to 85.21%. @*Conclusion@#(1)Autoverification can verify half of routine biochemical test results by setting intelligent logics and rules. (2)Autoverification rules must be verified by a certain amount of test results before they can be formally applied. (3)Autoverification could improve the speed and efficiency of post-test steps.(Chin J Lab Med, 2018, 41: 547-553)

Performance evaluation and study on open assembly line system in medical laboratory / 中华检验医学杂志

Objective To investigate the advantages and continuous optimization of laboratory automation system through analysis and assessment of the core data and performance after the application of open assembly line.Methods Collect the data of biochemical and immunoassay in Shuguang Hospital attached to Shanghai University of Traditional Chinese Medicine from April to October 2017.( 1 ) Cost analysis of the assembly line schemes;(2) Analysis of workflow before and after the application of assembly line;(3) Analysis of the volume of samples collecting before and after the application of assembly line ;(4) Analysis of TAT data before and after the application of assembly line; ( 5 ) Analysis of staffs allocation before and after the application of assembly line; (6) Analysis of samples rechecking before and after the application of assembly line .Results (1) Open assembly line costs least on hardware (8 million) and site among various projects;(2) Inspection process is greatly simplified after the application of assembly line;(3) The samples′volume of biochemical and immunoassay inspection were reduced by 31.85％;(4) The items′test cycle decreases after the application of assembly line , the average TAT is reduced by 32 minutes;(5) Staffs for samples pretreatment can be reduced by 50％after the application of assembly line , and the quantity of operators does not change;(6) The number of re-check samples increase except the gray zone and critical values , which ensures the reliability of the results .Conclusion To analyze the core data and to evaluate the performance , the laboratory improve on detection cycle ,staffs,and test efficiency.

Application status and prospect of clinical molecular diagnostics automation / 中华检验医学杂志

Molecular diagnosis plays more and more important role in disease diagnosis, prognosis evaluation and curative effect monitoring.With the support of relevant national policies and the gradual release of accurate medical needs from society, molecular diagnosis relies on its advantages of accuracy, convenience,sensitivity, non-invasiveness and automation to develop rapidly in the direction of precision inspection.The application of molecular diagnostic automation is undoubtedly the catalyst for the development of molecular diagnostics, but its application status is far from satisfactory.It is necessary to analyze the causes,study countermeasures and look forward to the future.

Comparison of MPure-12 Automatic Nucleic Acid Purification and Chelex-100 Method / 法医学杂志

<p><b>OBJECTIVES</b>To explore the forensic application value of MPure-12 automatic nucleic acid purification （MPure-12 Method） for DNA extraction by extracting and typing DNA from bloodstains and various kinds of biological samples with different DNA contents.</p><p><b>METHODS</b>Nine types of biological samples, such as bloodstains, semen stains, and saliva were collected. DNA were extracted using MPure-12 method and Chelex-100 method, followed by PCR amplification and electrophoresis for obtaining STR-profiles.</p><p><b>RESULTS</b>The samples such as hair root, chutty, butt, muscular tissue, saliva stain, bloodstain and semen stain were typed successfully by MPure-12 method. Partial alleles were lacked in the samples of saliva, and the genotyping of contact swabs was unsatisfactory. Additional, all of the bloodstains （20 μL, 15 μL, 10 μL, 5 μL, 1 μL） showed good typing results using Chelex-100 method. But the loss of alleles occurred in 1 μL blood volume by MPure-12 method.</p><p><b>CONCLUSIONS</b>MPure-12 method is suitable for DNA extraction of a certain concentration blood samples．Chelex-100 method may be better for the extraction of trace blood samples．This instrument used in nucleic acid extraction has the advantages of simplicity of operator, rapidity, high extraction efficiency, high rate of reportable STR-profiles and lower man-made pollution.</p>

Evaluation of an automated morphological analysis system in white blood cell identificaton / 中华检验医学杂志

Objective To evaluate the clinical performance of an automated image analysis systems named CellaVision DM96 in classifying White Blood Cells.Methods A total of 2267 peripheral blood samples (male 1 235, female 1 034, average age 46) were obtained from outpatient and inpatient in Peking Union Medical College Hospital ( PUMCH ) . These samples were selected to evaluate the precision, sensitivity, specificity and the analytical error of the system.We first evaluated the coincidence rate of reclassification and manual microscopy.On the base of favourable coincidence rate, we then evaluated the correlations between the pre-classification and reclassification of segmented neutrophil, band neutrophil, lymphocyte, monocyte, eosinophile, basophile, blast cell, promyelocyte, myelocyte, metamyelocyte, plasma cell and reactive lymphocyte.Results The sensitivity and specificity of pre-classification of White Blood Cell were 46% -100% and 24%-92%, respectively.When studied on the cell level, the total coincidence rate of pre-classification was 88%.And the coincidence rates of pre-classification and reclassification of White Blood Cell were 6%-95% and 25%-100%, respectively.When assessed on the sample level, the coincidence rates of pre-classification and reclassification of leukocytes were 64%-98%and 84%-100%, respectively.The correlations of pre-classification and reclassification of leukocytes in order from high to low were: lymphocyte, segmented neutrophil, eosinophile, band neutrophil, monocyte, basophile, when r were 0.943 9, 0.915 2, 0.785 4, 0.775 6, 0.676 2 and 0.289 1, respectively.The correlations between reclassification and manual microscopy of White Blood Cell were higher than those between pre-classification and manual microscopy.Order from high to low was: eosinophile, segmented neutrophil, lymphocyte, monocyte, band neutrophil, basophile.And r were 0.972 1, 0.968 5, 0.957 0, 0.831 9, 0.800 6 and 0.648 7, respectively.The ability of this automated image analysis systems at pre-classification in distinguishing between band cell and segment cell, atypical lymphocyte and normal lymphocyte was not good. Conclusion The performance of reclassification was better than pre-classification.The reclassification can be substitute for the microscopy inspection, and be used in the Clinical practice.

Validation of the Sysmex sp-1000i automated slide preparer-stainer in a clinical laboratory

Background: The speed and quality of information have become essential items in the release of laboratory reports. The Sysmex®SP1000-I device has been developed to prepare and stain smear slides. However, for a device to be cleared for use in the laboratory routine it must pass through a validation process. Objective: To evaluate the performance and reliability of the Sysmex® SP-1000i slide preparer-stainer incorporated into the routine of a hospital laboratory in Porto Alegre. Methods: Peripheral blood samples of patients attending the laboratory for ambulatory exams with leukocyte counts between 7000/°L and 12,000/°L were evaluated, independent of gender and age. Two slides were prepared for each sample using the Sysmex® SP-1000i equipment; one of the slides was used to perform quality control tests using the CellaVision® DM96 device, and the other slide was used to compare pre-classification by the same device and the classification performed by a pharmacist-biochemist. Results: The results of all the slides used as controls were acceptable according to the quality control test as established by the manufacturer of the device. In the comparison between the automated pre-classification and the classification made by the professional, there was an acceptable variation in the differential counts of leukocytes for 90% of the analyzed slides. Pearson correlation coefficient showed a strong correlation for band neutrophils (r = 0.802; p-value < 0.001), segmented neutrophils (r = 0.963; p-value < 0.001), eosinophils (r = 0.958; p-value < 0.001), lymphocytes (r = 0.985; p-value < 0.001) and atypical lymphocytes (r = 0.866; p-value < 0.001) using both methods. The red blood cell analysis was adequate for all slides analyzed by the equipment and by the professional. Conclusion: The new Sysmex®SP1000-i methodology was found to be reliable, fast and safe for the routines of medium ...

Indicadores de desempenho e decisão sobre terceirização em rede pública de laboratórios / Performance indicators and decision making for outsourcing public health laboratory services

OBJETIVO: Elaborar indicadores de desempenho e terceirização em rede de laboratórios clínicos, baseados em sistemas de informações e registros administrativos públicos. MÉTODOS: A rede tinha 33 laboratórios com equipamentos automatizados, mas sem informatização, 90 postos de coleta e 983 funcionários, no município de Rio de Janeiro, RJ. As informações foram obtidas de registros administrativos do Sistema de Informações de Orçamentos Públicos para a Saúde e do Sistema de Informações Ambulatoriais e Hospitalares do Sistema Único de Saúde. Os indicadores (produção, produtividade, utilização e custos) foram elaborados com dados colhidos como rotina de 2006 a 2008. As variações da produção, custos e preços unitários dos testes no período foram analisadas por índices de Laspeyres e de Paasche, específicos para medir a atividade dos laboratórios, e pelo Índice de Preços ao Consumidor Amplo do Instituto Brasileiro de Geografia e Estatística. RESULTADOS: A produção foi de 10.359.111 testes em 2008 (aumento de 10,6% em relação a 2006) e a relação testes/funcionário cresceu 8,6%. As despesas com insumos, salários e prestador conveniado aumentaram, respectivamente 2,3%, 45,4% e 18,3%. Os testes laboratoriais por consulta e internação cresceram 10% e 20%. Os custos diretos totalizaram R$ 63,2 milhões em 2008, com aumento de 22,2% em valores correntes no período. Os custos diretos deflacionados pelo Índice de Preços ao Consumidor Amplo (9,5% para o período) mostram aumento do volume da produção de 11,6%. O índice de volume específico para a atividade, que considera as variações do mix de testes, mostrou aumento de 18,5% no preço unitário do teste e de 3,1% no volume da produção. CONCLUSÕES: Os indicadores, em especial os índices específicos de volume e preços da atividade, constituem uma linha de base de desempenho potencial para acompanhar laboratórios próprios e terceirizados. Os indicadores de desempenho econômicos elaborados mostram a necessidade de informatização da rede, antecedendo a decisão de terceirização.

OBJECTIVE: To develop performance indicators for outsourcing clinical laboratory services, based on information systems and public administrative records. METHODS: In the municipality of Rio de Janeiro, Southern Brazil, the public health laboratory network comprised 33 laboratories with automated equipment (but no integrated information system), 90 primary care units (where sample collection was performed) and 983 employees. Information records were obtained from the administrative records of the Budget Information System for Public Health and the Outpatient and Hospital Information System of the Unified Health System. Performance indicators (production, productivity, usage and costs) were generated from data collected routinely from 2006 to 2008. The variations in production, costs and unit prices for tests were analyzed by Laspeyres and Paasche indices, which specifically measure laboratory activity, and by the Consumer Price Index from the Brazilian Institute of Geography and Statistics. RESULTS: A total of 10,359,111 tests were performed in 2008 (10.6% increase over 2006), and the test/employee ratio grew by 8.6%. The costs of supplies, wages and providers increased by 2.3%, 45.4% and 18.3%, respectively. The laboratory tests per visit and hospitalizations increased by 10% and 20%, respectively. The direct costs totaled R$ 63.2 million in 2008, representing an increase of 22.2% in current values during the period analyzed. The direct costs deflated by the Brazilian National Consumer Price Index (9.5% for the period) showed an 11.6% increase in production volumes. The activity-specific volume index, which considers changes in the mix of tests, showed increases of 18.5% in the test price and 3.1% in the production volume. CONCLUSIONS: The performance indicators, particularly the specific indices for volume and price of activity, constitute a baseline of performance potential for monitoring private laboratories and contractors. The economic performance indicators demonstrated the need for network information system integration prior to an outsourcing decision.