Base de dados : MEDLINE
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[PMID]:29048701
[Au] Autor:Food and Drug Administration, HHS
[Ti] Título:Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.
[So] Source:Fed Regist;82(200):48413-5, 2017 Oct 18.
[Is] ISSN:0097-6326
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
[Mh] Termos MeSH primário: Química Clínica/classificação
Química Clínica/instrumentação
Segurança de Equipamentos/classificação
Organofosfatos/urina
Toxicologia/classificação
Toxicologia/instrumentação
[Mh] Termos MeSH secundário: Colinesterases/envenenamento
Aprovação de Equipamentos/legislação & jurisprudência
Seres Humanos
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Organophosphates); EC 3.1.1.8 (Cholinesterases)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171031
[Lr] Data última revisão:
171031
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:171020
[St] Status:MEDLINE


  2 / 5729 MEDLINE  
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[PMID]:29016811
[Au] Autor:Amukele TK; Hernandez J; Snozek CLH; Wyatt RG; Douglas M; Amini R; Street J
[Ad] Endereço:Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.
[Ti] Título:Drone Transport of Chemistry and Hematology Samples Over Long Distances.
[So] Source:Am J Clin Pathol;148(5):427-435, 2017 Nov 02.
[Is] ISSN:1943-7722
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Objectives: We addressed the stability of biological samples in prolonged drone flights by obtaining paired chemistry and hematology samples from 21 adult volunteers in a single phlebotomy event-84 samples total. Methods: Half of the samples were held stationary, while the other samples were flown for 3 hours (258 km) in a custom active cooling box mounted on the drone. After the flight, 19 chemistry and hematology tests were performed. Results: Seventeen analytes had small or no bias, but glucose and potassium in flown samples showed an 8% and 6.2% bias, respectively. The flown samples (mean, 24.8°C) were a mean of 2.5°C cooler than the stationary samples (mean, 27.3°C) during transportation to the flight field as well as during the flight. Conclusions: The changes in glucose and potassium are consistent with the magnitude and duration of the temperature difference between the flown and stationary samples. Long drone flights of biological samples are feasible but require stringent environmental controls to ensure consistent results.
[Mh] Termos MeSH primário: Química Clínica/métodos
Hematologia/métodos
Manejo de Espécimes
[Mh] Termos MeSH secundário: Adulto
Feminino
Seres Humanos
Masculino
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171113
[Lr] Data última revisão:
171113
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171011
[St] Status:MEDLINE
[do] DOI:10.1093/ajcp/aqx090


  3 / 5729 MEDLINE  
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[PMID]:28967949
[Au] Autor:Ko DH; Park HI; Hyun J; Kim HS; Park MJ; Shin DH
[Ad] Endereço:Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
[Ti] Título:Utility of Reference Change Values for Delta Check Limits.
[So] Source:Am J Clin Pathol;148(4):323-329, 2017 Oct 01.
[Is] ISSN:1943-7722
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Objectives: To assess the utility of reference change values (RCVs) as delta check limits. Methods: A total of 1,650,518 paired results for 23 general chemistry test results from June 1, 2014, to October 31, 2016, were analyzed. The RCVs for each analyte were calculated from the analytical imprecision and within-subject biological variation. The percent differences between two consecutive results in one patient were categorized into one of four groups: outpatients, inpatients, emergency care, and general health care. For each, 2.5th and 97.5th percentile values were computed and compared with their RCVs. The distributions were assessed for normality using the Kolmogorov-Smirnov test. Results: Most of the estimated limits were larger than the corresponding RCVs and, furthermore, with notable differences across the groups. Patients in the emergency care group usually demonstrated larger delta percent values than those in the other groups. None of the distributions of the percent differences passed tests of normality when subjected to Kolmogorov-Smirnov analysis. Conclusions: Comparison of estimated RCVs and real-world patient data revealed the pitfalls of applying RCVs in clinical laboratories. Laboratory managers should be aware of the limitations of RCVs and exercise caution when using them.
[Mh] Termos MeSH primário: Análise Química do Sangue/normas
Química Clínica/normas
[Mh] Termos MeSH secundário: Seres Humanos
Valores de Referência
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171020
[Lr] Data última revisão:
171020
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171003
[St] Status:MEDLINE
[do] DOI:10.1093/ajcp/aqx083


  4 / 5729 MEDLINE  
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[PMID]:28886191
[Au] Autor:Mekonnen Z; Amuamuta A; Mulu W; Yimer M; Zenebe Y; Adem Y; Abera B; Gebeyehu W; Gebregziabher Y
[Ad] Endereço:Department of Biomedical Research, Biotechnology Research Institute, Bahir Dar University, Bahir Dar, Ethiopia.
[Ti] Título:Clinical chemistry reference intervals of healthy adult populations in Gojjam Zones of Amhara National Regional State, Northwest Ethiopia.
[So] Source:PLoS One;12(9):e0184665, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Reference interval is crucial for disease screening, diagnosis, monitoring, progression and treatment efficacy. Due to lack of locally derived reference values for the parameters, clinicians use reference intervals derived from western population. But, studies conducted in different African countries have indicated differences between locally and western derived reference values. Different studies also indicated considerable variation in clinical chemistry reference intervals by several variables such as age, sex, geographical location, environment, lifestyle and genetic variation. OBJECTIVE: This study aimed to determine the reference intervals of common clinical chemistry parameters of the community of Gojjam Zones, Northwest Ethiopia. METHOD: Population based cross-sectional study was conducted from November 2015 to December 2016 in healthy adult populations of Gojjam zone. Data such as, medical history, physical examination and socio-demographic data were collected. In addition, laboratory investigations were undertaken to screen the population. Clinical chemistry parameters were measured using Mindray BS 200 clinical chemistry autoanalyzer as per the manufacturer's instructions. Descriptive statistics was used to calculate mean, median and 95th percentiles. Independent sample T-test and one way ANOVA were used to see association between variables. RESULTS: After careful screening of a total of 799 apparently healthy adults who were consented for this study, complete data from 446 (224 females and 222 males) were included for the analysis. The mean age of both the study participants was 28.8 years. Males had high (P<0.05) mean and 2.5th-97.5th percentile ranges of ALT, AST, ALP, creatinine and direct bilirubin. The reference intervals of amylase, LDH, total protein and total bilirubin were not significantly different between the two sex groups (P>0.05). Mean, median, 95% percentile values of AST, ALP, amylase, LDH, creatinine, total protein, total bilirubin, and direct bilirubin across all age groups of participants were similar (P>0.05). But, there was a significant difference in the value of ALT (P<0.05). The reference intervals of ALT, total protein and creatinine were significantly (P<0.05) high in people having monthly income >1500 ETB compared to those with low monthly income. Significant (P<0.05) higher values of the ALT, ALP and total protein were observed in people living in high land compared to low land residences. CONCLUSION: The study showed that some of the common clinical chemistry parameters reference intervals of healthy adults in Gojjam zones were higher than the reference intervals generated from developed countries. Therefore, strict adherence to the reference values generated in developed countries could lead to inappropriate diagnosis and treatment of patients. There was also variation of reference interval values based on climate, gender, age, monthly income and geographical locations. Therefore, further study is required to establish reference intervals for Ethiopian population.
[Mh] Termos MeSH primário: Química Clínica/normas
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Estudos Transversais
Etiópia
Feminino
Seres Humanos
Masculino
Meia-Idade
Valores de Referência
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171016
[Lr] Data última revisão:
171016
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170909
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0184665


  5 / 5729 MEDLINE  
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[PMID]:28652005
[Au] Autor:Jenco J; Krcmová LK; Solichová D; Solich P
[Ad] Endereço:Department of Analytical Chemistry, Charles University, Faculty of Pharmacy in Hradec Králové, Akademika Heyrovského 1203, Hradec Králové 500 05, Czech Republic; 3rd Internal Gerontometabolic Clinic, University Hospital, Sokolská 581, Hradec Králové 500 05, Czech Republic.
[Ti] Título:Recent trends in determination of thiamine and its derivatives in clinical practice.
[So] Source:J Chromatogr A;1510:1-12, 2017 Aug 11.
[Is] ISSN:1873-3778
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:Over the last five decades, many methods to analyze thiamine (vitamin B ) and its phosphorylated forms in urine, whole blood, serum, plasma and erythrocytes have been proposed. Some of the methods are presently used in routine practice, but analytical problems regarding reproducibility, standardization, lack of automation, time consuming procedures for pretreatment and analysis are often discussed. With modern approaches to bioanalysis in clinical research of vitamins, whole processes can be automated, making analysis less time consuming, with reduced consumption of solvents and samples. This review critically discusses various analytical techniques, their advantages and disadvantages that are used for determination of thiamine and its derivatives in clinical practice, with emphasis on accurate, reliable and fast analytical procedures.
[Mh] Termos MeSH primário: Química Clínica/tendências
Tiamina/análise
[Mh] Termos MeSH secundário: Química Clínica/normas
Eritrócitos/química
Seres Humanos
Padrões de Referência
Reprodutibilidade dos Testes
Tiamina/sangue
Tiamina/urina
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
X66NSO3N35 (Thiamine)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171017
[Lr] Data última revisão:
171017
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170628
[St] Status:MEDLINE


  6 / 5729 MEDLINE  
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[PMID]:28615228
[Au] Autor:Bietenbeck A; Thaler MA; Luppa PB; Klawonn F
[Ad] Endereço:Institut für Klinische Chemie und Pathobiochemie, Klinikum rechts der Isar der Technischen Universität München, München, Germany; andreas.bietenbeck@tum.de.
[Ti] Título:Stronger Together: Aggregated Z-values of Traditional Quality Control Measurements and Patient Medians Improve Detection of Biases.
[So] Source:Clin Chem;63(8):1377-1387, 2017 Aug.
[Is] ISSN:1530-8561
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: In clinical chemistry, quality control (QC) often relies on measurements of control samples, but limitations, such as a lack of commutability, compromise the ability of such measurements to detect out-of-control situations. Medians of patient results have also been used for QC purposes, but it may be difficult to distinguish changes observed in the patient population from analytical errors. This study aims to combine traditional control measurements and patient medians for facilitating detection of biases. METHODS: The software package "rSimLab" was developed to simulate measurements of 5 analytes. Internal QC measurements and patient medians were assessed for detecting impermissible biases. Various control rules combined these parameters. A -like algorithm was evaluated and new rules that aggregate Z-values of QC parameters were proposed. RESULTS: Mathematical approximations estimated the required sample size for calculating meaningful patient medians. The appropriate number was highly dependent on the ratio of the spread of sample values to their center. Instead of applying a threshold to each QC parameter separately like the Westgard algorithm, the proposed aggregation of Z-values averaged these parameters. This behavior was found beneficial, as a bias could affect QC parameters unequally, resulting in differences between their Z-transformed values. In our simulations, control rules tended to outperform the simple QC parameters they combined. The inclusion of patient medians substantially improved bias detection for some analytes. CONCLUSIONS: Patient result medians can supplement traditional QC, and aggregations of Z-values are novel and beneficial tools for QC strategies to detect biases.
[Mh] Termos MeSH primário: Algoritmos
Controle de Qualidade
[Mh] Termos MeSH secundário: Viés
Química Clínica
Seres Humanos
Laboratórios
Software
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170616
[St] Status:MEDLINE
[do] DOI:10.1373/clinchem.2016.269845


  7 / 5729 MEDLINE  
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[PMID]:28594875
[Au] Autor:Danese E; Salvagno GL; Negrini D; Brocco G; Montagnana M; Lippi G
[Ad] Endereço:Section of Clinical Biochemistry, University of Verona, Verona, Italy.
[Ti] Título:Analytical evaluation of three enzymatic assays for measuring total bile acids in plasma using a fully-automated clinical chemistry platform.
[So] Source:PLoS One;12(6):e0179200, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Although the clinical significance of measuring bile acids concentration in plasma or serum has been recognized for long in patients with hepatobiliary disease and/or bile acid malabsorption, the reference separation techniques are expensive and mostly unsuitable for early diagnosis and for measuring large volumes of samples. Therefore, this study was aimed to evaluate the analytical performance of three commercial enzymatic techniques for measuring total bile acids in plasma using a fully-automated clinical chemistry platform. METHODS: Three commercial enzymatic assays (from Diazyme, Randox and Sentinel) were adapted for use on a Cobas Roche c501. We performed imprecision and linearity studies, and we compared results with those obtained using a reference liquid chromatography-mass spectrometry (LC-MS) technique on an identical set of lithium-heparin plasma samples. RESULTS: Total imprecision was optimal, always equal or lower than 3%. All assays had optimal linearity between 3-138 µmol/L. The comparison studies showed good correlation with LC-MS data (Spearman's correlation coefficients always >0.92), but all plasma samples values were significantly underestimated using the commercial enzymatic assays (-44% for Diazyme, -16% for Randox and -12% for Sentinel). The agreement at the 10 and 40 µmol/L diagnostic thresholds of total bile acids in plasma ranged between 86-92%. This discrepancy was found to be mainly attributable to a heterogeneous composition in terms of bile acids content of the three assay calibrators. CONCLUSIONS: This study suggests that the analytical performance of the three commercial enzymatic assays is excellent, thus confirming that automation of this important test by means of enzymatic assessment may be feasible, practical, reliable and supposedly cheap. Nevertheless, the underestimation of values compared to the reference LC-MS also suggests that the local definition and validation of reference ranges according to the combination between the specific enzymatic assay and the different clinical chemistry platforms may be advisable.
[Mh] Termos MeSH primário: Ácidos e Sais Biliares/sangue
Química Clínica/métodos
Ensaios Enzimáticos/métodos
[Mh] Termos MeSH secundário: Automação
Calibragem
Cromatografia Líquida
Seres Humanos
Espectrometria de Massas
Kit de Reagentes para Diagnóstico
Estatísticas não Paramétricas
[Pt] Tipo de publicação:EVALUATION STUDIES; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Bile Acids and Salts); 0 (Reagent Kits, Diagnostic)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170918
[Lr] Data última revisão:
170918
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170609
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0179200


  8 / 5729 MEDLINE  
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[PMID]:28593880
[Au] Autor:Diamandis EP
[Ti] Título:How I first met Dr. Morton K. Schwartz.
[So] Source:Clin Chem Lab Med;55(7):910-913, 2017 Jun 27.
[Is] ISSN:1437-4331
[Cp] País de publicação:Germany
[La] Idioma:eng
[Mh] Termos MeSH primário: Química Clínica/história
[Mh] Termos MeSH secundário: Biomarcadores Tumorais/análise
Biomarcadores Tumorais/sangue
História do Século XX
História do Século XXI
Neoplasias/diagnóstico
[Pt] Tipo de publicação:BIOGRAPHY; EDITORIAL; HISTORICAL ARTICLE
[Nm] Nome de substância:
0 (Biomarkers, Tumor)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170920
[Lr] Data última revisão:
170920
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170609
[St] Status:MEDLINE


  9 / 5729 MEDLINE  
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[PMID]:28402169
[Au] Autor:Schifman RB; Talbert M; Souers RJ
[Ti] Título:Delta Check Practices and Outcomes: A Q-Probes Study Involving 49 Health Care Facilities and 6541 Delta Check Alerts.
[So] Source:Arch Pathol Lab Med;141(6):813-823, 2017 Jun.
[Is] ISSN:1543-2165
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:CONTEXT: - Delta checks serve as a patient-based quality control tool to detect testing problems. OBJECTIVE: - To evaluate delta check practices and outcomes. DESIGN: - Q-Probes participants provided information about delta check policies and procedures. Information about investigations, problems, and corrective actions was prospectively collected for up to 100 testing episodes involving delta check alerts. RESULTS: - Among 4505 testing episodes involving 6541 delta check alerts, the median frequencies of actions taken among 49 laboratories were clinical review, 38.0%; retest, 25.0%, or recheck, 20.2%; current specimen, nothing, 15.4%; analytical check, 5.0%; other; 2%; and retest or check previous specimen, 0%. Rates of any action taken by analyte ranged from 84 of 179 (46.9%) for glucose to 748 of 868 (86.2%) for hemoglobin and potassium. Among 4505 testing episodes, nontesting problems included physiologic causes (1472; 32.7%); treatment causes (1318; 19.2%); and transfusion causes (846; 9.9%). Testing problems included 77 interference (1.7%), 62 contamination (1.4%), 51 clotting (1.1%), 27 other (0.6%), 12 mislabeling (0.3%), and 5 analytical (0.1%). Testing problems by analyte ranged from 13 of 457 (2.8%) for blood urea nitrogen to 12 of 46 (26.1%) for mean corpuscular hemoglobin concentration. Using more delta check analytes was associated with detecting more testing problems (P = .04). More delta check alerts per testing episode resulted in more actions taken (P = .001) and more problems identified (P < .001). The most common outcome among 4500 testing episodes was reporting results without modifications or comments in 2512 (55.8%); results were not reported in 136 (3.0%). CONCLUSIONS: - Actions taken in response to delta check alerts varied widely, and most testing problems detected were preanalytical. Using a higher number of different analytes and evaluating previous specimens may improve delta check practices.
[Mh] Termos MeSH primário: Erros de Diagnóstico/prevenção & controle
Laboratórios Hospitalares/normas
[Mh] Termos MeSH secundário: Química Clínica/normas
Hematologia/normas
Hospitais
Seres Humanos
Controle de Qualidade
Manejo de Espécimes/normas
[Pt] Tipo de publicação:EVALUATION STUDIES; JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171011
[Lr] Data última revisão:
171011
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170413
[St] Status:MEDLINE
[do] DOI:10.5858/arpa.2016-0161-CP


  10 / 5729 MEDLINE  
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[PMID]:28396561
[Au] Autor:Hage DS
[Ad] Endereço:Department of Chemistry, University of Nebraska-Lincoln, Lincoln, NE. dhage1@unl.edu.
[Ti] Título:Analysis of Biological Interactions by Affinity Chromatography: Clinical and Pharmaceutical Applications.
[So] Source:Clin Chem;63(6):1083-1093, 2017 Jun.
[Is] ISSN:1530-8561
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The interactions between biochemical and chemical agents in the body are important in many clinical processes. Affinity chromatography and high-performance affinity chromatography (HPAC), in which a column contains an immobilized biologically related binding agent, are 2 methods that can be used to study these interactions. CONTENT: This review presents various approaches that can be used in affinity chromatography and HPAC to characterize the strength or rate of a biological interaction, the number and types of sites that are involved in this process, and the interactions between multiple solutes for the same binding agent. A number of applications for these methods are examined, with an emphasis on recent developments and high-performance affinity methods. These applications include the use of these techniques for fundamental studies of biological interactions, high-throughput screening of drugs, work with modified proteins, tools for personalized medicine, and studies of drug-drug competition for a common binding agent. SUMMARY: The wide range of formats and detection methods that can be used with affinity chromatography and HPAC for examining biological interactions makes these tools attractive for various clinical and pharmaceutical applications. Future directions in the development of small-scale columns and the coupling of these methods with other techniques, such as mass spectrometry or other separation methods, should continue to increase the flexibility and ease with which these approaches can be used in work involving clinical or pharmaceutical samples.
[Mh] Termos MeSH primário: Química Clínica
Cromatografia de Afinidade
Preparações Farmacêuticas/análise
[Mh] Termos MeSH secundário: Cromatografia Líquida de Alta Pressão
Ensaios de Triagem em Larga Escala
Seres Humanos
Medicina de Precisão
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170725
[Lr] Data última revisão:
170725
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170412
[St] Status:MEDLINE
[do] DOI:10.1373/clinchem.2016.262253



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