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  1 / 1328 MEDLINE  
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[PMID]:29319937
[Au] Autor:Food and Drug Administration, HHS.
[Ti] Título:Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems. Final order.
[So] Source:Fed Regist;82(247):61162-3, 2017 Dec 27.
[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 reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general 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: Testes de Química Clínica/classificação
Testes de Química Clínica/instrumentação
Segurança de Equipamentos/classificação
Indicadores e Reagentes/classificação
Biologia Molecular/classificação
Biologia Molecular/instrumentação
Kit de Reagentes para Diagnóstico/classificação
[Mh] Termos MeSH secundário: DNA Polimerase Dirigida por DNA/classificação
Seres Humanos
Ácidos Nucleicos/classificação
Nucleotídeos/classificação
DNA Polimerase Dirigida por RNA/classificação
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Indicators and Reagents); 0 (Nucleic Acids); 0 (Nucleotides); 0 (Reagent Kits, Diagnostic); EC 2.7.7.49 (RNA-Directed DNA Polymerase); EC 2.7.7.7 (DNA-Directed DNA Polymerase)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180122
[Lr] Data última revisão:
180122
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE


  2 / 1328 MEDLINE  
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[PMID]:29190288
[Au] Autor:Nabi G; Hao Y; Zeng X; Jinsong Z; McLaughlin RW; Wang D
[Ad] Endereço:Institute of Hydrobiology, the Chinese Academy of Sciences, Wuhan, Hubei, PR China.
[Ti] Título:Hematologic and biochemical differences between two free ranging Yangtze finless porpoise populations: The implications of habitat.
[So] Source:PLoS One;12(11):e0188570, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The goals of this study were to compare the serum chemistry and hematology values of wild and semi-natural free-ranging Yangtze Finless Porpoises (Neophocaena asiaeorientalis ssp. asiaeorientalis) populations and to ascertain how these values change with the different environmental condition. For this study, samples were collected from 81 YFPs, 35 living in the wild and 46 living in a semi-natural reserve. Each population was divided into 8 life history categories; Male Calf, Female Calf, Juvenile Male, Juvenile Female, Adult Male, Pregnant, Lactating and Pregnant plus Lactating. Statistically significant differences in the various parameters were observed in the same life history categories for both populations. Generally, Lipid Profile, Hepatic Enzymes, Creatine Kinase, Red Blood Cells, Hemoglobin, Hematocrit and Neutrophils were significantly higher in the Tian-E-Zhou Oxbow population while, Creatinine, Phosphate, Lactate Dehydrogenase, Bilirubin and Lymphocytes were significantly higher in the Poyang Lake YFPs. Across the groups in the Tian-E-Zhou Oxbow population, a significant decrease in serum Albumin, Alkaline Phosphatase and Calcium, while a significant increase in the Neutrophils and Platelets was observed. Similarly, in the Poyang Lake, Alkaline Phosphatase levels in the Female Calves group, High Density Lipoprotein Cholesterol in Lactating group, basophil counts in Pregnant plus Lactating group, lymphocytes counts in Juvenile Females group and Globulin and Total Protein levels in Pregnant group were significantly higher. This study in health assessments can help us to understand the effect of sex, age, reproductive status and environmental conditions on the well-being of Yangtze Finless Porpoises.
[Mh] Termos MeSH primário: Ecossistema
Toninhas/metabolismo
[Mh] Termos MeSH secundário: Animais
China
Testes de Química Clínica
Feminino
Testes Hematológicos
Masculino
Toninhas/sangue
Gravidez
Rios
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1712
[Cu] Atualização por classe:171226
[Lr] Data última revisão:
171226
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171201
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0188570


  3 / 1328 MEDLINE  
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[PMID]:28593916
[Au] Autor:Moore M; Dougall T; Ferguson J; Rigsby P; Burns C
[Ad] Endereço:.
[Ti] Título:Preparation, calibration and evaluation of the First International Standard for human C-peptide.
[So] Source:Clin Chem Lab Med;55(8):1224-1233, 2017 Jul 26.
[Is] ISSN:1437-4331
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Measurement of C-peptide by immunoassay contributes to the diagnosis of a number of disorders related to ß cell function. Stocks of the current international reference reagent (IRR) for C-peptide, used to calibrate these immunoassays, are exhausted, and this report summarises the international study to establish a replacement World Health Organization (WHO) international standard (IS) to maintain the availability of a globally available reference material and support efforts to standardise C-peptide assays. METHODS: The study was conducted in three phases; phase I involved the assignment of a value to a primary calibrant in mass units by amino acid analysis and phase II applied this value to the calibration of a candidate standard, 13/146, by reversed phase high-performance liquid chromatography (RP-HPLC) assay. In phase III, the candidate standard was compared to the first IRR by current immunoassays to assess its suitability to serve as an IS. RESULTS: Calibration of the candidate standard by RP-HPLC gave a final estimated content of 8.64 µg/ampoule with expanded uncertainty of 8.21-9.07 µg/ampoule (95% confidence; k=2.45). The candidate standard also appears sufficiently stable to serve as an IS, based on HPLC analysis of accelerated thermal degradation samples of 13/146, and was also shown to have appropriate immunological activity. A difference in bias approach was used to assess the commutability of 13/146 with human serum and urine samples. With the exception of two laboratories, the candidate standard demonstrated commutability with respect to the serum and urine samples included in this study. CONCLUSIONS: The candidate standard, 13/146, is suitable to serve as the First International Standard for human C-peptide, and it has been formally adopted by the Expert Committee on Biological Standardisation of the WHO.
[Mh] Termos MeSH primário: Análise Química do Sangue/normas
Peptídeo C/análise
Testes de Química Clínica/normas
Internacionalidade
[Mh] Termos MeSH secundário: Sequência de Aminoácidos
Aminoácidos/análise
Viés
Peptídeo C/sangue
Peptídeo C/química
Peptídeo C/urina
Calibragem
Cromatografia Líquida de Alta Pressão
Seres Humanos
Imunoensaio
Padrões de Referência
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Amino Acids); 0 (C-Peptide)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170609
[St] Status:MEDLINE


  4 / 1328 MEDLINE  
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[PMID]:28328525
[Au] Autor:Liu J; Tan CH; Badrick T; Loh TP
[Ad] Endereço:.
[Ti] Título:Moving sum of number of positive patient result as a quality control tool.
[So] Source:Clin Chem Lab Med;55(11):1709-1714, 2017 Oct 26.
[Is] ISSN:1437-4331
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Recently, the total prostate-specific antigen (PSA) assay used in a laboratory had a positive bias of 0.03 µg/L, which went undetected. Consequently, a number of post-prostatectomy patients with previously undetectable PSA concentrations (defined as <0.03 µg/L in that laboratory) were being reported as having detectable PSA, which suggested poorer prognosis according to clinical guidelines. METHODS: Through numerical simulations, we explored (1) how a small bias may evade the detection of routine quality control (QC) procedures with specific reference to the concentration of the QC material, (2) whether the use of 'average of normals' approach may detect such a small bias, and (3) describe the use of moving sum of number of patient results with detectable PSA as an adjunct QC procedure. RESULTS: The lowest QC level (0.86 µg/L) available from a commercial kit had poor probability (<10%) of a bias of 0.03 µg/L regardless of QC rule (i.e. 1:2S, 2:2S, 1:3S, 4:1S) used. The average number of patient results affected before error detection (ANPed) was high when using the average of normals approach due to the relatively wide control limits. By contrast, the ANPed was significantly lower for the moving sum of number of patient results with a detectable PSA approach. CONCLUSIONS: Laboratory practitioners should ensure their QC strategy can detect small but critical bias, and may require supplementation of ultra-low QC levels that are not covered by commercial kits with in-house preparations. The use of moving sum of number of patient results with a detectable result is a helpful adjunct QC tool.
[Mh] Termos MeSH primário: Testes de Química Clínica/normas
Antígeno Prostático Específico/sangue
[Mh] Termos MeSH secundário: Reações Falso-Positivas
Seres Humanos
Limite de Detecção
Masculino
Probabilidade
Neoplasias da Próstata/diagnóstico
Controle de Qualidade
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
EC 3.4.21.77 (Prostate-Specific Antigen)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170323
[St] Status:MEDLINE


  5 / 1328 MEDLINE  
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[PMID]:28224767
[Au] Autor:Jang MA; Yoon YA; Song J; Kim JH; Min WK; Lee JS; Lee YW; Lee YK
[Ad] Endereço:Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
[Ti] Título:Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories.
[So] Source:Ann Lab Med;37(3):213-222, 2017 May.
[Is] ISSN:2234-3814
[Cp] País de publicação:Korea (South)
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. METHODS: We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. RESULTS: Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. CONCLUSIONS: These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing.
[Mh] Termos MeSH primário: Testes Diagnósticos de Rotina/normas
Laboratórios Hospitalares/normas
[Mh] Termos MeSH secundário: Acreditação
Alanina Transaminase/sangue
Aspartato Aminotransferases/sangue
Testes de Química Clínica
Controle de Qualidade
República da Coreia
Albumina Sérica/análise
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Serum Albumin); EC 2.6.1.1 (Aspartate Aminotransferases); EC 2.6.1.2 (Alanine Transaminase)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170501
[Lr] Data última revisão:
170501
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170223
[St] Status:MEDLINE
[do] DOI:10.3343/alm.2017.37.3.213


  6 / 1328 MEDLINE  
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[PMID]:28212712
[Au] Autor:Raman M
[Ad] Endereço:University of Calgary, Calgary, AB, Canada. Electronic address: mkothand@ucalgary.ca.
[Ti] Título:Testing for Chronic Diarrhea.
[So] Source:Adv Clin Chem;79:199-244, 2017.
[Is] ISSN:0065-2423
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Chronic diarrhea is a frequently encountered symptom in clinical practice. The etiologies for chronic diarrhea are diverse and broad with varying clinical implications. A useful method of categorizing chronic diarrhea to guide a diagnostic work-up is a pathophysiology-based framework. Chronic diarrhea may be categorized as malabsorptive, secretory, osmotic, and inflammatory or motility related. Frequently, overlap between categories may exist for any given diarrhea etiology and diagnostic testing must occur with an understanding of the differential diagnosis. Investigations to achieve a diagnosis for chronic diarrhea range from screening blood and stool tests to more directed testing such as diagnostic imaging, and endoscopic and histological evaluation. The pathophysiology-based framework proposed in this chapter will allow the clinician to select screening tests followed by targeted tests to minimize cost and complications to the patient, while providing a highly effective method to achieve an accurate diagnosis.
[Mh] Termos MeSH primário: Diarreia/diagnóstico
[Mh] Termos MeSH secundário: Doença Crônica
Testes de Química Clínica
Diarreia/fisiopatologia
Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170620
[Lr] Data última revisão:
170620
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170219
[St] Status:MEDLINE


  7 / 1328 MEDLINE  
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[PMID]:28212711
[Au] Autor:French D
[Ad] Endereço:University of California San Francisco, San Francisco, CA, United States. Electronic address: deborah.french@ucsf.edu.
[Ti] Título:Advances in Clinical Mass Spectrometry.
[So] Source:Adv Clin Chem;79:153-198, 2017.
[Is] ISSN:0065-2423
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Although mass spectrometry has been used clinically for decades, the advent of immunoassay technology moved the clinical laboratory to more labor saving automated platforms requiring little if any sample preparation. It became clear, however, that immunoassays lacked sufficient sensitivity and specificity necessary for measurement of certain analytes or for measurement of analytes in specific patient populations. This limitation prompted clinical laboratories to revisit mass spectrometry which could additionally be used to develop assays for which there was no commercial source. In this chapter, the clinical applications of mass spectrometry in therapeutic drug monitoring, toxicology, and steroid hormone analysis will be reviewed. Technologic advances and new clinical applications will also be discussed.
[Mh] Termos MeSH primário: Testes de Química Clínica
Espectrometria de Massas/métodos
[Mh] Termos MeSH secundário: Seres Humanos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170620
[Lr] Data última revisão:
170620
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170219
[St] Status:MEDLINE


  8 / 1328 MEDLINE  
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[PMID]:28151722
[Au] Autor:Haeckel R; Wosniok W; Arzideh F; Zierk J; Gurr E; Streichert T
[Ti] Título:Critical comments to a recent EFLM recommendation for the review of reference intervals.
[So] Source:Clin Chem Lab Med;55(3):341-347, 2017 Mar 01.
[Is] ISSN:1437-4331
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:In a recent EFLM recommendation on reference intervals by Henny et al., the direct approach for determining reference intervals was proposed as the only presently accepted "gold" standard. Some essential drawbacks of the direct approach were not sufficiently emphasized, such as unacceptably wide confidence limits due to the limited number of observations claimed and the practical usability for only a limited age range. Indirect procedures avoid these disadvantages of the direct approach. Furthermore, indirect approaches are well suited for reference limits with large variations during lifetime and for common reference limits.
[Mh] Termos MeSH primário: Testes de Química Clínica/normas
Ciência de Laboratório Médico/normas
[Mh] Termos MeSH secundário: Fatores Etários
Europa (Continente)
Seres Humanos
Padrões de Referência
Valores de Referência
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170203
[St] Status:MEDLINE


  9 / 1328 MEDLINE  
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[PMID]:28107395
[Au] Autor:Najat D
[Ad] Endereço:Department of Chemistry, College of Science, University of Sulaimani, Sulaimani, Iraq.
[Ti] Título:Prevalence of Pre-Analytical Errors in Clinical Chemistry Diagnostic Labs in Sulaimani City of Iraqi Kurdistan.
[So] Source:PLoS One;12(1):e0170211, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Laboratory testing is roughly divided into three phases: a pre-analytical phase, an analytical phase and a post-analytical phase. Most analytical errors have been attributed to the analytical phase. However, recent studies have shown that up to 70% of analytical errors reflect the pre-analytical phase. The pre-analytical phase comprises all processes from the time a laboratory request is made by a physician until the specimen is analyzed at the lab. Generally, the pre-analytical phase includes patient preparation, specimen transportation, specimen collection and storage. In the present study, we report the first comprehensive assessment of the frequency and types of pre-analytical errors at the Sulaimani diagnostic labs in Iraqi Kurdistan. MATERIALS AND METHODS: Over 2 months, 5500 venous blood samples were observed in 10 public diagnostic labs of Sulaimani City. The percentages of rejected samples and types of sample inappropriateness were evaluated. The percentage of each of the following pre-analytical errors were recorded: delay in sample transportation, clotted samples, expired reagents, hemolyzed samples, samples not on ice, incorrect sample identification, insufficient sample, tube broken in centrifuge, request procedure errors, sample mix-ups, communication conflicts, misinterpreted orders, lipemic samples, contaminated samples and missed physician's request orders. The difference between the relative frequencies of errors observed in the hospitals considered was tested using a proportional Z test. In particular, the survey aimed to discover whether analytical errors were recorded and examine the types of platforms used in the selected diagnostic labs. RESULTS: The analysis showed a high prevalence of improper sample handling during the pre-analytical phase. In appropriate samples, the percentage error was as high as 39%. The major reasons for rejection were hemolyzed samples (9%), incorrect sample identification (8%) and clotted samples (6%). Most quality control schemes at Sulaimani hospitals focus only on the analytical phase, and none of the pre-analytical errors were recorded. Interestingly, none of the labs were internationally accredited; therefore, corrective actions are needed at these hospitals to ensure better health outcomes. Internal and External Quality Assessment Schemes (EQAS) for the pre-analytical phase at Sulaimani clinical laboratories should be implemented at public hospitals. Furthermore, lab personnel, particularly phlebotomists, need continuous training on the importance of sample quality to obtain accurate test results.
[Mh] Termos MeSH primário: Testes de Química Clínica
Erros de Diagnóstico/estatística & dados numéricos
Laboratórios
[Mh] Termos MeSH secundário: Seres Humanos
Iraque/epidemiologia
Prevalência
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170810
[Lr] Data última revisão:
170810
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170121
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0170211


  10 / 1328 MEDLINE  
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[PMID]:28076303
[Au] Autor:Rossum HHV; Kemperman H
[Ad] Endereço:.
[Ti] Título:Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays.
[So] Source:Clin Chem Lab Med;55(8):1142-1151, 2017 Jul 26.
[Is] ISSN:1437-4331
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: General application of a moving average (MA) as continuous analytical quality control (QC) for routine chemistry assays has failed due to lack of a simple method that allows optimization of MAs. A new method was applied to optimize the MA for routine chemistry and was evaluated in daily practice as continuous analytical QC instrument. METHODS: MA procedures were optimized using an MA bias detection simulation procedure. Optimization was graphically supported by bias detection curves. Next, all optimal MA procedures that contributed to the quality assurance were run for 100 consecutive days and MA alarms generated during working hours were investigated. RESULTS: Optimized MA procedures were applied for 24 chemistry assays. During this evaluation, 303,871 MA values and 76 MA alarms were generated. Of all alarms, 54 (71%) were generated during office hours. Of these, 41 were further investigated and were caused by ion selective electrode (ISE) failure (1), calibration failure not detected by QC due to improper QC settings (1), possible bias (significant difference with the other analyzer) (10), non-human materials analyzed (2), extreme result(s) of a single patient (2), pre-analytical error (1), no cause identified (20), and no conclusion possible (4). CONCLUSIONS: MA was implemented in daily practice as a continuous QC instrument for 24 routine chemistry assays. In our setup when an MA alarm required follow-up, a manageable number of MA alarms was generated that resulted in valuable MA alarms. For the management of MA alarms, several applications/requirements in the MA management software will simplify the use of MA procedures.
[Mh] Termos MeSH primário: Testes de Química Clínica/instrumentação
Testes de Química Clínica/normas
[Mh] Termos MeSH secundário: Seres Humanos
Controle de Qualidade
Padrões de Referência
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1707
[Cu] Atualização por classe:170731
[Lr] Data última revisão:
170731
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170112
[St] Status:MEDLINE



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