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Pesquisa : N02.421.726.233.110 [Categoria DeCS]
Referências encontradas : 448 [refinar]
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[PMID]:29246998
[Au] Autor:Line K
[Ad] Endereço:APHA Woodham Lane, Addlestone, Surrey KT15 3NB.
[Ti] Título:Changes to APHA laboratory testing locations.
[So] Source:Vet Rec;181(24):660, 2017 12 16.
[Is] ISSN:2042-7670
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Serviços de Laboratório Clínico/organização & administração
Órgãos Governamentais
Medicina Veterinária
[Mh] Termos MeSH secundário: Animais
Seres Humanos
Reino Unido
[Pt] Tipo de publicação:LETTER
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180307
[Lr] Data última revisão:
180307
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171217
[St] Status:MEDLINE
[do] DOI:10.1136/vr.j5747


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[PMID]:29320558
[Au] Autor:Dolscheid-Pommerich RC; Dolscheid S; Eichhorn L; Stoffel-Wagner B; Graeff I
[Ad] Endereço:Department of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn, Bonn, Germany.
[Ti] Título:Thrombolysis in stroke patients: Comparability of point-of-care versus central laboratory international normalized ratio.
[So] Source:PLoS One;13(1):e0190867, 2018.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: In acute stroke patients, thrombolysis is one gold standard therapy option within the first four hours after the ischemic event. A contraindication for thrombolysis is an International Normalized Ratio (INR) value >1.7. Since time is brain, rapid and reliable INR results are fundamental. Aim was to compare INR values determined by central laboratory (CL) analyzer and Point-of-Care Testing(POCT)-device and to evaluate the quality of POCT performance in cases of potential therapeutic thrombolysis at a certified stroke unit. METHODS: In 153 patients INR measurements using POCT-devices (HEMOCHRON Signature Elite®) were compared to INR measurements (BCS®XP) performed at the central laboratory. Outlier evaluation was performed regarding the critical thrombolysis cut-off. RESULTS: Overall, we demonstrated a significant correlation (r = 0.809, p<0.0001) between both measurement methods. Mean value of the absolute difference between CL-INR and POCT-INR measurements was 0.23. In 95.4% of these cases, no differences regarding the critical cut-off (INR 1.7) were observed. POCT-INR values tended to be higher than the CL-INR values (p = 0.01). In 4.6% cases, a different value regarding thrombolysis cut-off was found. All patients were >75 years. CONCLUSIONS: POCT-INR measurements based on our POCT concept are suitable to determine INR values in critical stroke patients. Nevertheless, outlier evaluation is mandatory.
[Mh] Termos MeSH primário: Serviços de Laboratório Clínico
Coeficiente Internacional Normatizado/métodos
Testes Imediatos
Acidente Vascular Cerebral/sangue
Acidente Vascular Cerebral/tratamento farmacológico
Terapia Trombolítica
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Idoso de 80 Anos ou mais
Anticoagulantes/uso terapêutico
Serviços Médicos de Emergência
Feminino
Fibrinolíticos/uso terapêutico
Seres Humanos
Coeficiente Internacional Normatizado/instrumentação
Masculino
Meia-Idade
Estudos Retrospectivos
Terapia Trombolítica/métodos
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Anticoagulants); 0 (Fibrinolytic Agents)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180205
[Lr] Data última revisão:
180205
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0190867


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[PMID]:27770851
[Au] Autor:Doern CD; Butler-Wu SM
[Ad] Endereço:Association for Molecular Pathology's Matrix-Assisted Laser Desorption Ionization Time-of-Flight Working Group, Bethesda, Maryland; Department of Pathology, Virginia Commonwealth University Medical Center, Richmond, Virginia. Electronic address: cdoern@mcvh-vcu.edu.
[Ti] Título:Emerging and Future Applications of Matrix-Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) Mass Spectrometry in the Clinical Microbiology Laboratory: A Report of the Association for Molecular Pathology.
[So] Source:J Mol Diagn;18(6):789-802, 2016 11.
[Is] ISSN:1943-7811
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The performance of matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MS) for routine bacterial and yeast identification as well as direct-from-blood culture bottle identification has been thoroughly evaluated in the peer-reviewed literature. Microbiologists are now moving beyond these methods to apply MS to other areas of the diagnostic process. This review discusses the emergence of advanced matrix-assisted laser desorption ionization time-of-flight MS applications, including the identification of filamentous fungi and mycobacteria and the current and future state of antimicrobial resistance testing.
[Mh] Termos MeSH primário: Serviços de Laboratório Clínico
Técnicas Microbiológicas
Espectrometria de Massas por Ionização e Dessorção a Laser Assistida por Matriz/métodos
[Mh] Termos MeSH secundário: Bactérias/química
Bactérias/classificação
Serviços de Laboratório Clínico/tendências
Resistência Microbiana a Medicamentos
Seres Humanos
Infecção/diagnóstico
Infecção/microbiologia
Testes de Sensibilidade Microbiana
Técnicas Microbiológicas/métodos
Técnicas Microbiológicas/tendências
Leveduras/química
Leveduras/classificação
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1706
[Cu] Atualização por classe:180122
[Lr] Data última revisão:
180122
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE


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[PMID]:29073124
[Au] Autor:Patel JC; George J; Vuong J; Potts CC; Bozio C; Clark TA; Thomas J; Schier J; Chang A; Waller JL; Diaz MH; Whaley M; Jenkins LT; Fuller S; Williams DE; Redd JT; Arthur RR; Taweh F; Vera Walker Y; Hardy P; Freeman M; Katawera V; Gwesa G; Gbanya MZ; Clement P; Kohar H; Stone M; Fallah M; Nyenswah T; Winchell JM; Wang X; McNamara LA; Dokubo EK; Fox LM
[Ti] Título:Rapid Laboratory Identification of Neisseria meningitidis Serogroup C as the Cause of an Outbreak - Liberia, 2017.
[So] Source:MMWR Morb Mortal Wkly Rep;66(42):1144-1147, 2017 Oct 27.
[Is] ISSN:1545-861X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:On April 25, 2017, a cluster of unexplained illness and deaths among persons who had attended a funeral during April 21-22 was reported in Sinoe County, Liberia (1). Using a broad initial case definition, 31 cases were identified, including 13 (42%) deaths. Twenty-seven cases were from Sinoe County (1), and two cases each were from Grand Bassa and Monsterrado counties, respectively. On May 5, 2017, initial multipathogen testing of specimens from four fatal cases using the Taqman Array Card (TAC) assay identified Neisseria meningitidis in all specimens. Subsequent testing using direct real-time polymerase chain reaction (PCR) confirmed N. meningitidis in 14 (58%) of 24 patients with available specimens and identified N. meningitidis serogroup C (NmC) in 13 (54%) patients. N. meningitidis was detected in specimens from 11 of the 13 patients who died; no specimens were available from the other two fatal cases. On May 16, 2017, the National Public Health Institute of Liberia and the Ministry of Health of Liberia issued a press release confirming serogroup C meningococcal disease as the cause of this outbreak in Liberia.
[Mh] Termos MeSH primário: Surtos de Doenças
Meningite Meningocócica/epidemiologia
Meningite Meningocócica/microbiologia
Neisseria meningitidis Sorogrupo C/isolamento & purificação
[Mh] Termos MeSH secundário: Serviços de Laboratório Clínico/estatística & dados numéricos
Análise por Conglomerados
Seres Humanos
Libéria/epidemiologia
Meningite Meningocócica/mortalidade
Reação em Cadeia da Polimerase em Tempo Real
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171031
[Lr] Data última revisão:
171031
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171027
[St] Status:MEDLINE
[do] DOI:10.15585/mmwr.mm6642a5


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[PMID]:29064354
[Au] Autor:Jean Louis F; Buteau J; Boncy J; Anselme R; Stanislas M; Nagel MC; Juin S; Charles M; Burris R; Antoine E; Yang C; Kalou M; Vertefeuille J; Marston BJ; Lowrance DW; Deyde V
[Ad] Endereço:Centers for Disease Control and Prevention, Port-au-Prince, Haiti.
[Ti] Título:Building and Rebuilding: The National Public Health Laboratory Systems and Services Before and After the Earthquake and Cholera Epidemic, Haiti, 2009-2015.
[So] Source:Am J Trop Med Hyg;97(4_Suppl):21-27, 2017 Oct.
[Is] ISSN:1476-1645
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Before the 2010 devastating earthquake and cholera outbreak, Haiti's public health laboratory systems were weak and services were limited. There was no national laboratory strategic plan and only minimal coordination across the laboratory network. Laboratory capacity was further weakened by the destruction of over 25 laboratories and testing sites at the departmental and peripheral levels and the loss of life among the laboratory health-care workers. However, since 2010, tremendous progress has been made in building stronger laboratory infrastructure and training a qualified public health laboratory workforce across the country, allowing for decentralization of access to quality-assured services. Major achievements include development and implementation of a national laboratory strategic plan with a formalized and strengthened laboratory network; introduction of automation of testing to ensure better quality of results and diversify the menu of tests to effectively respond to outbreaks; expansion of molecular testing for tuberculosis, human immunodeficiency virus, malaria, diarrheal and respiratory diseases; establishment of laboratory-based surveillance of epidemic-prone diseases; and improvement of the overall quality of testing. Nonetheless, the progress and gains made remain fragile and require the full ownership and continuous investment from the Haitian government to sustain these successes and achievements.
[Mh] Termos MeSH primário: Cólera
Serviços de Laboratório Clínico
Desastres
Terremotos
Epidemias
Laboratórios
Saúde Pública
[Mh] Termos MeSH secundário: Cólera/epidemiologia
Disenteria/diagnóstico
Disenteria/epidemiologia
Infecções por HIV/diagnóstico
Infecções por HIV/epidemiologia
Haiti/epidemiologia
Seres Humanos
Malária/diagnóstico
Malária/epidemiologia
Técnicas de Diagnóstico Molecular
Tuberculose/diagnóstico
Tuberculose/epidemiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171025
[St] Status:MEDLINE
[do] DOI:10.4269/ajtmh.16-0941


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[PMID]:28767674
[Au] Autor:Mehrotra M; Duose DY; Singh RR; Barkoh BA; Manekia J; Harmon MA; Patel KP; Routbort MJ; Medeiros LJ; Wistuba II; Luthra R
[Ad] Endereço:Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America.
[Ti] Título:Versatile ion S5XL sequencer for targeted next generation sequencing of solid tumors in a clinical laboratory.
[So] Source:PLoS One;12(8):e0181968, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Next generation sequencing based tumor tissue genotyping involves complex workflow and a relatively longer turnaround time. Semiconductor based next generation platforms varied from low throughput Ion PGM to high throughput Ion Proton and Ion S5XL sequencer. In this study, we compared Ion PGM and Ion Proton, with a new Ion S5XL NGS system for workflow scalability, analytical sensitivity and specificity, turnaround time and sequencing performance in a clinical laboratory. METHODS: Eighteen solid tumor samples positive for various mutations as detected previously by Ion PGM and Ion Proton were selected for study. Libraries were prepared using DNA (range10-40ng) from micro-dissected formalin-fixed, paraffin-embedded (FFPE) specimens using the Ion Ampliseq Library Kit 2.0 for comprehensive cancer (CCP), oncomine comprehensive cancer (OCP) and cancer hotspot panel v2 (CHPv2) panel as per manufacturer's instructions. The CHPv2 were sequenced using Ion PGM whereas CCP and OCP were sequenced using Ion Proton respectively. All the three libraries were further sequenced individually (S540) or multiplexed (S530) using Ion S5XL. For S5XL, Ion chef was used to automate template preparation, enrichment of ion spheres and chip loading. Data analysis was performed using Torrent Suite 4.6 software on board S5XL and Ion Reporter. A limit of detection and reproducibility studies was performed using serially diluted DLD1 cell line. RESULTS: A total of 241 variant calls (235 single nucleotide variants and 6 indels) expected in the studied cohort were successfully detected by S5XL with 100% and 97% concordance with Ion PGM and Proton, respectively. Sequencing run time was reduced from 4.5 to 2.5 hours with output range of 3-5 GB (S530) and 8-9.3Gb (S540). Data analysis time for the Ion S5XL is faster 1 h (S520), 2.5 h (S530) and 5 h (S540) chip, respectively as compared to the Ion PGM (3.5-5 h) and Ion Proton (8h). A limit detection of 5% allelic frequency was established along with high inter-run reproducibility. CONCLUSION: Ion S5XL system simplified workflow in a clinical laboratory, was feasible for running smaller and larger panels on the same instrument, had a shorter turnaround time, and showed good concordance for variant calls with similar sensitivity and reproducibility as the Ion PGM and Proton.
[Mh] Termos MeSH primário: DNA de Neoplasias/análise
Sequenciamento de Nucleotídeos em Larga Escala/instrumentação
Neoplasias/genética
Análise de Sequência de DNA/instrumentação
[Mh] Termos MeSH secundário: Adulto
Idoso
Serviços de Laboratório Clínico
Feminino
Seres Humanos
Masculino
Meia-Idade
Mutação
Sensibilidade e Especificidade
Software
Fatores de Tempo
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (DNA, Neoplasm)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170829
[Lr] Data última revisão:
170829
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170803
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0181968


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[PMID]:28767284
[Au] Autor:Yue Y; Zhang S; Xu Z; Chen X; Wang Q
[Ti] Título:Commutability of Reference Materials for α-Fetoprotein in Human Serum.
[So] Source:Arch Pathol Lab Med;141(10):1421-1427, 2017 Oct.
[Is] ISSN:1543-2165
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:CONTEXT: - Reliable quantification of α-fetoprotein (AFP) is critical for clinical diagnosis. Accuracy in AFP analysis relies on traceability to reference materials with confirmed commutability. OBJECTIVE: - To assess the commutability of the reference materials for AFP. We screened for appropriate reference materials for the calibration of clinical AFP analysis and for application in an external quality assessment scheme. The feasibility of using water to dilute a reference material from the World Health Organization was also evaluated. DESIGN: - Patient serum samples with various levels of AFP were randomly interspersed among AFP reference materials from the World Health Organization, the Beijing Center for Clinical Laboratories, and Beijing Controls and Standards Biotechnology and quality controls from Bio-Rad. The samples were analyzed on 5 different platforms to assess the comparability of the results and commutability of the reference materials. RESULTS: - Significant variations in AFP measurement were observed among the 5 instrument platforms. The Beijing Center for Clinical Laboratories and Beijing Controls and Standards Biotechnology reference materials were commutable across all the instrument platforms. The World Health Organization AFP 72/225 reference material diluted with distilled water was also commutable at high concentrations. The Bio-Rad quality control materials for AFP were commutable among 4 out of 5 instrument platforms. CONCLUSIONS: - Our results suggested that the Beijing Center for Clinical Laboratories and Beijing Controls and Standards Biotechnology materials were commutable across all 5 instrument platforms, whereas the Bio-Rad quality controls were limited by the concentration of AFP and the instrument platforms used. Caution needs to be taken in using water to dilute the World Health Organization 72/225 reference material because its commutability is limited to high concentrations.
[Mh] Termos MeSH primário: Serviços de Laboratório Clínico/normas
Patologia Clínica/instrumentação
Patologia Clínica/normas
alfa-Fetoproteínas/análise
[Mh] Termos MeSH secundário: Seres Humanos
Padrões de Referência
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (alpha-Fetoproteins)
[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:170803
[St] Status:MEDLINE
[do] DOI:10.5858/arpa.2016-0441-OA


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[PMID]:28763096
[Au] Autor:Olsson E; Beck O; Elmgren A; Hansson T; Helander A
[Ad] Endereço:- Stockholm, Sweden - Stockholm, Sweden.
[Ti] Título:Tillgång till snabb laboratorieanalys vid akut förgiftning ger bättre och säkrare vård - Men möjligheten till akuta prov­­svar varierar över landet..
[So] Source:Lakartidningen;114, 2017 Jul 26.
[Is] ISSN:1652-7518
[Cp] País de publicação:Sweden
[La] Idioma:swe
[Ab] Resumo:Access to rapid laboratory analytical services in cases of acute poisoning provides better and safer patient care The Swedish Poisons Information Centre, a nationwide 24/7 service to healthcare providers and the public, answers many questions about serious cases of acute poisoning. In some of these, prompt and proper treatment recommendations can be crucial for the clinical outcome. In cases where self-reported information is missing or considered unreliable, more emphasis is placed on the clinical symptoms and results of toxicological analyses. However, rapid access to toxicological analysis for the most common set of poisoning agents varies between hospitals and laboratories. A priority list of toxic agents for which improved analytical techniques could offer a more widespread availability and rapid access to clinically important test results is presented.
[Mh] Termos MeSH primário: Serviços de Laboratório Clínico/normas
Envenenamento/diagnóstico
[Mh] Termos MeSH secundário: Acetaminofen/envenenamento
Analgésicos não Entorpecentes/envenenamento
Disparidades em Assistência à Saúde
Seres Humanos
Centros de Controle de Intoxicações
Envenenamento/terapia
Suécia
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Analgesics, Non-Narcotic); 362O9ITL9D (Acetaminophen)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171109
[Lr] Data última revisão:
171109
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170802
[St] Status:MEDLINE


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[PMID]:28751759
[Au] Autor:Ellison G; Wallace A; Kohlmann A; Patton S
[Ad] Endereço:AstraZeneca, Personalised Healthcare and Biomarkers, Alderley Park, Macclesfield SK10 4TG, UK.
[Ti] Título:A comparative study of germline BRCA1 and BRCA2 mutation screening methods in use in 20 European clinical diagnostic laboratories.
[So] Source:Br J Cancer;117(5):710-716, 2017 Aug 22.
[Is] ISSN:1532-1827
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Thousands of clinically relevant variations in BRCA1 and BRCA2 have been discovered and this poses a significant challenge with respect to the accurate detection, analysis turn-around time, characterisation and interpretation of these sequence variants. METHODS: We evaluated the performance of different BRCA1/2 gene testing practices in routine diagnostic use in 20 European laboratories, with a focus on next-generation sequencing-based strategies as this is the technical approach implemented by or under adoption by most European clinical laboratories. Participant laboratories, selected on expertise and diagnostic service quality, tested 10 identical DNA samples containing a range of challenging pathogenic variants. RESULTS: A small number of errors in the detection of pathogenic and significant variants were identified (2.6% diagnostic error rate). There was a high degree of concordance (>97%) across all laboratories for all variants detected. No systematic technical flaw was identified in the strategies employed across the participating laboratories. CONCLUSIONS: The discrepancies identified are most likely due to human error or the way the methodology has been implemented locally, for example, next-generation sequencing bioinformatics pipelines, rather than technical limitations of the methods. The choice of BRCA1/2 testing method will therefore depend on multiple factors including required throughput and turn-around times, access to equipment, expertise and budget.
[Mh] Termos MeSH primário: Análise Mutacional de DNA/métodos
Genes BRCA1
Genes BRCA2
Testes Genéticos/métodos
Ensaio de Proficiência Laboratorial
[Mh] Termos MeSH secundário: Serviços de Laboratório Clínico
Técnicas de Laboratório Clínico/normas
Biologia Computacional/métodos
Europa (Continente)
Reações Falso-Negativas
Reações Falso-Positivas
Genótipo
Mutação em Linhagem Germinativa
Sequenciamento de Nucleotídeos em Larga Escala
Seres Humanos
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[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:170729
[St] Status:MEDLINE
[do] DOI:10.1038/bjc.2017.223


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[PMID]:28687634
[Au] Autor:Genzen JR; Mohlman JS; Lynch JL; Squires MW; Weiss RL
[Ad] Endereço:Department of Pathology, University of Utah, Salt Lake City, UT; jonathan.genzen@path.utah.edu.
[Ti] Título:Laboratory-Developed Tests: A Legislative and Regulatory Review.
[So] Source:Clin Chem;63(10):1575-1584, 2017 Oct.
[Is] ISSN:1530-8561
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests-now commonly referred to as laboratory-developed tests (LDTs)-are subject to the same regulatory oversight as other in vitro diagnostics (IVDs) . In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved. CONTENT: This review provides an overview of federal statutes and regulations related to IVDs and clinical laboratory operations, with a focus on those potentially applicable to LDTs and proposed regulatory efforts. Sources reviewed include the Code of Federal Regulations, the Federal Register, congressional hearings, guidance and policy documents, position statements, published literature, and websites. SUMMARY: Federal statutes regarding IVDs were passed without substantive evidence of congressional consideration toward the concept of LDTs. The FDA has clear oversight authority over IVD reagents introduced into interstate commerce. A 16-year delay in publicly asserting FDA authority over LDTs, the pursuit of a draft guidance approach toward oversight, and establishment of regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) applicable to LDTs contributed to community uncertainty toward LDT oversight. Future regulatory and/or legislative efforts may be required to resolve this uncertainty.
[Mh] Termos MeSH primário: Serviços de Laboratório Clínico/legislação & jurisprudência
Técnicas de Laboratório Clínico
Laboratórios/legislação & jurisprudência
Legislação de Dispositivos Médicos
[Mh] Termos MeSH secundário: Testes Genéticos/legislação & jurisprudência
Seres Humanos
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171013
[Lr] Data última revisão:
171013
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170709
[St] Status:MEDLINE
[do] DOI:10.1373/clinchem.2017.275164



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