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1.
Clin Lab ; 65(7)2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31307171

RESUMO

BACKGROUND: Verification of the performance of analytical platforms is indicated prior to adoption of new Technology for patient sample analysis. Acceptance criteria for the performance of coagulation analytical platforms are not always readily available and is complicated by the multiple assays and test principles in this section of the clinical laboratory. Coagulation samples are also prone to pre-analytical, post-sample collection variables potentially interfering with accuracy analysis. METHODS: This verification study assessed the accuracy of the automated STAGO STA-R Max® coagulation analyzers by means of a comparison study of results obtained on the previously validated STAGO STA-R Evolution® analyzer for 22 coagulation parameters on 40 individual patient samples for each parameter. Within- and between- run reproducibility on commercial control material, carry-over from abnormal to normal samples and the interference of bilirubin, hemoglobin and lipids on the chromogenic analytical channel were also assessed. Ongoing evaluation of the analyzer performance was assessed by External Quality Assurance (EQA) scheme participation. RESULTS: The reproducibility (precision) on 2 levels (Normal and Pathological) commercial control material was acceptable with co-efficient of variance (CV) results below the manufacturer target % CVs. The correlation study demonstrated accuracy of results obtained on the analyzers for all parameters except for D-dimers and coagulation Factor VII. Subsequent EQA performance for these two parameters were however satisfactory. Interference from bilirubin, hemoglobin and lipids did occur in the chromogenic channel. No clinically significant carry over from abnormal to normal samples were observed. CONCLUSIONS: The performance of the STAGO STA-R Max® analyzer is acceptable across the full coagulation test repertoire with the exception of the von Willebrand activity assay. Participation in EQA scheme assessments will be an integral part of ongoing monitoring of the performance of this automated analyzer.


Assuntos
Automação Laboratorial/instrumentação , Testes de Coagulação Sanguínea/instrumentação , Coagulação Sanguínea , Técnicas de Laboratório Clínico/instrumentação , Garantia da Qualidade dos Cuidados de Saúde , Automação Laboratorial/métodos , Automação Laboratorial/normas , Testes de Coagulação Sanguínea/métodos , Testes de Coagulação Sanguínea/normas , Serviços de Laboratório Clínico/normas , Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Humanos , Laboratórios/normas , Reprodutibilidade dos Testes , África do Sul
2.
Biosens Bioelectron ; 141: 111451, 2019 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-31252261

RESUMO

Development of ultra-sensitive, high specific and cost-effective nucleic acids (NAs) biosensors is critical for early diagnosis of cancer, genetic diseases and follows up response to treatment. Metal-organic frameworks (MOFs) as sensing materials underwent significant development in recent years due to their unique merits, such as structural diversity, tunable pore scale, large surface area, remarkable adsorption affinities, and good thermal stability. MOFs have shown potential contribution in nucleic acids biosensors research. Herein, a comprehensive overview on NAs biosensors state of the art based on MOFs has been discussed extensively, including different MOFs platforms sensing strategies (fluorescence, electrochemistry, electrochemiluminescence, and colorimetric techniques), their analytical performance and figures of merit in clinical diagnostics, with the future perspective in introducing MOFs in clinical laboratory diagnostics. Moreover, the different MOFs synthesis methods have been highlighted to serve as a guide for the researchers in selecting the appropriate platform that suits their research needs, and applications.


Assuntos
Técnicas Biossensoriais/métodos , Estruturas Metalorgânicas/química , Ácidos Nucleicos/análise , Animais , Técnicas Biossensoriais/instrumentação , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/métodos , Colorimetria/instrumentação , Colorimetria/métodos , Técnicas Eletroquímicas/instrumentação , Técnicas Eletroquímicas/métodos , Humanos , Medições Luminescentes/instrumentação , Medições Luminescentes/métodos , Ácidos Nucleicos/genética
3.
Ann Biol Clin (Paris) ; 77(3): 295-305, 2019 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-30977732

RESUMO

Liquid wastes from clinical biology automated systems are currently evacuated in the urban network after chemical treatment to eliminate a possible risk of infection. Since these wastes are ecotoxic because of the presence of numerous chemical reagents, we studied their intrinsic microbicidal power towards a selection of infectious agents widely found in clinical specimens. The objective was to determine if an additional anti-infectious treatment before elimination is necessary. Thus, we evaluated the bactericidal effect of liquid wastes of several automated systems towards four bacterial species (Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Enterococcus faecalis) and their virucidal activity against a non-enveloped virus, resistant in the environment (adenovirus). This effect was determined for different exposure times. Our results showed that the antibacterial activity was highly variable depending on the waste-bacteria pair considered (varying from no activity to complete sterilization of a strong bacterial inoculum). The liquid wastes were on the other hand globally inactive towards adenovirus.


Assuntos
Anti-Infecciosos/isolamento & purificação , Técnicas de Laboratório Clínico , Resíduos de Serviços de Saúde , Esgotos/análise , Esterilização , Antibacterianos/isolamento & purificação , Antibacterianos/farmacologia , Anti-Infecciosos/farmacologia , Antivirais/isolamento & purificação , Antivirais/farmacocinética , Automação Laboratorial/instrumentação , Automação Laboratorial/métodos , Biodegradação Ambiental , Líquidos Corporais/microbiologia , Líquidos Corporais/virologia , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/métodos , França , Humanos , Laboratórios/normas , Testes de Sensibilidade Microbiana , Esgotos/microbiologia , Esterilização/métodos , Esterilização/normas , Purificação da Água/métodos , Purificação da Água/normas
4.
Clin Lab ; 65(4)2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30969071

RESUMO

BACKGROUND: Cardiac troponin I (TnI) is one of the most crucial biomarkers for the management of acute coronary syndrome. However, the TnI values can vary when using commercial TnI assays from different vendors. We assessed the feasibility of TnI harmonization using plasma and serum samples. METHODS: Leftover plasma and serum samples were collected from patients and stored for further analysis (n = 200). TnI measurements were performed using 3 different analyzers. The TnI values for plasma and serum were compared, and the mathematical recalibration was performed using the mean of 3 values from each analyzer as a reference value. The number of biased cases was counted before and after recalibration. RESULTS: The final analysis was performed in a total of 140 plasma and serum samples, and constant and/or proportional differences for each analyzer were observed. Mathematical recalibration of the TnI values resulted in improved correlation to the reference values. The number of TnI values that were remote from the reference values decreased after recalibration. The effects were more evident for serum samples. CONCLUSIONS: In this study, we reassured the possibility of TnI harmonization among 3 different immunoassays using plasma and serum samples. It is important to note the differences between sample types during TnI harmonization.


Assuntos
Biomarcadores/sangue , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/métodos , Imunoensaio/normas , Plasma , Soro , Troponina I/sangue , Síndrome Coronariana Aguda/sangue , Calibragem , Humanos , Modelos Teóricos , Infarto do Miocárdio/sangue , Valores de Referência , Troponina T/sangue
5.
Clin Lab ; 65(1)2019 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-30775875

RESUMO

BACKGROUND: The aim of this study was to compare the validity of two different cTnI assay methodologies. METHODS: We collected 82 plasma samples from a stat laboratory. The plasma values of cTnI ranged from 0.012 to 29.715 ng/mL when tested on the Access® platform and from 4.5 to >40,000 ng/L when tested on the VIDAS platform. The patients included 34 females ranging in age from 49 to 100 years of age [76.7 ± 12 years] and 48 males ranging from 29 to 97 years of age [69.7 ± 12 years]. RESULTS: Our results showed that the correlation between the two troponin results was r2 = 0.9836 (p < 0.001). In this study, the kappa statistic (0.89) indicated a high degree of agreement between the VIDAS® High-sensitivity Troponin I assay and the Beckman Coulter Unicel® DXI AccuTnI+3 assay. CONCLUSIONS: In summary, the VIDAS® High-sensitivity Troponin I assay is a reliable and feasible method for determining the levels of cTnI in plasma, but it requires manual operation, hands-on technical expertise, and time.


Assuntos
Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Laboratórios/normas , Troponina I/sangue , Adulto , Idoso , Idoso de 80 Anos ou mais , Técnicas de Laboratório Clínico/instrumentação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes
6.
Artigo em Espanhol | IBECS | ID: ibc-181153

RESUMO

La interpretación y el rigor de los resultados microbiológicos siguen dependiendo en gran medida de la calidad de las muestras y el procesamiento de las mismas dentro del Servicio de Microbiología. Conocer el tipo de muestra, el momento adecuado y la manera de obtención, su conservación y transporte determinará la rentabilidad de la misma en el proceso infeccioso. En este sentido, la disponibilidad de nuevas técnicas dentro del laboratorio y el manejo, cada vez menos excepcional, de muestras con sospecha de infección por patógenos no habituales nos obligan a revisar y actualizar todos los pasos implicados en el procesamiento de las muestras. Hoy día, la automatización del laboratorio y la amplia variedad de técnicas rápidas utilizadas han hecho que el diagnóstico microbiológico tenga la rapidez y precisión necesaria para realizar un diagnóstico de calidad y clínicamente relevante; sin olvidar que, en todos los casos, la información clínica es necesaria y de vital importancia para que el microbiólogo pueda aplicar las técnicas diagnósticas disponibles de la manera más eficiente


The interpretation and the accuracy of the microbiological results still depend to a great extent on the quality of the samples and their processing within the Microbiology laboratory. The type of specimen, the appropriate time to obtain the sample, the way of sampling, the storage and transport are critical points in the diagnostic process. The availability of new laboratory techniques for unusual pathogens, makes necessary the review and update of all the steps involved in the processing of the samples. Nowadays, the laboratory automation and the availability of rapid techniques allow the precision and turn-around time necessary to help the clinicians in the decision making. In order to be efficient, it is very important to obtain clinical information to use the best diagnostic tools


Assuntos
Humanos , Técnicas de Laboratório Clínico/métodos , Técnicas Microbiológicas/métodos , Manejo de Espécimes/métodos , Automação Laboratorial , Técnicas de Laboratório Clínico/instrumentação , Meios de Cultura , Indicadores e Reagentes , Técnicas Microbiológicas/instrumentação , Preservação Biológica/métodos , Saúde Pública , Manejo de Espécimes/instrumentação , Contenção de Riscos Biológicos
7.
Ann Clin Biochem ; 56(2): 275-282, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30674211

RESUMO

BACKGROUND: Clinical laboratory instrument verification testing is often an accreditation requirement. However, it is not known what verification procedures are in routine use or how often the process identifies problems which need addressing prior to testing clinical samples. OBJECTIVE: To investigate which standards are currently being used for laboratory verification in UK and New Zealand (NZ) clinical laboratories and to help establish if the activity justifies the effort required. METHODS: A survey of verification of clinical laboratory instrumentation was distributed to members of the Association for Clinical Biochemistry and Laboratory Medicine and New Zealand Institute of Medical Laboratory Scientists. The survey consisted of questions on the verification elements used and whether acceptance criteria were met. RESULTS: Nineteen of 72 (26%) of responders only used organization-developed protocols for verification, 20/72 (28%) solely used national/international guidelines, while 16/72 (22%) used a combination. Manufacturers' claims were partly or entirely used as acceptance criteria for imprecision (89%), accuracy (64%) and analytical measuring range (94%), with these being met on 61%, 67% and 93% of occasions, respectively. For patient comparison and linearity, acceptance criteria were met by 71% and 91%. Only 27-36% undertook any troubleshooting before accepting a failed component of verification. CONCLUSIONS: Laboratories in the UK and NZ are currently using a variety of verification standards and acceptance criteria for instrument verification. It is common for instruments to fail, especially following the assessment of imprecision and accuracy. While this suggests the process is warranted, only a minority address failed elements before accepting verification.


Assuntos
Técnicas de Laboratório Clínico/instrumentação , Inquéritos e Questionários , Técnicas de Laboratório Clínico/normas , Nova Zelândia , Controle de Qualidade , Reino Unido
8.
J Matern Fetal Neonatal Med ; 32(20): 3393-3400, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29635953

RESUMO

Purpose: Current modalities for glucose monitoring are invasive and inconvenient. The search for a noninvasive technique is still ongoing, without a clinically viable product. The aim of our study was to evaluate the safety and accuracy of a novel non-invasive continuous glucometer - the Wizmi™ device. Methods: Prospective, observational, controlled clinical trial. We included healthy pregnant women designated to undergo a 3-hour oral glucose tolerance test. Each participant underwent synchronous and simultaneous glucose measurement by venous sampling of plasma glucose and non-invasive glucose by Wizmi device. Primary outcome was the accuracy of the Wizmi device as assessed by comparing between paired measurements, i.e. non-invasive glucose measurements by Wizmi versus standard plasma glucose levels, which were taken at the exact same time. Results: Thirty-two women underwent oral glucose tolerance test (OGTT), contributing 224 paired glucose measurements. Of the 224 paired measurements, all were within the clinically appropriate zones of the Clarke error grid analysis zones -208 (93%) in Zone A and 16 (7%) in zone B. Mean absolute relative difference of the Wizmi non-invasive glucose versus plasma glucose laboratory reference was 7.23% or 9.66 mg/dl. Overall, for all 224 paired measurements, across all Wizmi glucose ranges, the agreement was 86.6, 92.0, 97.8 and 99.5% for deviations within ±15, 20, 30, 40% (if glucose >80 mg/dl) or mg/dl (if glucose ≤80 mg/dl). Conclusions: Wizmi device is novel non-invasive continuous glucose monitor, safe to use, with overall high accuracy compared to a gold standard reference of plasma glucose.


Assuntos
Análise Química do Sangue/instrumentação , Glicemia/análise , Técnicas de Laboratório Clínico/métodos , Equipamentos e Provisões , Adulto , Análise Química do Sangue/efeitos adversos , Análise Química do Sangue/métodos , Análise Química do Sangue/normas , Automonitorização da Glicemia/efeitos adversos , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/métodos , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/normas , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Diabetes Gestacional/sangue , Equipamentos e Provisões/efeitos adversos , Equipamentos e Provisões/normas , Feminino , Teste de Tolerância a Glucose , Humanos , Gravidez , Gravidez em Diabéticas/sangue , Padrões de Referência , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Veias/química , Dispositivos Eletrônicos Vestíveis/efeitos adversos , Dispositivos Eletrônicos Vestíveis/normas
9.
Enferm Infecc Microbiol Clin ; 37(2): 127-134, 2019 02.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-29426791

RESUMO

The interpretation and the accuracy of the microbiological results still depend to a great extent on the quality of the samples and their processing within the Microbiology laboratory. The type of specimen, the appropriate time to obtain the sample, the way of sampling, the storage and transport are critical points in the diagnostic process. The availability of new laboratory techniques for unusual pathogens, makes necessary the review and update of all the steps involved in the processing of the samples. Nowadays, the laboratory automation and the availability of rapid techniques allow the precision and turn-around time necessary to help the clinicians in the decision making. In order to be efficient, it is very important to obtain clinical information to use the best diagnostic tools.


Assuntos
Técnicas de Laboratório Clínico/métodos , Técnicas Microbiológicas/métodos , Manejo de Espécimes/métodos , Automação Laboratorial , Técnicas de Laboratório Clínico/instrumentação , Contenção de Riscos Biológicos , Meios de Cultura , Humanos , Indicadores e Reagentes , Técnicas Microbiológicas/instrumentação , Preservação Biológica/métodos , Saúde Pública , Manejo de Espécimes/instrumentação , Temperatura Ambiente , Transportes
10.
São Paulo; s.n; s.n; 2019. 79 p. graf, tab, ilus.
Tese em Português | LILACS | ID: biblio-1007570

RESUMO

Compostos de amônio quaternário (QACs) têm sido amplamente utilizados como desinfetantes e antissépticos, sendo essenciais na prevenção e controle de infecções bacterianas na medicina humana e veterinária. Embora patógenos prioritários multirresistentes têm sido muito bem caracterizados quanto ao perfil de suscetibilidade e contexto genético da resistência aos antibióticos, dados de resistência aos QACs são limitados. Assim, o objetivo do presente estudo foi avaliar a atividade in vitro dos QACs de uso doméstico e hospitalar [cloreto de benzalcônio (BAC), cloreto de cetilpiridinio (CPC) e brometo de cetiltrimetilamônio (CTAB)], contra patógenos prioritários multirresistentes, identificando os principais genes de resistência associados. Foram estudadas 100 cepas multirresistentes previamente sequenciados usando as plataformas Illumina MiSeq e NextSeq representativas de diferentes hospedeiros (humanos e animais) e fontes (ambientes e alimentos). As cepas foram identificadas como Klebsiella pneumoniae (n= 24), Escherichia coli (n= 30); Pseudomonas aeruginosa (n= 10), Enterobacter spp, (n= 8), Acinetobacter baumannii (n= 11) e Salmonella spp. (n= 17). Genes de resistência aos QACs foram identificados in silico através do alinhamento dos contigs obtidos de cada cepa sequenciada com genes de referência obtidos do GenBank, utilizando o programa Geneious versão 8 (Biomatters Ltd). A identidade de cada gene foi analisada utilizando o programa BLASTx, no qual um critério baseado em ≥90% identidade resultou na identificação dos genes mdfA (77%), qacE (44%), qacEΔ1 (43%), sugE(c) (29%), emrE (21%), qacA (19%), sugE(p) (5%), qacF (7%), qacH (7%) e qacL (7%) em 85 cepas; enquanto que 15 cepas não possuíam nenhum gene de resistência aos QACs. A concentração inibitória mínima (CIM) dos QACs para as 100 cepas foi determinada pelo método de microdiluição em caldo. Os resultados sugeriram que a resistência em patógenos prioritários circulando na interface humano-ambiente-animal não é restrita aos antibióticos, uma vez que a elevada ocorrência de genes qacE, qacEΔ1 e mdfA poderia estar associada com uma redução da suscetibilidade para QACs. Consequentemente, a resistência aos QACs poderia também contribuir para a persistência e adaptação destes patógenos nos seres humanos e outros animais, assim como em ambientes impactados antropogenicamente


Quaternary ammonium compounds (QACs) have been widely used as disinfectants and antiseptics, being applied as essential compounds in the prevention and control of bacterial infections in human-and veterinary hospital medicine. Although multiresistant priority pathogens have been well characterized with respect to their susceptibility profile and their genetic context of resistance for antibiotics, studies of resistance to QACs are limited. Thus, the objective of the present study was to evaluate the in vitro activity of QACs [(benzalkonium chloride (BAC), cetylpyridinium chloride (CPC) and cetyltrimethylammonium bromide (CTAB)] for household and hospital use against multiresistant priority pathogens, identifying the main resistance genes associated. A hundred multiresistant isolates (previously sequenced using the Illumina MiSeq and NextSeq platforms), representative of different hosts (humans and animals) and sources (environment and food) were studied. Isolates were identified as Klebsiella pneumoniae (n=24), Escherichia coli (n=30), Pseudomonas aeruginosa (n=10), Enterobacter spp. (n=8), Acinetobacter baumannii (n=11) and Salmonella spp. (n=17). In silico analysis for identification of genes conferring resistance to QACs were performed by aligning the contigs obtained from the strains with reference genes deposited in GenBank, using the Geneious version program (Biomatters Ltd). Similarities were analyzed using the BLASTx online program, considering the alignment criteria based on ≥ 90% identity. The result of these analysis revealed the presence of the following QAC genes: mdfA (77%), qacE (44%), qacEΔ1 (43%), sugE(c) (29%), emrE (21%), qacA (19%), sugE (p) (5%), qacF (7%), qacH (7%) e qacL (7%); while 15 strains showed no resistance genes for QACs. Determination of QACs minimum inhibitory concentration (MIC) for the 100 isolates, by the broth microdilution method. These results suggest that resistance to QACs in priority pathogens, circulating at the human-environment-animal interface, is not restricted to antibiotics, since the high occurrence of genes qacE, qacEΔ1 and mdfA were associated with a reduced susceptibility to QACs. Consequently, resistance to QACs could also contribute to the persistence and adaptation of these pathogens in humans and othes animals, as well as in anthropogenically impacted environments


Assuntos
Técnicas In Vitro/instrumentação , Compostos de Amônio Quaternário/análise , Noxas , Técnicas de Laboratório Clínico/instrumentação
11.
Int J Mycobacteriol ; 7(4): 332-337, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30531030

RESUMO

Background: Nucleic acid amplification techniques have become important machineries in the diagnosis of several diseases in clinical laboratories. Polymerase chain reaction (PCR) contamination/amplicon contamination leading to false positivity remains a major concern in these laboratories. Prevention of these contaminations in establishing these molecular biology laboratories has been very crucial over the years. Although closed system PCRs have substantial reduction in the PCR contamination rates, the conventional probe-based hybridization methods continue to show occurrence of contamination for various reasons. The study involved checking the crucial parameters as well as the probable candidates of causing the contamination at a high-burden setting. Bringing out the most effective interventions in controlling the PCR contaminations for future endeavors stood as priority. The study explored the efficacies of different sets of interventions contributed to the process of reducing the contaminants. Methods: The detection of the contaminating PCR products or amplicons or contaminating organism is done by the genotype MTBDR plus V2 kits (Hains Life Sciences) based on DNA strip technology. Results: The pre- and post-cleaning as well as cleaning of the working surfaces was able to bring down the mean contamination percentage by 36.5%. The combined effect of cleaning the work surfaces, the automated pipetting devices, and the AC machines was able to bring down the mean contamination percentage to 53.5% reducing the contamination rate nearly to 94.6%. Conclusion: Regularly cleaning the work surfaces, the automated pipetting devices, the PCR machine, and the AC machines along with it filters and exposure of UV rays significantly lowers down the mean contamination percentage.


Assuntos
Técnicas de Laboratório Clínico/normas , Contaminação por DNA , Contaminação de Equipamentos/prevenção & controle , Mycobacterium/genética , Reação em Cadeia da Polimerase/normas , Técnicas Bacteriológicas/instrumentação , Técnicas Bacteriológicas/normas , Técnicas de Laboratório Clínico/instrumentação , Descontaminação/métodos , Reações Falso-Positivas , Reação em Cadeia da Polimerase/instrumentação
12.
Analyst ; 143(24): 6037-6048, 2018 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-30403209

RESUMO

Oral injuries are currently diagnosed by histopathological analysis of biopsy, which is an invasive procedure and does not give immediate results. On the other hand, the Raman spectroscopy technique is a real-time and minimally invasive analytical tool with a notable diagnostic capability. At the current stage, researchers are widely aware of the diagnostic potential of the technique and how it is considered promising for providing biochemical information in real time and without damaging the tissue. The problem originates from a lack of relevant studies and clinical trials that could show the actual use of Raman spectroscopy to help patients. Our goal here is to narrow the relationship between physicists, chemists, engineers, computer scientists, and the medical community, and in fact discuss the potential of Raman spectroscopy as a novel clinical analysis method. In the present study, we focused on the use of Raman spectroscopy as a daily clinical practice. In this context, additional studies and in vivo tests should be performed with the same approach as a real application. We want to show the scientific and industrial community what is really necessary for this, starting from a clinical point of view. Using our previous experience publishing different oral pathologies and types of samples, we also aim to discuss the current state and potential of Raman spectroscopy and what is required to implement Raman spectroscopy for oral clinical applications.


Assuntos
Técnicas de Laboratório Clínico/métodos , Doenças da Boca/diagnóstico , Análise Espectral Raman/métodos , Animais , Técnicas de Laboratório Clínico/instrumentação , Humanos , Análise Espectral Raman/instrumentação
13.
Ann Biol Clin (Paris) ; 76(6): 716-718, 2018 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-30270823

RESUMO

The European parliament finally approved the new European in vitro diagnostic regulation (IVDR) on 5 April 2017. This new regulation is shaking up the industry as it has a wider scope than its predecessor, meaning manufacturers of in vitro diagnostic medical devices must revise their compliance strategies exhaustively. In order to help manufacturers begin the process of compliance, this article highlights the principal changes in the regulation, providing a starting point for industry players. Furthermore, the article draws attention to other obstacles to conformity, in particular the shortage of notified bodies, the organisations designated by member states to carry out compliance evaluations. In addition to the commercial stakes for businesses, it is essential to bear in mind the ultimate objective of this overhaul of the regulatory framework, namely, to improve patient safety.


Assuntos
Comércio/legislação & jurisprudência , União Europeia , Legislação de Dispositivos Médicos , Kit de Reagentes para Diagnóstico , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/normas , Segurança de Equipamentos , Europa (Continente) , União Europeia/economia , Humanos , Legislação de Dispositivos Médicos/economia , Segurança do Paciente , Kit de Reagentes para Diagnóstico/classificação , Kit de Reagentes para Diagnóstico/economia , Kit de Reagentes para Diagnóstico/normas
14.
Clin Chem ; 64(10): 1485-1495, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30087138

RESUMO

BACKGROUND: Despite the usefulness of standard lipid parameters for cardiovascular disease risk assessment, undiagnosed residual risk remains high. Advanced lipoprotein testing (ALT) was developed to provide physicians with more predictive diagnostic tools. ALT methods separate and/or measure lipoproteins according to different parameters such as size, density, charge, or content, and equivalence of results across methods has not been demonstrated. METHODS: Through a split-sample study, 25 clinical specimens (CSs) were assayed in 10 laboratories before and after freezing using the major ALT methods for non-HDL particles (non-HDL-P) or apolipoprotein B-100 (apoB-100) measurements with the intent to assess their comparability in the current state of the art. RESULTS: The overall relative standard deviation (CV) of non-HDL-P and apoB-100 concentrations measured by electrospray differential mobility analysis, nuclear magnetic resonance, immunonephelometry, LC-MS/MS, and vertical autoprofile in the 25 frozen CSs was 14.1%. Within-method comparability was heterogeneous, and CV among 4 different LC-MS/MS methods was 11.4% for apoB-100. No significant effect of freezing and thawing was observed. CONCLUSIONS: This study demonstrates that ALT methods do not yet provide equivalent results for the measurement of non-HDL-P and apoB-100. The better agreement between methods harmonized to the WHO/IFCC reference material suggests that standardizing ALT methods by use of a common commutable calibrator will improve cross-platform comparability. This study provides further evidence that LC-MS/MS is the most suitable candidate reference measurement procedure to standardize apoB-100 measurement, as it would provide results with SI traceability. The absence of freezing and thawing effect suggests that frozen serum pools could be used as secondary reference materials.


Assuntos
Apolipoproteína B-100/sangue , Doenças Cardiovasculares/sangue , Técnicas de Laboratório Clínico , Lipoproteínas LDL/sangue , Lipoproteínas VLDL/sangue , Calibragem , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Humanos , Padrões de Referência , Sensibilidade e Especificidade , Manejo de Espécimes
15.
J Antimicrob Chemother ; 73(12): 3368-3374, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-30137346

RESUMO

Objectives: Colistin is a last-resort antibiotic against the critical-status pathogen Pseudomonas aeruginosa. There is still uncertainty regarding how to accurately measure colistin susceptibility in P. aeruginosa. Evaluation of antimicrobial susceptibility testing (AST) methods is largely hampered by the lack of resistant isolates and those around the susceptibility breakpoint. The aim of this study was to generate such strains in a morbidostat device for use in AST method evaluation. Methods: A morbidostat device was used to cultivate susceptible clinical strains into isolates with a wide range of colistin MICs. Subsequently, five commercial AST methods were compared against the gold standard broth microdilution (BMD) method: MICRONAUT-S, SensiTest, Sensititre, Rapid Polymyxin Pseudomonas and Etest. Results: A total of 131 P. aeruginosa isolates were used for colistin susceptibility test evaluation (100 colistin susceptible and 31 colistin resistant). The 31 colistin-resistant isolates evolved resistance in the morbidostat to different MIC ranges (4-512 mg/L, 100% resistance generation efficacy). The categorical agreement (CA) rates for MICRONAUT-S, SensiTest and Rapid Polymyxin Pseudomonas were 94.7%, 93.9% and 92.4%, respectively. The Sensititre achieved the highest CA score (96.9%), whereas the Etests had the lowest CA score (84%). The very major discrepancy (VMD) rates for all tests were between 3.2% and 67.7%. Conclusions: The morbidostat device can efficiently provide laboratories with colistin-resistant strains for test evaluation. Although CA rates were high for commercial AST methods except for Etests, none met the ≤1.5% CLSI limit for VMD rates. Performance was generally inferior when using isolates with low-level resistance.


Assuntos
Antibacterianos/farmacologia , Técnicas de Laboratório Clínico/instrumentação , Colistina/farmacologia , Testes de Sensibilidade a Antimicrobianos por Disco-Difusão/normas , Farmacorresistência Bacteriana Múltipla/genética , Pseudomonas aeruginosa/efeitos dos fármacos , Acinetobacter baumannii/efeitos dos fármacos , Testes de Sensibilidade a Antimicrobianos por Disco-Difusão/instrumentação , Humanos , Testes de Sensibilidade Microbiana/instrumentação , Testes de Sensibilidade Microbiana/métodos , Pseudomonas/efeitos dos fármacos , Infecções por Pseudomonas/microbiologia , Pseudomonas aeruginosa/isolamento & purificação
16.
Clin Lab ; 64(5): 699-708, 2018 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-29739038

RESUMO

BACKGROUND: Immature platelet fraction (IPF) is a new biomarker for thrombopoiesis and inflammation. However, the reference interval (RI) is wildly discrepant among published reports. This study aimed to establish the RI of IPF for a population in Taiwan and evaluate the effects the detection method of the analyzer, ethnicity, and reference individuals have on the RI of IPF. METHODS: The RI of absolute IPF (A-IPF) and IPF% were established with healthy subjects from the outpatient services of the Health Management Department of Taichung Veterans General Hospital between January 1, 2015 and March 1, 2016. These values were used along with published reports for meta-analysis. RESULTS: A-IPF (109/L) and IPF% of Taiwanese were 6.9 - 7.6 and 3.1 - 3.4, respectively. Significant differences were found when performing paired comparisons of the RI of A-IPF and IPF% published in reports. For A-IPF, there was only one paired comparison with a significant difference (Z > 1.96) across 6 reports. Thus, the contribution of the factors examined on the RI of IPF cannot be determined. For IPF%, there were 8 paired comparisons with significant differences across 10 reports. The discrepancy rates of RI for IPF% were 41.2%, 50.0%, and 25.0% with the difference of reference individuals, the analyzer method, and ethnicity, respectively. CONCLUSIONS: The RIs of Taiwanese for A-IPF and IPF% were established. Furthermore, the analyzer detection method and the reference individuals contribute to the discrepancy of the RI for IPF% and should be considered cautiously when the value of IPF is interpreted.


Assuntos
Biomarcadores/sangue , Plaquetas/metabolismo , Inflamação/sangue , Contagem de Plaquetas/instrumentação , Trombopoese , Adulto , Grupo com Ancestrais do Continente Asiático , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/métodos , Feminino , Humanos , Inflamação/etnologia , Masculino , Pessoa de Meia-Idade , Contagem de Plaquetas/métodos , Valores de Referência , Taiwan
18.
J Clin Microbiol ; 56(8)2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29743302

RESUMO

Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices. Antimicrobial disks for use with disk diffusion testing are among the first AST devices available to clinical laboratories. However, many laboratories are reluctant to implement disk diffusion testing for a variety of reasons, including dwindling proficiency with this method, interruptions of the laboratory workflow, uncertainty surrounding the quality and reliability of disk diffusion tests, and a perceived need to report MIC values to clinicians. This minireview provides a report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group on the current standards and clinical utility of disk diffusion testing.


Assuntos
Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/normas , Testes de Sensibilidade a Antimicrobianos por Disco-Difusão/instrumentação , Testes de Sensibilidade a Antimicrobianos por Disco-Difusão/normas , Humanos , Padrões de Referência , Reprodutibilidade dos Testes
19.
SLAS Technol ; 23(5): 423-431, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29746790

RESUMO

Laboratory automation improves test reproducibility, which is vital to patient care in clinical laboratories. Many small and specialty laboratories are excluded from the benefits of automation due to low sample number, cost, space, and/or lack of automation expertise. The Minimum Viable Option (MVO) automation platform was developed to address these hurdles and fulfill an unmet need. Consumer 3D printing enabled rapid iterative prototyping to allow for a variety of instrumentation and assay setups and procedures. Three MVO versions have been produced. MVOv1.1 successfully performed part of a clinical assay, and results were comparable to those of commercial automation. Raspberry Pi 3 Model B (RPI3) single-board computers with Sense Hardware Attached on Top (HAT) and Raspberry Pi Camera Module V2 hardware were remotely accessed and evaluated for their suitability to qualify the latest MVOv1.2 platform. Sense HAT temperature, barometric pressure, and relative humidity sensors were stable in climate-controlled environments and are useful in identifying appropriate laboratory spaces for automation placement. The RPI3 with camera plus digital dial indicator logged axis travel experiments. RPI3 with camera and Sense HAT as a light source showed promise when used for photometric dispensing tests. Individual well standard curves were necessary for well-to-well light and path length compensations.


Assuntos
Automação Laboratorial/instrumentação , Técnicas de Laboratório Clínico/instrumentação , Impressão Tridimensional , Software , Humanos
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