Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 4.627
Filtrar
5.
J Med Syst ; 46(5): 25, 2022 Apr 04.
Artículo en Inglés | MEDLINE | ID: mdl-35378645

RESUMEN

After raising more than $700 million, Elizabeth Holmes, the founder and chief executive officer of a healthcare startup once valued at $10 billion, was found guilty on four charges of defrauding investors. Founded in 2003, Theranos Inc. was a privately held corporation that aimed to disrupt the diagnostics industry with rapid, direct-to-consumer laboratory testing using only "a drop of blood" and the company's patented Nanotainer technology. By exploiting gaps in regulatory policy, Theranos brought its panel of laboratory tests to patients without pre-market review or validation from peer-reviewed scientific research. Investigations into Theranos' dubious operations and inaccurate test results exposed the failed venture which had squandered millions of dollars. Theranos affected the lives and health of patients further disrupting an already tenuous relationship between healthcare and the public - the importance of which cannot be understated in the setting of the COVID-19 pandemic. As medical systems address a national public health crisis and pervasive structural inequities, we must align stakeholder incentives between industry and academic biomedical innovation to rebuild trust with our patients.


Asunto(s)
COVID-19/diagnóstico , Técnicas de Laboratorio Clínico/métodos , Fraude/prevención & control , Pandemias , COVID-19/epidemiología , Técnicas de Laboratorio Clínico/ética , Técnicas de Laboratorio Clínico/normas , Atención a la Salud , Fraude/economía , Fraude/legislación & jurisprudencia , Fraude/tendencias , Humanos , Nanoestructuras/normas , Nanotecnología/economía , Nanotecnología/normas , Salud Pública , Estados Unidos
6.
PLoS One ; 17(2): e0263736, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35134089

RESUMEN

Sudden emergence and rapid spread of COVID-19 created an inevitable need for expansion of the COVID-19 laboratory testing network across the world. The strategy to test-track-treat was advocated for quick detection and containment of the disease. Being the second most populous country in the world, India was challenged to make COVID-19 testing available and accessible in all parts of the country. The molecular laboratory testing network was augmented expeditiously, and number of laboratories was increased from one in January 2020 to 2951 till mid-September, 2021. This rapid expansion warranted the need to have inbuilt systems of quality control/ quality assurance. In addition to the ongoing inter-laboratory quality control (ILQC), India implemented an External Quality Assurance Program (EQAP) with assistance from World Health Organization (WHO) and Royal College of Pathologists, Australasia. Out of the 953 open system rRTPCR laboratories in both public and private sector who participated in the first round of EQAP, 891(93.4%) laboratories obtained a passing score of > = 80%. The satisfactory performance of Indian COVID-19 testing laboratories has boosted the confidence of the public and policy makers in the quality of testing. ILQC and EQAP need to continue to ensure adherence of the testing laboratories to the desired quality standards.


Asunto(s)
Prueba de COVID-19/normas , COVID-19/diagnóstico , Técnicas de Laboratorio Clínico/normas , Laboratorios/normas , Tamizaje Masivo/normas , Garantía de la Calidad de Atención de Salud/normas , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/normas , COVID-19/epidemiología , COVID-19/genética , COVID-19/virología , Humanos , India/epidemiología , Control de Calidad , SARS-CoV-2/genética , SARS-CoV-2/aislamiento & purificación , Manejo de Especímenes/métodos
8.
Indian J Pathol Microbiol ; 65(1): 111-116, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35074974

RESUMEN

BACKGROUND: : Many biomarkers have now been studied such as C-reactive Protein (CRP), procalcitonin (PCT), etc., and are widely used for the diagnosis of sepsis in clinical practice which may determine the appropriate antibiotic treatment. A flowcytometric cytokine bead array (CBA) assay has now been used to determine multiple interleukins (IL), simultaneously. The aim of this study was to determine the cytokine (IL2, IL4, IL6, IL10, TNFα, INFγ, and IL17) profiles of interleukins in plasma of sepsis patients by using multiplex Flowcytometric CBA array assay. MATERIALS AND METHOD: s: A total of 99 consecutive patients admitted with the suspected sepsis were studied. PCT concentrations were measured by using the enzyme-linked fluorescent immunoassay (ELFA) technique and flow cytometry-based BD™ CBA Cytokine Kit was used to evaluate levels of 7 cytokines [IL-2, IL-4, IL-6, IL-10, Tumour Necrosis Factor (TNF), Interferon- γ (IFN-γ), and IL-17A]. RESULTS: Microbiologically defined infection (MDI) demonstrated a positive culture report in 79/99 (79.7%) of patients. The IL6 [1873.7 (4-5000)] and IL10 [(154.7 (0-1764)] levels were significantly higher in septic patients than those in the negative MDI IL6 [901 (4-5000)] and IL10 [110.4 (4-1372)] levels. The AUROC value of IL6 [0.66 (0.53-0.79)] was found to be the highest among all followed by IL10 [0.65 (0.51-0.79)], IFNγ [0.63 (0.51-0.77)], PCT [0.61 (0.48-0.75)], and TNFα [0.55 (0.42-0.69)]. CONCLUSION: Our study suggests that that IL6 is substantially more economical and can reduce the investigation cost to half as compared with the procalcitonin assay.


Asunto(s)
Técnicas de Laboratorio Clínico/métodos , Técnicas de Laboratorio Clínico/normas , Interleucinas/sangre , Polipéptido alfa Relacionado con Calcitonina/sangre , Sepsis/diagnóstico , Biomarcadores/sangre , Enfermedad Crítica , Humanos , Curva ROC , Sepsis/inmunología , Atención Terciaria de Salud/estadística & datos numéricos
9.
Pediatr Infect Dis J ; 41(1): 6-11, 2022 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-34508026

RESUMEN

BACKGROUND: China has a high burden of tuberculosis and latent tuberculosis infection (LTBI). The aim of this study was to estimate the prevalence of LTBI among healthy young children and adolescents and test a 2-step approach to explore the threshold for the diagnosis of tuberculosis infection in Chengdu, China. METHODS: Healthy preschool children and school-going children in Chengdu, Sichuan Province, were screened for LTBI using the tuberculin skin test (TST). Preschool children with TST ≥ 5 mm also underwent interferon-γ release assay (IGRA) to explore the threshold of this 2-step approach. RESULTS: In total, 5667 healthy young children and adolescents completed TST test between July 2020 and January 2021 and were included in the present analysis. The age of the participants ranged from 2.4 to 18 years (median 7.25 ± 4.514 years), of which 2093 (36.9%) were younger than 5 years. The overall prevalence of LTBI was 6.37% and 6.64% in children younger than 5 years old. Fourteen of the 341 preschool children with TST ≥5 mm were interferon-γ release assay positive, of which 4 showed a TST result of 5-10 mm, and 6 preschool children received preventive treatment for LTBI. CONCLUSIONS: Healthy young children and adolescents should also be considered as important target populations for LTBI screening. TST can be recommended for first-line screening as part of a 2-step approach for LTBI screening using a positive threshold of 5 mm.


Asunto(s)
Técnicas de Laboratorio Clínico/métodos , Ensayos de Liberación de Interferón gamma/estadística & datos numéricos , Tuberculosis Latente/diagnóstico , Tuberculosis Latente/epidemiología , Prueba de Tuberculina/estadística & datos numéricos , Adolescente , Niño , Preescolar , China/epidemiología , Técnicas de Laboratorio Clínico/normas , Femenino , Voluntarios Sanos , Humanos , Ensayos de Liberación de Interferón gamma/economía , Ensayos de Liberación de Interferón gamma/métodos , Masculino , Prevalencia , Reproducibilidad de los Resultados , Prueba de Tuberculina/economía , Prueba de Tuberculina/métodos
10.
Front Immunol ; 12: 721289, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34858394

RESUMEN

Inborn errors of immunity (IEI), which were previously termed primary immunodeficiency diseases, represent a large and growing heterogeneous group of diseases that are mostly monogenic. In addition to increased susceptibility to infections, other clinical phenotypes have recently been associated with IEI, such as autoimmune disorders, severe allergies, autoinflammatory disorders, benign lymphoproliferative diseases, and malignant manifestations. The IUIS 2019 classification comprises 430 distinct defects that, although rare individually, represent a group affecting a significant number of patients, with an overall prevalence of 1:1,200-2,000 in the general population. Early IEI diagnosis is critical for appropriate therapy and genetic counseling, however, this process is deeply dependent on accurate laboratory tests. Despite the striking importance of laboratory data for clinical immunologists, several IEI-relevant immunoassays still lack standardization, including standardized protocols, reference materials, and external quality assessment programs. Moreover, well-established reference values mostly remain to be determined, especially for early ages, when the most severe conditions manifest and diagnosis is critical for patient survival. In this article, we intend to approach the issue of standardization and quality control of the nonfunctional diagnostic tests used for IEI, focusing on those frequently utilized in clinical practice. Herein, we will focus on discussing the issues of nonfunctional immunoassays (flow cytometry, enzyme-linked immunosorbent assays, and turbidimetry/nephelometry, among others), as defined by the pure quantification of proteins or cell subsets without cell activation or cell culture-based methods.


Asunto(s)
Técnicas de Laboratorio Clínico/normas , Inmunoensayo/normas , Enfermedades de Inmunodeficiencia Primaria/diagnóstico , Técnicas de Cultivo de Célula , Diagnóstico Precoz , Ensayo de Inmunoadsorción Enzimática , Citometría de Flujo , Humanos , Nefelometría y Turbidimetría , Garantía de la Calidad de Atención de Salud , Estándares de Referencia
11.
Dtsch Med Wochenschr ; 146(20): 1360-1368, 2021 10.
Artículo en Alemán | MEDLINE | ID: mdl-34644797

RESUMEN

The main symptom of hemorrhagic diathesis is an increased bleeding tendency. Due to the subjectivity of various features of the bleeding history, unclarity of the family history, and an individualization of the extent of diagnostic the evaluation of a suspected bleeding disorder represents a challenging endeavour in hematology. Hemorrhagic diathesis can be divided into the following sub-categories: disorders in primary hemostasis (e. g. von Willebrand disease, different causes of thrombocytopenia), secondary hemostasis (e. g. hemophilia A and B, Vitamin K deficiency) and fibrinolysis, and in connective tissue or vascular formation. This article reviews available diagnostic methods for bleeding disorders, from structured patient history to highly specialized laboratory diagnosis.


Asunto(s)
Técnicas de Laboratorio Clínico , Hemorragia/diagnóstico , Anamnesis , Examen Físico , Técnicas de Laboratorio Clínico/métodos , Técnicas de Laboratorio Clínico/normas , Diagnóstico Diferencial , Hemorragia/clasificación , Hemorragia/fisiopatología , Humanos , Anamnesis/métodos , Anamnesis/normas , Tiempo de Tromboplastina Parcial , Examen Físico/métodos , Examen Físico/normas , Pruebas de Función Plaquetaria , Trombocitopenia/clasificación , Trombocitopenia/diagnóstico , Trombocitopenia/fisiopatología
12.
Viruses ; 13(8)2021 08 10.
Artículo en Inglés | MEDLINE | ID: mdl-34452448

RESUMEN

Multiple serotypes and topotypes of foot-and-mouth disease virus (FMDV) circulate in endemic areas, posing considerable impacts locally. In addition, introductions into new areas are of great concern. Indeed, in recent years, multiple FMDV outbreaks, caused by topotypes that have escaped from their original areas, have been recorded in various parts of the world. In both cases, rapid and accurate diagnosis, including the identification of the serotype and topotype causing the given outbreaks, plays an important role in the implementation of the most effective and appropriate measures to control the spread of the disease. In the present study, we describe the performance of a range of diagnostic and typing tools for FMDV on a panel of vesicular samples collected in northern Tanzania (East Africa, EA) during 2012-2018. Specifically, we tested these samples with a real-time RT-PCR targeting 3D sequence for pan-FMDV detection; an FMDV monoclonal antibody-based antigen (Ag) detection and serotyping ELISA kit; virus isolation (VI) on LFBKαVß6 cell line; and a panel of four topotype-specific real-time RT-PCRs, specifically tailored for circulating strains in EA. The 3D real-time RT-PCR showed the highest diagnostic sensitivity, but it lacked typing capacity. Ag-ELISA detected and typed FMDV in 71% of sample homogenates, while VI combined with Ag-ELISA for typing showed an efficiency of 82%. The panel of topotype-specific real-time RT-PCRs identified and typed FMDV in 93% of samples. However, the SAT1 real-time RT-PCR had the highest (20%) failure rate. Briefly, topotype-specific real-time RT-PCRs had the highest serotyping capacity for EA FMDVs, although four assays were required, while the Ag-ELISA, which was less sensitive, was the most user-friendly, hence suitable for any laboratory level. In conclusion, when the four compared tests were used in combination, both the diagnostic and serotyping performances approached 100%.


Asunto(s)
Técnicas de Laboratorio Clínico/métodos , Ensayo de Inmunoadsorción Enzimática/métodos , Virus de la Fiebre Aftosa/clasificación , Virus de la Fiebre Aftosa/genética , Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Serotipificación/métodos , África Oriental , Animales , Anticuerpos Antivirales , Técnicas de Laboratorio Clínico/normas , Ensayo de Inmunoadsorción Enzimática/normas , Fiebre Aftosa/virología , Filogenia , Reacción en Cadena en Tiempo Real de la Polimerasa/normas , Sensibilidad y Especificidad , Serogrupo , Serotipificación/normas
13.
Nat Med ; 27(9): 1582-1591, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34426707

RESUMEN

Standardized lab tests are central for patient evaluation, differential diagnosis and treatment. Interpretation of these data is nevertheless lacking quantitative and personalized metrics. Here we report on the modeling of 2.1 billion lab measurements of 92 different lab tests from 2.8 million adults over a span of 18 years. Following unsupervised filtering of 131 chronic conditions and 5,223 drug-test pairs we performed a virtual survey of lab tests distributions in healthy individuals. Age and sex alone explain less than 10% of the within-normal test variance in 89 out of 92 tests. Personalized models based on patients' history explain 60% of the variance for 17 tests and over 36% for half of the tests. This allows for systematic stratification of the risk for future abnormal test levels and subsequent emerging disease. Multivariate modeling of within-normal lab tests can be readily implemented as a basis for quantitative patient evaluation.


Asunto(s)
Técnicas de Laboratorio Clínico/normas , Voluntarios Sanos , Medicina de Precisión , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Adulto Joven
14.
J Med Virol ; 93(11): 6404-6407, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34347299

RESUMEN

Heterophile antibody assays have been used to aid the diagnosis of infectious mononucleosis caused by the Epstein-Barr virus. Seven commercially available assays currently widely utilized in clinical laboratories were compared in this study. Variable performance characteristics and assay times are observed, and these pieces of data may assist clinical laboratories in assay selection and result interpretation.


Asunto(s)
Anticuerpos Heterófilos/sangre , Anticuerpos Antivirales/sangre , Técnicas de Laboratorio Clínico/normas , Infecciones por Virus de Epstein-Barr/diagnóstico , Mononucleosis Infecciosa/diagnóstico , Mononucleosis Infecciosa/inmunología , Juego de Reactivos para Diagnóstico/normas , Adolescente , Anticuerpos Heterófilos/inmunología , Niño , Técnicas de Laboratorio Clínico/métodos , Infecciones por Virus de Epstein-Barr/sangre , Humanos , Inmunoglobulina M/sangre , Mononucleosis Infecciosa/sangre , Adulto Joven
15.
AANA J ; 89(4): 281-282, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-34342564

RESUMEN

In a series of commentaries in recent issues of the New England Journal of Medicine, potential bias in pulse oximetry has been questioned.


Asunto(s)
Técnicas de Laboratorio Clínico/normas , Guías como Asunto , Oximetría/normas , Racismo , Humanos , Estados Unidos
17.
South Med J ; 114(7): 401-403, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34215891

RESUMEN

OBJECTIVES: The American Society of Hematology's 4T scoring system is a validated tool to assess a patient's probability of having heparin-induced thrombocytopenia (HIT) before testing is performed. There is no benefit to testing patients with a low probability 4T score for HIT. This study aimed to assess for inappropriate HIT testing at our institution based on 4T scoring. METHODS: We retrospectively reviewed 201 patient charts and calculated 4T scores and testing costs to assess for inappropriate testing and the economic impact of such testing. RESULTS: HIT testing often occurred in the least appropriate patients and resulted in tens of thousands of dollars of waste for unnecessary testing. CONCLUSIONS: Inappropriate testing for HIT is still a prevalent issue despite literature supporting the 4T score for guidance in testing appropriateness.


Asunto(s)
Análisis Costo-Beneficio/clasificación , Heparina/efectos adversos , Sobretratamiento/economía , Trombocitopenia/etiología , Adulto , Anciano , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Técnicas de Laboratorio Clínico/economía , Técnicas de Laboratorio Clínico/normas , Técnicas de Laboratorio Clínico/estadística & datos numéricos , Análisis Costo-Beneficio/métodos , Femenino , Heparina/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Sobretratamiento/prevención & control , Curva ROC , Estudios Retrospectivos
18.
Pediatr Infect Dis J ; 40(9): e351-e353, 2021 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-34260500

RESUMEN

We compared pathogen detection between saliva, nasopharyngeal and oropharyngeal swabs in children with respiratory symptoms. The sensitivity in nasopharyngeal swabs was 93% (95% confidence interval [CI]: 78%-98%), in oropharyngeal swabs 79% (95% CI: 60%-90%), in saliva overall 76% (95% CI: 58%-88%) and in 18 saliva samples collected with drooling or sponges, 94% (95% CI: 74%-99%). Saliva could be a relevant specimen alternative.


Asunto(s)
Técnicas de Laboratorio Clínico/normas , Infecciones del Sistema Respiratorio/diagnóstico , Saliva/microbiología , Saliva/virología , Virus/genética , Adolescente , Bordetella pertussis/genética , Bordetella pertussis/patogenicidad , Niño , Preescolar , Técnicas de Laboratorio Clínico/métodos , Femenino , Humanos , Lactante , Masculino , Reacción en Cadena de la Polimerasa Multiplex , Mycoplasma pneumoniae/genética , Mycoplasma pneumoniae/patogenicidad , Nasofaringe/microbiología , Nasofaringe/virología , Orofaringe/microbiología , Orofaringe/virología , Estudios Prospectivos , Infecciones del Sistema Respiratorio/microbiología , Infecciones del Sistema Respiratorio/virología , Sensibilidad y Especificidad , Manejo de Especímenes , Virus/clasificación , Virus/patogenicidad
19.
Indian J Pathol Microbiol ; 64(Supplement): S104-S111, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-34135151

RESUMEN

Nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) is a major cause of liver fibrosis/cirrhosis and liver-related mortality. Despite emergence of noninvasive tests, liver biopsy remains the mainstay for the diagnosis and assessment of disease severity and chronicity. Accurate detection and quantification of liver fibrosis with architectural localization are essential for assessing the severity of NAFLD and its response to antifibrotic therapy in clinical trials. Conventional histological scoring systems for liver fibrosis are semiquantitative. Collagen proportionate area is morphometric by measuring the percentage of fibrosis on a continuous scale but is limited by the absence of architectural input. Ultra-fast laser microscopy, e.g., second harmonic generation (SHG) imaging, has enabled in-depth analysis of fibrillary collagen based on intrinsic optical signals. Quantification and calculation of different detailed variables of collagen fibers can be used to establish algorithm-based quantitative fibrosis scores (e.g. qFibrosis, q-FPs) in NAFLD. Artificial intelligence is being explored to further develop quantitative fibrosis scoring methods. SHG microscopy should be considered the new gold standard for the quantitative assessment of liver fibrosis, reaffirming the pivotal role of the liver biopsy in NAFLD, at least for the near-future. The ability of SHG-derived algorithms to intuitively detect subtle nuances in liver fibrosis changes over a continuous scale should be employed to redress the efficacy endpoint for fibrosis in NASH clinical trials. The current decrease by 1-point or more in fibrosis stage may not be realistic for the evaluation of therapeutic response to antifibrotic drugs in relatively short-term trials.


Asunto(s)
Algoritmos , Técnicas de Laboratorio Clínico/métodos , Fibrosis/diagnóstico , Hígado/patología , Enfermedad del Hígado Graso no Alcohólico/diagnóstico , Inteligencia Artificial , Biopsia/métodos , Técnicas de Laboratorio Clínico/normas , Fibrosis/etiología , Humanos , Enfermedad del Hígado Graso no Alcohólico/complicaciones , Índice de Severidad de la Enfermedad
20.
Nutrients ; 13(6)2021 May 21.
Artículo en Inglés | MEDLINE | ID: mdl-34064098

RESUMEN

Vitamin D is a micronutrient with pleiotropic effects in humans. Due to sedentary lifestyles and increasing time spent indoors, a growing body of research is revealing that vitamin D deficiency is a global problem. Despite the routine measurement of vitamin D in clinical laboratories and many years of efforts, methods of vitamin D analysis have yet to be standardized and are burdened with significant difficulties. This review summarizes several key analytical and clinical challenges that accompany the current methods for measuring vitamin D. According to an external quality assessment, methods and laboratories still produce a high degree of variability. Structurally similar metabolites are a source of significant interference. Furthermore, there is still no consensus on the normal values of vitamin D in a healthy population. These and other problems discussed herein can be a source of inconsistency in the results of research studies.


Asunto(s)
Técnicas de Laboratorio Clínico/normas , Evaluación Nutricional , Deficiencia de Vitamina D/diagnóstico , Vitamina D/análisis , Técnicas de Laboratorio Clínico/métodos , Humanos , Laboratorios/normas , Estándares de Referencia , Valores de Referencia , Reproducibilidad de los Resultados
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA
...