Laboratory Results

Howanitz, Joan H.; Howanitz, Peter J.

doi:10.1309/h0dy-6vtw-nb36-u3l6

Cited by 86 publications

(29 citation statements)

References 19 publications

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“…Studies indicate that lengthy turnaround times, i.e. the time between ordering a lab and receiving the result, lead to dissatisfaction of physicians, nurses, and patients [81-83]. It is also quite likely that lengthy turnaround times reduce physician efficiency and increase the length of hospital stays [81,84].…”

Section: Assay Development: Additional Considerationsmentioning

confidence: 99%

Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges

et al. 2013

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Tremendous efforts have been made over the past few decades to discover novel cancer biomarkers for use in clinical practice. However, a striking discrepancy exists between the effort directed toward biomarker discovery and the number of markers that make it into clinical practice. One of the confounding issues in translating a novel discovery into clinical practice is that quite often the scientists working on biomarker discovery have limited knowledge of the analytical, diagnostic, and regulatory requirements for a clinical assay. This review provides an introduction to such considerations with the aim of generating more extensive discussion for study design, assay performance, and regulatory approval in the process of translating new proteomic biomarkers from discovery into cancer diagnostics. We first describe the analytical requirements for a robust clinical biomarker assay, including concepts of precision, trueness, specificity and analytical interference, and carryover. We next introduce the clinical considerations of diagnostic accuracy, receiver operating characteristic analysis, positive and negative predictive values, and clinical utility. We finish the review by describing components of the FDA approval process for protein-based biomarkers, including classification of biomarker assays as medical devices, analytical and clinical performance requirements, and the approval process workflow. While we recognize that the road from biomarker discovery, validation, and regulatory approval to the translation into the clinical setting could be long and difficult, the reward for patients, clinicians and scientists could be rather significant.

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Section: Assay Development: Additional Considerationsmentioning

confidence: 99%

Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges

et al. 2013

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“…Atualmente, diferentes modelos de acreditação de toda a gestão da qualidade endossam este atributo nas Tabela 1 Indicadores de qualidade em medicina laboratorial (por estágios do processo total do exame) Solicitação do exame (6) . CB: código de barras; CIQ: controle interno de qualidade; CV: coeficiente de variação; MTTR: tempo médio para reparo; MTBF: tempo médio entre falhas; TAT: turnaround time.…”

Section: Qualidadeunclassified

“…A insatisfação dos clientes gerada por atrasos em diversos processos da cadeia de saúde já foi descrita, assim como o julgamento das instituições de medicina diagnóstica é também baseado na velocidade e/ou entrega de resultados (6) . A confiabilidade pode ser traduzida como a avaliação do produto ou serviço no momento do seu uso.…”

Section: Confiabilidadeunclassified

“…O impacto de resultados rápidos e prazos reduzidos é positivo para a saúde pública, para uma atuação médica de maior qualidade; assim como é também um diferencial em atendimento e serviço ao cliente (20) . Destacamos também a necessidade de observar a velocidade de processamento e entrega de resultados de exames sob a ótica do cliente médico, e não por meio apenas de benchmarking de mercado (6) .…”

Section: Velocidadeunclassified

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Fatores competitivos de produção em medicina diagnóstica: da área técnica ao mercado

Campana¹,

Faro²,

Gonzalez³

2009

J. Bras. Patol. Med. Lab.

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A medicina diagnóstica é, hoje, um conglomerado de especialidades direcionadas à realização de exames complementares no auxílio ao diagnóstico. A maior competitividade do mercado fez com que os gestores realizassem os denominados trade offs entre diferentes fatores estratégicos de produção -qualidade, confiabilidade, flexibilidade, velocidade e custo -, com o objetivo de definir o posicionamento ante a contribuição da área de produção para a organização. A determinação dos fatores escolhidos, diante das expectativas dos clientes e de um benchmarking com a concorrência, analisados de forma sistemática, define o posicionamento estratégico da organização. Para sedimentar os conceitos defendidos neste artigo, uma simulação de um caso de definição da estratégia da área de produção é apresentada. 1. Médicos patologistas clínicos; sócios diretores da Formato Clínico. 2. Biomédica; mestra em Microbiologia; sócia diretora da Formato Clínico.

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“…First, it offers convenience as the preparation of blood tests only involves a standard blood draw. 15,16 Second, the blood test is regarded as safer because the process is conducted in vitro, and thus does not expose patients to allergens. 17,18 Third, the blood tests can serve as an alternative to skin tests for patients who suffer from severe symptoms and cannot interrupt medication.…”

Section: Introductionmentioning

confidence: 99%

A selective and sensitive nanosensor for fluorescent detection of specific IgEs to purified allergens in human serum

Yun

Duan

et al. 2018

RSC Adv.

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Food allergies are increasingly recognized as a major healthcare concern. In order to sensitively and specifically detect allergies from blood samples of at-risk allergic patients, an effective magnetic fluorescence sensing platform (EMFP) was constructed. The EMFP incorporated hollow mesoporous silica nanospheres (HMNs) to amplify signal from the target IgE in addition to magnetic nanoparticles (MNPs) to capture and separate the target IgE. The application of EMFP to immunoassays indicated a detection limit of 0.0159 ng mL À1 for low concentration specific immunoglobulin E (sIgE) against purified shellfish Metapenaeus ensis (Meta. E.) allergens, which is 15 fold more sensitive than the commercially available Food and Drug Administration-approved analyzers. Notably, EMFP was specific for the targeted sIgE even with interference by other sIgEs. In addition, the detection time is only 75 min, considerably faster than current commercial ELISA kits for IgE assays. Together, these results demonstrated that EMFP has excellent sensitivity and selectivity for the rapid detection of sIgE. The method thus exhibits potential toward the rapid monitoring of sIgE against Meta. E. allergens in clinical application.

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Laboratory Results

Cited by 86 publications

References 19 publications

Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges

Translation of proteomic biomarkers into FDA approved cancer diagnostics: issues and challenges

Fatores competitivos de produção em medicina diagnóstica: da área técnica ao mercado

A selective and sensitive nanosensor for fluorescent detection of specific IgEs to purified allergens in human serum

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