Preanalytic and Analytic Quality System Considerations in Noncoding RNA Biomarker Development for Clinical Diagnostics.

IF 1.1 4区 生物学 Q4 GENETICS & HEREDITY Genetic testing and molecular biomarkers Pub Date : 2023-05-01 DOI:10.1089/gtmb.2022.0086
William S Schleif, Sara M Sarasua, Jane M DeLuca
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Abstract

A frequent topic of biomedical research is the potential clinical use of non-coding (nc) RNAs as quantitative biomarkers for a broad spectrum of health and disease. However, ncRNA analyses have not been pressed into widespread diagnostic use. Strong preclinical evidence suggests obstacles in the translation and reproducibility of this type of biomarker which may result from preanalytical and analytical variation in the non-standardized processes used to collect, process, and store samples, as well as the substantive differences between small and long ncRNA. We performed a narrative review of selected literature, through the lens of key laboratory-developed test (LDT) regulations under the Clinical Laboratory Improvement Amendments (CLIA) in the United States, to study critical gaps in ncRNA validation studies. This review describes the leading candidate ncRNA subclasses, their biogenesis and cellular function, and identifies specific pre-analytical variables with disproportionate impact on testing performance. We summarize these findings with strategic recommendations to clinicians and biomedical scientists involved in the design, conduct, and translation of ncRNA biomarker development.

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临床诊断用非编码RNA生物标志物开发中的预分析和分析质量体系考虑因素。
生物医学研究的一个常见主题是非编码(nc)RNA作为广泛健康和疾病的定量生物标志物的潜在临床应用。然而,ncRNA分析尚未被广泛用于诊断。强有力的临床前证据表明,这类生物标志物的翻译和再现性存在障碍,这可能是由于用于收集、处理和储存样本的非标准化过程中的预分析和分析变化,以及小ncRNA和长ncRNA之间的实质性差异。我们通过美国《临床实验室改进修正案》(CLIA)下的关键实验室开发测试(LDT)法规,对选定的文献进行了叙述性审查,以研究ncRNA验证研究中的关键差距。这篇综述描述了主要的候选ncRNA亚类,它们的生物发生和细胞功能,并确定了对测试性能有不成比例影响的特定预分析变量。我们总结了这些发现,并向参与ncRNA生物标志物开发的临床医生和生物医学科学家提出了战略建议。
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来源期刊
CiteScore
2.50
自引率
7.10%
发文量
63
审稿时长
1 months
期刊介绍: Genetic Testing and Molecular Biomarkers is the leading peer-reviewed journal covering all aspects of human genetic testing including molecular biomarkers. The Journal provides a forum for the development of new technology; the application of testing to decision making in an increasingly varied set of clinical situations; ethical, legal, social, and economic aspects of genetic testing; and issues concerning effective genetic counseling. This is the definitive resource for researchers, clinicians, and scientists who develop, perform, and interpret genetic tests and their results. Genetic Testing and Molecular Biomarkers coverage includes: -Diagnosis across the life span- Risk assessment- Carrier detection in individuals, couples, and populations- Novel methods and new instrumentation for genetic testing- Results of molecular, biochemical, and cytogenetic testing- Genetic counseling
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