Hadd Andrew G, Brown Justin T, Andruss Bernard F, Ye Fei, WalkerPeach Cindy R
Ambion Diagnostics, 2130 Woodward Street, Austin, TX 78744, USA.
Expert Rev Mol Diagn. 2005 May;5(3):409-20. doi: 10.1586/14737159.5.3.409.
Array-based methods are making substantial contributions to the discovery of disease biomarkers and are fueling the growth of multianalyte testing for disease diagnosis and treatment. The distillation of high-density array results into sets of signature markers promises to improve disease staging, risk stratification and treatment decisions. To accommodate the growing requirement for multiplex testing, clinical laboratories are converting several single-analyte tests into array-based formats. However, adoption of array technologies provides several challenges to the laboratory, which must evaluate these new formats, train laboratory personnel, market the new services and obtain reimbursement for new analytes. Liquid-bead arrays are an attractive format for routine clinical diagnostics due to a combination of appropriate analyte density, simultaneous array decoding and detection, and flexibility for rapid customization. In this review, the suitability of several array platforms to diagnostic testing and applications of liquid-bead arrays for cystic fibrosis testing, multidisease carrier status assays and leukemia subtyping are discussed. As our understanding of the clinical utility of new or established biomarkers and recommendations for testing change, flexibility and adaptability of array platforms will be imperative. Future development of novel assay formats and improved quantitation will expand the number of diseases tested and lead to further integration into the diagnostic laboratory.
基于芯片的方法正在为疾病生物标志物的发现做出重大贡献，并推动用于疾病诊断和治疗的多分析物检测的发展。将高密度芯片结果提炼为特征性标志物集有望改善疾病分期、风险分层和治疗决策。为了满足多重检测不断增长的需求，临床实验室正在将多种单分析物检测转换为基于芯片的形式。然而，采用芯片技术给实验室带来了诸多挑战，实验室必须评估这些新形式，培训实验室人员，推广新服务并为新分析物获得报销。由于具有合适的分析物密度、同时进行芯片解码和检测以及快速定制的灵活性，液珠芯片是常规临床诊断的一种有吸引力的形式。在这篇综述中，讨论了几种芯片平台对诊断检测的适用性以及液珠芯片在囊性纤维化检测、多种疾病携带者状态检测和白血病亚型分型中的应用。随着我们对新的或已确立生物标志物的临床效用以及检测建议的理解发生变化，芯片平台的灵活性和适应性将变得至关重要。新型检测形式的未来发展和改进的定量方法将扩大检测疾病的数量，并导致进一步融入诊断实验室。
