Serum Multimarkers Assay based Rapid Test (SMART) for Systemic lupus erythematosus

 描述（由申请人提供）：用于系统性红斑狼疮的基于血清多标志物测定的快速检测（SMART）全血生物标志物蛋白质组的测量对于疾病的早期检测、个性化治疗的指导和药物开发具有很大的希望。为了广泛的临床应用，需要提供高便携性、低成本、高灵敏度和准确性、自动操作并且需要最少的技术专长的新设备。在这方面，微/纳米工程技术，如芯片实验室技术和纳米传感器正在成为下一个革命工具，用于候选生物标志物的用户友好的定量多重诊断的未实现的承诺。这些优点可以整合到基于ELISA的测定中，其具有电可记录格式，用于测量来自全血的复杂疾病如系统性红斑狼疮（SLE）的血清生物标志物。临床症状的变化、不稳定的发作和缓解、不可预测的严重程度和缺乏真正的生物标志物（需要多种生物标志物特征来反映SLE的所有方面）影响了多方面疾病的临床管理。此外，护理点分析优于非现场测定，这带来了更艰巨的生物分析挑战。因此，迫切需要开发低成本、可靠、便携、人工干预少的SLE多标志物诊断设备。因此，Biopico Systems Inc.与加州大学欧文分校合作，推出了一种真正革命性的基于血清多标记物检测的快速检测（SMART），该检测使用从全血中提取的微流体血清和使用纳米传感器阵列的多路传感。该SMART系统将使实验室分析能够更快，直接，准确和选择性地用于各种疾病面板，因此有可能被小型化和集成为接受治疗的患者的用户友好的护理点系统。将统计分析种族背景、年龄、性别和疾病阶段对大量患者样品中实验结果的影响，以建立SLE候选生物标志物的表达模式和百分比关联。

 DESCRIPTION (provided by applicant): Serum Multimarkers Assay Based Rapid Test (SMART) for Systemic Lupus Erythematosus Measurement of panels of biomarker proteins from whole blood holds great promise for early detection of diseases, guidance to personalized therapy, and drug development. For broad clinical applicability, new devices are needed that offer high portability, low cost, high sensitivity and accuracy, automatic operation and require minimal technical expertise. In this regard, micro/nano engineering techniques such as lab-on-a-chip technologies and nanosensors are emerging as the next revolution tools for this unrealized promise of user-friendly quantitative multiplexed diagnostics for candidate biomarkers. Such advantages can be integrated in ELISA based assay with an electrically recordable format for the measurement of serum biomarkers from whole blood for complex diseases such as Systemic Lupus Erythematosus (SLE). The clinical management of the multifaceted diseases is tampered by variation of clinical symptoms, unsteady flares and remissions, unpredictable severity and absence of true biomarkers which demand multiple biomarker signatures to reflect all aspects of SLE. Further, point-of-care analyses are preferred over off-site determinations, posing an even more formidable bioanalytical challenge. So there is an urgent need for the development of low cost, reliable and portable devices with less human intervention for the multimarker diagnostics of SLE. Therefore Biopico Systems Inc. teams with University of California, Irvine to bring out a truly revolutionary Serum Multimarkers Assay based Rapid Test (SMART) using microfluidic serum extraction from whole blood and multiplexed sensing using nanosensor array. This SMART system will enable laboratory analysis for faster, direct, accurate and selective for a wide variety of diseases panel and so has the potential to be miniaturized and integrated as a user-friendly point of care system for patients undergoing therapy. The influence of racial background, age, gender and disease stage on experimental outcome among large number of patients' samples will be statistically analyzed to establish expression pattern and percent association of the candidate biomarkers of SLE.