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

 描述(申请人提供)：基于血清多标记物分析的快速检测(SMART)治疗系统性红斑狼疮从全血中检测生物标记物蛋白质组在早期发现疾病、指导个性化治疗和药物开发方面具有很大的希望。为了广泛的临床应用，需要具有高便携性、低成本、高灵敏度和精确度、自动化操作且需要最少技术专业知识的新设备。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，正在成为下一次革命的工具，以实现对候选生物标志物进行用户友好的定量多路诊断这一未实现的承诺。这些优势可以整合到基于ELISA法和电子记录格式的分析中，用于从全血中测量系统性红斑狼疮(SLE)等复杂疾病的血清生物标记物。多方面疾病的临床处理受到临床症状的变化、不稳定的病情和缓解、严重程度不可预测以及缺乏真正的生物标记物的影响，这些都需要多个生物标记物的签名来反映SLE的各个方面。此外，与非现场测定相比，现场分析更受欢迎，这给生物分析带来了更大的挑战。因此，迫切需要开发低成本、可靠、便携、人为干预少的设备用于系统性红斑狼疮的多标记诊断。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分析的快速检测(SMART)，该方法使用从全血中提取微流控血清并使用纳米传感器阵列进行多路传感。这一智能系统将使实验室能够对各种疾病进行更快、直接、准确和选择性的分析，因此有可能被微型化并集成为接受治疗的患者的用户友好的护理点系统。在大量的患者样本中，统计分析种族背景、年龄、性别和疾病阶段对实验结果的影响，以建立SLE候选生物标志物的表达模式和百分比关联度。

 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.