LOW RANGE NUCLEIC ACID CONTROLS FOR M. TUBERCULOSIS

描述(由申请人提供)：结核分枝杆菌的低范围核酸控制--这项小型企业创新研究补助金(SBIR)第一阶段申请的目标是证明为分子结核分枝杆菌检测生产定量、合成、非传染性质量控制的可行性。实验室将使用这些产品监测结核分枝杆菌脱氧核糖核酸(DNA)检测的较低检测范围，从而确保患者结果的准确性。 将使用两种新的方法。结核分枝杆菌DNA将通过创新的寡核苷酸杂交链以确定的数量结合到微粒表面。这种混合体被设计成在遵守Mtb DNA提取协议的情况下熔化并定量释放核酸。在另一种方法中，结核分枝杆菌DNA将在实验室细菌中以低拷贝数克隆。将开发创新技术来使细菌膜交联，以产生可与结核分枝杆菌相媲美的裂解抗性。这两种产品都将在商业化验的所有步骤中进行测试。该项目开发的技术将用于为诊断行业生产一系列定量分子控制并将其商业化。 用于分子分析的稳定、非传染性的质量控制材料并不广泛可用；限制了这些测试的广泛采用。结核病(TB)或其他疾病的分子检测是一项重要的医学进步；因此，公共卫生将直接受益于支持这一检测的产品。

DESCRIPTION (provided by applicant): Low Range Nucleic Acid Controls for M. tuberculosis -- The goal of this Small Business Innovation Research Grants (SBIR) Phase I application is to demonstrate feasibility of producing quantitative, synthetic, non-infectious quality controls for molecular Mtb testing. Laboratories will use these products to monitor the lower detection range of Mtb deoxyribonucleic acid (DNA) tests, thus ensuring the accuracy of patient results. Two novel approaches will be used. The Mtb DNA will be bound in defined quantity to microparticulate surfaces through innovative oligonucleotide hybrid links. The hybrid is designed to melt and quantitatively release nucleic acid when subjected to a Mtb DNA extraction protocol. In another approach, Mtb DNA will be cloned in low copy number in laboratory bacteria. Innovative techniques will be developed to cross link the bacterial membrane to produce lysis resistance comparable to the Mtb. Both products will be tested in all steps of a commercial assay. Technology developed in this project will be used to produce and commercialize a family of quantitative molecular controls for the diagnostics industry. Stable, non-infectious quality control materials for molecular assays are not widely available; limiting the widespread adoption of these tests. Molecular testing for tuberculosis (TB) or other diseases is an important medical advance; therefore public health will directly benefit from products supporting this testing.