LOW RANGE NUCLEIC ACID CONTROLS FOR M. TUBERCULOSIS

结核分枝杆菌的低范围核酸对照

• 批准号: 6583658
• 负责人: Clark A. Rundell
• 金额: $ 12.02万
• 依托单位: MAINE MOLECULAR QUALITY CONTROLS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-15 至 2005-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6583658
• 关键词: Mycobacterium tuberculosis; bacterial DNA; biotechnology; cell membrane; communicable disease diagnosis; crosslink; diagnosis design /evaluation; molecular cloning; nucleic acid hybridization; nucleic acid probes; nucleic acid quantitation /detection; oligonucleotides; technology /technique development; tuberculin test; tuberculosis

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.

描述（由申请人提供）：结核分枝杆菌的低范围核酸控制-这项小企业创新研究资助（SBIR）第一期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。