LOW RANGE NUCLEIC ACID CONTROLS FOR M. 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.