Maine Medical Center

Maine Molecular Quality Controls, Inc.

Other

Clark A Rundell

Joan E Gordon

Calvin P Vary

The invention relates to novel nucleic acid reference standards comprising a nucleic acid comprising a known target sequence bound with a microparticulate binding agent where the binding agent includes liposomes, polyamines (e.g., nylon), siliceous compounds (e.g., silica gel, fumed silica, diatomaceous earth, glass particles, amine-modified silica, and the like), zeolites (e.g., low alumina zeolyte), polystyrene (e.g., amine-modified polystyrene, carboxy-polystyrene particles, and the like), chitin, chitosan, and combinations of these compounds. The reference standard is useful for use as a standard in any nucleic acid assay where the presence or absence of a nucleic acid of interest is being assessed. The reference standard is stable and provides a control for assessing whether the nucleic acid assay was performed properly. The invention further relates to methods of producing such reference standards and kits for using and producing the same pursuant to the teachings of the invention.

Compositions and methods relating to nucleic acid reference standards

The invention relates to novel control DNA constructs, and methods and kits for using and making the same, which provide comprehensive controls useful for quality assurance in the diagnostic detection of complex genetic diseases such as, but not limited to, cystic fibrosis, and for quality assurance in nucleic acid assays to detect components associated with an environmental condition or a biological organism.

Compositions and methods relating to control DNA construct

Stable reference nucleic acid for use in all steps of molecular screening and diagnostic assays and method of making. A desired nucleic acid sequence is amplified, ligated into an expression vector, and used to transform a vehicle. A cellular vehicle is subsequently killed without affecting the encapsulated nucleic acid. The vehicle membrane is stabilized under controlled conditions to a stability substantially matching that of a test cell membrane. The recovered nucleic acid is used as a standard or control in molecular diagnostic and genetic testing assays.

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Standish, ME, United States of America

Clark A Rundell