Compositions and methods relating to control DNA construct
AssigneesMaine Molecular Quality Controls, Inc., Maine Medical Center Research Institute
InventorsJoan Gordon, Clark A. Rundell
Life of this patent
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Abstract
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.
Claims13
An isolated control DNA construct comprising a vector portion for expression in a cell and a target nucleic acid comprising two or more nucleic acid fragments wherein each fragment specifies a component associated with at least one of a disease state, an environmental condition, or a biological organism, wherein said component is different from a component specified by any other fragment present elsewhere in said construct, and wherein the 5′-most fragment is linked to said vector portion via a restriction site not present elsewhere in said construct, and wherein the 3′-most fragment is linked to said vector portion via a restriction site not present elsewhere in said construct, and further wherein each said fragment is flanked by a restriction site not present elsewhere in said construct, wherein each of said fragments comprise at least one exon of a gene, wherein said exon is a cystic fibrosis transmembrane conductance regulator (CFTR) exon, further wherein said CFTR exon is selected from the group consisting of exon 10 and exon 11, and wherein said restriction site is selected from the group consisting of a BssH II site, a Csp45 I site, a Age I site, and a Nco I site.
An isolated control DNA construct comprising a vector portion for expression in a cell and a target nucleic acid comprising two or more nucleic acid fragments wherein each fragment specifies a component associated with at least one of a disease state, an environmental condition, or a biological organism, wherein said component is different from a component specified by any other fragment present elsewhere in said construct, and wherein the 5′-most fragment is linked to said vector portion via a restriction site not present elsewhere in said construct, and wherein the 3′-most fragment is linked to said vector portion via a restriction site not present elsewhere in said construct, and further wherein each said fragment is flanked by a restriction site not present elsewhere in said construct, wherein said fragments comprise a nucleic acid selected from the group consisting of a Giardia lamblia nucleic acid, a Cryptosporidium parvum nucleic acid, a human immunodeficiency virus nucleic acid, a hepatitis C virus nucleic acid, a factor V nucleic acid, a Chlamydia trachomatis nucleic acid, a Mycobacterium tuberculosis nucleic acid, a nucleic acid associated with hereditary hemochromatosis, a parvovirus B19 nucleic acid, a lipoprotein lipase gene, a methyltetrahydrofolate reductase gene, a beta cystathionase synthetase nucleic acid, a Factor II nucleic acid, a Factor VII nucleic acid, a Factor VIII nucleic acid, Factor IX nucleic acid, a prothrombin nucleic acid, and a nucleic acid comprising a translocation associated with hematologic disease, wherein said nucleic acid comprising a translocation associated with hematologic disease is a BCR/abl nucleic acid.
Dependencies are inferred from the claim text.