Claims for Patent: 8,859,199

Summary for Patent: 8,859,199

Title:	Use of an extraction control in a method of extracting nucleic acids
Abstract:	The present invention relates to a method of ensuring the effectiveness of the extraction workup from a biological sample of nucleic acid. The inventive method is able to distinguish between possible defects in the extraction of nucleic acid from a sample and possible defects in a subsequent amplification step. The present invention also relates to a packaged array for extracting nucleic acid from a biological sample.
Inventor(s):	Hellyer; Tobin (Westminster, MD), Fort; Thomas (Hanover, PA), McMillian; Ray A. (Timonium, MD)
Assignee:	Becton, Dickinson and Company (Franklin Lakes, NJ)
Application Number:	12/062,602
Patent Claims:	1. A method of detecting, verifying, and/or calibrating the extraction of nucleic acid from a biological sample in an assay, the method comprising: a) obtaining a biological sample; b) combining one or more nucleic acid extraction control sequences with the biological sample; c) extracting nucleic acid from the biological sample concurrently with and/or after step b to yield an extract; d) subjecting the extract to an amplification reaction that produces additional copies of the extracted nucleic acid e) detecting the presence of and/or quantifying the amount of the nucleic acid extraction control sequences in the extract; wherein the one or more nucleic acid extraction control sequences are structurally modified to be non-extendable and therefore not amplifiable when the biological sample is subjected to the amplification reaction and is detected and/or quantified without an amplification step, and further wherein the nucleic acid extraction control sequence is capable of being detected without interference from material in the biological sample. 2. The method of claim 1, wherein the biological sample is body fluid from a human selected from the group consisting of urine, saliva, whole blood, plasma, lymph fluid, semen, vaginal fluid, sweat, tears, and mixtures thereof. 3. The method of claim 1, wherein the one or more extraction control sequences comprise RNA or DNA labeled with a detectable moiety selected from the group consisting of a chromophore, a fluorophor, a radiolabel, or an enzyme, or is detectable by hybridization. 4. The method of claim 3, wherein the one or more extraction control sequences have a 3' end modified to essentially prohibit enzymatic chain extension. 5. The method of claim 3, wherein the one or more extraction control sequences contain a nucleic acid sequence selected from a known intron sequence and/or is capable of forming an internal hairpin structure. 6. The method of claim 1, wherein step c comprises either c1) reversibly binding nucleic acid to a solid support, washing the solid support to remove molecules that are bound less tightly than nucleic acid, and releasing nucleic acid from the solid support; or c2) irreversibly binding nucleic acid to a solid support, and washing the solid support to remove molecules that are bound less tightly than nucleic acid. 7. The method of claim 1, wherein the biological sample contains nucleic acid obtained from an organism selected from the group consisting of Chlamydia trachomatis and Neisseria gonorrhoeae. 8. The method of claim 1, wherein the one or more extraction control sequences comprise a set of two or more different nucleic acids that can be detected and/or quantified independently of each other. 9. A kit for extracting nucleic acid from multiple biological samples for use in an assay, wherein the kit comprises: a) a set of first vessels containing nucleic acid extraction control sequences, wherein the nucleic acid extraction control sequences are structurally modified to be non-extendable and therefore not amplifiable when biological samples combined with the nucleic acid control sequences are subjected to an amplification step in the assay and are detected and/or quantified without interference from target nucleic acid, and further wherein the detection and/or quantification is through a labeled moiety attached to the nucleic acid extraction control sequences or through hybridization without amplification of the nucleic acid extraction control sequences to a labeled species; b) an aliquot of a solid support having an affinity for nucleic acid located in at least the first set of vessels; c) a means for extracting nucleic acid; d) means for amplifying extracted nucleic acid whereby additional copies of the extracted nucleic acid are produced and wherein during such amplification the extraction control is not amplified; and e) optionally a set of second vessels for independent placement of multiple biological samples that allows for transfer of material between the first vessels and the second vessels. 10. The kit of claim 9, wherein the nucleic acid extraction control sequences are in a dry form suitable for combination with a biological sample and subsequent extraction. 11. The kit of claim 9, further comprising aliquots of a solid support having an affinity for nucleic acid located in the optional second set of vessels for placement of multiple biological samples. 12. The kit of claim 9, wherein the multiple biological samples are to be tested for the presence of one or more nucleic acids obtained from an organism selected from the group consisting of Chlamydia trachomatis and Neisseria gonorrhoeae.

Details for Patent 8,859,199

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2024-04-23
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2024-04-23
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2024-04-23