Patent ID: 11970732
Assignee: LOGONE BIO CONVERGENCE RESEARCH FOUNDATION
Field: Biotechnology (Chemistry)
Classification: CPC C  G | IPC C

Claim 7:
8. A method for selecting a nucleic acid from a biological sample which provides a reliable gene analysis result, the method comprising the steps of:
(a) extracting a nucleic acid from a biological sample obtained from a subject;
(b) performing a first digital Polymerase Chain Reaction (PCR) on the extracted nucleic acid with i) primers or ii) a set of primers and a probe which are capable of amplifying an internal quality control region in the extracted nucleic acid, wherein the internal quality control region is located at a site adjacent to and within 20 kilobases (kb) of a target gene or a gene comprising a mutation site in the extracted nucleic acid;
(c) calculating a copy number of the internal quality control region from the result of the first digital PCR;
(d) performing a second digital Polymerase Chain Reaction (PCR) on the extracted nucleic acid with iii) primers or iv) a set of primers and a probe which are capable of amplifying a target gene or mutation site;
(e) calculating the copy number of the target gene or the mutation site from the result of the second digital PCR; and
(f) calculating a % mutation index according to the following equation:

% mutation index=the copy number of the target gene or mutation site/the copy number of the internal quality control region×100; and

(g) selecting a nucleic acid from the biological sample for a reliable gene analysis in accordance with the % mutation index as determined quantitatively in step (f);
wherein a detected copy number of the internal quality control region/the copy number of input DNA of the reference standard substance is 0.90 to 1.10 in case where the primers are subjected to quantitative digital PCR on a reference standard material of which copy number of the internal quality control region is known.