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

Claim 0:
1. 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 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 digital PCR;
(d) calculating an internal quality control index (iQC index) according to the following equation:

Internal quality control index=the copy number of the internal quality control region/the copy number of input DNA of the digital PCR; and

(e) determining that the nucleic acid quality of the sample is appropriate in case where the internal quality control index is equal to or higher than a predetermined threshold, or determining that the nucleic acid quality of the sample is better as the internal control quality index becomes closer to 1; and
(f) selecting a nucleic acid from the biological sample for a reliable gene analysis in accordance with the nucleic acid quality as determined quantitatively in step (e);
wherein the nucleic acid quality of the sample is determined to detect or analyze the integrity of the target gene or the gene comprising the mutation site as an amplifiable template in the sample; and
wherein a detected copy number of the internal quality control region/the copy number of input DNA of the reference standard 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.