Patent ID: 11970732
Assignee: GENCURIX INC.
Field: Biotechnology (Chemistry)
Classification: CPC C  G | IPC C

Claim 8:
9. 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) measuring the mutational frequency of a target gene or a mutation site in a biological sample; and
(b) calculating a normalized mutation frequency by dividing the measured mutation frequency by an internal quality control index of the sample,
wherein the internal quality control index (iQC index) is calculated in a method comprising the steps of:
(i) extracting a nucleic acid from a biological sample obtained from a subject;
(ii) 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 a nucleic acid fragment of an internal quality control region;
(iii) calculating a copy number of the internal quality control region from the result of the digital PCR; and
(iv) calculating the internal quality control index (iQC index) according to the following equation:

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

(c) selecting a nucleic acid from the biological sample for a reliable gene analysis in accordance with the mutational frequency of a target gene or a mutation site as determined quantitatively in step (b);
wherein the internal quality control region in a nucleic acid extracted from the biological sample 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; and
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.