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

Claim 5:
6. A method for preparing i) primers or ii) a set of primers and a probe for selecting a nucleic acid from a biological sample which provides a reliable gene analysis result, the method comprising the steps of:
(a) designing 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 in a nucleic acid extracted from a biological sample of a subject, 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;
(b) performing digital Polymerase Chain Reaction (PCR) on a nucleic acid contained in a reference standard material with the primers or the set of the primers and the probe;
(c) calculating a copy number of the internal quality control region from the result of the digital PCR;
(d) evaluating the copy number of the internal quality control region detected/the copy number of input DNA of the reference standard substance of the designed primers or the designed set of the primers and the probe; and
(e) selecting primers or a set of primers and a probe of which the copy number of the internal quality control region detected/the copy number of input DNA of the reference standard substance is quantitatively determined as 0.90 to 1.10, as primers or a set of primers and a probe for selecting a nucleic acid from a biological sample which provides a reliable gene analysis result.