Real-time quantitative PCR that is the most widely used method for molecular diagnostic testing or nucleic acid testing (NAT) can rapidly perform quantitative and qualitative analysis of gene, and it is the fastest growing area in the world in-vitro diagnostic market, averaging about 20 percent a year.
This method can be applied to various fields such as: of a blood screening test for preventing infections caused by a blood transfusion, a viral load test for checking the effectiveness of a new treatment for viral diseases, a confirmatory test for independently confirming results of diagnostic testing, a pharmacogenomic test for determination of a treatment, selection of medication and estimation of medicinal effect, and a process of checking a genetic predisposition, or detecting or monitoring an abnormal gene in order to prevent disease.
However, since the real-time quantitative PCT is very complicated to operate, it is not yet used as widely as immunohistochemistry regardless of its various advantages. This method performs the testing with a pure nucleic acid in which substances interfering with gene amplification are removed, and thus it is necessary to isolate the pure nucleic from the biological sample. Accordingly, in order to carry out real-time quantification of gene amplification, it is required to perform nucleic acid purification. The nucleic acid purification has been traditionally carried out manually. But as the number of testing times is increased and the necessity of quality control also becomes higher, various automation equipments are propagated rapidly. However, even when using automatic nucleic acid purification equipment, a process of mixing the purified nucleic acid and various reagents and then analyzing the mixture is performed manually in order to perform the real-time quantitative analysis, and thus it is difficult to completely exclude operator s mistake. To solve the problem, there has been developed various equipments for automatically carrying out, in turn, a chain of steps from the nucleic acid purification to the real-time quantification of gene amplification.
By Cepheid, Inc., there have been developed cartridges (U.S. Pat. Nos. 6,818,185, 6,783,736, 9,970,434 and 11,977,697) which can extract a nucleic acid in a sealed structure, cartridges (U.S. Pat. Nos. 6,660,228 and 7,101,509) which can perform real-time quantitative PCR, and cartridge type automation equipments (U.S. Pat. Nos. 6,660,228, 7,101,509 and 11,742,028) which can independently perform the nucleic acid extraction and real-time quantitative PCR, wherein GeneXpert instruments as infinity systems use one, four or sixteen cartridges (by the cartridge unit), and cartridge installation and testing are automatically performed.
By IQuum, Inc., there have been developed equipments (U.S. Pat. Nos. 7,718,421, 7,785,535 and 12,782,354) which can automatically and rapidly perform the nucleic acid extraction and real-time quantitative PCR in a semi-fixed and divided tube based on Liat (Lab-in-a-tube) technology.
By Idaho technology, Inc., there has been developed a method based on Lab-in-a-film technology (U.S. Pat. Nos. 10,512,255 and 7,670,832), which can automatically and rapidly perform the real-time quantitative PCT by extracting a nucleic acid in a sealing film and moving between two different temperature blocks.
In these technologies, a module for treating a single sample is used as a standard unit, and thus a large number of equipments or a large scale system is needed to perform the real-time quantitative PCR on multiple samples required in clinical experiments, and also since the biological samples are treated one by one, it takes a lot of time and money to prepare the clinical samples. To solve the problem, there had been developed various equipments for treating multiple samples at the same time
By Handy lab, Inc., there have been new equipments which extracts nucleic acids from multiple biological samples at the same time using a nucleic acid extractor having an XYZ-Cartesian robot with a cylinder, injects the extracted nucleic acids into a microfluidic cartridge for PCR reaction and then performs real-time quantitative PCR (U.S. Pat. Nos. 12,515,003, 200090719, 20090130745 and 20080714).
Roche diagnostic, Inc. releases a cobas s201 system which can automatically perform the nucleic purification and real-time quantitative PCR.
In these technologies, the number of samples which can be treated at a time is 32 or less, and the number of samples which can be installed at a time is 72 or less. Accordingly, there is inconvenience in that an operator has to install again the biological samples and the consumed reagents for a next analysis operation. Further, it takes too much time to treat hundreds of samples like in a blood bank screening test and also the operator has to check them often.
Furthermore, these equipments can be used only for the real-time quantitative PCR. Therefore, it is impossible to automatically perform various tests using real-time quantitative genetic analysis, such as microorganism culture testing, rapid antibiotics susceptibility testing and immune gene quantitative amplification testing.
Experiments of culturing and analyzing microorganism using a real-time genetic quantitative analysis are very important to obtain various useful information. However, since these experiments have several steps of culture, nucleic acid extraction and real-time quantitative PCR, and each step is performed manually, it requires much effort and artificial mistakes may occur. Therefore, it is required to develop new equipment for automatically performing the steps. The present invention relates to a multipurpose automatic real-time quantitative amplification system which can automatically such various experiments and thus can perform the analysis of biological samples.
Immuno real-time qPCR that is a protein detection method using high sensitivity of the real-time quantitative PCR is an immunodiagnostic method having the highest sensitivity. However, the immune real-time qPCR also have multiple steps of antigen antibody reaction, cleaning and real-time quantitative PCR, and each step has a significant influence on genetic sensitivity, specificity and excompression. Therefore, it is required to develop new equipment for automatically and uniformly performing the steps.