Nucleic acid amplification tests (NATs) are powerful tools for the molecular diagnostic laboratory, such as virus detection, mRNA profiling, SNPs (single nucleotide polymorphism) typing and detection of somatic cell mutation. However, the manual operation of NATs are time consuming and require technical experience, with the workflow including several processes (extraction of nucleic acids, amplification, detection and analysis of data). Moreover, NATs should be processed by skilled laboratory technicians in regulated laboratory environments for assuring the quality of NATs results. These requirements seem to be limiting factors for further expansion of NATs in molecular diagnostic laboratory testing, especially for point-of-care (POC) and STAT testing. To eliminate these difficulties, easy to use, fully-automated and -integrated instruments are necessary.
We have developed two platforms which are fully-automated and integrated instruments for NATs. They are the egeneLEADf and egeneTYPISTf. These instruments can process all steps for NATs, including extraction of DNA/RNA from various samples, reaction set up, amplification of target gene and detection/analysis of the products. These instruments use Magtration technology for nucleic acid extraction and incorporate different methods for analysis of the amplified products. Gene-LEAD can measure fluorescence signals from amplified products and can be used for endpoint or real time monitoring of amplified products. Gene-TYPIST uses a capillary bead array (eBISTf technology) for multiplex SNPs typing (up to 9 genes). We will present data obtained from these instruments for detection of mRNA in simple and multiplex SNPs typing.