Life Technologies Corp, Carlsbad, Calif, has launched its Applied Biosystems QuantStudio Dx Real-Time PCR Instrument designed to meet the specific needs of clinical diagnostic laboratories. The instrument is CE-IVD marked for use in Europe.
The QuantStudio Dx Real-Time PCR Instrument can perform numerous diagnostic functions, including pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection, micro-RNA and other non-coding RNA analysis, and high-resolution melt analysis.
The instrument's touch screen, reagent and sample tracking, and Laboratory Information Management Systems interface are specifically designed for ease of use. Interchangeable thermal cycling blocks accommodate 96- or 384-well plates and a proprietary qPCR microfluidics card, which can perform 48 tests on eight samples simultaneously without the need for liquid-handling robots. The card can also be used to design and implement custom tests. Life Technologies is currently developing diagnostic tests utilizing this format.
Two software options are available on the instrument. The QuantStudio Dx Software runs IVD (in vitro diagnostic) tests in a secure mode with pre-set run and analysis parameters, while the QuantStudio Test Development Software enables development of custom tests and supports clinical research projects.
The instrument is being released with CE-marked Quidel molecular assay for C. difficile for detection of hospital-acquired infections, which Life Technologies distributes. Additional Quidel Molecular infectious disease applications are currently under development and will be available in 2013, including an influenza A + B Assay, a human metapneuomvirus (hMPV) + respiratory syncytial virus (RSV) Assay, and a herpes simplex virus 1 and 2, and varicella zoster virus (chicken pox and shingles) Assay.
Life Technologies plans to submit the QuantStudio Dx Real-Time PCR Instrument for 510(k) clearance to the United States Federal Food and Drug Administration in December 2012.
[source: Life Technologies]