Real-Time PCR Instrument Designed for Clinical Diagnostic Laboratories

A Real-Time polymerase chain reaction (PCR) instrument can perform numerous diagnostic functions, including pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection, micro-RNA and other noncoding RNA analysis, and high-resolution melt analysis.

Life Technologies Corp. (Carlsbad, CA, USA) has launched its Applied Biosystems QuantStudio Dx Real-Time PCR instrument. The instrument is CE-in vitro diagnostic (IVD) marked for use in Europe and represents a significant extension of Life Technologies’ product offerings in the diagnostics arena.

The instrument is being released with CE-marked Quidel Molecular Assay for Clostridium difficile for detection of hospital-acquired infections. Additional Quidel Molecular infectious disease applications are currently under development and will be available in 2013, including an Influenza A + B Assay, a Human metapneumovirus (hMPV) + respiratory syncytial virus (RSV) assay, and a herpes simplex virus 1 and 2, and varicella zoster virus (chicken pox and shingles) assay.

The instrument’s touch screen, reagent, sample tracking, and Laboratory Information Management Systems (LIMS) interface are simple to use, and flexible. Easily 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.

Two software options are available on the instrument. The QuantStudio Dx Software runs in vitro diagnostic (IVD) 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.

“Molecular diagnostic tests based on real-time PCR have become indispensable to the clinical lab,” said Ronnie Andrews, president of Medical Sciences at Life Technologies. “Molecular testing is the fastest-growing segment of the diagnostics market, and the QuantStudio Dx instrument has unique features that will allow us to capture that market growth.”

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