Detect-Ready MRSA Kit

Detect-Ready™ MRSA Kit

The Detect-Ready™ MRSA Kit is a qualitative real time PCR (rt-PCR) in vitro diagnostic test for the direct detection of MRSA nasal colonization to aid in the prevention and control of MRSA infections in hospitals and other health care settings. Samples for testing are simple to obtain using nasal swabs. The Detect-Ready ready-to-use pre-mixed reagents require only the addition of patient sample to run the assay, which provides test results in one to two hours. Unlike other testing products that require special handling, Detect-Ready kits are off-the-shelf room temperature-stabilized and require no refrigeration.

The unique technology in the Detect-Ready kits provides a differential diagnosis engine that produces highly accurate results, minimizing the false positives and false negatives experienced with other diagnostic screening kits. Detect-Ready kits are compatible with multiple rt-PCR platforms currently found in clinical laboratories, including the Roche LightCycler®, Corbett RotorGene® and Cepheid SmartCycler®. The flexibility to leverage existing infrastructure and equipment to run Detect-Ready assays eliminates the need for additional hospital capital investment.

Detect-Ready MRSA Kit Advantages
The Detect-Ready MRSA kit provides a number of important performance advantages over other testing methods, including increased accuracy, decreased time and effort to produce results and reduced risk of technician error and cross contamination.

Developmental testing of the MRSA assay in over 12,000 patient samples suggests it will have excellent sensitivity, specificity and accuracy. Confirmatory clinical studies are currently ongoing.

This expected superior performance is due in part to the fact that the Detect-Ready MRSA assay is based on novel patent-pending technologies that make it possible to make a differential diagnosis engine, which distinguishes between pathogens by assessing multiple DNA targets and genetic markers to determine if MRSA is present and also enables the room temperature stabilization that eliminates the need for refrigeration and enhances the ease of use of the kit. Unlike other rt-PCR kits, Detect-Ready assays do not require hours of assay preparation time and are ready for immediate use. The technician simply opens the ready-to-use reaction microtube or rt-PCR reaction plate and adds the patient DNA sample. The Detect-Ready kits also eliminate entirely the need for a reagent preparation clean room at the clinical laboratory site and substantially reduce the risk of technician error and cross contamination.

The Detect-Ready assays also offer the advantage of cross platform compatibility, allowing the test to be run on the most common rt-PCR instruments found in hospital clinical laboratories. As a result of these factors, the Detect-Ready MRSA assay is expected to reduce hospital testing costs due to its lower resource requirements for technician handling, preparation, space and specialized equipment.

Using the Detect-Ready™ MRSA Assay
To screen for MRSA with the Detect-Ready MRSA assay, samples are collected from potential MRSA carriers with nasal swabs, which are sent to the laboratory without the need for any transport medium. In the clinical laboratory, the specimen-containing swab is placed in a Detect-Ready preparation tube that comes preloaded with sample preparation buffer, for concentrating and lysing the sample. A portion of this lysed sample is then added to a Detect-Ready reaction tube, which contains all the reagents required to process the sample. The application is then run on a real time PCR instrument, and Detect-Ready proprietary software interprets the data and reports results. With the Detect-Ready MRSA kit, results can be obtained within one to two hours after samples arrive at the laboratory. Each Detect-Ready MRSA assay kit can test up to 96 samples simultaneously, depending on the platform used.