Detect-Ready™ MRSA Kit The Detect-Ready™ MRSA Assay 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. The Detect-Ready™ ready-to-use pre-mixed reagents require only the addition of DNA from the patient sample to run the assay, which provides test results in less than three hours. Samples for testing are simple to obtain using nasal swabs that can be delivered to the laboratory without the need for transport medium. 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®, Qiagen Rotor-Gene® and Cepheid SmartCycler®. The flexibility to leverage existing infrastructure and equipment to run Detect-Ready™ assays eliminates the need for additional hospital capital investment. The Detect-Ready™ MRSA assay kit has received CE mark certification for sales in the European Union and is currently being sold in several countries in Europe. 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. The Detect-Ready™ MRSA Assay Offers Unique Advantages to MRSA Control Programs RAPID: Sample-to-answer in less than 3 hours ACCURATE: Superior specificity and sensitivity–designed to minimize false positive & negative results EASY: Ready-to-use pre-mixed reagents reduce preparation time–just add sample Room temperature-stabilized, no refrigeration needed–true Off-the-Shelf kit FLEXIBLE: Compatible with multiple commonly used qPCR instruments Developmental testing of the MRSA assay in over 12,000 patient samples suggests it will have excellent sensitivity, specificity and accuracy. Following are results from a recent study of the Detect-Ready™ MRSA kit that compare favorably to results seen with other marketed MRSA detection kits: Sensitivity 94.9% Specificity 99.4% Positive Predictive Value 93.3% Negative Predictive Value 99.6% This superior performance is due in part to the fact that the Detect-Ready™ MRSA assay is based on novel patent-pending technologies that enable our differential diagnosis engine, a unique feature that distinguishes between pathogens by assessing multiple DNA targets and genetic markers to determine if MRSA is present. They also make possible the room temperature stabilization that eliminates the need for refrigeration and enhances the ease of use of the kit. The differential diagnosis engine identifying multiple MRSA DNA gene targets also improves test accuracy by: Using multiple primer sequences to provide effective detection of a wide range of variant MRSA strains Employing a 4-plex assay simultaneously targeting an internal control and three MRSA DNA regions, including the mecA gene, nuc gene & SCCmec:orfX junction (Types I – V). Other benefits of our unique differential diagnosis engine include: Reduction of false positive results from SCCmec-positive MSSA strains and mixed bacterial samples Detection of the presence/absence of multiple DNA gene targets Comparison of real-time amplification rates of multiple simultaneous PCR reactions across cycles. Unlike other rt-PCR kits, Detect-Ready™ assays do not require hours of assay preparation time and are ready for immediate use. The Detect-Ready™ instrument-specific reaction tube contains all of the required reagents, including primers and probes. The technician simply opens the ready-to-use reaction microtube or rt-PCR reaction plate and adds extracted DNA from the patient sample. The Detect-Ready™ kit also entirely eliminates the need for an on-site reagent preparation clean room and substantially reduces the risk of technician error and cross contamination. The Detect-Ready™ kit’s innovative hot-start primer chemistry provides an efficient PCR reaction at every cycle, achieving more efficient sample detection and amplification by: Substantially reducing primer competition Enabling incorporation of a large number of primers in a single reaction. 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 to extract the DNA. A portion of the extracted DNA from the sample is then added to a Detect-Ready™ reaction tube, which contains all the reagents required to process it, including primers and probes. 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 less than three 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. MRSA and Detect-Ready™ MRSA Assay References and Resources