Detect-Ready® MRSA Panel Introduction
The Detect-Ready® MRSA Panel is a qualitative real-time PCR (rt-PCR) in vitro diagnostic test for the rapid differential detection of methicillin-sensitive and methicillin-resistant S. aureus (MSSA and MRSA) colonization to aid in the prevention and control of MRSA, MSSA and related infections in hospitals and other healthcare settings. The Detect-Ready ready-to-use pre-mixed reagents require only the addition of DNA from the patient sample to run the panel, which provides test results in less than three hours. Samples for testing are simple to obtain using nasal swabs, alone or in combination with perineal 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 Panel provides a differential diagnosis engine that produces highly accurate results, minimizing the false positives and false negatives experienced with other diagnostic screening kits. This differential diagnosis technology measures three separate genes associated with S. aureus and antibiotic resistance, giving MDI’s panel the ability to simultaneously detect MRSA, MSSA and methicillin-resistant non-S. aureus pathogens, as well as mixed samples. The Detect-Ready Panel is the only screening kit with CE mark designation to distinguish between these types of infections, an important advantage for healthcare providers responsible for treatment decisions.
Detect-Ready kits are compatible with multiple rt-PCR platforms currently found in most clinical laboratories, including the Roche LightCycler®, Qiagen Rotor-Gene® and Cepheid SmartCycler®. The flexibility to leverage existing infrastructure and equipment to run Detect-Ready panels eliminates the need for additional hospital capital investment.
The Detect-Ready MRSA Panel has received CE mark certification for sales in the European Union and is currently being sold in Europe and in Australia, with additional launches expected soon.
The Detect-Ready® MRSA Panel 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, as well as the ability to distinguish between infections caused by different types of S. aureus and related pathogens.
The Detect-Ready MRSA Panel 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|
|INFORMATIVE:||Clear & precise results reported: MRSA, MSSA, CNR (coagulase negative resistant bacteria), or mixed sample (MSSA & CNR)
Unique software enables easy display of additional result details
|EASY:||Ready-to-use individual sample tubes pre-loaded with reagents to reduce preparation time
Room temperature-stabilized, no refrigeration needed–-true off-the-shelf kit
|FLEXIBLE:||Compatible with multiple commonly used qPCR instruments|
The Detect-Ready MRSA Panel received independent validation in a study conducted at St. George’s Healthcare NHS Trust, a leading teaching hospital in the UK. These study results were presented at HIS 2010, the Seventh International Conference of the Hospital Infection Society.
In a comparative study of the Detect-Ready assay and two other widely used PCR-based MRSA screening tests, the St. George’s researchers confirmed that the performance of the Detect-Ready MRSA Panel was better than or equivalent to Becton Dickinson’s GeneOhm™ MRSA ACP Assay and Roche’s LightCycler® MRSA Advanced Test. Based on the results of this study, MDI’s Detect-Ready is now used as the molecular assay of choice in the MRSA screening programs at St. George’s.
Following are results for MRSA detection from a recent study of the Detect-Ready MRSA Panel that compare favorably to results seen with other marketed MRSA detection kits:
|Positive Predictive Value||96.6%|
|Negative Predictive Value||99.9%|
This superior performance is due in part to the fact that the Detect-Ready MRSA Panel is based on novel patent-pending technologies that enable MDI’s differential diagnosis engine. This feature uniquely enables the Detect-Ready test to distinguish between patient samples containing MRSA and patient samples containing a mixture of MSSA and coagulase negative resistant (CNR) bacteria. It does this by assessing the amplification rate of certain genetic markers in the sample to determine if all of those genetic markers came from a single bacterial species (leading to a diagnosis of MRSA) or if those genetic markers came from a mixture of two bacterial species (leading to a diagnosis of mixed sample MSSA & CNR). The Detect-Ready Panel is the only MRSA screening kit with CE mark designation to distinguish between these types of infections, an important advantage. MDI’s patent-pending technologies also make possible the room temperature stabilization that eliminates the need for refrigeration and enhances the ease of use of the Detect-Ready kit.
The Detect-Ready kit’s innovative hot-start primer chemistry also provides an efficient PCR reaction at every cycle by:
- Substantially reducing primer competition
- Enabling incorporation of a large number of primers in a single reaction
- Achieving more efficient sample amplification, which in turn enables a more precise comparison of the rate of amplification of different genetic markers in the same sample.
The Detect-Ready MRSA Panel 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, the mecA gene and two S. aureus-associated genetic regions.
Other benefits of MDI’s unique differential diagnosis engine include:
- Reduction of false positive MRSA 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 kits do not require hours of preparation time and are ready for immediate use. The Detect-Ready catalyst tube and instrument-specific reaction tube contain all of the required reagents, including primers and probes. The technician simply opens the ready-to-use tubes and adds extracted DNA from the patient sample. The Detect-Ready kit 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 MRSA Panel also offers 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 its lower resource requirements for technician preparation and handling, for space and for specialized equipment, the Detect-Ready MRSA Panel is expected to reduce hospital testing costs.
Using the Detect-Ready® MRSA Panel
To screen for MRSA and related pathogens with the Detect-Ready® MRSA Panel, 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 catalyst tube and transferred to a Detect-Ready qPCR instrument specific reaction tube, both of which are pre-loaded with all the reagents required for processing and which are ready-to-use. 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 Panel, results can be obtained less than three hours after samples arrive at the laboratory. Each Detect-Ready MRSA Panel kit can test up to 96 samples simultaneously, depending on the platform used.
Detect-Ready® MRSA Swab Lysis Kit
The Detect-Ready® Swab Lysis kit is a precursor to the Detect-Ready® MRSA Panel. Samples are collected from potential MSSA or MRSA carriers with nasal swabs alone or together with perineal swabs. The swabs are sent to the laboratory without the need for any transport medium. In the clinical laboratory, the Detect-Ready MRSA Swab Lysis kit quickly and efficiently removes the bacterial sample from the swab, concentrates the sample and extracts DNA from the bacteria, which is then ready for testing with the Detect-Ready MRSA Panel. Up to 36 samples can be prepared in 30 minutes.
Detect-Ready® MRSA Products
|PRODUCT||NUMBER OF TESTS||PRODUCT CODE|
|Detect-Ready MRSA Swab Lysis Kit||96||34-00|
|Detect-Ready MRSA Lysis & Panel Rotor-Gene Compatible Version||16||30-05|
|Detect-Ready MRSA Panel Rotor-Gene Compatible Version||96||30-04|
|Detect-Ready MRSA Panel Rotor-Gene HT Compatible Version||192||30-03|
|Detect-Ready MRSA Lysis & Panel SmartCycler Compatible Version||16||31-05|
|Detect-Ready MRSA Panel SmartCycler Compatible Version||96||31-04|
|Detect-Ready MRSA Lysis & Panel LightCycler 480 Compatible Version||16||32-05|
|Detect-Ready MRSA Panel LightCycler 480 Compatible Version||96||32-04|
|Detect-Ready MRSA – LightCycler 480 Colour Compensation Kit||2 Calibrations||32-02|
|Detect-Ready MRSA Lysis & Panel LightCycler 2.0 Compatible Version||16||33-05|
|Detect-Ready MRSA Panel LightCycler 2.0 Compatible Version||96||33-04|
|Detect-Ready MRSA – LightCycler 2.0 Colour Compensation Kit||2 Calibrations||33-02|