QC management tools for molecular testing
EZQC™ Online provides laboratories with quality assurance management tools that guide molecular testing from assay setup to implementation and performance monitoring. The expanded EZQC Online includes three modules, each of which provides electronic or printed reports. The Validation and Verification module, modeled after the previous EZValidation™ Tool, can assist with interpretation of regulatory guidelines, optimize reagent usage, and provide a detailed reagent preparation protocol to perform validation and verification of quantitative, qualitative, and multiplex assays. The QC Monitoring module can track daily quality control values and provide peer comparison to connect with laboratories in your network. The Calibration Verification module will help maintain regular six-month calibration checks.
SoftMolecular, an intuitive workflow solution for the diagnostic genetics laboratory, enables geneticists and pathologists to create customized protocols for managing testing workflows, deriving data and images from automated instruments by interfaces, auto-populating report text based on result-driven reporting rules, and accessing patient and family medical and testing histories. It empowers users to manage data and analysis stemming from current molecular testing methods in order to generate accurate interpretations and meaningful reports. This robust and user-friendly application enables users to streamline workflows, interface with automated instrumentation, manage patient and family cases, track sample storage, and control inventory. SCC’s Genetics Information Systems Suite™ products allow communication with other laboratories, whether they are separate technology-based departments or multiple sites.
Cytomegalovirus viral load test
An FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens, the COBAS AmpliPrep/COBAS TaqMan CMV Test is intended for use as an aid in the management of solid-organ transplant patients who are undergoing anti-CMV therapy. In this population, the test can be used to assess virological response to antiviral treatment. Roche’s automated COBAS AmpliPrep/COBAS TaqMan System combines the COBAS AmpliPrep Instrument for automated sample preparation and the COBAS TaqMan Analyzer or the smaller COBAS TaqMan 48 Analyzer for automated real-time PCR amplification and detection. The system has parallel processing with other key molecular diagnostics assays targeting medically relevant diseases (HBV, HCV, and HIV).
Blood culture ID panel
The FilmArray® Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic assay for the rapid identification of bloodstream pathogens. In only an hour, and with over 97% sensitivity and 99% specificity, the panel is capable of simultaneous detection and identification of nucleic acids from 24 gram-positive and -negative bacteria, yeast, and three genetic determinants of antimicrobial resistance from positive blood cultures. Rapid identification of specific agents of septicemia by the BCID Panel can be used in conjunction with other clinical and laboratory findings to guide appropriate pharmacotherapy for patients in a time-sensitive manner.
Reliable PCR in less than 17 minutes
The Philisa® Thermal Cycler is a high-speed polymerase chain reaction (PCR) instrument with the potential to improve laboratory efficiency and flexibility. The instrument has industry-leading ramp rates, excellent thermal control, and thin-walled plastic tubes, allowing a laboratory to perform reliable PCR in as little as 17 minutes, compared to several hours with a standard thermal cycle. Easily create complex protocols with Philisa’s intuitive Windows-based software. Developed with input from industry experts, the simple yet versatile program will meet your protocol design needs both now and in the future.
New molecular amplification test
illumigene® Mycoplasma is the fourth assay on the illumigene platform. Aiding in identifying an important respiratory pathogen, illumigene Mycoplasma amplifies the specific DNA for the detection of Mycoplasma pneumoniae, thereby providing a definitive result. The test utilizes both throat and nasopharangeal swab samples. The test procedure is simple and highly sensitive, allowing the flexibility of multiple sample types. It requires no expensive capital equipment and relies on a procedure that takes less than one hour. The simplicity, cost efficiency, and small footprint of this technology enable users to provide more rapid diagnoses, early identification of outbreaks, and prevention of secondary cases through implementation of control measures.
Supporting the molecular workflow
Sunquest Molecular™ brings the molecular workflow into the clinical lab setting, building upon capabilities in the Sunquest Laboratory™ system for molecular testing and results. It provides the means to define complex protocols, presenting the end user with a workflow process that is standardized, error-free, and efficient. Laboratories using Sunquest Molecular will replace paper-based systems, allowing for reallocation of FTEs and enabling labs to manage multiple tests per specimen to better defend lab-developed tests in audit through automation of complex protocols, proactive inventory management, and robust quality controls. Sunquest Molecular, designed to support the growing demand for molecular testing, fully integrates with Sunquest Laboratory to maximize existing functionality including specimen routing, tracking, robust autofiling rules, flexible billing, and bar-coding.
Environmentally friendly qPCR mixture
rEVAlution qPCR Master Mix is an environmentally safe, ready-to-use, hot-start qPCR mixture specifically formulated with high-quality components to offer superior safety, speed, and signaling. EvaGreen® dye was selected for this formulation because it’s cell–impermeable, making it a non-mutagenic, non-cytotoxic PCR dye that’s safe for aquatic life and safe for handling and can be directly disposed of down the drain. Similar master mixes typically utilize SYBR® green dyes that are mutagenic. EvaGreen also helps rEVAlution produce signals that are stronger than the SYBR green dyes. In addition, Syzygy FlashTaq, a chemically-modified hot-start Taq DNA polymerase recognized for its rapid two-minute activation time and high level of compatibility, was also selected for use in rEVAlution.
Epigenetic test for prostate cancer
ConfirmMDx for prostate cancer is an epigenetic assay to help urologists distinguish patients who have a true-negative biopsy from those who may have occult cancer. The test helps rule out prostate cancer in cancer-free men so they need not undergo unnecessary repeat biopsies, and identify high-risk patients who may require repeat biopsies and potential treatment. Testing residual tissue from the previous negative biopsy, ConfirmMDx helps reduce excessive screening and patient visits, and unnecessary and potentially harmful repeat biopsy procedures.
ChimerMarker™ software improves chimerism analysis efficiency, typically with a time saving of up to 80%; automatically identifies donor, recipient, shared peaks, and informative loci in post-BMT samples; and calculates percent chimerism and quality metrics for single or double donor cases. Individual projects are easily appended with samples from later time points for rapid visualization of chimeric trend during long-term monitoring. The linked maternal-cell-contamination application automates MCC calculations for cord blood banking. Flexible analysis settings can be optimized to meet the lab’s standard operating procedures. Print reports or save to LIMS systems in .txt, .xls, .png, or .jpeg format for electronic record keeping. ChimerMarker is compatible with the output from all major capillary electrophoresis systems, human identity chemistries, and Windows® XP, Vista, 7 and 8.
Automated molecular assay platform
The Rheonix EncompassMDx™ platform is a highly customizable technology platform that performs fully automated, complex molecular assays in an easy to use format on the disposable Rheonix CARD® cartridge. The manufacturing process of the plastic Rheonix CARD creates all of the necessary pumps, valves, and reagent and reaction reservoirs needed to automatically perform all aspects of molecular testing in an unattended manner. The system can be used to process a wide range of samples such as whole blood, serum, plasma, urine, swabs, and FFPE blocks. The system can easily process sample volumes ranging from 5 µl to 5 ml. It is currently available for Research Use Only, with FDA approval expected in 2014 for a variety of indications. Through a recently announced partnership with Life Technologies, the platform will also be used in applied markets such as food testing.