GHP September 2015

ghp September 2015 | 51 health and social care Multiplex PCR Panels at the Point-of-Care Clinical laboratories are increasingly using mo- lecular diagnostic tests for infectious diseases, since they generally provide higher sensitivity and specificity along with a shorter turnaround time than traditional methods. Due to the increasing acceptance and demand, manufacturers are developing a range of platforms that have evolved from manual to fully automated sample-to-result systems requiring less training, expe- rience and technical skills. Molecular diagnostic tests have evolved from clinicians ordering a series of tests to detect single pathogens to simultaneously detecting multiple pathogens along with their drug resistance that are associated with infectious syndromes using one patient sample. These molecular diagnostic syndromic panels enable accurate etiologic diagnosis by reporting comprehen- sive results simultaneously for multiple pathogens associated with infectious syndromes; however, the downside for physicians is that they wait 6 to 48 hours to receive these results from the central laboratory. For critical care patients, time to diagnosis is precious. Enigma® Diagnostics is focused on empowering physicians with comprehensive actionable molecular diagnostic results on demand by providing a range of syndromic panels for the MiniLab, an easy-to-use Point-of-Care (POC) highly multiplex PCR platform. Enigma Diagnostics’ MiniLab is the world’s first POC Highly Multiplex PCR platform that provides clinicians 24/7 access to laboratory-quality molecular diagnostic results using a range of highly multiplex PCR syndro- mic panels for the simultaneous in vitro diagnostic detection of pathogens reducing test result waiting times to about one hour. The easy-to-use sample to results MiniLab has a small footprint. It is well-suited for a range of clinical settings where fast laboratory-quality results are imperative. Its fast comprehensive actionable on demand results empower clinicians by providing molecular diagnostic results at the POC thereby elim- inating the long wait time associated with sending specimens to the central laboratory. Another benefit is that these comprehensive results do not require interpretation. It is well documented that an accu- rate fast diagnosis and targeted treatment improves clinical outcomes while reducing costs and supports good antimicrobial stewardship, since the team can act on results in real time. The MiniLab features a fully integrated Control Module that has a touch-screen computer for user input, display of operating status and results, barcode reader to scan the users’ identification, patient specimen and type of cartridge, as well as a printer and connection for data transmission. The MiniLab display provides on screen feedback and animations at each step in the process assisting the operator thereby reducing the chance for mistakes. The MiniLab carries out built in checks, such as ensuring that the user is approved to run the test, quality control checks are up-to-date, cartridge is not expired and more. These checks are configurable to meet the needs of different clinical settings. Additionally, the Control Module has a number of configurable options, such as whether to print and/or transmit the results. The MiniLab’s lowest throughput configuration is a single Processing Module attached to the Control Module making the adoption of this inexpensive platform attractive. The MiniLab’s throughput is easily expandable by adding up to a total of six Processing Modules, which can run different syndromic panels simultaneously with independent random access. Each Processing Module is fully automated from sample preparation, nucleic acid amplification and target detection using single-use dedicated cartridges without requiring the operator to be familiar with PCR technology. These single-use cartridges contain all of the reagents required for sample processing and nu- cleic acid detection. These comparatively inexpensive cartridges can easily be stored next to the MiniLab, since they are stable at ambient temperature. The easy-to-use fully integrated and automated MiniLab requires simple training and has nil operator variance. It is designed to be used in developed and emerging health care programs. In developed health care pro- grams, the MiniLab provides the central laboratory with a cost-effective method of decentralizing their services by providing clinicians with short test result waiting times when time is precious, especially for critical care patients. A faster test result waiting time allows patients to be tested, isolated and treated before they are able to spread the infection to other patients resulting in re- duced outbreaks. In emerging health care programs, it enables rapidly-expanding health care systems the op- portunity to build a diagnostic health care architecture that is cost-effective and patient-centric across multiple testing sites, unconstrained by traditional laboratory costs and limited physician availability. MiniLab empowers clinicians with molecular diagnostic results on demand.