At CVS, ARIES® Users Presented Comparison Studies for LDT and FDA-Cleared Assays

This year’s Clinical Virology Symposium (CVS), held in Daytona Beach, Fla., was a great reminder of how important this conference has become to the microbiology community. With late-breaking information on the Zika virus, leading scientists sharing data on historical and recent viral infections, and fascinating case presentations, CVS kept us hooked from start to finish.

We’re grateful to the many attendees who took time from a busy conference schedule to attend our workshop, “ARIES®—The New Way to Work in Sample to Answer Molecular Diagnostics.” It was a terrific event, and we’ll have a video to share with you soon. In the meantime, here are a few highlights:

Xiaotian Zheng, Director of Microbiology at the Ann & Robert H. Lurie Children’s Hospital of Chicago, spoke about developing and evaluating a laboratory developed test (LDT) on the ARIES® System for detecting enteroviruses in blood samples from children. Zheng noted that current tests focus on cerebrospinal fluid and other invasive samples, and that some new data showed the potential for testing blood instead, though there is no FDA-approved test for this. The team produced an LDT with the ARIES® platform and found that they could successfully detect enteroviruses from blood samples, which could significantly improve diagnosis in pediatric cases. Zheng added that the ARIES® System was efficient, with a number of advantages to improve reliability and reduce the opportunity for human error, such as barcode scanning and reduced hands-on time.

Anami Patel, Vice President of Molecular Diagnostics & Genomics at Poplar Healthcare, shared his experience testing the HSV 1&2 assay on the ARIES® System. Nearly 300 samples were tested, and results were compared to another FDA-cleared assay as well as an LDT method. Patel reported strong concordance between ARIES® System results and those from the other FDA-cleared assay and other LDT approach. Notably, his team also evaluated workflow and found that the ARIES® System delivered answers in less time, enabling them to return same-day results from samples submitted much later in the day. The system also required minimal training and offered a significantly streamlined protocol compared to the other assay workflows.

Ted Schutzbank, Technical Director for Special Testing and Microbiology at St. John Hospital and Medical Center, presented data from an ARIES® System LDT for varicella zoster virus. Compared to a TaqMan-based LDT, the new assay was found to have equal sensitivity and accuracy. Schutzbank told attendees that a major difference between the two protocols was workflow: the ARIES® System requires significantly fewer steps and no up-front sample processing, reduces the risk of amplicon contamination, and delivers results in less time. He also noted that the SYNCT™ software running ARIES was intuitive and easy to use.

Since the ARIES® System received IVD clearance last year, many labs have been implementing the platform and evaluating LDT and FDA-cleared assays on it. We were honored to host these terrific speakers in our CVS workshop and learn more about the impressive work they’ve done!

Disclaimer: Luminex does not endorse the use of any LDT for diagnostic use.