Autoimmune & Infectious Disease Testing Improvements Realized with AtheNA Multi-Lyte® Multiplexing Technology

First fully integrated and open Automated Immunoassay Multiplexing System (AIMS) instrumentation launched.

Pressure for increasingly accurate, timely and cost effective diagnostic testing impacts nearly all diagnostic disciplines today and that pressure is felt by physicians, labs, hospital administrators and all other healthcare stakeholders. The corresponding result of that pressure leads to an increasing demand for further automation with lab instrumentation as the main driver enabling accuracy, consistency, speed, and cost effectiveness in diagnostic testing. One of the newest advances in diagnostic technology is multiplex testing. Unlike previous tests that detect only a single analyte at a time, multiplexing provides the diagnostic results for a number of different assays on a single specimen, saving valuable time and money and leading to faster diagnosis and start of treatment. Multiplexing microsphere technology is at the forefront of a new generation of more flexible and efficient testing platforms that provide fast accurate test results with a minimum of interaction between the operator and the testing system. The AtheNA Multi-Lyte® Test System platform has been used in lab settings for over 5 years to conduct multiplex diagnostic testing. The system uses microsphere-based immunoassays that simultaneously detect and quantitate multiple analytes in a single well.

One area where AtheNA Multi-Lyte® technology is being used is in autoimmune disease testing where accurate testing for autoantibodies has become increasingly important in the diagnosis and treatment of autoimmune disorders. Traditionally the diagnostic tests in this field, specifically the older ANA determinations by IFA, have been inconsistent and highly dependent on subjective technician interpretation. Accuracy and reliability have declined, with many labs being overwhelmed by the volume of tests, a lack of trained technicians and the financial stresses imposed by third party payers. This has contributed to laboratories and physicians losing confidence in the FANA and IFA assays and looking to the newer technologies. Autoantibody testing by multiplexing with objective tests not only provides more reliable and consistent results, but it is more cost effective for many laboratories.

One important application of the AtheNA Multi-Lyte® technology is within the autoimmune field of rheumatology. The diagnosis of inflammatory and autoimmune diseases depends not only on the clinical presentation of the patient, but the best laboratory determination of autoantibodies available. The technology has been well tested in the laboratory and now with over 5 years in the marketplace and literally millions of tests performed, it has proven itself to be reliable and accurate. The Test Systems directly measure the known antigens associated with autoimmune diseases giving a semi-quantitative value that eliminates the subjectivity associated with other techniques.

Providing quantitative and objective results by multiplexing changes how physicians interpret the patient’s results. Older clinical tests, specifically ANA IFA, provided the physician with antibody titres and patterns. The AtheNA Multi-Lyte® ANA Test System quantitates each antigen that comprises the Test System, in this case 9 specific antigens and a qualitative Hep-2 bead. This has led to more accurate patient diagnosis by removing the subjectivity of the IFA test and allows the physician to better follow patients on treatment. The removal of test subjectivity means that there are fewer false positive ANA tests reported with the AtheNA Multi-Lyte® Test Systems, which has the added benefit of reducing costs by eliminating the need for unnecessary tests and visits and further allows the physicians to focus on clinically defined patients. Multiplex technology further eliminates the need to run multiple samples from the same patient or having the patient return for another blood draw for reflex testing. Since all of the tests are accomplished on the same sample and all of the data is captured, an initial screen can be quickly reflexed to identify the specific Extractable Nuclear Antigen (ENA) that the autoantibody is reactive to by simply querying the patient data on the AtheNA® platform. There is far less technician time involved in processing the results and no objective input from the technicians is needed.

Dr. Steven L. Mendelsohn is a leading health professional in Rheumatology and a strong advocate for the use of AtheNA® multiplex technology in the laboratory. He practices at the Mountain Regional Arthritis Center, P.A. in Asheville, North Carolina.

“I have used the AtheNA Multi-Lyte® system for over 4 years, currently at the Mountain Regional Arthritis Center in Asheville North Carolina. I have found the results to be consistent, accurate, and reproducible. The quantitative nature of the results allows me to diagnose and follow patients more confidently. Although there is some getting used to not seeing titers and patterns, the individual antibody levels have proven to be more helpful. There have been far fewer false-positive ANA results with the newer tests.”

Extending the multiplexing technology even further, is the recently introduced AIMS (Automated Immunoassay Multiplexing System). Introduced within the past year, AIMS is the natural progression of the Athena Multi-Lyte® Test system. AIMS offers the benefits of the AtheNA Multi-Lyte® Technology with the option of also running ELISA tests, making it the first fully integrated and automated multi-methodology system. Because of the number of conditions which now fall under the umbrella of autoimmune disease and due to an aging population with growing susceptibility to autoimmune diseases, this testing is on the rise and there is an increasing need for complete automation. Couple this with the dire need for consolidated testing platforms and the extensive infectious disease testing environment, where automation has been key to volume testing for some time, and this makes AIMS a timely and much needed addition to the testing laboratory. The laboratories understand that there is a real need to fully automate autoimmune and infectious disease on one platform in a multiple assay format and to be able to include many different types of additional tests on one platform (such as infectious disease and autoimmune disease). This saves space, time, money, and limits medical waste. Additionally, as labor costs rise there is a need in every laboratory, whether hospital based, commercial, or the physician’s office for consolidation and efficiencies of testing coupled with automation of assays. These conditions have forced laboratory personnel to adapt by being more efficient and cost conscious in their approach and to search out newer, more fully automated technologies in order to accommodate their changing environment. The AIMS allows everyone in the process to benefit as tests are being performed with more efficient sample processing, faster turnaround of test results and better patient treatment. Combining ELISA testing on the same platform as multiplexing microsphere technology combines an up and coming testing format with a tried and true testing method. Making the platform open for both multiplexed and ELISA assays makes the AIMS platform even more appealing.

The AIMS system is the first fully integrated and open system that allows the processing of microplate based assays utilizing the proprietary Luminex® xMAP® based technology as well as traditional ELISA based assays. This unique system seamlessly incorporates the AtheNA Multi-Lyte® reader and an ELISA reader to fully automate both microplate processes on the same platform for the first time. Current AtheNA Multi-Lyte® users can easily upgrade to full automation by acquiring the AIMS system and having their current AtheNA Multi-Lyte® reader installed on the platform. The test menu associated with the AtheNA Multi-Lyte® Test System is the broadest in the diagnostic market, with a number of assays in both the autoimmune and infectious disease fields. As the test menu increases, the potential cost and throughput benefits realized by the laboratory increase exponentially. Recent additions to the test menu include ANCA II, with GBM (Glomerular Basement Membrane); which further enhances the AtheNA Multi-Lyte® autoimmune test menu, and MMRV, expanding the test menu for infectious disease customers.

With technology advancements in diagnostic testing being critical to alleviating pressure on physicians, labs, hospital administrators and all other healthcare stakeholders, multiplex testing is gaining more acceptance today. Multiplexing diagnostic testing enables increased accuracy, consistency, speed, and cost effectiveness above and beyond previous testing methods. Because multiplexing provides the diagnostic results for a number of different analytes on a single specimen, it saves valuable time and money and leads to faster diagnosis and start of treatment when compared to previous tests. The AtheNA Multi-Lyte® system, along with the new AIMS platform, are instrumentation solutions that provide leading automation technology to best meet the demands of today’s diagnostic laboratory environment.

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