SLE-key® is a molecular diagnostic test developed by ImmunArray to support a physician’s ability to rule-out a diagnosis of Systemic Lupus Erythematosus (SLE). SLE-key® works by determining the pattern of circulating antibodies to an array of antigens which are printed on ImmunArray’s proprietary iCHIP®. This pattern is compared to SLE affected and healthy control patterns. Proprietary analytic algorithms are then used to determine the likelihood of the patient being affected with SLE, along with a probability score.
The validated SLE-key®, developed based on autoantibody fingerprints from 250 affected and 250 healthy females, has been shown to exclude SLE during differential diagnosis with >90% sensitivity and >70% specificity.
SLE-key Instructional Videos
SLE-key Training Video
This video gives an overview of the SLE-key® kit contents and use for drawing, packaging, and returning the SLE-key® test to Veracis for analysis. It is intended for office or practice training for phlebotomist, nurses, or other support staff that will be directly obtaining and shipping the SLE-key® test. In addition to the materials for actually obtaining the specimen, review of all documentation materials used to insure accuracy and proper analysis is shown.
SLE-key Webinar Module 1
This module introduces the SLE-key® test technology and format to the new user. It is intended to give a basic familiarization to our novel testing procedure and a brief demonstration on its impact in clinical decision-making. Included is an example of the test report, highlighting the easy to interpret, binary results of Ruled Out or Not Ruled Out. The slides included are the key takeaways from the remaining modules as well.
SLE-key Webinar Module 2
The second module provides greater detail on the science underlying the SLE-key® test. Discussed is the original hypothesis by the developer and company Founder, Irun Cohen, MD, as well as examples of autoantibodies in the analysis of SLE. The operational aspects of the chip technology, as well as the breadth of antigens arrayed to detect autoantibodies is also presented, including novel, proprietary antigens only available via the SLE-key® test.
SLE-key Webinar Module 3
The third module demonstrates the rigorous development program to development and validate the SLE-key® test on 500 patient samples. Specific aspects of the SLE-key® test, including the statistical power and multi-model development of the final classifier is reviewed. The final test report format, as well as individual autoantibody results are discussed, both for the classifier antigens and those antigens that are analogous to those currently analyzed via an extended ANA or ENA panels.
SLE-key Webinar Module 4
In the final module, the current clinical impact of the SLE-key® test is highlighted. This was developed in conjunction with early adopters of large practices to show how the SLE-key® test can have a potential impact on clinical decision making for the potential SLE patient. A specific example of use in a patient with low suspicion for SLE but presenting with a positive ANA screening test was analyzed during the initial test development.
SLE-key Webinar Full Slideshow
This video incorporates all of the elements of the above modules into a single video. Longer in duration, it provides the fully integrated story seen in the smaller modules. It is intended for use a single viewing and provides the same information as the first 4 modules.