What is SLE-key Rule-Out and how does it help with the diagnosis of SLE?SLE-key is a unique diagnostic test that can rule out the presence of lupus in a patient. Using the iCHIP®, ImmunArray’s proprietary antigen microarray, the simple blood test profiles a patient’s immune system, gaining insight into the state of the disease by analyzing a broad array of antibodies. Simply put, SLE-key can assist in determining a diagnosis of SLE. Developed in consultation with some of the nation’s leading rheumatologists, it is an accurate diagnostic tool available today.
What is the difference between SLE-key and other SLE diagnostic methods?
To date, no single test establishes sufficient sensitivity and/or specificity to diagnose SLE. The American Rheumatism Association has established 11 criteria (symptoms associated with SLE patients) to serve as a guide in determining whether or not a patient has lupus. When four or more of the criteria are met, a diagnosis of SLE is highly suggestive though not definitive. Because there has been no definitive test for lupus, it is often misdiagnosed.
The SLE-key Rule-Out test is an accurate test available for reliably ruling out the presence of SLE. The simple blood test works by measuring the repertoire of circulating antibodies to an array of antigens which are printed on ImmunArray’s proprietary iCHIP®. This circulating autoantibody “fingerprint” of known SLE patient samples is compared to those of healthy individuals. Proprietary analytical algorithms are then used to determine the likelihood of the patient being affected, or not, with SLE, in conjunction with a clinical assessment.
SLE-key has been shown to exclude SLE during differential diagnoses with 94% sensitivity and 75% specificity. To date, two-thirds of patients who had positive ANA test results, were found not to have lupus, or ruled out based on SLE-key test results.
Why should I test my patients using SLE-key? How does it work?
As you know, lupus is difficult to diagnose with any degree of accuracy. A survey by the Lupus Foundation of America suggests that more than half of those afflicted with lupus waited at least four years and saw at least three doctors before obtaining an accurate diagnosis. SLE-key can accelerate the diagnosis of SLE and do so accurately, helping you focus on the proper treatment for your patient.
The SLE-key test is easy to administer with a single blood draw. Unlike other diagnostic tests available to rheumatologists, no processing of the sample is required. In addition, the sample is stable for eight days, eliminating the need for a 24-hour receipt. The blood is analyzed at ImmunArray’s VERACIS® laboratory, with results sent to your office within five business days. The test also is covered by many major insurance companies as well as Medicare and Medicaid.
How much does the SLE-key test cost, and which insurances cover it?
Insurance coverage depends on the patient’s policy and needs to be verified on an individual basis. Similar types of tests are covered under some policies, and ImmunArray’s support team can assist you with any questions related to coverage and reimbursements, along with available programs to reduce a patient’s out of pocket responsibility. For questions related to these matters, please call us at 1-804-709-0144, and we’d be happy to provide you with additional details. You also can contact us at info@SLE-key.com.
How do I order an SLE-key test?
If you are a physician, you can order the test by calling our support team at 1-804-709-0144 or through this form..
What are the steps that are necessary to take on my end?
Ordering and preparing the kit is easy through these five simple steps.
- Order and receive your kit(s) from VERACIS
- Prepare the test requisition
- Draw blood
- Package serum tubes
- Ship package to VERACIS using self-mailer
For step-by-step instructions, you can also watch this short training video.
How long will it take to have an answer?After your patient’s blood is received at the VERACIS testing lab, you will receive a comprehensive report with your patient’s diagnosis within five business days.
What is VERACIS?A wholly owned subsidiary of ImmunArray USA located in Richmond, Virginia, VERACIS provides analytical and diagnostic testing, particularly for products using the iCHIP platform.
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