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2016 ; 10
(ä): 71-80
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The Avise Lupus Test and Cell-bound Complement Activation Products Aid the
Diagnosis of Systemic Lupus Erythematosus
#MMPMID27867431
Mossell J
; Goldman JA
; Barken D
; Alexander RV
Open Rheumatol J
2016[]; 10
(ä): 71-80
PMID27867431
show ga
BACKGROUND: Systemic lupus erythematosus (SLE) is a multifaceted disease, and its
diagnosis may be challenging. A blood test for the diagnosis of SLE, the Avise
Lupus test, has been recently commercialized and validated in clinical studies.
OBJECTIVES: To evaluate the use of the Avise Lupus test by community
rheumatologists. METHODS: The study is a longitudinal, case-control,
retrospective review of medical charts. Cases had a positive test result, and
controls had a negative result; all patients were anti-nuclear antibodies (ANA)
positive but negative for SLE-specific autoantibodies. Features of SLE,
diagnosis, and medications at two time points were recorded. RESULTS: Twenty of
the 23 cases (87%) and 4 of the 23 controls (17%) were diagnosed with SLE
(sensitivity=83%; specificity=86%). More cases than controls (43% vs. 17%)
fulfilled 4 American College of Rheumatology (ACR) classification criteria of
SLE. Sensitivity of the test was significantly higher than the ACR score (83% vs.
42%, p=0.006). A higher percentage of patients who met the classification
criteria had elevated cell-bound complement activation products (CB-CAPs)
compared to patients who did not. Anti-rheumatic medications were used in a
higher percentage of cases than controls (83% vs. 35% at baseline, p=0.002),
suggesting that cases were treated more aggressively early on. CONCLUSION: A
positive Avise Lupus test result aids in formulating a SLE diagnosis when
diagnosis based on standard-of-care tests and clinical features may be
challenging, and impacts patient management. Prospective studies will be
performed to better evaluate the clinical utility of the test and of CB-CAPs as
biomarkers of SLE.
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