The Avise Lupus Test and Cell-bound Complement Activation Products Aid the Diagnosis of Systemic Lupus Erythematosus

Mossell, James; Goldman, John A.; Barken, Derren; Alexander, Roberta Vezza

doi:10.2174/1874312901610010071

Cited by 13 publications

(18 citation statements)

References 31 publications

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“…Our study represents an advance in research regarding the clinical utility of the AVISE CTD test. While previous studies have shown that the test improves the sensitivity and specificity of diagnosing SLE in cases versus controls,15 16 we have demonstrated that AVISE positivity can not only predict development of SLE within a 2-year interval, but also with equal or greater specificity and greater sensitivity than traditional biomarkers. AVISE positivity at baseline in this cohort also demonstrated a 10.7-fold increased OR for a confirmed SLE diagnosis at 2 years.…”

Section: Discussioncontrasting

confidence: 56%

“…The AVISE CTD test has been demonstrated to aid in differentiation of SLE diagnosis from other CTDs and FM 15 16. We present here the first study to evaluate its clinical utility in a real-world cohort.…”

Section: Discussionmentioning

confidence: 99%

“…It contains SLE-associated markers and extractable nuclear antigen, rheumatoid arthritis (RA), antiphospholipid syndrome and thyroid panels. This two-tiered test has been shown to have high sensitivity and specificity for differentiating SLE from patients with other CTDs or FM 15. However, there have been no studies assessing the clinical utility of the test in predicting future clinical diagnoses and outcomes in a real-world cohort.…”

Section: Introductionmentioning

confidence: 99%

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Utility of the AVISE Connective Tissue Disease test in predicting lupus diagnosis and progression

2020

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Background The AVISE Connective Tissue Disease (CTD) test uses autoantibody, erythrocyte-bound C4d (EC4d) and B-cell-bound C4d (BC4d) levels to aid in diagnoses of SLE, other CTDs and fibromyalgia. We evaluated the utility of the AVISE CTD test in predicting SLE disease development and damage progression. Methods Patients who had undergone AVISE CTD testing were assessed for SLE diagnosis by the Systemic Lupus International Collaborating Clinics (SLICC) and American College of Rheumatology criteria and for SLE damage by the Systemic Lupus International Collaborating Clinics Damage Index (SDI) at the time of AVISE testing (t=0) and 2 years later (t=2).Results Among 117 patients without a previous diagnosis of SLE, 65% of patients who tested positive developed SLE at t=2, compared with 10.3% of patients who tested non-positive (p<0.0001). AVISE-positive patients fulfilled significantly more SLICC diagnostic criteria than AVISEnon-positive patients at both t=0 (3.8±2.1 vs 1.9±1.1, p=0.001) and t=2 (4.5±2.2 vs 2.1±1.2, p<0.0001). AVISEpositive patients also had had significantly higher SDI at t=2 (1.9±1.3 vs 1.03±1.3, p=0.01). BC4d levels correlated with the number of SLICC criteria at t=0 (r=0.33, p<0.0001) and t=2 (r=0.34, p<0.0001), as well as SDI at t=0 (r=0.25, p=0.003) and t=2 (r=0.26, p=0.002).Conclusions The AVISE CTD test can aid in SLE evaluation by predicting SLE disease development and future damage progression.

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Section: Discussioncontrasting

confidence: 56%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Utility of the AVISE Connective Tissue Disease test in predicting lupus diagnosis and progression

2020

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“…Furthermore, MAP and CB-CAPs consistently outperform serum complement levels for SLE diagnosis. A case–control, retrospective review of medical charts also suggested the clinical utility of MAP/CB-CAPs laboratory testing in assisting rheumatologists in real-world practice 11. However, prospective data comparing standard diagnosis laboratory testing (SDLT) to MAP/CB-CAPs laboratory testing is lacking.…”

Section: Introductionmentioning

confidence: 99%

Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE

Wallace

Alexander²,

O'Malley³

et al. 2019

Lupus Sci Med

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ObjectiveWe compared the physician-assessed diagnostic likelihood of SLE resulting from standard diagnosis laboratory testing (SDLT) to that resulting from multianalyte assay panel (MAP) with cell-bound complement activation products (MAP/CB-CAPs), which reports a two-tiered index test result having 80% sensitivity and 86% specificity for SLE.MethodsPatients (n=145) with a history of positive antinuclear antibody status were evaluated clinically by rheumatologists and randomised to SDLT arm (tests ordered at the discretion of the rheumatologists) or to MAP/CB-CAPs testing arm. The primary endpoint was based on the change in the physician likelihood of SLE on a five-point Likert scale collected before and after testing. Changes in pharmacological treatment based on laboratory results were assessed in both arms. Statistical analysis consisted of Wilcoxon and Fisher’s exact tests.ResultsAt enrolment, patients randomised to SDLT (n=73, age=48±2 years, 94% females) and MAP/CB-CAPs testing arms (n=72, 50±2 years, 93% females) presented with similar pretest likelihood of SLE (1.42±0.06 vs 1.46±0.06 points, respectively; p=0.68). Post-test likelihood of SLE resulting from randomisation in the MAP/CB-CAPs testing arm was significantly lower than that resulting from randomisation to SDLT arm on review of test results (−0.44±0.10 points vs −0.19±0.07 points) and at the 12-week follow-up visit (−0.61±0.10 points vs −0.31±0.10 points) (p<0.05). Among patients randomised to the MAP/CB-CAPs testing arm, two-tiered positive test results associated significantly with initiation of prednisone (p=0.034).ConclusionOur data suggest that MAP/CB-CAPs testing has clinical utility in facilitating SLE diagnosis and treatment decisions.

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“…While objective measures (SLICC criteria) were correlated with AVISE, there is no assurance that knowledge of the test did not affect the scoring. This is hinted at by other studies showing that a patient with a positive AVISE test is more likely to be diagnosed with SLE regardless of the number of criteria met,18 and that rheumatologists are less likely to diagnose lupus in a patient with a negative AVISE test, regardless of other features 19…”

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confidence: 91%

Finding lupus in the ANA haystack

Olsen

Karp

2020

Lupus Sci Med

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Diagnosis of SLE in early stages is challenging due to the heterogeneous nature of presenting symptoms and the poor performance metrics of the screening ANA test. Even the more specific double-stranded DNA autoantibody has relatively low predictive value in early disease. A consequence is delayed referral, with the likelihood that some patients have progression of disease prior to specialist evaluation. Tests that might fill this diagnostic gap are therefore needed. The AVISE Connective Tissue Disease Test that uses a multiplex approach to detect autoantibodies and cell-bound complement products has shown utility in distinguishing SLE from other rheumatological conditions. Whether it might be useful in early disease stages to predict progression is addressed in a recent study by Liang and colleagues, who tested clinic patients who had non-specific findings with the objective of determining whether AVISE could predict onset of SLE. While this test provided more useful prognostic information than other available diagnostics, it had relatively low sensitivity, suggesting that significant numbers of patients with preclinical SLE would be missed by this screening. The need remains for development of diagnostics with robust sensitivity and specificity in early disease that would also deliver prognostic information about risk for SLE. Such tests would have great value as a tool for primary providers to more efficiently triage ANA-positive patients for appropriate specialty evaluation.

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The Avise Lupus Test and Cell-bound Complement Activation Products Aid the Diagnosis of Systemic Lupus Erythematosus

Cited by 13 publications

References 31 publications

Utility of the AVISE Connective Tissue Disease test in predicting lupus diagnosis and progression

Utility of the AVISE Connective Tissue Disease test in predicting lupus diagnosis and progression

Randomised prospective trial to assess the clinical utility of multianalyte assay panel with complement activation products for the diagnosis of SLE

Finding lupus in the ANA haystack

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