A Multianalyte Assay Panel with Cell-Bound Complement Activation Products Demonstrates Clinical Utility in Systemic Lupus Erythematosus

 

  • Positive AVISE
    Lupus Test Results:

The study clearly establishes a link between the superiority of the AVISE test and the benefit to patients through early treatment intervention. Delayed diagnosis can lead to increased disease burden and diminished quality of life.

Diagnosis

6X greater odds

AVISE Lupus [+]1 vs traditional ANA [+]2 establishing SLE diagnosis following AVISE

Treatment Initiation

3X greater odds

AVISE Lupus [+]1 vs traditional ANA [+]2 initiating SLE treatment following AVISE

  • Negative AVISE
    Lupus Test Results:

The study demonstrated that a negative AVISE test is more conclusive than the standard of care, as it is reflected by the lower number of repeat testing and fewer follow-up visits. Convincingly ruling out lupus is often a critical step for achieving diagnostic clarity for the patient and reducing costs on the system.

Repeat Testing

3.5X less frequent

AVISE Lupus vs. traditional ANA tested patients in a mean 285 days of follow up for AVISE and 305 days of follow-up for tANA

Repeat Testing

3.5X less frequent

AVISE Lupus vs. traditional ANA tested patients in a mean 285 days of follow up for AVISE and 305 days of follow-up for tANA

Laboratory Cost

2X lower

AVISE Lupus [-] vs traditional ANA [-] in first six-month follow-up period

Follow-up Visits

1 fewer visits

AVISE Lupus [-] vs traditional ANA [-] in first sixth-month follow-up period

References:
1. AVISE Lupus + = Tier 1 and Tier 2 Positive.
2. tANA + = ANA (IFA) 1:160 ≥ and/or one or more of the following
positive: anti-dsDNA, anti-smith.

Summary

This multi-center, retrospective chart review assessed the clinical utility of AVISE Lupus in patients suspected of systemic lupus erythematosus (SLE). The findings indicated that AVISE Lupus significantly enhanced physician confidence in both ruling in and ruling out lupus, providing valuable insights that informed appropriate treatment decisions. This suggests that the test could play a crucial role in the diagnostic process and management of SLE, potentially leading to more targeted and effective patient care.

Methods

A systematic review of medical records of ANA-positive patients with a positive (>0.1) or negative (<−0.1) MAP score was conducted. The records were assessed at 3 different time points: when the MAP was ordered (T0), when the test results were reviewed (T1) and at a later time (T2, ≥8 months after T1). Confidence in the diagnosis of SLE and initiation of hydroxychloroquine (HCQ) were assessed.

Conclusions

The MAP helped increase the confidence in ruling in and ruling out SLE in patients suspected of the disease and informed on appropriate treatment decisions.

Results

A total of 161 patient records from 12 centers were reviewed at T0 and T1. T2 was analyzed for 90 patients. At T0, low, moderate and high confidence in SLE diagnosis was reported for 58%, 30% and 12% patients, respectively. Confidence in SLE diagnosis increased for the MAP positive, while MAP negative made SLE less likely. Odds of higher confidence in SLE diagnosis increased by 1.74-fold for every unit of increase of the MAP score (p<0.001). Using the MAP-negative/anti-double-stranded DNA-negative patients as reference, the HR of assigning an International Classification of Diseases, Tenth Revision lupus code was 7.02-fold, 11.2-fold and 14.8-fold higher in the low tier-2, high tier-2 and tier-1 positive, respectively (p<0.001). The HR of initiating HCQ therapy after T0 was 2.90-fold, 4.22-fold and 3.98-fold higher, respectively (p<0.001).

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References:

  • Lupus Sci Med., 2021 Jul 12;8(1):e000528. doi: 10.1136/lupus-2021-000528
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