interpretation guide - avise · 2020. 4. 16. · (cia) s s s m anti-ss-b/la igg 40-60%8 anti-u1rnp...
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AVISE®
Interpretation Guide
Marker (method) Associated Disease Interpretation
EC4d (FACS) 46-66%1
BC4d (FACS)
C3/C4 (IT) 44%
Anti-C1q(ELISA)
60%
Anti-dsDNA IgG(ELISA and IIF)
30-40%3 all
of the
Anti-dsDNA IgG(CIA)
43%
Anti-Nuclear Antibodies (ANA) (ELISA and IIF)
97%
Anti-Ribosomal P (ELISA)
30%
Anti-Smith IgG (ELISA)
Anti-CENP IgG(ELISA)
20-60%7
Anti-Jo-1 IgG(ELISA)
20-30%5
Anti-RNP70(ELISA)
90%
Anti-Scl-70 IgG(ELISA)
28-70%6
A(CIA)
SS S M
Anti-SS-B/La IgG 40-60%8
Anti-U1RNP IgG(ELISA)
95-99%11
X
X
X
X
X
X
X
X
X
X
X
XX
X
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X
AVISE Interpretation GuideSL
E Ass
ocia
ted
Mar
kers
ENA
Mar
kers
Prevalence
C4d (FACS) %
Marker (method) Associated Disease Prevalence Interpretation
s(ELISA)
SS S M
A(CIA)
A Pol III(ELISA)
S
Anti-Histone(ELISA)
Lupus95%
SLE P
oSL
E Mnit
o
Lupu
s
AVIS
PS
AVISE
CTD
EESIVA
ro E A
r
1
Marker (method) Associated Disease Prevalence Interpretation
Anti-Cyclic Citrullinated Peptide IgG(ELISA)
70-90%12
Rheumatoid Factor IgM & IgA (ELISA)
70-90%12
Associated Disease Prevalence Interpretation
β2-Glycoprotein 1 IgG, IgM & IgA(CIA)
45%
Cardiolipin IgG, IgM & IgA(CIA)
o
97%
Anti-Phosphatidylserine/Prothrombin (PS/PT) IgM & IgG (ELISA)
38-49%1
Marker (method) Associated Disease Prevalence Interpretation
Thyroglobulin IgG(ELISA) 60-85%1 t
Thyroid Peroxidase IgG (ELISA)
71-97%1 t
Thyr
oid
Mar
kers
APS M
arke
rs
X X
RA M
arke
rs
X X
X X
X* X X
2
(ELISA)
- 2
X
Marker (method)
or Underexposed (<200 ng/ml)
AVISE MTXto
AVISE HCQ to
Any of the Following:Anti-Sm > 10 U/mLEC4d > 75 Net MFI
BC4d > 200 Net MFIAnti-dsDNA > 301 U/ML
If Tier 1 is Negative move to Tier 2
Negative
Tier 1
Positive
A deeper look at the AVISE® Lupus two tier algorithm
Tier 2 criteria combines CB-CAPs with additional markers to yield an aggregate index value
Tier 2 generates an index value based on the following components• ANA component• CB-CAPs component•
Tier 2
Tier 1 criteria is highly speci�c for SLE
3
The result for the AVISE Lupus
lotted along a gradient of increasing likelihood for presence of SLE(See page 6 for likelihood ratios)
4
AVISE® CTD and AVISE Lupus result report
Analytes included in Tier 1 and Tier 2 along with respecti ve assessments are reported in two distinct sections
Details for ANA (HEp-2) are at the top of the page including any observed nuclear and cytoplasmic patterns
5
Far left column iden es positive(+) and strong positive(++) interpretations for each analyte
Notes providsummary statements
Call Provider Relations with any questions, or to arrange for a clinical consultation
Notes:
AVISE® CTD and AVISE Lupus page 2
(Note: AVISE SLE Prognostic values will be reported separately)
Provider Relations: 888.452.1522
6
Figure adapted from Putterman et al. Lupus Science & Medicine. 2014.
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l
l
l l
P
Sensitivity: 80%Speci�city vs. other disease: 86%
Index Value
www.AviseTest.com | 888.452.1522
eecnecseroulfonummI :AFI ELISA: En yyassA tnebrosonummI dekniL-emy CIA: Chemiluminesc yyassA yassaonummI tne IT: ImmunoturbidimetryMethodology De�nitions: FACS: Fluorescence-Activated Cell SortingReferences:
2020
1. Putterman C, et al. Cell-Bound Complement Activation Products in Systemic Lupus Erythematosus: Comparison with Anti-Double-Stranded Dna and Standard Complement Measurements. Arthritis & Rheumatism. 2014.
2. Wallace D, et al. Systemic Lupus Erythematosus And Primary Fibromyalgia can be Distinguished by Testing for Cell-Bound Complement Activation Products. Lupus Science & Medicine. 2016.3. Wichainun R, et al. Sensitivity and Speci�city of ANA And Anti-Dsdna In The Diagnosis of Systemic Lupus Erythematosus: A Comparison using Control Sera Obtained from Healthy Individuals
and Patients with Multiple Medical Problems. Asian Pac J Allergy Immunol. 2013.4. Migliorini P, et al. Anti-Sm And Anti-Rnp Antibodies. Clinical Immunology Unit, Department Of Internal Medicine. Autoimmunity. 2005.5. Zampieri S, et al. Anti-Jo-1 Antibodies. Autoimmunity. 2005.6. Basu D, et al. Anti-Scl-70. Autoimmunity. 2005. 7. Russo K, et al. Circulating Anticentromere Cenp-A and Cenp-B Antibodies In Patients with Di�use and Limited Systemic Sclerosis, Systemic Lupus Erythematosus, and Rheumatoid Arthritis.
The Journal Of Rheumatology. 2000. 8. Montecucco C, et al. Anti-Ssb/La Antibodies In Sjögren’s Syndrome and Related Autoimmune Diseases. Results of A Quantitative Immunoassay Using a Highly Puri�ed Antigen. Clin Exp
Rheumato.1989.9.
.10.11. Ho�man R, et al. Mixed Connective Tissue Disease. Modern Therapeutics In Rheumatic Diseases. 2002.12. Rantapää-Dahlqvist S, et al. Antibodies Against Cyclic Citrullinated Peptide And Iga Rheumatoid Factor Predict the Development of Rheumatoid Arthritis. Arthritis & Rheumatism. 2003.13. Perches P, et al. Evaluation of Antiphospholipid Antibodies Testing for the Diagnosis of Antiphospholipid Syndrome. Revista Brasileira De Reumatologia. 2009.14. Galli M, et al. Anti–Β2-Glycoprotein I, Antiprothrombin Antibodies, And The Risk Of Thrombosis In The Antiphospholipid Syndrome. Blood. 2003.15. Engler H, et al. Anti-Thyroid Peroxidase (Anti-Tpo) Antibodies in Thyroid Diseases, Non-Thyroidal Illness And Controls. Clinical Validity of a New Commercial Method for Detection of Anti-TPO
(Thyroid Microsomal) Autoantibodies. Clin Chim Acta. 1994.16. Akhter E, et al. Utility of Antiphosphatidylserine/Prothrombin and Iga Antiphospholipid Assays in Systemic Lupus Erythematosus. J Rheumatol. 2013.17. Yin Y, et al. Diagnostic Value of Serum Anti-C1q Antibodies in Patients with Lupus Nephritis: A Meta-Analysis. Lupus. 2012.18. Hanly J, et al. Autoantibodies as Biomarkers for the Prediction of Neuropsychiatric Events In Systemic Lupus Erythematosus. Ann Rheum Dis. 2011.19. Buyon J, et al. Reduction in erythrocyte-bound complement activation products titers of anti-C1q antibodies association with clinical improvement in systemic lupus erythematosus. Lupus
Science of Medicine. 2016.20. Data on �le. Exagen Inc. 2016.21.
2292-2302. 22. et al. with emphasis on skin manifestations and role of 2012 23. Kao A, et al. Relation of platelet C4d with all-cause mortality and ischemic stroke in patients with systemic lupus erythematosus. Transl Stroke Res. 2014 Aug;5(4):510-824. Petri M, et al. Complement C4d Split Products in Combination with Lupus Anticoagulant and Low Complement Associate with Thrombosis in Systemic Lupus Erythematosus [abstract].
Arthritis Rheumatol. 2018; 70 (suppl 10).