AVISE Interpretation Guide - Advanced Testing For Lupus ...

AVISE? Interpretation Guide

ENA Markers

SLE Associated Markers

AVISE Interpretation Guide

SSAALLVVEEIISSPEMErooLCnuTitpDours AVISE APS

Marker (method)

EC4d (FACS) BC4d (FACS)

C4d (FACS)

XX X X

C3/C4 (IT)

Anti-C1q (ELISA)

Associated Disease

Prevalence 46-66%1

% 44% 60%

Anti-dsDNA IgG (ELISA and IIF)

Anti-dsDNA IgG

X

(CIA)

Anti-Nuclear Antibodies (ANA) (ELISA and IIF)

Anti-Ribosomal P

X

(ELISA)

Anti-Smith IgG X X (ELISA)

Marker (method)

Anti-CENP IgG

XX

(ELISA)

Anti-Jo-1 IgG

XX

(ELISA)

Anti-RNP70

X

(ELISA)

Anti-Scl-70 IgG X (ELISA)

A (CIA)

A (CIA)

A

Pol III

(ELISA)

Anti-SS-B/La IgG X X (ELISA)

Anti-U1RNP IgG (ELISA)

Anti-Histone (ELISA)

30-40%3 43% 97% 30%

Associated Disease

Prevalence 20-60%7 20-30%5

90%

S

S

S

M

S

S

S

M

S

28-70%6

40-60%8

95-99%11

Lupus 95%

1

Interpretation Interpretation

s

all of the

RA Markers

Marker (method)

Anti-Cyclic

Citrullinated

XX

Peptide IgG

(ELISA)

Associated Disease

Prevalence

70-90%12

(ELISA)

-2

Rheumatoid Factor X IgM & IgA (ELISA)

Marker (method) 2-Glycoprotein 1 IgG, IgM & IgA (CIA)

Cardiolipin IgG, IgM & IgA (CIA)

X*

AntiPhosphatidylserine /Prothrombin (PS/PT) IgM & IgG (ELISA)

Marker (method) Thyroglobulin IgG (ELISA)

Thyroid Peroxidase IgG (ELISA)

70-90%12

XX

Associated Disease

Prevalence 45%

97%

XX

o

38-49%1 XX

Associated Disease

Prevalence 60-85%1

71-97%1

AVISE HCQ

to

Interpretation

Interpretation

Interpretation t t

AVISE MTX

to

APS Markers

Thyroid Markers

Underexposed

or

( 10 U/mL EC4d > 75 Net MFI BC4d > 200 Net MFI

Anti-dsDNA > 301 U/ML

Positive

If Tier 1 is Negative move to Tier 2

Tier 2 criteria combines CB-CAPs with additional markers to yield an aggregate index value

Tier 2

Tier 2 generates an index value based on the following components ? ANA component ? CB-CAPs component ?

3

AVISE? CTD and AVISE Lupus result report

The result for the AVISE Lupus lotted along a gradient of increasing

likelihood for presence of SLE (See page 6 for likelihood ratios)

Analytes included in Tier 1 and Tier 2 along with respective assessments are reported in two distinct sections

4

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