??? ?? - EliA MPOS

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• ??? ?? - EliA MPOS

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Why a new EliA MPOS test?

• ???? ??
• ??? EliA MPO?? ??? ??
• ?? ???? ??? ??
• EliA PR3S? ?? ????
• ? ?? ?? ?? anchor technique? ???? ANCA ??? ????
• ??? international reference? ?? ???,
  International Units (IU/ml) ??? ?? ??

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The new sensitive anti-MPO test

• Product name Package size Article number
• EliA MPOS Well 48 14-5537-01 new

• S? sensitivity? ??
• High sensitivity? anchor technique? ??? indirect
  coating ???? antigen? ? ? ???? ?? ?? ??

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EliA MPOS - Calibration

• CDC MPO-ANCA Human Reference Serum 15? ????
  calibration curve? ???? International Units
  (IU/ml)?? ?? ??
• ???, ??? EliA MPO ??? ?? ???? ??
• negative lt 3.5 IU/ml
• equivocal 3.5 5.0 IU/ml
• positive gt 5.0 IU/ml

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EliA MPOS - Blood Donors and Normal Range

• 400 blood donors were measured on Phadia 250.
• A substudy using 70 blood donors showed good
  comparison of Phadia 100.

Test Unit No of Mean 95 99 samples
value percentile percentile EliA MPOS IU/ml
400 0.6 0.9 1.5
Frequency
IU/ml
All blood donors far below cut-off. Good
discrimination.
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EliA MPOS - Serum / Plasma ?? ?? ????
Serum? ?? types? plasma ?? ????
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EliA MPOS - ??? ????, ??? ??? ??

• Samples used for performance validation n
• Microscopic polyangiitis (MPA) 80
• Churg-Strauss syndrome (CSS) 60
• Necrotizing crescentic glomerulonephritis (NCGN)
  12
• Disease controls 150
• Non-ANCA associated vasculitis (NAAV) 22
• Ulcerative colitis 30
• Crohns disease 30
• Systemic lupus erythematodes (SLE) 15
• Systemic Scleroderma 15
• Infections 38
• Total 302

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EliA MPOS - ??? ????
Good sensitivity in MPA. Only one false positive
(EBV infection).
Microsc. Polyangiitis
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High Specificity

• ? ??? disease control? ??
• ? ??? EBV infection ??
• ? ??? ?? IFA ANCA ??? ?? ??? p-ANCA pattern?
  ????, ?? ?? ???? MPO-antibodies? ??

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MPO antibodies in Churg-Strauss Syndrome

• ??? ???, CSS ??? ? 38? IFA ???? ??. ? ????? ?
  ¾? MPO antibodies? ?? (30) (Sinico RA et al,
  2005, Arthritis Rheum 522926-35)
• ?? ??? ??? 60?? CSS ?? ?? ? 23??? ANCA pattern?
  ??? (38.3). ??? ? 10??? IFA ???? ???? pANCA
  pattern? ?? (16.7). 11?? ???? MPO antibodies?
  ??? (18).
• EliA MPOS?? ???? ?? ?? ??? ??? ???, ?? ???? EliA
  ??? ??? sample panel ??? ??.
• ??? ??? Churg-Strauss ???? anti-MPO antibodies?
  prevalence? ?? 2?? assay ??? ??? ?? (with and
  without Churg-Strauss sera).

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EliA MPOS - ??? ????, ?? ???? ????

• ?? ?? ???? ??
• EliA MPO
• Inova QuantaLite MPO IgG ELISA
• Orgentec Anti-MPO (p-ANCA)
• Euroimmun Anti-MPO-ELISA (IgG)
• Eurodiagnostica Wieslab Capture-MPO-ANCA (only
  test with IU/ml)
• Nippro
• The Binding Site
• IFA?? ??

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3. EliA MPOS - ??? ???, ???!
?? ???? ????
EliA MPO (n 302) EliA MPOs (n 302) INOVA (n 302) Orgentec (n 302) Euroimmun (n 302) Eurodiagnostica (n 302) Nippro (n 240) Binding Site (n 240)
Sensitivity 27,63 41,45 23,03 37,50 40,79 40,13 30,67 28,67
Specificity 99,33 99,33 99,33 98,67 97,33 99,33 98,89 100,00
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3. EliA MPOS - ??? ???, ???! Comparison to
Competition with preset specificity
The performance of tests can be evaluated better
if you look at the sensitivity at a certain set
specificity. Using ROC analysis we calculated
the sensitivity at a specificity of 99.
EliA MPO EliA MPOs INOVA Orgentec Euroimmun Eurodiagnostica Nippro Binding Site
Sensitivity at 99 specificity 35.5 44.1 34.9 37.5 32.2 40.1 38.0 34.0
This evaluation shows that EliA MPOS performs
best and this is not dependent on the
recommended cut-off.
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EliA MPOS ??? ????, ?? ???? ????
Churg-Strauss Sera ??
EliA MPO (n 242) EliA MPOs (n 242) INOVA (n 242) Orgentec (n 242) Euroimmun (n 242) Eurodiagnostica (n 242) Nippro (n 180) Binding Site (n 180)
Sensitivity 35,87 56,52 29,35 50,00 55,43 55,43 40,00 38,89
Specificity 99,33 99,33 99,33 98,67 97,33 99,33 98,89 100,00
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EliA MPOS ??? ????, ?? ???? ????
Churg-Strauss Sera ??
The performance of tests can be evaluated better
if you look at the sensitivity at a certain set
specificity. Using ROC analysis we calculated
the sensitivity at a specificity of 99.
EliA MPO EliA MPOs INOVA Orgentec Euroimmun Eurodiagnostica Nippro Binding Site
Sensitivity at 99 specificity 47.8 59.8 48.9 54.3 43.5 40.1 50.0 45.6
This evaluation shows that EliA MPOS performs
best and this is not dependent on the
recommended cut-off.
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EliA MPOS EliA MPO? ROC ?? ??
EliA MPOS
EliA MPO

• EliA MPOS performs clearly better than the old
  EliA MPO.

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EliA MPOS ROC Analysis compared to
CompetitionWieslab MPO Capture and Orgentec
Anti-MPO
EliA MPOS vs. Orgentec Anti-MPO
EliA MPOS vs. Orgentec MPO Capture
EliA MPOS vs. Wieslab MPO Capture

• ROC Analysis reveals that EliA MPOS performs
  better than the MPO tests from Wieslab
  (Eurodiagnostica) and Orgentec.

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EliA MPOS ROC Analysis compared to
CompetitionInova and Euroimmun Anti-MPO Assay
EliA MPOS vs. Invoa
EliA MPOS vs. Euroimmun MPO

• ROC Analysis reveals that EliA MPOS performs
  better than the Euroimmun and the Inova Anti-MPO
  tests.

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EliA MPOS Comparison with IFA on granulocytes
An ANCA pattern was found in 63.2 of
ANCA-associated vasculitis (AAV) and in 29.3 of
controls. The classical MPO-associated pANCA
pattern was found in 35.5 of AAV and 2.7 of
controls. x-ANCA in most cases positive in
ethanol-fixed granulocytes but negative in
formalin-fixation. Measurements are based on
the MPOs serum panel (see slide 8) plus 30
additional sera from patients with Wegeners
granulomatosis
in
Almost 30 of non-AAV are positive in IFA. pANCA
is less sensitive and less specific than EliA
MPOS. The clinical usefulness of IFA as screening
test is questionable.
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EliA MPOS - ??? ????, ??

• EliA MPOS ??? ??? EliA MPO ?? ??? ??.
• EliA MPOS ??? ?? ????? ???? ??.
• EliA MPOS ? Wieslab? Capture-MPO-ANCA (capture
  assay)?? ?? ? ????, ? ? ?? ???? IU/ml
  (standardized to the CDC standard)? ??? ? ?? ???
  ??? ????? ??.
• IFA? AAV (ANCA associated vasculitis)?? ???? ???
  ???? ?? ??. Disease control? ¼ ???? ANCA ??
  (granulocytes)? ??? ??.
• pANCA? EliA MPOS? ?? ???? ???? ?? ??.
• ???, IFA? ??? ???? ??? ??? ??.

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EliA GBM for detection of anti-GBM in
ANCA-positive samples

• ANCA ?? ??? GBM antibodies? ??? ???? ??!
• ANCA ?? ??? 5-14 ??? anti-GBM? ??. Anti-GBM ???
  vasculitis ???? ? ???? ?? ??? ??? ??? ?? ??? ?
  ??. (Levy et al, 2004, see PoM 01/05)
• ??? ???? glomerulonephritis? ???? ?? ? ? 2?
  ANCA? anti-GBM ?? ??. ??? ANCA? ??? ??? anti-GBM?
  ??? ???? ??. (Jayne DRW et al, Kidney Int 1990
  37965-70)

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EliA MPOS and EliA PR3SCutting edge automated
ANCA testing!