PMID- 22265712
OWN - NLM
STAT- MEDLINE
DCOM- 20120615
LR  - 20120305
IS  - 1873-3492 (Electronic)
IS  - 0009-8981 (Linking)
VI  - 413
IP  - 7-8
DP  - 2012 Apr 11
TI  - Development and performance evaluation of novel chemiluminescence assays for 
      detection of anti-PR3 and anti-MPO antibodies.
PG  - 719-26
LID - 10.1016/j.cca.2012.01.004 [doi]
AB  - BACKGROUND: The detection of anti-proteinase 3 (PR3) and anti-myeloperoxidase 
      (MPO) autoantibodies represents a serological hallmark in the diagnosis of small 
      vessel vasculitis such as granulomatosis with polyangiitis (GPA) and microscopic 
      polyangiitis (MPA). We evaluated novel chemiluminescence assays (CIAs) for PR3- 
      and MPO-ANCA detection and investigated their utility for disease activity 
      monitoring. METHODS: Sera collected from GPA (n=41) and MPA (n=30) patients were 
      tested by QUANTA Lite(R) PR-3 and MPO ELISAs (INOVA Diagnostics) and by the QUANTA 
      Flash PR3 and MPO CIAs (INOVA). Precision and linearity were analyzed following 
      reference guidelines. The recently launched reference sera for PR3-and MPO-ANCA 
      (Centers of Disease Control and prevention, CDC) were used to establish 
      international units for the new assays. Disease activity was determined using the 
      Birmingham Vasculitis Activity Score. RESULTS: The international standards for 
      PR3-and MPO-ANCA yielded results of 403 CU and 332 CU in the novel CIAs, 
      respectively. The linearity analysis showed linear regression values>0.97 with 
      slopes between 0.96 and 1.04. Total variation obtained from the precision study 
      showed CV% of </=7.4 for PR3-ANCA and </=12.8 for MPO-ANCA. Good agreement (Spearman 
      rho >/= 0.89) was observed between CIA and ELISA. PR3-ANCA determined by CIA, but 
      not by ELISA, was correlated with disease activity. No correlation was found for 
      MPO-ANCA. CONCLUSION: The novel PR3- and MPO-ANCA CIAs show good precision, 
      linearity and correlation to ELISA. In addition, PR3-ANCA by CIA show correlation 
      with disease activity.
CI  - Copyright A(c) 2012 Elsevier B.V. All rights reserved.
FAU - Mahler, M
AU  - Mahler M
AD  - INOVA Diagnostics, INC., San Diego, CA 32131-1638, USA. mmahler@inovadx.com
FAU - Radice, A
AU  - Radice A
FAU - Yang, W
AU  - Yang W
FAU - Bentow, C
AU  - Bentow C
FAU - Seaman, A
AU  - Seaman A
FAU - Bianchi, L
AU  - Bianchi L
FAU - Sinico, R A
AU  - Sinico RA
LA  - eng
PT  - Journal Article
DEP - 20120113
PL  - Netherlands
TA  - Clin Chim Acta
JT  - Clinica chimica acta; international journal of clinical chemistry
JID - 1302422
RN  - 0 (Autoantibodies)
RN  - EC 1.11.1.7 (Peroxidase)
RN  - EC 3.4.21.76 (Myeloblastin)
SB  - IM
MH  - Autoantibodies/*blood
MH  - Enzyme-Linked Immunosorbent Assay
MH  - Humans
MH  - Luminescence
MH  - Myeloblastin/*immunology
MH  - Peroxidase/*immunology
MH  - Reference Values
MH  - Reproducibility of Results
EDAT- 2012/01/24 06:00
MHDA- 2012/06/16 06:00
CRDT- 2012/01/24 06:00
PHST- 2011/11/11 00:00 [received]
PHST- 2011/12/22 00:00 [revised]
PHST- 2012/01/03 00:00 [accepted]
PHST- 2012/01/24 06:00 [entrez]
PHST- 2012/01/24 06:00 [pubmed]
PHST- 2012/06/16 06:00 [medline]
AID - S0009-8981(12)00010-1 [pii]
AID - 10.1016/j.cca.2012.01.004 [doi]
PST - ppublish
SO  - Clin Chim Acta. 2012 Apr 11;413(7-8):719-26. doi: 10.1016/j.cca.2012.01.004. Epub 
      2012 Jan 13.