PMID- 15706478
OWN - NLM
STAT- MEDLINE
DCOM- 20050628
LR  - 20061115
IS  - 0094-6176 (Print)
IS  - 0094-6176 (Linking)
VI  - 31
IP  - 1
DP  - 2005 Feb
TI  - A multilaboratory peer assessment quality assurance program-based evaluation of 
      anticardiolipin antibody, and beta2-glycoprotein I antibody testing.
PG  - 73-84
AB  - We evaluated the performance of anticardiolipin (aCL) and beta2-glycoprotein I 
      (beta2-GPI) antibody assays through a large external quality assurance program. 
      Data from the 2002 cycle of the Royal College of Pathologists of Australasia 
      Quality Assurance Program (RCPA QAP) were analyzed for variation in reported 
      numerical values and semiquantitative results or interpretations according to 
      method type or group and in conjunction with available clinical data. High 
      interlaboratory variation in numerical results and notable method-based 
      variation, combined with a general lack of consensus in semiquantitative 
      reporting, continues to be observed. Numerical results from cross-laboratory 
      testing of 12 serum samples (for immunoglobulin G [IgG]-aCL, IgM-aCL, and 
      IgG-beta2-GPI) yielded interlaboratory coefficients of variation (CVs) that were 
      higher than 50% in six of 12 (50%) specimens for IgG-aCL, and 12 of 12 (100%) 
      specimens for IgM-aCL and IgG-beta2-GPI. Semiquantitative reporting also varied 
      considerably, with total (100%) consensus occurring in only four of 36 (11%) 
      occasions. General consensus (where > 90% of participating laboratories agreed 
      that a given serum sample gave a result of either negative or positive) was only 
      obtained on 13 of 36 (36%) occasions. Variation in results between different 
      method types or groups were also present, resulting in potential biasing of the 
      RCPA QAP-defined target results by the large number of laboratories using the 
      dominant aCL assays. Finally, laboratory findings frequently did not agree with 
      the available clinical information. In conclusion, in a large proportion of 
      specimens from the 2002 RCPA QAP cycle, laboratories could not agree on whether a 
      serum sample tested was aCL-positive or aCL-negative, or beta2-GPI-positive or 
      beta2-GPI-negative. Despite prior attempts to improve the standardization of 
      testing and reporting practices, laboratory testing for aCL and anti-beta2-GPI 
      still demonstrates significant interlaboratory and intermethod variation, which 
      needs to be taken into account for the clinical interpretation of test results, 
      especially those from different laboratories.
FAU - Favaloro, Emmanuel J
AU  - Favaloro EJ
AD  - Haemostasis Laboratories, Department of Haematology, Institute of Clinical 
      Pathology and Medical Research, Westmead Hospital, Westmead, New South Walls, 
      Australia. emmanuel@icpmr.wsahs.nsw.gov.au
FAU - Wong, Richard C W
AU  - Wong RC
FAU - Silvestrini, Roger
AU  - Silvestrini R
FAU - McEvoy, Robert
AU  - McEvoy R
FAU - Jovanovich, Susan
AU  - Jovanovich S
FAU - Roberts-Thomson, Peter
AU  - Roberts-Thomson P
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - Semin Thromb Hemost
JT  - Seminars in thrombosis and hemostasis
JID - 0431155
RN  - 0 (Antibodies, Anticardiolipin)
RN  - 0 (Autoantibodies)
RN  - 0 (Glycoproteins)
RN  - 0 (Immunoglobulin G)
RN  - 0 (beta 2-Glycoprotein I)
SB  - IM
MH  - Antibodies, Anticardiolipin/*analysis/*immunology
MH  - Antiphospholipid Syndrome/diagnosis/immunology
MH  - Australasia
MH  - Autoantibodies/analysis
MH  - Glycoproteins/*analysis/*immunology
MH  - Humans
MH  - Immunoglobulin G/analysis
MH  - Observer Variation
MH  - *Quality Assurance, Health Care
MH  - Quality Control
MH  - Reproducibility of Results
MH  - beta 2-Glycoprotein I
EDAT- 2005/02/12 09:00
MHDA- 2005/06/29 09:00
CRDT- 2005/02/12 09:00
PHST- 2005/02/12 09:00 [pubmed]
PHST- 2005/06/29 09:00 [medline]
PHST- 2005/02/12 09:00 [entrez]
AID - 10.1055/s-2005-863808 [doi]
PST - ppublish
SO  - Semin Thromb Hemost. 2005 Feb;31(1):73-84. doi: 10.1055/s-2005-863808.