Abstract
Current classification criteria for definite antiphospholipid syndrome (APS) mandate the use of one or more of three positive 'standardized' laboratory assays to detect antiphospholipid antibodies (aPL) (viz: anticardiolipin [aCL] IgG and IgM; anti-β2glycoprotein I [anti-β2GPI] antibodies IgG and IgM; and/or a lupus anticoagulant [LAC]), when at least one of the two major clinical manifestations (thrombosis or pregnancy losses) are present. Although, efforts of standardization for these 'criteria' aPL tests have been conducted over the last 27 years, reports of inconsistencies, inter-assay and inter-laboratory variation in the results of aCL, LAC, and anti-β2GPI, and problems with the interpretation and the clinical value of the tests still exist, which affect the consistency of the diagnosis of APS. A Task Force of scientists and pioneers in the field from different countries, subdivided in three working groups, discussed and analyzed critical questions related to 'criteria' aPL tests in an evidence-based manner, during the 13th International Congress on Antiphospholipid Antibodies (APLA 2010, April 13-16, 2010, Galveston, TX). These included: review of the standardization and the need for international consensus protocol for aCL and anti-β2GPI tests; the use of monoclonal and/or polyclonal standards in the calibration curve of those tests; and the need for establishment of international units of measurement for anti- β2GPI tests. The group also reviewed the recently updated guidelines for LAC testing, and analyzed and discussed the possibility of stratification of 'criteria' aPL tests as risk factors for APS, as well as the clinical value of single positive vs. multiple aPL positivity. The group members presented, discussed, analyzed data, updated and re-defined those critical questions at a preconference workshop that was open to congress attendees. This report summarizes the findings, conclusions, and recommendations of this Task Force.
| Original language | English |
|---|---|
| Pages (from-to) | 182-190 |
| Number of pages | 9 |
| Journal | Lupus |
| Volume | 20 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 2011 Feb 1 |
| Externally published | Yes |
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Keywords
- anti-βGlycoprotein I antibodies
- Anticardiolipin antibodies
- Antiphospholipid Syndrome
- lupus anticoagulant
- standardization
ASJC Scopus subject areas
- Rheumatology
Cite this
'Criteria' aPL tests : Report of a Task Force and preconference workshop at the 13th International Congress on Antiphospholipid Antibodies, Galveston, Texas, April 2010. / Pierangeli, S. S.; De Groot, P. G.; Dlott, J.; Favaloro, E.; Harris, E. N.; Lakos, G.; Ortel, T.; Meroni, P. L.; Otomo, Kotaro; Pengo, V.; Tincani, A.; Wong, R.; Roubey, R.
In: Lupus, Vol. 20, No. 2, 01.02.2011, p. 182-190.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - 'Criteria' aPL tests
T2 - Report of a Task Force and preconference workshop at the 13th International Congress on Antiphospholipid Antibodies, Galveston, Texas, April 2010
AU - Pierangeli, S. S.
AU - De Groot, P. G.
AU - Dlott, J.
AU - Favaloro, E.
AU - Harris, E. N.
AU - Lakos, G.
AU - Ortel, T.
AU - Meroni, P. L.
AU - Otomo, Kotaro
AU - Pengo, V.
AU - Tincani, A.
AU - Wong, R.
AU - Roubey, R.
PY - 2011/2/1
Y1 - 2011/2/1
N2 - Current classification criteria for definite antiphospholipid syndrome (APS) mandate the use of one or more of three positive 'standardized' laboratory assays to detect antiphospholipid antibodies (aPL) (viz: anticardiolipin [aCL] IgG and IgM; anti-β2glycoprotein I [anti-β2GPI] antibodies IgG and IgM; and/or a lupus anticoagulant [LAC]), when at least one of the two major clinical manifestations (thrombosis or pregnancy losses) are present. Although, efforts of standardization for these 'criteria' aPL tests have been conducted over the last 27 years, reports of inconsistencies, inter-assay and inter-laboratory variation in the results of aCL, LAC, and anti-β2GPI, and problems with the interpretation and the clinical value of the tests still exist, which affect the consistency of the diagnosis of APS. A Task Force of scientists and pioneers in the field from different countries, subdivided in three working groups, discussed and analyzed critical questions related to 'criteria' aPL tests in an evidence-based manner, during the 13th International Congress on Antiphospholipid Antibodies (APLA 2010, April 13-16, 2010, Galveston, TX). These included: review of the standardization and the need for international consensus protocol for aCL and anti-β2GPI tests; the use of monoclonal and/or polyclonal standards in the calibration curve of those tests; and the need for establishment of international units of measurement for anti- β2GPI tests. The group also reviewed the recently updated guidelines for LAC testing, and analyzed and discussed the possibility of stratification of 'criteria' aPL tests as risk factors for APS, as well as the clinical value of single positive vs. multiple aPL positivity. The group members presented, discussed, analyzed data, updated and re-defined those critical questions at a preconference workshop that was open to congress attendees. This report summarizes the findings, conclusions, and recommendations of this Task Force.
AB - Current classification criteria for definite antiphospholipid syndrome (APS) mandate the use of one or more of three positive 'standardized' laboratory assays to detect antiphospholipid antibodies (aPL) (viz: anticardiolipin [aCL] IgG and IgM; anti-β2glycoprotein I [anti-β2GPI] antibodies IgG and IgM; and/or a lupus anticoagulant [LAC]), when at least one of the two major clinical manifestations (thrombosis or pregnancy losses) are present. Although, efforts of standardization for these 'criteria' aPL tests have been conducted over the last 27 years, reports of inconsistencies, inter-assay and inter-laboratory variation in the results of aCL, LAC, and anti-β2GPI, and problems with the interpretation and the clinical value of the tests still exist, which affect the consistency of the diagnosis of APS. A Task Force of scientists and pioneers in the field from different countries, subdivided in three working groups, discussed and analyzed critical questions related to 'criteria' aPL tests in an evidence-based manner, during the 13th International Congress on Antiphospholipid Antibodies (APLA 2010, April 13-16, 2010, Galveston, TX). These included: review of the standardization and the need for international consensus protocol for aCL and anti-β2GPI tests; the use of monoclonal and/or polyclonal standards in the calibration curve of those tests; and the need for establishment of international units of measurement for anti- β2GPI tests. The group also reviewed the recently updated guidelines for LAC testing, and analyzed and discussed the possibility of stratification of 'criteria' aPL tests as risk factors for APS, as well as the clinical value of single positive vs. multiple aPL positivity. The group members presented, discussed, analyzed data, updated and re-defined those critical questions at a preconference workshop that was open to congress attendees. This report summarizes the findings, conclusions, and recommendations of this Task Force.
KW - anti-βGlycoprotein I antibodies
KW - Anticardiolipin antibodies
KW - Antiphospholipid Syndrome
KW - lupus anticoagulant
KW - standardization
UR - http://www.scopus.com/inward/record.url?scp=79953299697&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79953299697&partnerID=8YFLogxK
U2 - 10.1177/0961203310395055
DO - 10.1177/0961203310395055
M3 - Article
C2 - 21303835
AN - SCOPUS:79953299697
VL - 20
SP - 182
EP - 190
JO - Lupus
JF - Lupus
SN - 0961-2033
IS - 2
ER -