In ECAT veritas?
Abstract
The laboratory criteria of the antiphospholipid syndrome include one coagulation assay (lupus anticoagulant [LA]) and two solid phase assays (anticardiolipin [aCL] and anti-ß(2)glycoprotein I antibodies [aß(2)GPI]). External quality control (EQC) surveys show that negative and clearly positive LA samples are classified correctly by about 95% of laboratories. For 'weak' LA there is a wide variability in samples' classification. Furthermore, when a weak LA sample is used in two different EQC surveys more than 50% of laboratories classify it differently. In some surveys weak LA samples were found to be positive for aCL and for aß(2)GPI by a majority of laboratories; the main reason for laboratories which classified these samples as LA negative was a negative result in the mixing test. It is likely that, depending on the sensitivity of the assay, a weak LA cannot be detected anymore after 1:1 dilution of the sample with normal plasma. Therefore, we recommend the use of integrated assays, such as screen/confirm ratios, for the detection of weak LA samples.
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A reduced sensitivity is likely to be expected for weak LAC when these are diluted in the mixture of PP and NPP except in the case of the cofactor effect.
“A reduced sensitivity is likely to be expected for weak LAC, when these are diluted in the mixture of PP and NPP except in the case of the cofactor effect (4, 13).”
From Mixing studies in lupus anticoagulant testing are required at least in some type of samples (2015) · cites this paper as [13]
Cites
Update of the guidelines for lupus anticoagulant detection
PENGO, V., TRIPODI, A., REBER, G., RAND, J. H., ORTEL, T. L., GALLI, M., & DE GROOT, P. G. (2009) · Journal of Thrombosis and Haemostasis · doi:10.1111/j.1538-7836.2009.03555.x · Cited by 1,197 · see citing works
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Clinical course of high‐risk patients diagnosed with antiphospholipid syndrome
PENGO, V., RUFFATTI, A., LEGNANI, C., GRESELE, P., BARCELLONA, D., ERBA, N., TESTA, S., MARONGIU, F., BISON, E., DENAS, G., et al. (2010) · Journal of Thrombosis and Haemostasis · doi:10.1111/j.1538-7836.2009.03674.x · Cited by 633 · see citing works
Normal plasma mixing studies in the laboratory diagnosis of lupus anticoagulant
Thom, J., Ivey, L., & Eikelboom, J. (2003) · Journal of Thrombosis and Haemostasis · doi:10.1111/j.1538-7836.2003.0543h.x · Cited by 39 · see citing works
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Recent Guidelines and Recommendations for Laboratory Detection of Lupus Anticoagulants
Moore, G. (2014) · Seminars in Thrombosis and Hemostasis · doi:10.1055/s-0033-1364185 · Cited by 148 · see citing works
“48,49,51,62,63,66 The principle arises from the fact that the traditional testing order of screen-mix-con fi rm is circumvented and the presence of a LA can be immediately apparent without performing the mixing test.”
BackgroundMethodAntiphospholipid antibody testing and standardization
Devreese, K. M. J. (2014) · International Journal of Laboratory Hematology · doi:10.1111/ijlh.12234 · Cited by 98 · see citing works
Chayoua, W., Kelchtermans, H., Moore, G. W., Musiał, J., Wahl, D., de Laat, B., & Devreese, K. M. J. (2018) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.14261 · Cited by 71 · see citing works
Mixing studies in lupus anticoagulant testing are required at least in some type of samples
Devreese, K. M. J., & de Laat, B. (2015) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.13020 · Cited by 63 · see citing works
Moore, G. W., Culhane, A. P., Daw, C. R., Noronha, C. P., & Kumano, O. (2016) · Thrombosis Research · doi:10.1016/j.thromres.2016.01.019 · Cited by 42 · see citing works
Current Controversies in Lupus Anticoagulant Detection
Moore, G. (2016) · Antibodies · doi:10.3390/antib5040022 · Cited by 36 · see citing works
Mixing studies for lupus anticoagulant: mostly no, sometimes yes
Moore, G. W. (2020) · Clinical Chemistry and Laboratory Medicine (CCLM) · doi:10.1515/cclm-2019-1248 · Cited by 19 · see citing works
Analytical dilemmas in lupus anticoagulant detection
Moore, G. W. (2023) · Exploration of Immunology · doi:10.37349/ei.2023.00104 · Cited by 5 · see citing works
- Authors
- Reber, G., & Meijer, P.
- Affiliations
- University of Geneva (CH)
- The External quality Control for Assays and Tests (ECAT) Foundation, Leiden, The Netherlands
- Corresponding author
- Reber, G
- ORCID
- Meijer, P
- Venue
- Lupus
- Publisher
- SAGE Publications
- Published
- 2012-05-25
- Volume
- 21
- Issue
- 7
- Pages
- 722-724
- ISSN
- 0961-2033 (ISSN-L)
- 1477-0962
- OpenAlex
- W1980441380
- Cited by
- 21
- References
- 4
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 1 · 2022: 2 · 2019: 1 · 2018: 1 · 2017: 2 · 2016: 3 · 2015: 1 · 2014: 4 · 2013: 3
- FWCI
- 1.96
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Lupus (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Keywords
- antiphospholipid syndrome, lupus anticoagulant, anticardiolipin antibodies, anti-beta2-glycoprotein I antibodies, external quality assessment, laboratory criteria, mixing test, assay sensitivity
- MeSH terms
- Blood Coagulation Tests, Humans, Lupus Coagulation Inhibitor, Antiphospholipid Syndrome
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