Abstract
The antiphospholipid syndrome (APS) is an autoimmune condition characterised by a wide range of clinical features (primarily thrombosis and/or obstetric related), associated with the presence of antiphospholipid antibodies (aPL) as detected by a diverse range of laboratory tests. APS remains a significant diagnostic challenge for clinicians across a wide range of specialities, largely due to issues related to laboratory testing as well as the expanding range of reported clinical manifestations of APS. The laboratory issues include limitations in detailed knowledge by both clinical and laboratory personnel regarding the ‘complete’ range of available aPL tests, as well as ongoing problems with assay reproducibility and standardisation. aPL are identified using diverse laboratory procedures based on one of two distinct test processes, namely solid phase and liquid phase assays. The former includes anticardiolipin antibodies (aCL) and anti-β2-glycoprotein I antibodies (aβ2GPI). The latter are centred on clot-based tests that are used to identify the so-called lupus anticoagulant (LA). This article will discuss: (i) issues related to laboratory testing for APS in terms of the currently available solid-phase and liquid-phase assays, and identifiable biases resulting from these tests usually being performed in different laboratories; (ii) current problems with calibration, standardisation and reproducibility of these assays; (iii) pre-analytical, analytical and post-analytical considerations and ongoing initiatives for improvement; (iv) issues related to potential combinations/panels of available aPL tests; and (v) the entities of seropositive APS, seronegative APS and non-APS aPL-positivity. In doing so, this review will hopefully help bridge the two disciplines of haematology and immunology (‘representing’ liquid-phase and solid-phase aPL testing, respectively), by improving the understanding of those working in each of these disciplines of the merits and limitations of the assays performed in the other discipline, and encouraging inter-discipline cooperation in the reporting of aPL test results.
©2011 by Walter de Gruyter Berlin New York
Articles in the same Issue
- Editorial
- Biomarkers of neurodegenerative diseases
- Reviews
- CSF biomarkers in neurodegenerative diseases
- Tau and p-tau as CSF biomarkers in dementia: a meta-analysis
- Amyloid β (Aβ) and phospho-tau (p-tau) as diagnostic biomarkers in Alzheimer's disease
- The effect of apolipoprotein E (ApoE) genotype on biomarkers of amyloidogenesis, tau pathology and neurodegeneration in Alzheimer's disease
- Advanced glycation endproducts as gerontotoxins and biomarkers for carbonyl-based degenerative processes in Alzheimer's disease
- Parkinson's disease – the continuing search for biomarkers
- α-Synuclein in Parkinson disease and other neurodegenerative disorders
- S100B protein in neurodegenerative disorders
- Inflammatory and structural biomarkers in acute traumatic spinal cord injury
- Homocysteine: a biomarker in neurodegenerative diseases
- Editorial
- ROMA or death: advances in epithelial ovarian cancer diagnosis
- Review
- Laboratory testing for the antiphospholipid syndrome: making sense of antiphospholipid antibody assays
- General Clinical Chemistry and Laboratory Medicine
- Quality indicators and specifications for key analytical-extranalytical processes in the clinical laboratory. Five years’ experience using the Six Sigma concept
- Determination of oxidative and occupational stress in palliative care workers
- Effect of cigarette smoking on plasma homocysteine concentrations
- Erythrocyte membrane protein analysis by sodium dodecyl sulphate-capillary gel electrophoresis in the diagnosis of hereditary spherocytosis
- Evaluation of hematological parameters on admission for the prediction of 7-day in-hospital mortality in a large trauma cohort
- Platelet function testing in hirudin and BAPA anticoagulated blood
- Evaluation of the iChem® Velocity™ Urine Chemistry Analyzer in a hospital routine laboratory
- Crystalluria: prevalence, different types of crystals and the role of infrared spectroscopy
- Cancer Diagnostics
- The ROMA (Risk of Ovarian Malignancy Algorithm) for estimating the risk of epithelial ovarian cancer in women presenting with pelvic mass: is it really useful?
- Evaluation of the accuracy of serum human epididymis protein 4 in combination with CA125 for detecting ovarian cancer: a prospective case-control study in a Korean population
- Cardiovascular Diseases
- APOA5 −1131T/C polymorphism is associated with coronary artery disease in a Chinese population: a meta-analysis
- Assessment of the nickel-albumin binding assay for diagnosis of acute coronary syndrome
- Letters to the Editor
- AGER gene -374T>A (rs1800624) polymorphism is not associated with the severity of non-diabetic coronary artery disease in Han Chinese
- Some lessons learned from using medium scale genotyping techniques in pharmacogenetic research
- Improved neopterin ELISA kit: a good compromise between HPLC results and clinical practice
- Cross-reactivity of 25-hydroxy vitamin D2 from different commercial immunoassays for 25-hydroxy vitamin D: an evaluation without spiked samples
- Modulated human maternal and premature neonatal erythrocyte membrane enzyme activities in relation to the mode of delivery: in vitro restoration with L-Carnitine
Articles in the same Issue
- Editorial
- Biomarkers of neurodegenerative diseases
- Reviews
- CSF biomarkers in neurodegenerative diseases
- Tau and p-tau as CSF biomarkers in dementia: a meta-analysis
- Amyloid β (Aβ) and phospho-tau (p-tau) as diagnostic biomarkers in Alzheimer's disease
- The effect of apolipoprotein E (ApoE) genotype on biomarkers of amyloidogenesis, tau pathology and neurodegeneration in Alzheimer's disease
- Advanced glycation endproducts as gerontotoxins and biomarkers for carbonyl-based degenerative processes in Alzheimer's disease
- Parkinson's disease – the continuing search for biomarkers
- α-Synuclein in Parkinson disease and other neurodegenerative disorders
- S100B protein in neurodegenerative disorders
- Inflammatory and structural biomarkers in acute traumatic spinal cord injury
- Homocysteine: a biomarker in neurodegenerative diseases
- Editorial
- ROMA or death: advances in epithelial ovarian cancer diagnosis
- Review
- Laboratory testing for the antiphospholipid syndrome: making sense of antiphospholipid antibody assays
- General Clinical Chemistry and Laboratory Medicine
- Quality indicators and specifications for key analytical-extranalytical processes in the clinical laboratory. Five years’ experience using the Six Sigma concept
- Determination of oxidative and occupational stress in palliative care workers
- Effect of cigarette smoking on plasma homocysteine concentrations
- Erythrocyte membrane protein analysis by sodium dodecyl sulphate-capillary gel electrophoresis in the diagnosis of hereditary spherocytosis
- Evaluation of hematological parameters on admission for the prediction of 7-day in-hospital mortality in a large trauma cohort
- Platelet function testing in hirudin and BAPA anticoagulated blood
- Evaluation of the iChem® Velocity™ Urine Chemistry Analyzer in a hospital routine laboratory
- Crystalluria: prevalence, different types of crystals and the role of infrared spectroscopy
- Cancer Diagnostics
- The ROMA (Risk of Ovarian Malignancy Algorithm) for estimating the risk of epithelial ovarian cancer in women presenting with pelvic mass: is it really useful?
- Evaluation of the accuracy of serum human epididymis protein 4 in combination with CA125 for detecting ovarian cancer: a prospective case-control study in a Korean population
- Cardiovascular Diseases
- APOA5 −1131T/C polymorphism is associated with coronary artery disease in a Chinese population: a meta-analysis
- Assessment of the nickel-albumin binding assay for diagnosis of acute coronary syndrome
- Letters to the Editor
- AGER gene -374T>A (rs1800624) polymorphism is not associated with the severity of non-diabetic coronary artery disease in Han Chinese
- Some lessons learned from using medium scale genotyping techniques in pharmacogenetic research
- Improved neopterin ELISA kit: a good compromise between HPLC results and clinical practice
- Cross-reactivity of 25-hydroxy vitamin D2 from different commercial immunoassays for 25-hydroxy vitamin D: an evaluation without spiked samples
- Modulated human maternal and premature neonatal erythrocyte membrane enzyme activities in relation to the mode of delivery: in vitro restoration with L-Carnitine