Cooperation experience in a multicentre study to define the upper limits in a normal population for the diagnostic assessment of the functional lupus anticoagulant assays
-
Paola Pradella
, Gabriella Azzarini
, Liliana Santarossa , Livio Caberlotto , Cristina Bardin , Alessandra Poz , Federica D’Aurizio and Roberta Giacomello
Abstract
Background: Phospholipid-dependent coagulation tests for lupus anticoagulant (LA) are considered an important step for the diagnosis of anti-phospholipid syndrome; however, LA laboratory detection is difficult because of many variables. Five hospital laboratories, located in a North-Italy area and using the same method for LA testing, cooperated to standardise sample treatment and analytical procedure in order to define the upper values for LA negativity.
Methods: In total, 200 normal subjects (40 for each centre) were studied for six LA functional assays, using the same procedure, reagent lot and analyser type. The first tests done were LA screen and LA confirm assays, based on diluted Russell’s Viper Venom Time, with low and high phospholipid content, respectively. The second tests performed were silica clotting time screen and confirm assays, based on activated partial thromboplastin time, with low and high phospholipid content, respectively. Finally, two mixing assays were executed for both screening assays, diluting patient sample with a pool prepared with plasma collected from the study population.
Results: Data analysis demonstrated a difference between centres for all assays when results were expressed in seconds; the difference disappeared when results are normalised with the local mean normal value of each centre and are expressed as a normalised ratio. The study population was normally distributed; so the value corresponding to 99th percentile was used as limit value for LA negativity. Values expressed as normalised ratio, for LA and silica clotting time screenings were 1.22 and 1.23, respectively.
Conclusions: The study allowed us to define a uniform approach to LA testing and evaluation for laboratories employing the same methods.
A wholehearted acknowledgement to Dr. Massimo Gion, director of the Department of Clinical Pathology, AULLS 12, General Hospital “Dell’Angelo”, Venezia-Mestre, Italy, for his helpful feedback and suggestions. The authors would like to thank the Instrumentation Laboratory for providing reagent kits to perform the assays.
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
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©2013 by Walter de Gruyter Berlin Boston
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Articles in the same Issue
- Letters to the Editor
- Performance evaluation of three different immunoassays for detection of antibodies to hepatitis B core
- Serum homocysteine concentrations in Chinese children with autism
- Interchangeability of venous and capillary HbA1c results is affected by oxidative stress
- Interference of hemoglobin (Hb) N-Baltimore on measurement of HbA1c using the HA-8160 HPLC method
- First human isolate of Mycobacterium madagascariense in the sputum of a patient with tracheobronchitis
- Protein S and protein C measurements should not be undertaken during vitamin K antagonist therapy
- α2-HS glycoprotein is an essential component of cryoglobulin associated with chronic hepatitis C
- An unusual interference in CK MB assay caused by a macro enzyme creatine phosphokinase (CK) type 2 in HIV-infected patients
- An automated technique for the measurement of the plasma glutathione reductase activity and determination of reference limits for a healthy population
- Is osteopontin stable in plasma and serum?
- Evidence-based approach to reducing perceived wasteful practices in laboratory medicine
- Masthead
- Masthead
- Editorials
- Testing volume is not synonymous of cost, value and efficacy in laboratory diagnostics
- Lessons from controversy: biomarkers evaluation
- Commercial immunoassays in biomarkers studies: researchers beware!1)
- Trials and tribulations in lupus anticoagulant testing
- Reviews
- Mass spectrometry: a revolution in clinical microbiology?
- Chronic Chagas disease: from basics to laboratory medicine
- General Clinical Chemistry and Laboratory Medicine
- Shop for quality or quantity? Volumes and costs in clinical laboratories
- Minor improvement of venous blood specimen collection practices in primary health care after a large-scale educational intervention
- Evaluation of high resolution gel β2-transferrin for detection of cerebrospinal fluid leak
- Serum kallikrein-8 correlates with skin activity, but not psoriatic arthritis, in patients with psoriatic disease
- Soluble urokinase plasminogen activator receptor (suPAR) in the assessment of inflammatory activity of rheumatoid arthritis patients in remission
- Bone mass density selectively correlates with serum markers of oxidative damage in post-menopausal women
- Validation of a fast and reliable liquid chromatography-tandem mass spectrometry (LC-MS/MS) with atmospheric pressure chemical ionization method for simultaneous quantitation of voriconazole, itraconazole and its active metabolite hydroxyitraconazole in human plasma
- Performance of different screening methods for the determination of urinary glycosaminoclycans
- Intestinal permeability and fecal eosinophil-derived neurotoxin are the best diagnosis tools for digestive non-IgE-mediated cow’s milk allergy in toddlers
- An internal validation approach and quality control on hematopoietic chimerism testing after allogeneic hematopoietic cell transplantation
- Serum levels of IgG antibodies against oxidized LDL and atherogenic indices in HIV-1-infected patients treated with protease inhibitors
- Cooperation experience in a multicentre study to define the upper limits in a normal population for the diagnostic assessment of the functional lupus anticoagulant assays
- Contribution of procoagulant phospholipids, thrombomodulin activity and thrombin generation assays as prognostic factors in intensive care patients with septic and non-septic organ failure
- Suitability of POC lactate methods for fetal and perinatal lactate testing: considerations for accuracy, specificity and decision making criteria
- Point-of-care testing on admission to the intensive care unit: lactate and glucose independently predict mortality
- Reference Values and Biological Variations
- CA125 reference values change in male and postmenopausal female subjects
- Distributions and ranges of values of blood and urinary biomarker of inflammation and oxidative stress in the workers engaged in office machine manufactures: evaluation of reference values
- Cancer Diagnostics
- Association of acute phase protein-haptoglobin, and epithelial-mesenchymal transition in buccal cancer: a preliminary report
- Comparison of diagnostic and prognostic performance of two assays measuring thymidine kinase 1 activity in serum of breast cancer patients
- Evaluation of the BRAHMS Kryptor® Thyroglobulin Minirecovery Test in patients with differentiated thyroid carcinoma