Variability of cut-off values for the detection of lupus anticoagulants: results of an international multicenter multiplatform study

Journal of Thrombosis and Haemostasis

Volumn 15, Issue 6, 2017, Pages 1180-1190

  Tripodi, A ^a   Chantarangkul, V ^a   Cini, M ^b   Devreese, K ^c   Dlott, J S ^d   Giacomello, R ^e,f   Gray, E ^g   Legnani, C ^b   Martinuzzo, M E ^h   Pradella, P ⁱ   Siegemund, A ^j   Subramanian, S ^k   Suchon, P ^l,m   Testa, S ⁿ  

^a UNIVERSITY OF MILAN   (Italy)

^b UNIVERSITY OF BOLOGNA   (Italy)

^c GHENT UNIVERSITY HOSPITAL   (Belgium)

^d QUEST DIAGNOSTICS NICHOLS INSTITUTE   (United States)

^e UNIVERSITY OF UDINE   (Italy)

^f UNIVERSITY HOSPITAL OF UDINE   (Italy)

^g NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^h Instituto Universitario del Hospital Italianode Buenos Aires and   (Argentina)

ⁱ UNIVERSITY OF TRIESTE   (Italy)

^j Coagulation Laboratory ^*  (Germany)

^k ST JOHN'S NATIONAL ACADEMY OF HEALTH SCIENCES   (India)

^l ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE   (France)

^m AIX MARSEILLE UNIVERSITY   (France)

ⁿ GENERAL HOSPITAL   (Italy)

more..

Author keywords

activated partial thromboplastin time; antiphospholipid syndrome; dilute Russell viper venom test; screening; standardization

Indexed keywords

LUPUS ANTICOAGULANT; VIPER VENOM;

ADULT; AGED; ANTIBODY DETECTION; ANTICOAGULATION; ARTICLE; BLOOD CLOTTING TIME; BLOOD SAMPLING; CENTRIFUGATION; CONTROLLED STUDY; DABOIA RUSSELLII; FEMALE; FREEZE DRYING; HUMAN; HUMAN EXPERIMENT; KOLMOGOROV SMIRNOV TEST; MALE; NORMAL HUMAN; PARTIAL THROMBOPLASTIN TIME; POLICY; PRIORITY JOURNAL; PROTEIN EXPRESSION; VALIDITY; VEIN PUNCTURE; ADOLESCENT; ANTIPHOSPHOLIPID SYNDROME; BLOOD; BLOOD CLOTTING TEST; CHEMISTRY; CLINICAL TRIAL; MIDDLE AGED; MULTICENTER STUDY; NORMAL DISTRIBUTION; PLASMA; PROCEDURES; PROTHROMBIN TIME; REFERENCE VALUE; REPRODUCIBILITY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIPHOSPHOLIPID SYNDROME; BLOOD COAGULATION TESTS; FEMALE; HEALTHY VOLUNTEERS; HUMANS; LUPUS COAGULATION INHIBITOR; MALE; MIDDLE AGED; NORMAL DISTRIBUTION; PARTIAL THROMBOPLASTIN TIME; PLASMA; PROTHROMBIN TIME; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; YOUNG ADULT;

EID: 85018855801     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/jth.13678     Document Type: Article

References (19)

1. Tripodi A, de Groot PG, Pengo V. Antiphospholipid syndrome. laboratory detection, mechanisms of action and treatment. J Intern Med 2011; 270: 110–22.
2. Miyakis S, Lockshin MD, Atsumi T, Branch DW, Brey RL, Cervera R, Derksen RH, DE Groot PG, Koike T, Meroni PL, Reber G, Shoenfeld Y, Tincani A, Vlachoyiannopoulos PG, Krilis SA. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost 2006; 4: 295–306.
3. Pengo V, Tripodi A, Reber G, Rand JH, Ortel TL, Galli M, de Groot PG. Update of the guidelines for lupus anticoagulant detection. J Thromb Haemost 2009; 7: 1737–40.
4. Rosner E, Pauzner R, Lusky A, Modan M, Many A. Detection and quantitative evaluation of lupus circulating anticoagulant activity. Thromb Haemost 1987; 57: 144–7.
5. Tripodi A, Chantarangkul V, Clerici M, Mannucci PM. Laboratory diagnosis of lupus anticoagulants for patients on oral anticoagulant treatment. Performance of dilute Russell viper venom test and silica clotting time in comparison with Staclot LA. Thromb Haemost 2002; 88: 583–6.
6. Tripodi A, Biasiolo A, Chantarangkul V, Pengo V. Lupus anticoagulant(LA) testing: performance of clinical laboratories assessed by a national survey using lyophilized affinity-purified immunoglobulin with LA activity. Clin Chem 2003; 49: 1608–14.
7. Jennings I, Kitchen S, Woods TA, Preston FE, Greaves M. Potentially clinically important inaccuracies in testing for the lupus anticoagulant: an analysis of results from three surveys of the UK National External Quality Assessment Scheme (NEQAS) for Blood Coagulation. Thromb Haemost 1997; 77: 934–7.
8. Brandt JT, Triplett DA, Rock WA, Bovill EG, Arkin CF. Effect of lupus anticoagulants on the activated partial thromboplastin time: results of the College of American Pathologists survey program. Arch Pathol Lab Med 1991; 115: 109–14.
9. Roussi J, Roisin JP, Goguel A. Lupus anticoagulants: first French interlaboratory Etalonorm survey. Am J Clin Pathol 1996; 105: 788–93.
10. Favaloro EJ, Bonar R, Sioufi J, Wheeler M, Low J, Aboud M, Duncan E, Smith J, Exner T, Lloyd J, Marsden K; RCPA QAP in Haematology. Multilaboratory testing of thrombophilia: current and past practice in Australasia as assessed through the Royal College of Pathologists of the Australasia Quality Assurance Programs for Hematology. Sem Thromb Hemost 2005; 31: 49–58.
11. Favaloro EJ, Bonar R, Duncan E, Earl G, Low J, Aboud M, Just S, Sioufi J, Street A, Marsden K; RCPA QAP in Haematology Haemostasis Committee. Identification of factor inhibitors by diagnostic haemostasis laboratories: a large multicenter evaluation. Thromb Haemost 2006; 96: 73–8.
12. Arnout J, Meijer P, Vermylen J. Lupus anticoagulant testing in Europe: an analysis of results from the first European Concerted Action on Thrombophilia (ECAT) survey using plasmas spiked with monoclonal antibodies against human beta2-glycoprotein I. Thromb Haemost 1999; 81: 929–34.
13. Pengo V, Biasiolo A, Gresele P, Marongiu F, Erba N, Veschi F, Ghirarduzzi A, deCandia E, Montaruli B, Testa S, Barcellona D, Tripodi A; Participating Centres of Italian Federation of Thrombosis Centres (FCSA). Survey on lupus anticoagulant diagnosis by central evaluation of positive plasma samples. J Thromb Haemost 2007; 5: 925–30.
14. Tripodi A. Laboratory testing for lupus anticoagulants: a review of issues affecting results. Clin Chem 2007; 53: 1629–35.
15. Pradella P, Azzarini G, Santarossa L, Caberlotto L, Bardin C, Poz A, D'Aurizio F, Giacomello R. 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. Clin Chem Lab Med 2013; 51: 379–85.
16. Gardiner C, MacKie IJ, Malia RG, Jones DW, Winter M, Leeming D, Taberner DA, Machin SJ, Greaves M. The importance of locally derived reference ranges and standardized calculation of dilute Russell's viper venom time results in screening for lupus anticoagulant. Br J Haematol 2000; 111: 1230–5.
17. Tripodi A, Chantarangkul V, Clerici M, Palmucci C, Bison E, Banzato A, Biguzzi E, Pengo V. Standardization of lupus anticoagulant. feasibility study of a calibration model to minimize between-method variability. Thromb Res 2011; 127: 589–94.
18. Pengo V, Biasiolo A, Gresele P, Marongiu F, Erba N, Veschi F, Ghirarduzzi A, Barcellona D, Tripodi A. A comparison of lupus anticoagulant-positive patients with clinical picture of antiphospholipid syndrome and those without. Arterioscler Thromb Vasc Biol 2007; 27: e309–10.
19. Horowitz GL, Altaie S, Boyd JC, Ceriotti F, Garg U, Horn P, Pesce A, Sine HE, Zakowski J. Defining, establishing, and verifying reference intervals in the clinical laboratory; approved guideline-third edition. CLSI Document C28-A3; Clinical and Laboratory Standards Institute, Wayne PA, Vol 28, Number 30, 2008.