Аннотация
Цель работы заключается в выявлении частоты и характера типичных ошибок лабораторного определения волчаночного
антикоагулянта (ВА). Проведено межлабораторное сравнительное исследование по программе Федеральной системы внеш-
ней оценки качества (ФСВОК) клинических лабораторных исследований. Определяли правильность тестирования контроль-
ных плазм с различным содержанием ВА. Проанализированы возможные погрешности выявления ВА. Определена частота
допущенных ошибок при детекции ВА. Показано, что основной ошибкой является нарушение алгоритма исследования. На
основании данных литературы проведена оценка характера зарегистрированных ошибок определения ВА и представлены
соответствующие рекомендации.
Annotation
The aim of the work is to identify the frequency and nature of typical errors in laboratory determination of lupus anticoagulant (LA). An
interlaboratory comparative study was carried out according to the programme of the Federal System of External Quality Assessment
of Clinical Laboratory Studies. The correctness of testing of control plasmas with different VA content was determined. Possible errors
of VA detection were analysed. The frequency of errors in VA detection was determined. It is shown that the main error is the violation
of the algorithm of the study. On the basis of the literature data the character of registered VA detection errors was assessed and
corresponding recommendations were presented.
Key words: lupus anticoagulant; laboratory detection; characteristic errors; external quality control; haemostasis
Список литературы
Л И Т Е РАТ У РА
1. Keeling D., Mackie I., Moore G., Greer I., Greaves M. Guidelines on
the investigation and management of antiphospholipid syndrome. Br. J.
Haematology. 2012; 157: 47-58.
2. Galli M., Luciani D., Bertolini G. Barbui T. Lupus anticoagulants are
stronger risk factors for thrombosis than anticardiolipin antibodies in
the antiphospholipid syndrome: a systematic review of the literature.
Blood. 2003; 101: 1827-–32.
3. Берковский А.Л., Калашникова Л.А., Сергеева Е.И., Суворов А.В.,
Качалова Н.Д., Васильев С.А. и др. Диагностика волчаночного анти-
коагулянта. Методическое руководство. М.: Изд-во «Принт»: 2011.
4. Devreese K.M.J., de Groot P.G., de Laat B., Erkan D., Favaloro F.J.,
Mackie I. et al. Guidance from the scientific and standardization committee
for lupus anticoagulant/antiphospholipid antibodies of the International
society on thrombosis and haemostasis. J. Thromb. Haemost.
2020; 18: 2828–39. DOI: 10.1111/jth.15047.
5. Ledford-Kraemer M.R., Moore G.W., Bottenus R., Daniele C., de Groot
P.G., Exner T. et al. Laboratory testing for the lupus anticoagulant.
Approved guideline. 1st ed. CLSI document H60. Wayne, PA: Clinical
and Laboratory Standards Institute; 2014.
6. Pengo V., Tripodi A., Reber G., Rand J., Ortel T., Galli M. et al.
Subcommittee on lupus anticoagulant/antiphospholipid antibody of the
scientific and standardisation committee of the International society
on thrombosis and haemostasis. Update of the guidelines for lupus
anticoagulant detection. J. Thromb. Haemost. 2009; 7(10):1737-47.
7. Tripodi A., Cohen H., Devreese K.M.J. Lupus anticoagulant
detection in anticoagulated patients. Guidance from the scientific and
standardization committee for lupus anticoagulant/antiphospholipid
antibodies of the International society on thrombosis and haemostasis.
J. Thromb. Haemost. 2020; 18(7): 1569-75.
8. Favaloro E.J., Bonar R., Marsden K. Internal quality control and external
quality assurance in testing for antiphospholipid antibodies: part II–lupus
anticoagulant. Semin Thromb. Hemost. 2012; 38(4): 404-11.
9. Liestol S., Jacobsen E.M., Wisloff F. Dilute prothrombin timebased
lupus ratio test. Integrated LA testing with recombinant tissue
thromboplastin. Thrombosis Research. 2002; 105: 177–82.
10. Moore G.W., Savidge G.F. Heterogeneity of Russell’s viper venom
affects the sensitivity of the dilute Russell’s viper venom time to lupus
anticoagulants. Blood Coagulation and Fibrinolysis. 2004; 15: 279–82.
11. Horowitz G., Altaie S., Boyd J., Ceriotti F., Garg U., Horn P. et al.
Defining, establishing, and verifying reference intervals in the clinical
laboratory: Approved Guideline. 3rd еd. CLSI document C28-A3c.
2008; Clinical and Laboratory Standards Institute, Wayne, PA, USA.
R E F E R E NC E S
1. Keeling D., Mackie I., Moore G., Greer I., Greaves M. Guidelines on
the investigation and management of antiphospholipid syndrome. Br.
J. haematology, 2012; 157: 47-58.
2. Galli M., Luciani D., Bertolini G. Barbui T. Lupus anticoagulants are
stronger risk factors for thrombosis than anticardiolipin antibodies in
the antiphospholipid syndrome: a systematic review of the literature.
Blood. 2003; 101: 1827-–32.
3. Berkovskij A.L., Kalashnikova L.A., Sergeeva E.I., Suvorov A.V.,
Kachalova N.D., Vasil’ev S.A. et al. Lupus anticoagulant diagnosis
[Diagnostika volchanochnogo antikoagulyanta. Metodicheskoe
rukovodstvo]. Moscow: Print; 2011. (in Russian)
4. Devreese K.M.J., de Groot P.G., de Laat B., Erkan D., Favaloro F.J.,
Mackie I. et al. Guidance from the scientific and standardization
committee for lupus anticoagulant/antiphospholipid antibodies of
the International society on thrombosis and haemostasis. J. Thromb.
Haemost.. 2020; 18: 2828–39. DOI: 10.1111/jth.15047.
5. Ledford-Kraemer M.R., Moore G.W., Bottenus R., Daniele C., de Groot
P.G., Exner T. et al. Laboratory testing for the lupus anticoagulant.
Approved guideline, 1st ed. CLSI document H60. Wayne, PA:
Clinical and Laboratory Standards Institute; 2014.
6. Pengo V., Tripodi A., Reber G., Rand J., Ortel T., Galli M. et al.
Subcommittee on lupus anticoagulant/antiphospholipid antibody
of the scientific and standardisation committee of the International
society on thrombosis and haemostasis. Update of the guidelines
for lupus anticoagulant detection. J. Thromb. Haemost. 2009;
7(10):1737-47.
7. Tripodi A., Cohen H., Devreese K.M.J. Lupus anticoagulant
detection in anticoagulated patients. Guidance from the Scientific
and Standardization Committee for lupus anticoagulant/antiphospholipid
antibodies of the International Society on Thrombosis and
Haemostasis. J. Thromb. Haemost. 2020; 18(7): 1569-75.
8. Favaloro E.J., Bonar R., Marsden K. Internal quality control and
external quality assurance in testing for antiphospholipid antibodies:
part II–lupus anticoagulant. Semin Thromb. Hemost. 2012; 38(4):
404-11.
9. Liestol S., Jacobsen E.M., Wisloff F. Dilute prothrombin time-based
lupus ratio test. Integrated LA testing with recombinant tissue
thromboplastin. Thrombosis Research. 2002; 105: 177–82.
10. Moore G.W., Savidge G.F. Heterogeneity of Russell’s viper venom
affects the sensitivity of the dilute Russell’s viper venom time to
lupus anticoagulants. Blood Coagulation and Fibrinolysis. 2004; 15:
279–82.
11. Horowitz G., Altaie S., Boyd J., Ceriotti F.,Garg U., Horn, P.
et al. Defining, Establishing, and Verifying Reference Intervals in
the Clinical Laboratory: Approved Guideline. 3rd еd. CLSI document
C28-A3c. 2008; Clinical and Laboratory Standards Institute,
Wayne, PA, USA.