False-positive results in ELISA-based anti FVIII antibody assay may occur with lupus anticoagulant and phospholipid antibodies

The evaluation of a prolonged aPTT often includes Lupus Anticoagulant, Antiphospholipid Antibodies, and Factor VIII (FVIII) inhibitors. We have noticed that patient samples positive for lupus antibody (LA) are frequently also positive for FVIII IgG antibodies in an enzyme‐linked immunosorbent assay...

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Veröffentlicht in:Haemophilia : the official journal of the World Federation of Hemophilia 2012-09, Vol.18 (5), p.777-781
Hauptverfasser: SAHUD, M., ZHUKOV, O., MO, K., POPOV, J., DLOTT, J.
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container_issue 5
container_start_page 777
container_title Haemophilia : the official journal of the World Federation of Hemophilia
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creator SAHUD, M.
ZHUKOV, O.
MO, K.
POPOV, J.
DLOTT, J.
description The evaluation of a prolonged aPTT often includes Lupus Anticoagulant, Antiphospholipid Antibodies, and Factor VIII (FVIII) inhibitors. We have noticed that patient samples positive for lupus antibody (LA) are frequently also positive for FVIII IgG antibodies in an enzyme‐linked immunosorbent assay (ELISA), indicating the need for follow‐up testing with a more labour‐intensive functional assay for FVIII inhibition. This study evaluates the potential for a FVIII IgG ELISA to yield false‐positive results in patient samples positive for LA or other antiphospholipid antibodies. A total of 289 residual de‐identified patient samples positive for LA (n = 143), anti‐cardiolipin IgG (n = 84), or beta2‐glycoprotein antibody (n = 62) were tested for FVIII IgG using a commercial ELISA. Samples with positive FVIII IgG ELISA results were further tested for FVIII activity using a clot‐based FVIII inhibitor assay. The FVIII IgG ELISA yielded positive results in 39 (13%) of the samples tested, including 13/143 (13%) LA‐positive, 15/85 (18%) aCL IgG‐positive and 6/62 (10%) β2‐glycoprotein IgG‐positive samples. The clot‐based FVIII inhibitor assay yielded negative results in all 39 FVIII IgG‐positive specimens tested, indicating discrepancy with the FVIII IgG ELISA results. Patient specimens positive for LA, aCL IgG, or β2‐glycoprotein IgG may yield false‐positive results for FVIII antibodies. Caution is warranted in interpreting FVIII antibody results in these cases.
doi_str_mv 10.1111/j.1365-2516.2012.02781.x
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We have noticed that patient samples positive for lupus antibody (LA) are frequently also positive for FVIII IgG antibodies in an enzyme‐linked immunosorbent assay (ELISA), indicating the need for follow‐up testing with a more labour‐intensive functional assay for FVIII inhibition. This study evaluates the potential for a FVIII IgG ELISA to yield false‐positive results in patient samples positive for LA or other antiphospholipid antibodies. A total of 289 residual de‐identified patient samples positive for LA (n = 143), anti‐cardiolipin IgG (n = 84), or beta2‐glycoprotein antibody (n = 62) were tested for FVIII IgG using a commercial ELISA. Samples with positive FVIII IgG ELISA results were further tested for FVIII activity using a clot‐based FVIII inhibitor assay. The FVIII IgG ELISA yielded positive results in 39 (13%) of the samples tested, including 13/143 (13%) LA‐positive, 15/85 (18%) aCL IgG‐positive and 6/62 (10%) β2‐glycoprotein IgG‐positive samples. The clot‐based FVIII inhibitor assay yielded negative results in all 39 FVIII IgG‐positive specimens tested, indicating discrepancy with the FVIII IgG ELISA results. Patient specimens positive for LA, aCL IgG, or β2‐glycoprotein IgG may yield false‐positive results for FVIII antibodies. 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We have noticed that patient samples positive for lupus antibody (LA) are frequently also positive for FVIII IgG antibodies in an enzyme‐linked immunosorbent assay (ELISA), indicating the need for follow‐up testing with a more labour‐intensive functional assay for FVIII inhibition. This study evaluates the potential for a FVIII IgG ELISA to yield false‐positive results in patient samples positive for LA or other antiphospholipid antibodies. A total of 289 residual de‐identified patient samples positive for LA (n = 143), anti‐cardiolipin IgG (n = 84), or beta2‐glycoprotein antibody (n = 62) were tested for FVIII IgG using a commercial ELISA. Samples with positive FVIII IgG ELISA results were further tested for FVIII activity using a clot‐based FVIII inhibitor assay. The FVIII IgG ELISA yielded positive results in 39 (13%) of the samples tested, including 13/143 (13%) LA‐positive, 15/85 (18%) aCL IgG‐positive and 6/62 (10%) β2‐glycoprotein IgG‐positive samples. The clot‐based FVIII inhibitor assay yielded negative results in all 39 FVIII IgG‐positive specimens tested, indicating discrepancy with the FVIII IgG ELISA results. Patient specimens positive for LA, aCL IgG, or β2‐glycoprotein IgG may yield false‐positive results for FVIII antibodies. 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We have noticed that patient samples positive for lupus antibody (LA) are frequently also positive for FVIII IgG antibodies in an enzyme‐linked immunosorbent assay (ELISA), indicating the need for follow‐up testing with a more labour‐intensive functional assay for FVIII inhibition. This study evaluates the potential for a FVIII IgG ELISA to yield false‐positive results in patient samples positive for LA or other antiphospholipid antibodies. A total of 289 residual de‐identified patient samples positive for LA (n = 143), anti‐cardiolipin IgG (n = 84), or beta2‐glycoprotein antibody (n = 62) were tested for FVIII IgG using a commercial ELISA. Samples with positive FVIII IgG ELISA results were further tested for FVIII activity using a clot‐based FVIII inhibitor assay. The FVIII IgG ELISA yielded positive results in 39 (13%) of the samples tested, including 13/143 (13%) LA‐positive, 15/85 (18%) aCL IgG‐positive and 6/62 (10%) β2‐glycoprotein IgG‐positive samples. The clot‐based FVIII inhibitor assay yielded negative results in all 39 FVIII IgG‐positive specimens tested, indicating discrepancy with the FVIII IgG ELISA results. Patient specimens positive for LA, aCL IgG, or β2‐glycoprotein IgG may yield false‐positive results for FVIII antibodies. Caution is warranted in interpreting FVIII antibody results in these cases.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>22458845</pmid><doi>10.1111/j.1365-2516.2012.02781.x</doi><tpages>5</tpages></addata></record>
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subjects Antibodies, Anticardiolipin - blood
Antibodies, Antiphospholipid - blood
Antibodies, Neutralizing - blood
beta 2-Glycoprotein I - antagonists & inhibitors
beta 2-Glycoprotein I - immunology
Blood Coagulation Factor Inhibitors - blood
Blood Coagulation Factor Inhibitors - immunology
Blood Coagulation Tests
Enzyme-Linked Immunosorbent Assay - methods
Factor VIII - antagonists & inhibitors
Factor VIII - immunology
False Positive Reactions
FVIII antibodies
FVIII ELISA
Hemophilia A - blood
Hemophilia A - immunology
Humans
Immunoglobulin G - blood
lupus anticoagulants
Lupus Coagulation Inhibitor - blood
Male
neutralizing inhibitors
phospholipid antibodies
title False-positive results in ELISA-based anti FVIII antibody assay may occur with lupus anticoagulant and phospholipid antibodies
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