Variability of anti-PF4/heparin antibody results obtained by the rapid testing system ID-H/PF4-PaGIA.

Détails

ID Serval
serval:BIB_7E46325C2067
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Variability of anti-PF4/heparin antibody results obtained by the rapid testing system ID-H/PF4-PaGIA.
Périodique
Journal of Thrombosis and Haemostasis
Auteur(s)
Schneiter S., Colucci G., Sulzer I., Barizzi G., Lämmle B., Alberio L.
ISSN
1538-7836 (Electronic)
ISSN-L
1538-7836
Statut éditorial
Publié
Date de publication
2009
Peer-reviewed
Oui
Volume
7
Numéro
10
Pages
1649-1655
Langue
anglais
Notes
Publication types: Evaluation Studies ; Journal Article ; Research Support, Non-U.S. Gov't Publication Status: ppublish
Résumé
BACKGROUND: Recent studies have shown that a low clinical pretest probability may be adequate for excluding heparin-induced thrombocytopenia. However, for patients with intermediate or high pretest probability, laboratory testing is essential for confirming or refuting the diagnosis. Rapid assessment of anti-PF4/heparin-antibodies may assist clinical decision-making.
OBJECTIVES: To evaluate the performance of rapid ID-H/PF4-PaGIA. In particular, we verified reproducibility of results between plasma and serum specimens, between fresh and frozen samples, and between different ID-H/PF4-polymer lots (polystyrene beads coated with heparin/PF4-complexes).
PATIENTS/METHODS: The samples studied were 1376 plasma and 914 corresponding serum samples from patients investigated for suspected heparin-induced thrombocytopenia between January 2000 and October 2008. Anti-PF4/heparin-antibodies were assessed by ID-H/PF4-PaGIA, commercially available ELISAs and heparin-induced platelet aggregation test.
RESULTS: Among 914 paired plasma/serum samples we noted discordant results (negative vs. low-titre positive) in nine instances (1%; 95%CI, 0.4-1.6%). Overall, agreement between titres assessed in plasma vs. serum was highly significant (Spearman correlation coefficient, 0.975; P < 0.0001). Forty-seven samples tested both fresh and after freezing/thawing showed a good agreement, with one discordant positive/negative result (Spearman correlation coefficient, 0.970; P < 0.0001). Among 1376 plasma samples we noted a strikingly variable incidence of false negative results (none - 82%; 95%CI, 66-98%), depending on the employed ID-H/PF4-polymer lot. Faulty lots can be recognized by titrating commercial positive controls and stored samples of HIT-patients.
CONCLUSION: Laboratories performing the assay should implement stringent internal quality controls in order to recognize potentially faulty ID-H/PF4-polymer lots, thus avoiding false negative results.
Mots-clé
Antigen-Antibody Reactions, Artifacts, Autoantibodies/blood, Centrifugation, Early Diagnosis, Enzyme-Linked Immunosorbent Assay, Freezing, Gels, Heparin/immunology, Heparin/pharmacology, Humans, Immunosorbent Techniques/instrumentation, Microspheres, Platelet Aggregation/drug effects, Platelet Factor 4/immunology, Platelet Function Tests, Polystyrenes, Purpura, Thrombocytopenic, Idiopathic/blood, Purpura, Thrombocytopenic, Idiopathic/diagnosis, Reproducibility of Results, Sensitivity and Specificity, Specimen Handling
Pubmed
Web of science
Création de la notice
10/02/2015 10:50
Dernière modification de la notice
03/03/2018 18:41
Données d'usage