New laboratory test in flow cytometry for the combined analysis of serologic and cellular parameters in the diagnosis of heparin‐induced thrombocytopenia

Gobbi, Giuliana; Mirandola, Prisco; Tazzari, Pier Luigi; Talarico, Enrica; Caimi, Luigi; Martini, Giuliana; Papa, Stefano; Conte, Roberto; Manzoli, Francesco A.; Vitale, Marco

doi:10.1002/cyto.b.10062

Cited by 25 publications

(16 citation statements)

References 24 publications

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“…Several assays are available or under development. 39,40 Platelet-activation or functional methods include the serotonin-release assay and heparin-induced platelet aggregation. The serotonin-release assay is considered to be most specific for pathogenic immunoglobulin G antibodies: however, it may not detect all relevant heparin-platelet factor-4 antibodies.…”

Section: Laboratory Testingmentioning

confidence: 99%

“…51,52 Other methods, such as flow cytometry, particle agglutination, rapid antigen assays, and monoclonal ELISA to detect immunoglobulin G antibodies, are under development. 39,40 A preliminary evaluation of a rapid particle gel immunoassay (PaGIA; DiaMed AG, Cressier sur Morat, Switzerland) showed that it can detect heparin-platelet factor-4 antibody in the absence of a clinical picture consistent with HIT. The sensitivity, specificity, and negative predictive value with the rapid particle gel immunoassay were 90.9%, 84%, and 99.2%, respectively, when the serotonin-release assay was the reference standard.…”

Section: Laboratory Testingmentioning

confidence: 99%

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Heparin‐Induced Thrombocytopenia: Treatment Options and Special Considerations

et al. 2007

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Heparin-induced thrombocytopenia (HIT) is an immune-mediated adverse effect that typically manifests several days after the start of heparin therapy, although both rapid- and delayed-onset HIT have been described. Its most serious complication is thrombosis. Although not all patients develop thrombosis, it can be life threatening. The risk of developing HIT is related to many factors, including the type of heparin product administered, route of administration, duration of therapy, patient population, and previous exposure to heparin. The diagnosis of HIT is typically based on clinical presentation, exposure to heparin, and presence of thrombocytopenia with or without thrombosis. Antigen and activation laboratory assays are available to support the diagnosis of HIT. However, because of the limited sensitivity and specificity of these assays, bedside probability scales for HIT were developed. When HIT is suspected, prompt cessation of all heparin therapy is necessary, along with initiation of alternative anticoagulant therapy. Two direct thrombin inhibitors--argatroban and lepirudin--are approved for the management of HIT in the United States, and bivalirudin is approved for use in patients with HIT who are undergoing percutaneous coronary intervention. Other agents, although not approved to manage HIT, have also been used; however, their role in therapy requires further evaluation. A comprehensive HIT management strategy involves the evaluation of numerous factors. Many patients, including those undergoing coronary artery bypass surgery, those with acute coronary syndromes, those with hepatic or renal insufficiency, and children, require special attention. Clinicians must become familiar with the available information on this serious adverse effect and its treatment so that optimum patient management strategies may be formulated.

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Section: Laboratory Testingmentioning

confidence: 99%

Section: Laboratory Testingmentioning

confidence: 99%

Heparin‐Induced Thrombocytopenia: Treatment Options and Special Considerations

et al. 2007

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“…A flow cytometry-based functional assay measuring CD62 was first described by Jy et al 74 and later modified by Denys and colleagues. 2 It has been reported that CD62 is a more reliable marker of platelet activation as a result of the presence of pathogenic H-PF4 antibodies than the procoagulant phospholipid annexin V. 75,76 Thrombin Generation…”

Section: Flow Cytometrymentioning

confidence: 99%

Evaluating Heparin-Induced Thrombocytopenia: The Old and the New

Tan

Ward

2012

Semin Thromb Hemost

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Heparin-induced thrombocytopenia (HIT) is a rare but potentially serious complication of heparin use. Prompt diagnosis is crucial and requires the integration of clinical assessment and laboratory testing. Pretest clinical scoring systems (i.e., 4 Ts) have been established. Immunoassays can detect the presence of antibodies directed toward heparin-platelet factor 4 (H-PF4) complexes, but provide no information about their ability to activate platelets. A low clinical score, when combined with a negative immunoassay result obviates the need for further testing. However, immunoassays and 4 Ts scores have only modest specificity. Functional testing (serotonin release assay or heparin-induced platelet activation) remain important in confirming the presence of pathogenic H-PF4 antibodies, but are technically demanding to perform and limited in guiding clinical decisions in the acute setting. This review evaluates current immuno- and functional assays available in the laboratory diagnosis of HIT, and describes recent attempts to improve the specificity of enzyme immunoassays, including adopting an immunoglobulin G-specific assay and raising the optical density value cutoff for a positive result. The importance of donor selection and newer functional assays, including flow cytometry-based assays, are also discussed. A current approach to integrating clinical scoring, immunoassays, and functional testing for HIT is also outlined.

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“…The results of the flow cytometric screen for HIT antibodies correlated strictly with EIA and PaGIA: 30/30 HIT patients tested positive by EIA, PaGIA, and flow cytometry; 0/10 non-HIT patients with thrombocytopenia and 0/30 normal healthy subjects tested negative by all three assays. Gobbi et al took the application of flow cytometry a step further by combining the antibody screen described above with a functional assay using donor platelets [46]. In their study, donor platelets were incubated with HIT patient serum in a second test tube.…”

Section: Laboratory Detection Of Hit Antibodiesmentioning

confidence: 99%

Heparin‐induced thrombocytopenia: Current status and diagnostic challenges

Otis

Zehnder

2010

American J Hematol

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Heparin‐induced thrombocytopenia (HIT) is a fairly common and potentially catastrophic complication of heparin therapy. Diagnosing HIT remains a challenge, as the patients at risk often have other reasons for thrombocytopenia and/or thrombosis. HIT is considered a clinicopathologic disorder whose diagnosis is generally made on the basis of both clinical criteria and the presence of “HIT antibodies” in the patient's serum or plasma. There are two basic laboratory approaches to detect HIT antibodies. The immunoassays detect antibodies based on their binding properties, whereas the functional assays detect antibodies based on their platelet‐activating properties. Prompt and accurate diagnosis of HIT is imperative, as overdiagnosis exposes patients to alternative anticoagulants and their associated bleeding risks, whereas under‐ or delayed diagnosis leaves patients vulnerable to the thromboembolic sequelae of HIT, which can be life threatening. A critical interpretation of laboratory results by the clinician is an essential component of diagnosing HIT. This requires a keen understanding of the current concepts in the pathophysiologic mechanisms of the disease, and the application of these concepts when interpreting the results of both the functional and immunoassays. Equally important is an awareness of the strengths and weaknesses, as well as the current lack of standardization and proficiency testing, of these assays. Am. J. Hematol., 2010. © 2010 Wiley‐Liss, Inc.

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New laboratory test in flow cytometry for the combined analysis of serologic and cellular parameters in the diagnosis of heparin‐induced thrombocytopenia

Cited by 25 publications

References 24 publications

Heparin‐Induced Thrombocytopenia: Treatment Options and Special Considerations

Heparin‐Induced Thrombocytopenia: Treatment Options and Special Considerations

Evaluating Heparin-Induced Thrombocytopenia: The Old and the New

Heparin‐induced thrombocytopenia: Current status and diagnostic challenges

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