Impact of an Immunoglobulin <scp>G</scp>–Specific Enzyme‐Linked Immunosorbent Assay on the Management of Heparin‐Induced Thrombocytopenia

Sylvester, Katelyn W.; Fanikos, John; Anger, Kevin E.; Matta, Lina; Southard, Robert A.; Beik, Nahal; Lemire, Susan J.; Dorfman, David M.; Berliner, Nancy

doi:10.1002/phar.1322

Cited by 8 publications

(4 citation statements)

References 18 publications

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“…This characteristic can make results from polyvalent ELISAs misleading, since polyvalent results have good negative predictive value for HIT, but may not have good positive predictive value due to potential identification of clinically irrelevant antibodies. 21,22 In clear positive samples, we observed good agreement between the two types of ELISAs. It should be noted that even IgG-specific ELISAs have imperfect positive predictive value because they indicate only that antibodies are present, but cannot demonstrate the platelet activating properties of the antibodies.…”

Section: Discussionsupporting

confidence: 61%

Proficiency Testing Results for Heparin-Induced Thrombocytopenia in North America

Smock

Ledford‐Kraemer

Meijer³

et al. 2014

Semin Thromb Hemost

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Between 2010 and 2012, North American Specialized Coagulation Laboratory Association (NASCOLA) distributed five proficiency testing challenges to evaluate laboratory testing for heparin-induced thrombocytopenia (HIT). Results (n = 355) were submitted from 43 unique laboratories for 10 samples (3 positive, 2 weak positive, and 5 negative). The vast majority of results were from commercial enzyme-linked immunosorbent assay (ELISA) methods, predominantly polyvalent assays. Laboratories performed well in the classification of clear negative and positive samples. All results (100%) submitted for the five negative samples (n = 173) and 97% of immunological results submitted for the three positive samples (n = 105) were correctly classified (the incorrect responses were two borderline classifications and, from a gel-agglutination method, one negative classification). There was more difficulty in the classification of the two weak positive samples (n = 70). In one survey, 61% of results from the weak positive sample were classified as positive, while 21% were called negative, 16% were called borderline, and 2% were called inconclusive. In a second survey, 16% of results from the weak positive sample were called positive, while 56% were called negative, and 28% were called borderline. Significant interlaboratory variation was observed for ELISA results, with coefficients of variation of about 20 to 30%. We conclude that there is variability in HIT laboratory testing and that identification of weak positive samples can be challenging.

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Section: Discussionsupporting

confidence: 61%

Proficiency Testing Results for Heparin-Induced Thrombocytopenia in North America

Smock

Ledford‐Kraemer

Meijer³

et al. 2014

Semin Thromb Hemost

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“…Cycle 3 found that extended VTE prophylaxis was not effective, and heparin‐induced thrombocytopenia (HIT) emerged as a concerning adverse effect . In cycle 4, HIT diagnosis and management was explored, leading to an assessment and change in the diagnostic assay that was then evaluated in cycle 5 . A diverse group (pharmacists, physicians, nurses, laboratory staff) participated in this MUE, and each cycle led to a follow‐up cycle, all with continuous measurements and practice changes.…”

Section: Medication Use Evaluation Modelsmentioning

confidence: 99%

Medication Use Evaluation: Pharmacist Rubric for Performance Improvement

et al. 2014

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Despite rigorous expert review, medications often fall into routine use with unrecognized and unwanted complications. Use of some medications remains controversial because information to support efficacy is conflicting, scant, or nonexistent. Medication use evaluation (MUE) is a performance improvement tool that can be used when there is uncertainty regarding whether a medication will be beneficial. It is particularly useful when limited evidence is available on how best to choose between two or more medications. MUEs can analyze the process of medication prescribing, preparation, dispensing, administration, and monitoring. MUEs can be part of a structured or mandated multidisciplinary quality management program that focuses on evaluating medication effectiveness and improving patient safety. Successful MUE programs have a structure in place to support completion of rapid-cycle data collection, analysis, and intervention that supports practice change. KEY WORDS medication use evaluation, drug utilization, target drug program, drug therapy management guidelines.

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“…This time frame was chosen to include only results from an IgG antiheparin-PF4 ELISA, as our institution had transitioned from a non-Ig-specific antiheparin-PF4 ELISA prior to 2012. 6 The major endpoint was to assess the incidence of positive SRA results in patients with antiheparin-PF4 ELISA values !0.4 OD units when compared to patients with antiheparin-PF4 ELISA values greater than or equal to 0.8 and 1.0 OD units. We also sought to explore the ability of each antiheparin-PF4 ELISA threshold to correctly classify patients according to SRA results by calculating the sensitivity, specificity, PPV, NPV, and accuracy.…”

Section: Methodsmentioning

confidence: 99%

Comparison of an IgG-Specific Enzyme-Linked Immunosorbent Assay Cutoff of 0.4 Versus 0.8 and 1.0 Optical Density Units for Heparin-Induced Thrombocytopenia

Ritchie

Connors

Sylvester

2016

Clin Appl Thromb Hemost

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Impact of an Immunoglobulin G–Specific Enzyme‐Linked Immunosorbent Assay on the Management of Heparin‐Induced Thrombocytopenia

Abstract: Use of an IgG-specific PF4 ELISA was associated with a lower rate of positive PF4 test results. Direct thrombin inhibitor prescribing was also significantly lower during the time period where the IgG-specific PF4 ELISA was used, with no significant differences noted in safety outcomes.

Cited by 8 publications

References 18 publications

Proficiency Testing Results for Heparin-Induced Thrombocytopenia in North America

Proficiency Testing Results for Heparin-Induced Thrombocytopenia in North America

Medication Use Evaluation: Pharmacist Rubric for Performance Improvement

Comparison of an IgG-Specific Enzyme-Linked Immunosorbent Assay Cutoff of 0.4 Versus 0.8 and 1.0 Optical Density Units for Heparin-Induced Thrombocytopenia

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