Combinations of rapid immunoassays for a speedy diagnosis of heparin‐induced thrombocytopenia

Rittener-Ruff, Luana; Marchetti, Matteo; Matthey‐Guirao, Elena; Grandoni, Francesco; Gómez, Francisco; Alberio, Lorenzo

doi:10.1111/jth.15811

Cited by 5 publications

(21 citation statements)

References 33 publications

(158 reference statements)

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“…The benefit of this assay is that it is performed on a widely available analyser with sensitivity and specificity superior to manual rapid assays. Reports using stratification of values into weak, moderate and strong positivity in conjunction with chemiluminescent‐based assays achieved 98% comparability with the gold standard SRA 50,58 …”

Section: Rapid Screeningmentioning

confidence: 99%

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Diagnosis and management of heparin‐induced thrombocytopenia: Third edition

Arachchillage,

Thachil,

Anderson

et al. 2023

Br J Haematol

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This guideline was compiled according to the BSH process at (https:// b-s-h. org. uk/ media/ 16732/ bsh-guida nce-devel opmen t-proce ss-dec-5-18. pdf). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) nomenclature was used to evaluate levels of evidence and to assess the strength of recommendations. The GRADE criteria can be found at http:// www. grade worki nggro up. org. A literature search was carried out using the terms given in Appendix until August 2022.

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Section: Rapid Screeningmentioning

confidence: 99%

“…Reports using stratification of values into weak, moderate and strong positivity in conjunction with chemiluminescent-based assays achieved 98% comparability with the gold standard SRA. 50,58 R ECOM M E N DATIONS…”

Section: Qualitativementioning

confidence: 99%

Diagnosis and management of heparin‐induced thrombocytopenia: Third edition

Arachchillage,

Thachil,

Anderson

et al. 2023

Br J Haematol

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“…Fig. 2 Sequential analytic algorithm adopted from Rittener-Ruff et al 22 Color coding represents categories of sequential LIA-CLIA algorithm results. Dark green ¼ HIT predicted (>6.0 LIA), light green ¼ inconclusive LIA results (0.73-6.0) but HIT is predicted due to a secondary CLIA test result >3.0, red ¼ HIT is excluded (based on first test LIA <0.73), and gray ¼ results within the inconclusive LIA (0.73-6.0) and CLIA (0.13-3.0) range.…”

Section: Operating Characteristics Of Anti-pf4 Immunoassays and Rapid...mentioning

confidence: 99%

“…20,21 Recently, the performance of these assays when used in combination have also been explored due to their complementary nature, as the LIA and CLIA are based on different approaches to antibody detection (LIA: competitive inhibition of HIT-like monoclonal antibody binding to PF4/heparin-coated particles; CLIA, detection of patient antibodies bound directly to PF4/heparin complexes coated on particles). 14,22 However, further prospective evaluations of these assays are required to determine their diagnostic performance in real-world clinical scenarios.…”

mentioning

confidence: 99%

“…Here, we evaluate the Immucor IgG/A/M PF4-enhanced EIA (IgG/A/M EIA) and compare the independent and combined performance of the LIA and CLIA using a single prospective cohort of suspected HIT patients from across Canada to determine their diagnostic performance. To further validate the combined performance of rapid IAs for HIT diagnosis (LIA-CLIA), we employed two statistical approaches developed in previous retrospective studies: (1) the simultaneous algorithm adapted from Warkentin et al 14 and (2) the sequential algorithm adapted from Rittener-Ruff et al 22 We aim to provide an assessment of these diagnostic assays in a setting that reflects the reality for most HIT reference laboratories, where access to patients' clinical information is limited.…”

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confidence: 99%

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Evaluating Diagnostic Algorithms for Heparin-Induced Thrombocytopenia using Two Combined Automated Rapid Immunoassays

Bissola,

Zhang,

Cranstone

et al. 2024

Semin Thromb Hemost

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Heparin-induced thrombocytopenia (HIT) is an autoimmune disorder caused by antibodies against platelet factor 4 (PF4) and heparin complexes. Rapid immunoassays (IAs) for detection of these antibodies mark a milestone in HIT diagnosis, despite a higher false-positive rate compared with functional platelet-activation assays. However, combining different rapid IAs may help to improve their diagnostic specificity. Here, we compared the individual performance of the latex immunoturbidimetric assay (LIA; HemosIL HIT-Ab [PF4-H]; sensitivity 91.7%, specificity 68.4%) and chemiluminescence immunoassay (CLIA; HemosIL AcuStarHIT-Ab [PF4-H]; sensitivity 92.4%, specificity 85.8%) with their combined performance using two unique diagnostic algorithms in a single prospective cohort of suspected HIT patients. Using the simultaneous algorithm adapted from Warkentin et al, the combined LIA–CLIA had a sensitivity of 99.0% and specificity of 64.3%. The sequential algorithm adapted from Rittener-Ruff et al was applied in two theoretical scenarios to reflect real-world circumstances in diagnostic laboratories where access to clinical information is limited: (1) assuming all patients had an intermediate 4Ts score and (2) assuming all patients had a high 4Ts score. This algorithm correctly predicted HIT in 94.5% (high 4Ts) and 96.0% (intermediate 4Ts) and excluded HIT in 82.6% (high 4Ts) and 80.1% (intermediate 4Ts) of patients in either scenario, respectively. Although both combined algorithms improved diagnostic performance of individual IAs, the simultaneous algorithm showed fewer false predictions (7.9%) than the sequential algorithm (intermediate 4Ts: 37.6% and high 4Ts: 41.5%) and proved more practical as it does not rely on physician evaluations. Our findings highlight the importance of accounting for clinician and interlaboratory variability when evaluating diagnostic tests for HIT.

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