2019
DOI: 10.1111/hae.13901
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Evaluation of pre‐analytic heat treatment protocol used in the CDC Nijmegen‐Bethesda assay for heat inactivation of extended half‐life haemophilia treatment products

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Cited by 6 publications
(8 citation statements)
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“…The first study demonstrated that a 30‐minute incubation at 56 resulted in heat inactivation of EHL‐FVIII and allowed accurate determination of FVIII inhibitors using either one‐stage or chromogenic assays 67. This finding was confirmed in the subsequent study, which also showed that pre‐analytic heat treatment can remove interference by EHL‐FIX agents 68. Collectively, these findings mean that patients do not need to undergo a washout period prior to inhibitor measurement.…”
Section: Effects Of Extended Half‐life Factors or Emicizumab On Diagnmentioning
confidence: 81%
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“…The first study demonstrated that a 30‐minute incubation at 56 resulted in heat inactivation of EHL‐FVIII and allowed accurate determination of FVIII inhibitors using either one‐stage or chromogenic assays 67. This finding was confirmed in the subsequent study, which also showed that pre‐analytic heat treatment can remove interference by EHL‐FIX agents 68. Collectively, these findings mean that patients do not need to undergo a washout period prior to inhibitor measurement.…”
Section: Effects Of Extended Half‐life Factors or Emicizumab On Diagnmentioning
confidence: 81%
“…It is well established that heat activation and centrifugation can be used to eliminate interference from endogenous and therapeutic FVIII, and facilitate low‐level inhibitor detection; 34 however, until recently the effectiveness of this pre‐analytical protocol in samples containing EHL‐FVIII and EHL‐FIX agents had not been investigated. Two small studies have now demonstrated that molecular modification of FVIII and FIX does not impact heat inactivation 67,68 . The first study demonstrated that a 30‐minute incubation at 56 resulted in heat inactivation of EHL‐FVIII and allowed accurate determination of FVIII inhibitors using either one‐stage or chromogenic assays 67.…”
Section: Effects Of Extended Half‐life Factors or Emicizumab On Diagnmentioning
confidence: 99%
“…Pre-analytic heat inactivation of patients’ plasma (56⁰C for 30 minutes) is important to eliminate interference caused by endogenous or therapeutic FVIII in the plasma samples. While heat-inactivation of plasma samples is an effective and well established pre-analytical measure during application of the Nijmegen-Bethesda-Assay [ 38 ], the influence of heat-inactivation of plasma samples directly added to one- or two-stage assays originally developed for functional assessment of clotting factor-activity has not been systematically investigated yet. In order to ensure emicizumab-specificity of the optimized emi-tenase assay, we decided to include heat-inactivation of samples as an integral part of the assay procedure.…”
Section: Discussionmentioning
confidence: 99%
“…Additionally, it is possible that false‐negative NBA results can explain the NBA‐FLI discrepancies observed in the current study, and on‐board BPAs and the frequent high doses of FVIII used for ITI may compromise the NBA results. A previous study in our laboratory showed that FVIII:C in plasma spiked with a conventional FVIII infusion product was inactivated by the heat treatment utilized by the CDC NBA at levels up to 125 u/dL, 23 but it is unclear whether the frequent high doses of infused FVIII received by ITI patients would be affected in the same manner. Similar studies for BPAs have not been done.…”
Section: Resultsmentioning
confidence: 99%