2020
DOI: 10.1111/ijlh.13189
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Real‐world assay variability between laboratories in monitoring of recombinant factor IX Fc fusion protein activity in plasma samples

Abstract: Introduction:Monitoring of factor IX (FIX) replacement therapy in haemophilia B relies on accurate coagulation assays. However, considerable interlaboratory variability has been reported for one-stage clotting (OSC) assays. This study aimed to evaluate the realworld, interlaboratory variability of routine FIX activity assays used in clinical haemostasis laboratories for the measurement of recombinant FIX Fc fusion protein (rFIXFc) activity.Methods: Human FIX-depleted plasma was spiked with rFIXFc at 0.80, 0.20… Show more

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Cited by 5 publications
(11 citation statements)
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“…5,67 Both rFVIIIFc and rFIXFc can be accurately monitored by either the one-stage clotting assay or chromogenic assay using commercial assay reagents readily available in laboratories. [68][69][70] This is important for securing both efficacy and safety, and serves to facilitate their implementation into real-world practice. 5,70 However, assay reagents that use kaolin as an activator may result in an underestimation of FIX levels for rFIXFc.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…5,67 Both rFVIIIFc and rFIXFc can be accurately monitored by either the one-stage clotting assay or chromogenic assay using commercial assay reagents readily available in laboratories. [68][69][70] This is important for securing both efficacy and safety, and serves to facilitate their implementation into real-world practice. 5,70 However, assay reagents that use kaolin as an activator may result in an underestimation of FIX levels for rFIXFc.…”
Section: Discussionmentioning
confidence: 99%
“…Currently, optimal dosing of factor replacement products during surgery relies on the ability to accurately monitor plasma factor activity levels, ensuring patients remain protected against excessive blood loss 5,67 . Both rFVIIIFc and rFIXFc can be accurately monitored by either the one‐stage clotting assay or chromogenic assay using commercial assay reagents readily available in laboratories 68–70 . This is important for securing both efficacy and safety, and serves to facilitate their implementation into real‐world practice 5,70 .…”
Section: Discussionmentioning
confidence: 99%
“…When using a CSA for sample analysis, acceptable recoveries were found. 72 However, a recent single-centre study revealed analyser-dependent differences of assay results, as well as underestimation of Alprolix by CSAs at lower input concentrations. 73 Furthermore, another field study also demonstrated interlaboratory differences during analysis of Alprolix, which, however, were not different from that of pFIX and rFIX processed in parallel.…”
Section: Eftrenonacog Alfa (Alprolix)mentioning
confidence: 99%
“…While this was especially and reproducibly true for SynthAFax, a high interlaboratory variability of results was found for other aPTT reagents tested. 71,72 In contrast to the ellagic acid-based aPTT reagents, silica-based reagents showed more acceptable results, while the kaolin-based CK Prest demonstrated significant underestimation. When using a CSA for sample analysis, acceptable recoveries were found.…”
Section: Eftrenonacog Alfa (Alprolix)mentioning
confidence: 99%
“…With the expanding prescription of eftrenonacog-alfa, the concern to accurately and reliably measure its recovery has risen within hemostasis laboratories. Several studies have evaluated OSA and CSA performances in samples spiked with eftrenonacog-alfa and have evidenced significant discrepancies between reagents (Sommer et al, 2014;Sommer et al, 2020;Kitchen et al, 2017;Wilmot et al, 2014). Although CSA might be more suitable for accurately monitoring this product, no definitive conclusion is 4 presently drawn and published results obtained with spiked plasmas deserve to be confirmed in plasma samples from treated patients (Tripodi et al, 2019).…”
Section: Introductionmentioning
confidence: 99%