Comparison of Three Methods for Measuring Factor VIII Levels in Plasma

Chandler, Wayne L.; Ferrell, Chris; Lee, Joo Sang; Tun, Theingi; Kha, Hien

doi:10.1309/c8t8ynb4g3w45prf

Cited by 58 publications

(39 citation statements)

References 4 publications

(4 reference statements)

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“…The results obtained with the amidolytic assay and the one-stage clotting assay highly correlate with each other [27,28]. No significant differences in the results between the two methods were detected in the blood of donors with normal or high FVIII levels, in patients with a chronic liver disease and in normal persons with high FVIII levels after treatment with desmopressin.…”

Section: Chromogenic Assaymentioning

confidence: 59%

Diagnosis of factor VIII deficiency

Verbruggen

Meijer²,

Nováková

2008

Haemophilia

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Summary. The correct diagnosis of factor VIII deficiency and the assessment of severity of the disease are essential for a patient-tailored treatment strategy. An optimal diagnostic procedure comprises sensitive and specific screening methods and factor VIII activity assays. Different screening reagents show variable characteristics and receiver operator characteristic curves are presented showing the relation between sensitivity and specificity of eleven activated partial thromboplastin time reagents. The details of the three methods for factor VIII activity assay, onestage and two-stage assay and chromogenic assays, are discussed. The chromogenic assay seems to be more sensitive than the one-stage assay with regard to the detection of severe haemophilia. Discrepant results obtained with one-stage and two-stage assays are reviewed and discussed.

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Section: Chromogenic Assaymentioning

confidence: 59%

Diagnosis of factor VIII deficiency

Verbruggen

Meijer²,

Nováková

2008

Haemophilia

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“…Chromogenic and fluorescence-based assays were chosen because of their potential to improve on the specificity and sensitivity of clot-based assays. Chromogenic assays are appealing for FVIII inhibitor detection, because they have been shown to be insensitive to heparin, lupus anticoagulants and other non-specific inhibitors of coagulation [20,21]. Their use in the Bethesda assay has been reported previously [3,10,22].…”

Section: Discussionmentioning

confidence: 99%

Comparison of clot‐based, chromogenic and fluorescence assays for measurement of factor VIII inhibitors in the US Hemophilia Inhibitor Research Study

Miller

Rice

Boylan

et al. 2013

Journal of Thrombosis and Haemostasis

112

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Summary Background Detection and validation of inhibitors (antibodies) to hemophilia treatment products are important for clinical care, evaluation of product safety, and assessment of population trends. Methods Centralized monitoring for factor VIII (FVIII) inhibitors was conducted for patients in the Hemophilia Inhibitor Research Study using a previously reported modified Nijmegen-Bethesda clotting assay (NBA), a chromogenic Bethesda assay (CBA), and a novel fluorescence immunoassay (FLI). Results NBA and CBA were performed on 1005 specimens and FLI on 272 specimens. CBA was negative on 880/883 specimens (99.7%) with Nijmegen-Bethesda units (NBU)<0.5 and positive on 42/42 specimens (100%) with NBU≥2.0 and 43/80 specimens (53.8%) with NBU 0.5–1.9. Among specimens with positive NBA and negative CBA, 58.1% were FLI-negative, 12.9% had evidence of lupus anticoagulant, and 35.5% had non-time-dependent inhibition. CBA and FLI were positive on 72.4% and 100% of 1.0–1.9 NBU specimens and 43.1% and 50.0% of 0.5–0.9 NBU specimens. FLI detected antibodies in 98.0% of CBA-positive and 81.6% of NBA-positive specimens (P=0.004). Among 21 new inhibitors detected by NBA, 5 (23.8%) with 0.7–1.3 NBU did not react in CBA or FLI. Among previously positive patients with 0.5–1.9 NBU, 7/25 (28%) were not CBA or FLI positive. FLI was positive on 36/169 NBU-negative specimens (21.3%). Conclusions FVIII specificity could not be demonstrated by CBA or FLI for 26% of inhibitors of 0.5–1.9 NBU; such results must be interpreted with caution. Low titer inhibitors detected in clot-based assays should always be repeated, with consideration given to evaluating their reactivity with FVIII using more specific assays.

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“…Two previous reports have assessed the performance of automated chromogenic assays, using reagents from Chromogenix and an STA analyser, and compared it with the one-stage clotting assay (Kleinveld et al, 1999;Chandler et al, 2003). Both reports showed good precision for the chromogenic assay, and good correlation with one-stage results, but the discrepant haemophilia phenotype was not considered in either of them (Kleinveld et al, 1999;Chandler et al, 2003).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of three automated chromogenic FVIII kits for the diagnosis of mild discrepant haemophilia A

Rodgers

Duncan

Sobieraj‐Teague

et al. 2009

Int J Lab Hematology

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In some mild haemophilia A patients (discrepant phenotype), coagulation FVIII levels by one-stage assay (FVIII-1st) are more than double those by classical two-stage coagulation assay (FVIII-2st), and may fall within the normal range. Our aim was to assess automated two-stage chromogenic FVIII assays (FVIII-chr) for diagnosis of mild discrepant haemophilia A. Three chromogenic FVIII kits (Biophen, Coamatic and Dade-Behring) were evaluated, using recommended and extended incubation times. Samples were tested from patients with discrepant haemophilia (n = 7) and equivalent mild haemophilia (agreement between FVIII-1st and FVIII-2st, n = 4). For equivalent haemophilia, FVIII-chr were consistent with FVIII-1st and FVIII-2st for all kits at all incubation times. For discrepant haemophilia, using recommended incubation times, mean FVIII-chr using Biophen reagents was 22 IU/dl (range 13-31), with Coamatic 26 (17-34) and with Dade-Behring 41 (33-47), compared with 36 (27-44) for FVIII-1st and 8 (6-9) for FVIII-2st. FVIII-chr decreased as incubation time was increased with Biophen and Coamatic, but decreased less with Dade-Behring. FVIII-chr using the Dade-Behring kit gave similar results to FVIII-1st and is not suitable for diagnosis of mild discrepant haemophilia A. FVIII-chr by Biophen and Coamatic kits is suitable for diagnosis of these patients, especially with an extended incubation time.

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Comparison of Three Methods for Measuring Factor VIII Levels in Plasma

Cited by 58 publications

References 4 publications

Diagnosis of factor VIII deficiency

Diagnosis of factor VIII deficiency

Comparison of clot‐based, chromogenic and fluorescence assays for measurement of factor VIII inhibitors in the US Hemophilia Inhibitor Research Study

Evaluation of three automated chromogenic FVIII kits for the diagnosis of mild discrepant haemophilia A

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