Main considerable factors for correct laboratory test interpretation under DOA treatment

Mani, Helen; Lindhoff-Last, Edelgard

doi:10.1186/1477-9560-11-22

Cited by 10 publications

(6 citation statements)

References 13 publications

(21 reference statements)

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“…Similarly, anti-Xa, Rivaroxaban also results in elevated protein C levels determined by clot-based assay. These DOACs have no effect on protein C determination by chromogenic assay [16,17].…”

Section: Discussionmentioning

confidence: 99%

Comparison of clot-based and chromogenic assay for the determination of protein c activity

Roshan

Stein

Jiang

2019

Blood Coagulation &Amp; Fibrinolysis

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Activated protein C inactivates factor Va and VIIIa. Deficiency of this natural anticoagulant may result in recurrent venous thrombosis. Performance characteristics of clot-based and chromogenic protein C activity assays are different. The clot-based assay has limitations because of interference with coagulation inhibitors resulting in spuriously increased protein C levels or underestimation because of elevated levels of factor VIII and Factor V-Leiden mutation. The chromogenic assay is not influenced by such interferences but only detects functional defects of protein C that involve the active site rendering it insensitive to rare mutations. To compare two methods, we conducted a retrospective study from January 2015 to June 2017. Our results showed a good correlation between clot-based and chromogenic assay ( R = 0.94 and r 2 = 0.88). The study of agreement between the two methods by the Bland–Altman method showed that chromogenic method on an average measures 7.8% more protein C than that of clot-based. The results also showed that the bias between the two methods is significant. The positive trend noted was contributed by the values of less than 20% of protein C. Both clot-based and chromogenic assays had high sensitivity; however, the chromogenic assay showed better specificity (97%) as compared with the clot-based assay (93%). In conclusion, we recommend the chromogenic method as the assay of choice, which is also recommended by the College of American Pathologist Consensus Study over activated partial thromboplastin time-based assay. We have shown here that despite a good correlation between the two techniques, there is a difference as highlighted by the difference plots.

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Section: Discussionmentioning

confidence: 99%

Comparison of clot-based and chromogenic assay for the determination of protein c activity

Roshan

Stein

Jiang

2019

Blood Coagulation &Amp; Fibrinolysis

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“…Preactivation of FVIII increases activity in the OSA but not in the CSA (provided that FXa production is measured after a sufficiently long activation period), and the OSA is more likely to be affected by impurities such as lipids or heparin . In both the OSA and the CSA performed on samples collected from patients receiving direct‐acting oral anticoagulants, artefacts may appear, with the observed FVIII concentration being reduced . Discussion continues over which assay is best and provides a better indication of ‘true’ FVIII activity .…”

Section: Fviii Activity Assaysmentioning

confidence: 99%

A critical appraisal of one‐stage and chromogenic assays of factor VIII activity

Peyvandi

Oldenburg²,

Friedman

2016

Journal of Thrombosis and Haemostasis

130

191

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To cite this article: Peyvandi F, Oldenburg J, Friedman KD. A critical appraisal of one-stage and chromogenic assays of factor VIII activity. 2016; 14: 248-61. Summary: Accurate and precise potency determination by manufacturers of different types of factor VIII product (plasma-derived and recombinant FVIII [rFVIII]) is vital to clinicians and patients using FVIII concentrates. A separate, but related, requirement is ascertaining the FVIII activity levels in clinical samples for diagnosing and treating hemophilia A. The one-stage clotting assay (OSA) and the chromogenic substrate assay (CSA) are the main assays used for these measurements, with both assays being used for potency assignments, and the OSA also being widely used for clinical monitoring. Although the assays can produce concordant results, discrepancies often occur, e.g. when measuring FVIII levels in patients with mild or moderate hemophilia A, or when assaying highpurity FVIII products. Modifications to rFVIII proteins, such as B-domain deletion (BDD), and technologies for improving the pharmacokinetic profile of rFVIII may exacerbate assay discrepancies. The CSA appears to be essentially unaffected by these modifications. However, the OSA underestimates the FVIII activity levels and therapeutic potential of some further modified BDD rFVIII products, especially those conjugated to poly(ethylene glycol); the extent of the effects is dependent on the specific OSA reagents used. Although the OSA remains the preferred choice for clinical monitoring in Europe and the USA, an awareness of the limitations of that assay has prompted more laboratories to adopt the CSA. J Thromb Haemost

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“…The impact of DOACs on the laboratory assays depends on the type of the drug, the drug concentrations, the assay, reagents and instruments used to test the sample [48]. Assays based on thrombin are more affected by direct thrombin inhibitors, whereas direct FXa inhibitors influenced much more FXa-based methods.…”

Section: Effect Of Doacs On Routine Coagulation Testsmentioning

confidence: 99%

“…The APTT demonstrates a concentration-dependent prolongation in a nonlinear manner in response to direct FXa inhibitors in samples, although to a lesser extent than to dabigatran [48,[63][64][65]. APTT reagents are much more sensitive to rivaroxaban and edoxaban than to apixaban [52].…”

Section: Effect Of Doacs On Routine Coagulation Testsmentioning

confidence: 99%

“…Dabigatran can be quantified using a chromogenic ecarin assay, ecarin clotting time or a modified (dilute) TT, where excessive sensitivity is overcome by lower concentrations of heparin or sample dilution [60,68]. Since FXa is not involved in fibrinogen conversion into fibrin, the TT is not affected by direct FXa inhibitors [48,64].…”

Section: Effect Of Doacs On Routine Coagulation Testsmentioning

confidence: 99%

See 1 more Smart Citation

Direct Oral Anticoagulants in Patients with Thrombophilia: Challenges in Diagnostic Evaluation and Treatment

Undas

Góralczyk

2016

Adv Clin Exp Med

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Main considerable factors for correct laboratory test interpretation under DOA treatment

Cited by 10 publications

References 13 publications

Comparison of clot-based and chromogenic assay for the determination of protein c activity

Comparison of clot-based and chromogenic assay for the determination of protein c activity

A critical appraisal of one‐stage and chromogenic assays of factor VIII activity

Direct Oral Anticoagulants in Patients with Thrombophilia: Challenges in Diagnostic Evaluation and Treatment

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