Inhibitor Index in the Clot Waveform Analysis-Based Mixing Test Differentiates among Hemophilia A without and with Inhibitors, and Lupus Anticoagulant

Thromb Haemost. 2021 Jun;121(6):792-799. doi: 10.1055/s-0040-1721776. Epub 2021 Jan 7.

Abstract

Background: The mixing test is used to identify the pathway to follow-up testing and is also useful for the investigation of lupus anticoagulant (LA) positivity. "To completely correct" indicates clotting factor deficiency, while "to not correct" indicates the presence of a clotting factor inhibitor including LA. "Index of circulation anticoagulant" and/or "percent correction" is used to interpret the results of mixing studies, but it does not accurately differentiate factor inhibitors from LA.

Aim: To precisely differentiate hemophilia A (HA), HA with inhibitor (HA-inh), and LA using the clot waveform analysis (CWA)-based mixing test.

Methods: Plasma samples from HA, LA, and HA-inh including acquired HA were incubated with normal plasma in 9:1, 1:1, and 1:9 mix ratios. From activated partial thromboplastin time CWA at 0-minute (immediately) and 12-minute incubation, the ratios of CWA parameters at 12 minutes/0 minute (inhibitor index) were assessed.

Results: The inhibitor index values of CWA parameters obtained using the mixing test in a 1:1 ratio demonstrated a significant difference between HA-inh and LA but could not differentiate LA from HA-inh completely. Plasmas used for the mixing tests in 9:1 and 1:9 ratios were able to fully distinguish between HA-inh (>0.5 BU/mL) and LA. These indices significantly correlated with inhibitor titer below 40 BU/mL (r > 0.90), possibly estimating FVIII inhibitor titer from the inhibitor index. Plasmas in HA and LA could be distinguished by mixing in a 1:1 ratio at 0 minute (immediately).

Conclusion: The inhibitor index from CWA-based mixing tests with a 12-minute incubation could differentiate among HA, HA-inh, and LA quickly.

MeSH terms

  • Blood Coagulation*
  • Diagnosis, Differential
  • Hemophilia A / blood
  • Hemophilia A / diagnosis*
  • Hemophilia A / immunology
  • Humans
  • Immunoglobulins / blood*
  • Lupus Coagulation Inhibitor / blood*
  • Partial Thromboplastin Time*
  • Predictive Value of Tests
  • Reproducibility of Results
  • Time Factors
  • Workflow

Substances

  • Immunoglobulins
  • Lupus Coagulation Inhibitor
  • circulating anticoagulants