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Reagent Effects on the Activated Partial Thromboplastin Time Clot Waveform Analysis: A Multi-Centre Study.

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Activated partial thromboplastin time (APTT)-based clot waveform analysis (CWA) shows reagent-specific variations. Standardizing reagents is crucial for reliable diagnostic applications of APTT-based CWA across laboratories.

Keywords:
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Area of Science:

  • Hematology
  • Clinical Chemistry
  • Diagnostic Assays

Background:

  • Activated partial thromboplastin time (APTT)-based clot waveform analysis (CWA) offers quantitative insights beyond standard APTT measurements.
  • Pre-analytical variables, particularly reagent effects, are not well-understood and require standardization for CWA's diagnostic potential.

Purpose of the Study:

  • To investigate reagent lot variations and inter-laboratory effects on APTT-based CWA parameters.
  • To establish reagent-specific reference intervals for APTT-based CWA.

Main Methods:

  • Analyzed CWA with three common APTT reagents (Pathromtin SL, Actin FS, Actin FSL) using patient samples.
  • Collected CWA data from 1055 healthy volunteers across seven Asia-Pacific institutions on Sysmex CS analyzers.
  • Utilized linear mixed model and nonparametric methods for data analysis.

Main Results:

  • CWA parameters exhibited less than 10% variation between reagent lots.
  • Minimal site-specific effects were observed within the same reagent group.
  • Significant differences in CWA parameters were found among different reagent groups, necessitating reagent-specific reference intervals.
  • Age and gender showed a weak correlation with CWA parameters.

Conclusions:

  • Reagent type is a significant factor influencing APTT-based CWA results.
  • Data pooling across laboratories is feasible for the same coagulometer series due to minimal inter-laboratory variations.
  • Further research is needed to establish age- and gender-specific reference intervals for APTT-based CWA.