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To normalize or not?: Dilute Russell viper venom time testing.

Yong Zhang1, Michael Creer1, Olajumoke O Oladipo1

  • 1Department of Pathology and Laboratory Medicine, Penn State Health Milton S. Hershey Medical Center, Penn State College of Medicine, Hershey, PA, US.

American Journal of Clinical Pathology
|February 19, 2024
PubMed
Summary

Normalization of dilute Russell viper venom time (dRVVT) screen/confirm ratio (SCR) did not alter lupus anticoagulant (LA) status in patients. This normalization step offered no clinical benefit for within-method LA detection in this population.

Keywords:
antiphospholipid antibodyantiphospholipid syndromedRVVTlupus anticoagulantnormalization

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Area of Science:

  • Hematology
  • Clinical Chemistry
  • Immunology

Background:

  • Lupus anticoagulant (LA) testing is crucial for diagnosing thrombotic disorders.
  • Dilute Russell viper venom time (dRVVT) is a common assay for LA detection.
  • Normalization of dRVVT results using reference plasma is a potential method to standardize results.

Purpose of the Study:

  • To compare nonnormalized and normalized dRVVT screen/confirm ratios (SCRs).
  • To evaluate the impact of normalization on lupus anticoagulant (LA) status determination.
  • To assess the clinical utility of normalization in a patient cohort.

Main Methods:

  • Retrospective analysis of 464 patients undergoing dRVVT testing.
  • Inclusion of mixing studies and confirmatory testing for positive screens.
  • Measurement of dRVVT in reference pooled plasma for normalization.

Main Results:

  • 5.6% of samples were confirmed positive for LA by both nonnormalized and normalized methods.
  • 100% concordance in LA status between nonnormalized and normalized SCRs.
  • A statistically significant difference in SCRs was observed, but with minimal bias (0.04).

Conclusions:

  • Normalization of dRVVT SCR did not change the lupus anticoagulant status.
  • Normalization provided no additional clinical benefit for within-method LA detection.
  • Normalization may be more relevant for intermethod and interlaboratory comparisons.