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Specimen Age Stability for Human Papilloma Virus DNA Testing Using BD SurePath.

Melanie J Kubik1, Terri Permenter2, Jinous Saremian2

  • 1Department of Pathology and Laboratory Medicine, University of Florida College of Medicine-Jacksonville mekubik@ucsd.edu.

Laboratory Medicine
|January 25, 2015
PubMed
Summary

BD SurePath Pap tests aged over 21 days may yield false-negative human papilloma virus (HPV) results. This degradation impacts diagnostic accuracy, necessitating updated guidelines for specimen age to ensure reliable HPV testing.

Keywords:
ASCUSBD SurePathHPVHuman Papilloma DNARoche Cobas 4800

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Area of Science:

  • Clinical diagnostics
  • Molecular pathology
  • Gynecologic oncology

Background:

  • BD SurePath liquid-based Pap tests are widely used for human papilloma virus (HPV) testing, despite FDA approval solely for Pap testing.
  • The study addresses the common practice of using Pap test specimens for HPV detection.

Purpose of the Study:

  • To evaluate the impact of specimen age on the accuracy of high-risk HPV DNA testing.
  • To determine the false-negative rate of HPV testing in aged BD SurePath specimens.

Main Methods:

  • 50 BD SurePath specimens, initially positive for high-risk HPV via Roche Cobas 4800 assay, were retested 21 days post-collection.
  • Comparison of repeat HPV test results with original results to identify discrepancies.

Main Results:

  • 8 out of 50 initially HPV-positive specimens tested negative when retested at 21 days.
  • A 16.0% false-negative rate was observed in aged BD SurePath specimens.

Conclusions:

  • Aged BD SurePath specimens (>21 days) may lead to false-negative HPV DNA test results due to DNA degradation.
  • Guidelines recommending specimen age <2 weeks are needed to improve diagnostic accuracy and patient care for HPV testing.