Patient safety and the next generation of HPV DNA tests

Walter Kinney, Mark H. Stoler, Philip E. Castle

Research output: Contribution to journalComment/debate

74 Citations (Scopus)

Abstract

Human papillomavirus (HPV) testing is more sensitive for the detection of cervical precancer and cancer than cervical cytology. The increased sensitivity of HPV testing and cytology combined ("cotesting") compared to cytology alone permitted professional societies to recommend 3-year screening intervals among the cotest-negative results. However, there is an increasing recognition that both clinical sensitivity and specificity of cervical cancer screening are important to patient safety and must be considered in the context of using current and future HPV DNA tests. Exquisite analytic sensitivity for HPV does not increase clinical sensitivity of an HPV test but does result in excessive test positivity and decreased clinical specificity. A recent US Food and Drug Administration (FDA)-approved HPV test, Cervista (Hologic, Bedford, MA), demonstrated excessive test positivity - 2 to 4 times more positive than the other FDA-approved HPV test - from its premarketing approval trial. The poor specificity of Cervista raises questions about the safety and applicability of using this test in routine cervical cancer screening. These data provide a didactic example of the potential dangers of mistaking excellent analytic sensitivity and even clinical sensitivity for good clinical performance.

Original languageEnglish (US)
Pages (from-to)193-199
Number of pages7
JournalAmerican Journal of Clinical Pathology
Volume134
Issue number2
DOIs
StatePublished - Aug 2010
Externally publishedYes

Fingerprint

Human Papillomavirus DNA Tests
Patient Safety
Uterine Cervical Neoplasms
Cell Biology
United States Food and Drug Administration
Early Detection of Cancer
Safety
Sensitivity and Specificity

Keywords

  • Cervical cancer
  • Cytology
  • HPV
  • HPV DNA testing
  • Human papillomavirus

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

Cite this

Patient safety and the next generation of HPV DNA tests. / Kinney, Walter; Stoler, Mark H.; Castle, Philip E.

In: American Journal of Clinical Pathology, Vol. 134, No. 2, 08.2010, p. 193-199.

Research output: Contribution to journalComment/debate

Kinney, Walter ; Stoler, Mark H. ; Castle, Philip E. / Patient safety and the next generation of HPV DNA tests. In: American Journal of Clinical Pathology. 2010 ; Vol. 134, No. 2. pp. 193-199.
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