Abuses in Human Papillomavirus DNA Testing

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Excerpt

The discovery that persistent cervical infections by high-risk human papillomavirus (HPV) genotypes cause virtually all cervical cancer has led to revolutionary advances in cervical cancer prevention, including HPV vaccination for primary prevention and HPV DNA testing for secondary prevention.1 With respect to the latter, the U.S. Food and Drug Administration (FDA) approved the first HPV DNA test, Hybrid Capture 2, a pooled test for 13 high-risk HPV genotypes, in 2003. Several other tests recently have received FDA approval.
National guidelines accept HPV DNA testing for the following indications2:
In this issue of Obstetrics & Gynecology (see p. 4), Lee et al3 report patterns of HPV test usage from a survey of nationally representative samples of Pap test providers. Data were collected as a supplement to the Centers for Disease Control and Prevention, National Center for Health Statistics National Ambulatory Medical Care Survey (n=376 providers) and National Hospital Ambulatory Medical Care Survey (n=216 clinics). Lee et al found a number of disturbing patterns for HPV test use (only one test, Hybrid Capture 2, was commercially available at the time of the survey). First, approximately one quarter of the surveyed clinicians and clinics used both high-risk and low-risk HPV tests, the latter of which is commercially available through Qiagen. However, testing for low-risk HPV genotypes offers no benefit to patients because these HPV types have been proven to be unrelated to cervical carcinogenesis4 and do not meaningfully predict other morbidities, such as genital warts. Remarkably, a small percentage (2%) tested for low-risk HPV only. The specialty of obstetrics and gynecology was most likely to use the low-risk HPV test. Second, approximately 60% of the clinicians and clinics reported cotesting women under the age of 30 years, despite guidelines that strongly recommend against such testing.2 Owing to the high prevalence of high-risk HPV in women under 30 years of age, cotesting is not recommended because most occurrences of high-risk HPV in this age group have proven to be transient. Finally, the study found widespread use of reflex HPV testing in women with severe cytologic interpretations, notably high-grade squamous intraepithelial lesions (HSIL), for which reflex HPV testing is not recommended.
Previous studies have reported the overuse of HPV testing; for example, the repetition of cotesting annually and biannually rather than triannually.5 Ironically, these types of abuses are not restricted to HPV testing. High volumes of unnecessary Pap tests are being performed on women who receive no benefit from cervical cancer screening, such as hysterectomized women without a cervix and young women who are not yet sexually active and thus have never being exposed to the causal agent (HPV).6 It was estimated that more than half of the 75 million Pap tests performed in 2010 were probably outside of guideline compliance and therefore unnecessary.7
What is the effect on the patient? A positive result of any medical test has a negative psychosocial effect on the patient; HPV and cytology are no exceptions. A patient who tests HPV-positive has a wide range of negative psychosocial and psychosexual outcomes, including anxiety, distress, and a decreased sense of sexual well-being. For example, women with normal Pap tests may experience more anxiety if they have HPV-positive results compared with women with normal Pap tests who do not know their HPV status.8
Overuse and improper use also have potentially important negative medical, health care, and economic consequences. As the result of cotesting, some women under the age of 30 years may tested HPV positive and have undergone colposcopy that otherwise would not have.

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