Interim Guidance for the Use of Human Papillomavirus DNA Testing as an Adjunct to Cervical Cytology for Screening

Abstract

Human papillomavirus (HPV) DNA testing was recently approved by the Food and Drug Administration for use as an adjunct to cytology for cervical cancer screening. To help provide guidance to clinicians and patients when using HPV DNA testing as an adjunct to cervical cytology for screening, a workshop was cosponsored by the National Institutes of Health-National Cancer Institute, American Society of Colposcopy and Cervical Pathology (ASCCP), and American Cancer Society. Consensus was reached based on a literature review, expert opinion, and unpublished results from large ongoing screening studies. The conclusions of the workshop were that HPV DNA testing may be added to cervical cytology for screening in women aged 30 years or more. Women whose results are negative by both HPV DNA testing and cytology should not be rescreened before 3 years. Women whose results are negative by cytology, but are high-risk HPV DNA positive, are at a relatively low risk of having high-grade cervical neoplasia, and colposcopy should not be performed routinely in this setting. Instead, HPV DNA testing along with cervical cytology should be repeated in these women at 6 to 12 months. If test results of either are abnormal, colposcopy should then be performed. This guidance should assist clinicians in utilizing HPV DNA testing in an effective manner, while minimizing unnecessary evaluations and treatments.

Cervical neoplasia in pregnancy. Part 1: screening and management of preinvasive disease

“…This has led to the recommendation, restated in the 2006 consensus guidelines, that women with negative cervical cytology and positive high-risk HPV be followed up with a repeat of both tests at 12 months. 9,11,23 Because most women with such findings have only transient HPV infections, it is recommended that pregnant women with negative cervical cytology and positive high-risk HPV results undergo a repeat of both tests at the 6 week postpartum visit.…”

Identificação de tipos de papilomavirus e de outros fatores de risco para neoplasia intra-epitelial cervical

“…O percentual de positividade nos casos é semelhante ao encontrado na literatura 62, 78,5, 82, e 91,2% 9,[18][19][20][21] . A diferente distribuição de tipos oncogênicos nas populações, tal como constata-se na literatura, tem importância na produção de vacinas adequadas a cada região, contendo os tipos virais mais prevalentes 12 .…”

“…A disponibilização dos testes para HPV, como método adjuvante à colpocitologia na prevenção das neoplasias cervicais, é um importante avanço, porém, até o momento, não há dados comprobatórios suficientes de que esta combinação promoverá melhores resultados, redução dos custos ou melhor aceitação pelas mulheres do que a colpocitologia isolada 18 . Além do mais, para os mesmos autores, metade dos casos de câncer cervical surge entre aquelas que não participam do rastreamento regular.…”

“…Além do mais, para os mesmos autores, metade dos casos de câncer cervical surge entre aquelas que não participam do rastreamento regular. Reconhecem ainda como elevadas a sensibilidade e a especificidade dos dois exames na detecção das lesões de alto grau, quando utilizados em conjunto, em mulheres com idade superior a 30 anos 18 .…”

High-risk Human Papillomavirus Genotype Detection by Electrochemical DNA Chip Method

“…According to the manufacturer's guidelines, relative light unit/cut-off (RLU/CO) ratios that are ≥ 1.00 indicate a positive result while a ratio below 1 is interpreted as a negative result. The Food and Drug Administration (FDA) approved the use of HPV DNA testing as an adjunct to cervical cytology screening in women aged over 30 years to manage ambiguous cytology results and with a cut-off for a positive test result of 1.0 pg HPV DNA/ml or about 5,000 HPV DNA copies, 13 high/probable high-risk and 5 low-risk genotypes (Wright et al, 2004) can be detected. Its main limitation is that the result does not show a specific genotype of HPV but that it provides a positive result when at least one genotype is present.…”