Comparison of the Digene Hybrid Capture 2 Assay and Roche AMPLICOR and LINEAR ARRAY Human Papillomavirus (HPV) Tests in Detecting High-Risk HPV Genotypes in Specimens from Women with Previous Abnormal Pap Smear Results

Abstract

Persistent infection with high-risk (HR) human papillomaviruses (HPV) has been demonstrated as the necessary causal factor for developing high-grade cervical intraepithelial neoplasia (CIN) and potential progression to carcinoma of the cervix (1, 2, 21, 33, 47). There are more than 100 recognized HPV genotypes, of which approximately 40 have tropism specifically for the anogenital mucosa. Based on their epidemiological association with high-grade CIN and cervical cancer, anogenital HPV genotypes are divided into HR and low-risk (LR) types (11,22). Nearly all cases of cervical cancer have been shown to contain HR-HPV genotypes, with declining proportions found among high-grade and low-grade CIN lesions, respectively (1, 7, 22, 47). Most HPV infections, regardless of risk association, are transient and asymptomatic and cleared by host immunity without leading to obvious cellular abnormalities. However, persistent infection with the same HR-type substantially increases the risk for developing highgrade dysplasia (ՆCIN2), and ultimately cervical cancer (14,16,30,48).Considering the substantial association between HR-HPV infection and cervical cancer, it has been proposed that incorporation of highly sensitive HPV detection methods, such as HPV DNA testing, into current screening programs may improve the identification of cervical abnormalities in women. Several studies have shown that HR-HPV testing, either as an independent screening tool or as an adjunct to current Pap smear cytology, could improve the efficacy of population-based screening programs in detecting underlying lesions or their subsequent development, for triage of women with equivocal or minor cytological lesions and, as a follow-up test for women treated for high-grade lesions to predict treatment success or failure (4,9,19,42,49).There are a myriad of molecular tests for detecting HPV infection, of which the Hybrid Capture 2 assay (HC2; Digene Corp., Gaithersburg, MD) is the only commercial HPV DNA test currently approved by the U.S. Food and Drug Administration (5,8,27,46). In addition, there are numerous PCR amplification methods in widespread use, although most largely constitute nonstandardized in-house assays. PCR-based systems frequently used for HPV detection include the primer sets GP5ϩ/GP6ϩ (10, 15) and MY09/11 and their subsequently modified and improved derivatives PGMY09/11 (12, 13) and the SPF10 system (18,24,25), which have been coupled with reverse line-dot blot systems for additional HPV

Age-specific prevalence of cervical human papillomavirus infection and cytological abnormalities in women in Gauteng Province

“…[37] These data predict that prophylactic vaccination of females prior to their sexual debut in this and similar populations could potentially prevent a large proportion of cervical HPV infections attributed to HPV 16 and 18. Catch-up vaccination will be less beneficial and cost-effective, as at least 20% of women <25 years old are already exposed to HPV 16 and/ or 18 (Fig.…”

“…Studies among women with cytological abnormalities have shown HC2 to have lower HPV positivity compared with PCR assays such as the LA. [36,37] The observed high HPV prevalence can not, however, be attributed to the sensitivity of the assay alone, as reflected by the concurrent high prevalence of cytological abnormalities and the pattern of multiple and single HPV infections that appears to mirror the background HIV prevalence per age groups (Figs 2 and 3). In view of the well-known large regional and population differences in HPV epidemiology, the results of this study cannot be generalised to the whole region or to the country.…”

Ocorrência de papilomavírus humano na cérvice uterina de mulheres da região ocidental da Amazônia Brasileira

“…A prevalência do HPV-53 em estudos epidemiológicos no mundo apresentam variação de 0,5% a 25% (Stevens et al 2007). No Brasil observaram a prevalência deste genótipo com variação de 3,0% a 24,4% (INCA 2008).…”

“…No Distrito Federal a prevalência foi de 6,0% em mulheres HIV-1 soronegativas e de 6,2% em mulheres HIV-1 soropositivas (Camara et al 2003). Stevens et al (2007) em estudo epidemiológico no mundo observou a prevalência de 0,1% a 18% do HPV-56. No Brasil a prevalência varia de 1% a 11% (INCA 2008).…”

Commercially available assays for multiplex detection of alpha human papillomaviruses

“…Several studies, which included more that 15,000 patients in total, have compared the analytical and clinical performance of Amplicor with hc2 or with other commercial HPV tests or clinical criteria [37,[49][50][51][52][53][54][55][56][57][58][59][60][61]. Amplicor performed well in the prediction of CIN2+ lesions in women with abnormal cervical smears, using colposcopic biopsy and liquid-based cytology as the reference standards [60].…”