Abstract
BackgroundIn Norway, repeat cytology and HPV testing comprise delayed triage of women with minor cytological lesions. The objective of this study was to evaluate HPV DNA and HPV mRNA testing in triage of women with an ASC-US/LSIL diagnosis.Materials and MethodsWe used repeat cytology, HPV DNA testing (Cobas 4800) and HPV mRNA testing (PreTect HPV-Proofer) to follow up 311 women aged 25–69 years with ASC-US/LSIL index cytology.ResultsOf 311 women scheduled for secondary screening, 30 women (9.6%) had ASC-H/HSIL cytology at triage and 281 women (90.4%) had ASC-US/LSIL or normal cytology. The HPV DNA test was positive in 92 (32.7%) of 281 instances, and 37 (13.2%) were mRNA positive. Of the 132 women with repeated ASC-US/LSIL, we received biopsies from 97.0% (65/67) of the DNA-positive and 92.9% (26/28) of the mRNA-positive cases. The positive predictive values for CIN2+ were 21.5% (14/65) for DNA positive and 34.6% (9/26) for mRNA positive (ns). The odds ratio for being referred to colposcopy in DNA-positive cases were 2.8 times (95% CI: 1.8–4.6) higher that of mRNA-positive cases. Compared to the mRNA test, the DNA test detected four more cases of CIN2 and one case of CIN3.ConclusionsThe higher positivity rate of the DNA test in triage leads to higher referral rate for colposcopy and biopsy, and subsequent additional follow-up of negative biopsies. By following mRNA-negative women who had ASC-US/LSIL at triage with cytology, the additional cases of CIN2+ gained in DNA screening can be discovered. Our study indicates that in triage of repeated ASC-US/LSIL, HPV mRNA testing is more specific and is more relevant in clinical use than an HPV DNA test.
Highlights
The goal in primary screening for cervical cancer is to detect and treat high-grade cervical intraepithelial lesions before invasive cancer develops [1]
Women with high-grade squamous intraepithelial lesions (HSIL) or atypical squamous cell of undetermined significance (ASC-US)/ low-grade squamous intraepithelial lesions (LSIL) with a positive human papilloma virus (HPV) outcome are referred to colposcopy/ biopsy immediately after triage
Most discordant pairs were seen for other HPV types (HPV 16 and 18 negative), where 70 out of 71 were HPV DNA positive, relative to 17 HPV mRNApositive women (Table 2)
Summary
The goal in primary screening for cervical cancer is to detect and treat high-grade cervical intraepithelial lesions before invasive cancer develops [1]. The Norwegian cervical cancer program recommends secondary screening with repeat cytology and an HPV test 6–12 months after the index diagnosis of an atypical squamous cell of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesions (LSIL). Women with high-grade squamous intraepithelial lesions (HSIL) or ASC-US/ LSIL with a positive HPV outcome are referred to colposcopy/ biopsy immediately after triage. In Norway, cytological high-grade lesions are detected in 1.0– 1.2% in each screening round of the national cervical cancer screening program [3]. The major challenge in any cervical cancer screening program is the management of minor cervical lesions such as ASC-US and LSIL [4]. In Norway, repeat cytology and HPV testing comprise delayed triage of women with minor cytological lesions. The objective of this study was to evaluate HPV DNA and HPV mRNA testing in triage of women with an ASC-US/LSIL diagnosis
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