Abstract

BackgroundCervical cancer is the fourth most common malignancy in women worldwide. However, screening with human papillomavirus (HPV) molecular tests holds promise for reducing cervical cancer incidence and mortality in low- and middle-income countries. The performance of the Abbott RealTime High-Risk HPV test (AbRT) was evaluated in 83 cervical smear specimens and compared with a conventional nested PCR coupled to high-throughput sequencing (HTS) to identify the amplicons.ResultsThe AbRT assay detected at least one HPV genotype in 44.57% of women regardless of the grade of cervical abnormalities. Except for one case, good concordance was observed for the genotypes detected with the AbRT assay in the high-risk HPV category determined with HTS of the amplicon generated by conventional nested PCR.ConclusionsThe AbRT test is an easy and reliable molecular tool and was as sensitive as conventional nested PCR in cervical smear specimens for detection HPVs associated with high-grade lesions. Moreover, sequencing amplicons using an HTS approach effectively identified the genotype of the hrHPV identified with the AbRT test.

Highlights

  • Cervical cancer is the fourth most common malignancy in women worldwide

  • 83 women were included in this study and collected specimens were divided into five groups according to cytological analysis: normal, atypical squamous cells of undetermined significance (ASCUS, group 2, n = 12), low-grade squamous intraepithelial lesions (LSIL, group 3, n = 7), high-grade squamous intraepithelial lesions (HSIL, group 4, n = 7) and carcinoma

  • The two methods used in this study demonstrated their ability to detect at least one high-risk human papillomavirus (hrHPV) genotype (HPV16 or HPV18 or other hrHPV or a mix of several hrHPVs) among 100% (14/14) of the High-grade squamous intraepithelial lesion (HSIL)+ cases tested (Table 1)

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Summary

Introduction

Cervical cancer is the fourth most common malignancy in women worldwide. screening with human papillomavirus (HPV) molecular tests holds promise for reducing cervical cancer incidence and mortality in low- and middle-income countries. The hc test is associated with crossreactivity of the probe mixture with untargeted HPV types [7] To overcome this limitation, new HPV DNA testing assays (Abbott, Wiesbaden, Germany; LG Life Science, Seoul, Korea, etc.) based on real-time PCR, have been developed and can distinguish HPV16 or HPV18 from other major hrHPVs, and some are currently approved by the FDA for clinical use [7]. New HPV DNA testing assays (Abbott, Wiesbaden, Germany; LG Life Science, Seoul, Korea, etc.) based on real-time PCR, have been developed and can distinguish HPV16 or HPV18 from other major hrHPVs, and some are currently approved by the FDA for clinical use [7] These molecular tests are recommended by the Guideline Development Group for the screen-and-treat strategy because their contribution may be greater than visual inspection with acetic acid and/or Lugol’s iodine (VIA/ VILI) to reduce cervical cancer and its related mortality. The level of technical training of the healthcare staff has only a minor impact on the performance of the test

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