In France, cervical cytology is used as the principal screening test to detect cervical cancer in asymptomatic women. The French Health Authority (HAS) recommends cervical cytology screening every three years (between 25 and 65 years of age) after 2 annual smears have been normal.
In 2015, we have adopted a new technology for HPV testing the Xpert® HPV assay used on the GeneXpert® system (Cepheid, Sunnyvale, USA).
We are now performing routine HPV testing for women ages 17 to 85 years who present abnormal cervical cytology: ASCUS and LSIL.
This study was conducted between January 1st 2015 and December 31st 2015 in the anatomo-cytology laboratory Technipath (Limonest, France). HPV genotyping was performed on 4980 specimens collected into Thinprep (Hologic) collection vials, using real-time PCR with Xpert HPV which allows the detection in one hour of the14 high-risk HPV types, using 5 fluorescent channels either separated or combined: HPV 16; HPV18 and45; HPV 31-33-35-52-58; HPV 51, 59; HPV 39-56-66-68. The 335 health care practitioners who prescribed the HPV test were physicians, gynecologists, obstetricians or mid-wives located in the Rhône-Alpes area in France.
Among the 4980 samples tested, 2876 samples were negative for high risk HPV types and 2098 samples presented at least one oncogenic high-risk HPV type :
HPV 16: 527 (25.12 %)
HPV 18, 45: 207 (9.7 %)
HPV 31-33-35-52-58: 750 (35.75 %)
HPV 51-59: 275 (13.11 %)
HPV 39-56-66-68: 339 (16.16 %)
6 samples were excluded due to insufficient cellularity. Indeed, Xpert HPV has a sample adequacy control (SAC) that monitors whether the sample contains human DNA and eliminates the risk of false negative results.
Among the infected patients in 2015, 32.6 % were younger than 30 and 67.4 % were over 30. The mean age was 37 years. For the group under 30, the mean age was 25 years and for the group over 30 it was 42 years.
In our patient population, the infections caused by HPV other than 16 and 18 are the most frequent ones (65%). The positivity rate (i.e. cases with at least one high risk HPV type detected) was 58.96 % (1160 cases) before 30 years of age and 37.07 % (3814 cases) after 30 years of age. There is no significant difference in the mean age according to the HPV genotype. Likewise we did not observe any significant difference in the mean age when a single channel is positive (1504 cases) or when multiple channels are positive (1191 cases).
With Xpert HPV routinely used in our laboratory, we are now able to provide rapid comprehensive HPV results to effectively risk stratify patients based on cytology and high risk HPV.