High-risk human papillomavirus (HR-HPV) infection is one of the most important factors in the development of cervical cancer. The aim of this study is, in combination with cytological screening, to detect the development of high-grade cervical intraepithelial neoplasia in a quick and easy way.
Liquid-based cervical cytology samples of 32 women in PAP-SPIN™ medium (ThermoScientific – Shandon) were first screened according to the Bethesda classification. Then these samples were tested for HR-HPV with the Xpert HPV® assay (Cepheid), which detects DNA in a cartridge-based RT-PCR-test. The same samples were also tested on the Cobas® HPV Test (Roche) in the laboratory of molecular biology AZ Sint-Lucas Ghent.
GeneXpert is a random-access platform, testing can be completed in 1 hour and the Xpert HPV® assay provides individual HPV16, HPV18/HPV45 genotyping with a simultaneous result for 11 other high-risk HPV genotypes (31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68).
Reproducibility was tested for 10 samples on the Xpert HPV® (1 sample 5x, 8 samples 6x, 1 sample 7x). For these samples, reproducibility is 100%.
Concordance between the Xpert HPV® and Cobas® HPV Test was determined for 31 samples with a result of 93.5% (29/31). Our criterion for the comparison method is > 90%.
In these 31 samples a comparison between cytological screening and Xpert HPV® for HR-HPV was made. Results are as follows:
| Screening | RT-PCR HR HPV | |||||
|---|---|---|---|---|---|---|
| Total Positive | Positive for 16 | Positive for 18 | Positive Others | Negative | ||
| RC | 15 | 3 | 3 | 12 | ||
|
RC after conisation for min. CIN 2 |
2 | 2 | 2 | |||
| ASC-US / AG-C / ASC-H | 13 | 7 | 2 | 5 | 6 | |
| LSIL | 1 | 1 | ||||
HPV detection with the Xpert HPV® assay is a simple, reliable and fast method to test the presence of HR-HPV.