Hologic-Aptima® HPV study
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Aim: Compatibility of the Hologic Aptima HPV assay for testing first-void urine specimens
Partners: Hologic, University of Antwerp (VAXINFECTIO), University Hospital Antwerp, Novosanis nv
Results from the Proof of Concept study will be presented via a poster at the HPV conference, February 2017, Cape Town
This study focuses on the detection of E6/E7 HPV mRNA in first-void urine (FVU).
Women referred for colposcopy were asked to collect a FVU sample (Colli-Pee™). Qualitative detection of E6/E7 mRNA of high-risk HPV genotypes (APTIMA® HPV mRNA assay-on Panther®) in FVU was performed. Cytology and histology were investigated at UZA, followed by HPV DNA type-specific qPCR on cervical smears at AML (Belgium).
Main results included:
- 57 women were included (25-65y; median36), from whom 53 paired FVU (mRNA) and cervical (DNA) HPV results are available
- HPV was detected in 73.58% and 35.85% of cervical and FVU samples, respectively (Kappa 0.268, 95%CI:0.090-0.446)
- Histology results from 17 women revealed following positive/negative FVU outcome; no dysplasia:0+/3-; CIN1:2+/4-; CIN2:2+/1-; CIN3:4+/1-.
The study is finilazed and illustrates that it is feasible to detect E6/E7 HPV mRNA in first-void urine
samples from 25 to 64 year old women referred for colposcopy in Belgium.
These preliminary findings support the assertion that the APTIMA® HPV mRNA assay is compatible with FVU. However, further study is required to evaluate the clinical performance.
