Clinical, colposcopic and pathological characteristics of cervical and vaginal high-grade lesions negative for HPV by Hybrid Capture 2

ObjectiveLess than 5% of women with cervical or vaginal biopsy proven high-grade squamous intraepithelial lesions (HG-SIL) show a negative Hybrid Capture 2 (HC2) result. We analyzed 1) human papillomavirus (HPV) genotypes by PCR in order to determine whether these cases represent infections by common or unusual types, and 2) the clinical, colposcopic and pathological differential characteristics of these patients.Methods646 women with a histological diagnosis of HG-SIL and a HC2 test collected within 6 months prior to the diagnosis were identified. Patients with a negative HC2 result were selected. HPV was typed in the biopsy specimen in all by PCR using SPF10 and GP5+/6+ primers, and p16INK4a immunostaining was performed. The clinical and colposcopy findings of these women were compared with a control group of HG-SIL with positive HC2 result.Results20 women (3.1%) with HG-SIL had a negative HC2. All biopsies were positive for p16INK4. PCR analysis detected HPV types included in HC2 test in 55% of the cases, with an identical percentage of common viruses between women with relative light unit values above or below 0.40 (p = .361). False negative HC2 tests increased with age (p = .002) and were more frequent in patients with non satisfactory colposcopy or small sized lesions (p < .001).ConclusionA negative HC2 test is an infrequent event in women with HG-SIL. Common HPV types are identified in over half of the cases. Older women and patients with small lesions or non satisfactory colposcopy have a higher rate of HC2 negative results.

Research highlights
► A negative HC2 test is an infrequent event in women with HG-SIL.
► Common HPV types are identified in over half of the cases.
► Patients with small lesions or non satisfactory colposcopy have a higher rate of HC2 negative results.