Concordance between hybrid capture 2 results performed on cervical samples obtained before and immediately after visual inspection with acetic Acid test.

BACKGROUND: VIA is a simple, inexpensive test widely advocated for resource-limited settings. Major limitation of VIA is its low specificity. HPV DNA testing can be used to triage VIA-positive women if the facilities are available. The major concern for such strategy would be whether sample collection after acetic acid wash will alter HPV test characteristics. This study aimed to evaluate whether samples for HPV testing by Hybrid Capture 2 (HC2) technology can be collected immediately after VIA without altering test performance. METHODS: Total 204 VIA-positive women were recruited. Cervical samples were collected for HC2 test before and after VIA at the same sitting by the same provider. The paired samples were analyzed at the same laboratory by the same technician in the same batch of testing. Agreement in HC2 results between pre-VIA and post-VIA samples was estimated using kappa statistics. All women had colposcopy and biopsies were obtained if colposcopy was suspicious of neoplasia. Sensitivity and specificity of HC2 test in detecting CIN2+ lesions were calculated using negative colposcopy or biopsy as the gold standard and were compared between the pre and post VIA samples. RESULTS: Almost perfect agreement in HC2 results (kappa=0.85) and RLU/Cut off ratios (correlation coefficient=0.92) was observed between samples collected before and after VIA. The sensitivity and specificity to detect CIN2+ lesions remained unaltered even when cervical samples were collected after VIA. This confirmed that acetic acid wash did not alter HC2 performance. CONCLUSIONS: Collection of samples for HC2 test is feasible immediately after VIA.

Interobserver agreement in the reporting of cervical biopsy specimens obtained from women screened by visual inspection with acetic acid and hybrid capture 2.

Visual inspection with acetic acid (VIA) and human papillomavirus detection have sensitivity higher than cytology but lower specificity. The high false-positive rate of either test poses a challenge to the colposcopists who obtain biopsies from the innocuous changes and to the pathologists who have to interpret large numbers of specimens that are either normal or have low-grade abnormalities. Interobserver variation in histopathologic interpretations of cervical punch biopsy specimens is high, specially for the lower-grade abnormalities. Use of the modified Bethesda system to report histology in place of the cervical intraepithelial neoplasia (CIN) system has the potential to reduce such variability as there are fewer categories. The present study aimed to assess the interobserver agreement to interpret cervical punch biopsies when both pathologists followed the modified Bethesda classification system and also when one pathologist followed the modified Bethesda classification system and the other followed the CIN classification system. Colposcopy-directed punch biopsies were obtained from VIA and/or Hybrid Capture 2-positive women. The Institute pathologist interpreted the slides using the CIN system. Blinded review was done by 2 external pathologists who independently interpreted cervical punch biopsies using the Bethesda system. The Institute pathologist's diagnoses based on CIN system were converted post hoc into categories belonging to the Bethesda system for comparison. The overall agreement was poor (κ=0.36). The lowest agreement was observed in the low-grade squamous intraepithelial lesion category (κ=0.23) and the highest in the squamous cell carcinoma category (κ=0.76). The agreement between the reviewers, both of whom used the Bethesda system, was substantial.