A guide for standardizing colposcopic observations for the evaluation of topical microbicide products in the pigtailed macaque model

Abstract

This laboratory has been conducting colposcopy on Macaca nemestrina research animals since the mid-1990s. Our observations are always based on those recorded in human studies, and we have developed a standardized colposcopic observation form specifically for pigtailed macaque studies. All findings are based on the ‘Manual for the Standardization of Colposcopy for the Evaluation of Vaginal Products: Update 2004’, developed by WHO and CONRAD for use with humans [1]. Our studies have been conducted exclusively at the Washington National Primate Research Center (WaNPRC) in Seattle, Washington. Approval for the use of monkeys was obtained from the Institutional Animal Care and Use Committee at the University of Washington. Animals were handled humanely, and the experiments were performed within the National Institutes of Health's animal-use guidelines, in compliance with the Guide for the Care and Use of Laboratory Animals and the Animal Welfare Act. The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health. Our earliest studies were conducted with a modified endoscope, which was hand held through the speculum-opened vagina. It was attached to a video camera for video documentation of mucosal tissue assessments. We have since upgraded to a Leisegang swing arm colposcope, fitted with a digital camera and a video recording unit (CooperSurgical, Inc., Trumbull, CT, USA). Standardized studies conducted in this laboratory assess cervicovaginal tissues prior to and after single and repeated vaginal exposures to test products. One or two members of a team of cross-trained colposcopists conduct the vaginal examinations. The findings are recorded on standardized observation sheets and documented by still and video photography. Our primary use of colposcopy in the macaques is to evaluate the safety of topical microbicide products being developed for eventual use by humans [4–12]. Similar use of colposcopy in various rhesus and cynomolgus macaque models has been reported by other laboratories [2, 3, 13–16]. It is our hope that the terminology and photo atlas presented here will provide a reference for documenting colposcopic findings across multiple macaque models.