Universal Collection Medium (UCM) is as suitable as the Standard Transport Medium (STM) for Hybrid Capture II (HC-2) assay.

BACKGROUND

Collection of cervical-vaginal material in liquid media enables simultaneous evaluation of both oncologic cytology and molecular tests for the detection of Human papillomavirus (HPV), Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). Universal Collection Medium (UCM) has been developed to fulfill this objective.

OBJECTIVES

To compare Hybrid Capture II (HC-2) to diagnose HPV, NG and CT in specimens collected in UCM and in the current Digene Standard Transport Medium (STM).

STUDY DESIGN

The study was cross-sectional. Three collections of endocervical and ectocervical material were performed in each of 893 women referred for colposcopy in the following order: (1) to prepare a conventional Pap smear slide using the accompanying brush of the STM kit and with Ayre spatula; (2) for HC-2 test and liquid-based cytology using a 1 ml UCM vial as transport medium; material was collected with another similar brush; (3) for HC-2 test using a 1 ml STM vial as transport medium; material was collected with the same brush that we used in the procedure no. (1) (conventional Pap smear). HC-2 results from samples taken from STM and UCM media were compared by using simple linear regression analysis and Kappa statistic.

RESULTS AND CONCLUSIONS

HC-2 results from the two media were highly correlated: high-risk HPV (kappa=0.92; r(2)=0.92), low-risk HPV (kappa=0.85; r(2)=0.86) and NG/CT (kappa=0.96; r(2)=0.81). Despite being obtained from a second specimen, the UCM HC-2 results were equivalent to those obtained with the standard medium STM and the UCM medium.