Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2012 Sep;39(9):710-2.
doi: 10.1097/OLQ.0b013e3182641f08.

Trypan blue staining to determine vaginal exposure in two types of plastic vaginal applicators containing two different microbicide formulations

Anke Hemmerling  1 , William G Harrison, Joelle Morgan Brown, Barbara Moscicki, Maria Oziemkowska, Elizabeth A Bukusi, Craig R Cohen
Affiliations

Trypan blue staining to determine vaginal exposure in two types of plastic vaginal applicators containing two different microbicide formulations

Anke Hemmerling et al. Sex Transm Dis. 2012 Sep.

Abstract

Dye staining of applicators has been shown to be a reliable and objective method to test vaginal insertion in clinical microbicide trials, but different plastics, dyes, and product formulations may impact the accuracy of this method. Reportedly used applicators returned from 3 clinical trials were stained with 1% trypan blue. In a phase 1 study (VivaGel), using gel-filled HTI polypropylene applicators, 1271 (97%) of applicators stained positive. In a phase 1 and a phase 2a study (LACTIN-V) using linear low-density polyethylene applicators to deliver a dry powder formulation, 57 (95%) and 135 (86%) tested positive, respectively. Dye staining of vaginal applicators is an objective low-cost measure suitable for low-resource settings.

PubMed Disclaimer

Figures

Figure 1
Figure 1. Applicators stained with 1% Trypan Blue
To the left, stained applicator shows characteristic streaking of vaginal mucous as seen after vaginal insertion. To the right, applicator shows no signs of stained vaginal mucous.
See this image and copyright information in PMC

References

    1. Skoler-Karpoff S, Ramjee G, Ahmed K, et al. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:1977–1987. - PubMed
    1. Van Damme L, Govinden R, Mirembe FM, et al. Lack of Effectiveness of Cellulose Sulfate Gel for the Prevention of Vaginal HIV Transmission. NEJM. 2008;359(5):463–472. - PubMed
    1. Padian NS, van der Straten A, Ramjee G, et al. Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial. Lancet. 2007;370:251–261. - PMC - PubMed
    1. Turner AN, De Kock AE, Meehan-Ritter A, et al. Many vaginal microbicide trial participants acknowledged they had misreported sensitive sexual behavior in face-to-face interviews. J Clin Epidemiol. 2009;62:759–765. - PubMed
    1. Wallace AR, Thorn M, Maguire RA, et al. Assay for establishing whether microbicide applicators have been exposed to the vagina. Sex Transm Dis. 2004;31(8):465–468. - PubMed

Publication types