A Quantitative Glycogen Assay to Verify Use of Self-Administered Vaginal Swabs

Details

• Alternative Title:
  Sex Transm Dis
• Personal Author:
  Anderson, Deborah J. ; Politch, Joseph A. ; Pudney, Jeffrey ; Marquez, Cecilia I. ; Snead, Margaret C. ; Mauck, Christine
• Description:
  Background
  
  Self-administered swabs are used to sample vaginal contents for a variety of clinical purposes including detection of sexually transmitted infections, condom breakage, and vaginal product use. The goal of this study was to determine whether a quantitative glycogen assay can be used to assess whether a swab has been exposed to the vagina to assure study compliance.
  
  Study Design
  
  Buccal, skin, or vaginal samples were tested to determine whether a commercial quantitative glycogen assay can differentiate vaginal specimens. In addition, archived remnant de-identified vaginal swabs from clinical trials were tested. Periodic acid–Schiff stain was used to identify glycogen-positive cells as a confirmation test.
  
  Results
  
  Glycogen concentrations in eluates of vaginal swabs from reproductive-aged women were significantly higher than those from unused swabs (mean ± SE, 964 ± 135 μg/mL vs. 14.7 ± 2.5 μg/mL, P < 0.001) and swabs exposed to buccal and finger/hand epithelia (40.3 ± 4.8 and 18.5 ± 5.4 μg/mL, P < 0.001). Glycogen concentrations were lower and more variable in vaginal swabs from older perimenopausal/menopausal women (mean ± SE, 235 ± 123, P < 0.01). Semen and sample storage longer than 1 year did not affect glycogen detection. Using a cutoff of 100 μg/mL of glycogen, 30 of 30 vaginal swabs from reproductive-aged women versus 0 of 28 control swabs were positive, for an assay sensitivity of 1 (95% confidence interval, 0.86–1) and specificity of 1 (95% confidence interval, 0.85–1). Periodic acid–Schiff stain correlated with soluble glycogen results but was less specific.
  
  Conclusions
  
  The quantitative glycogen assay provides a simple and inexpensive method to validate the use of self-administered swabs for sampling vaginal contents in clinical studies.
  
  
• Subjects:
  Adult Age Factors Female Glycogen Hand Humans Mouth Mucosa Predictive Value Of Tests Reagent Kits, Diagnostic Sensitivity And Specificity Sexually Transmitted Diseases Specimen Handling Vagina Vaginal Smears

  More +
• Source:
  Sex Transm Dis. 2012; 39(12):949-953.
• Pubmed ID:
  23191948
• Pubmed Central ID:
  PMC4452942
• Document Type:
  Journal Article
• Funding:
  AUN5/Intramural CDC HHS/United States
• Volume:
  39
• Issue:
  12
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:ea3a8294fc0702890478972dcd73a4c2b77dfdd6b7ffe66ccd77c7f461970537
• Download URL:
  https://stacks.cdc.gov/view/cdc/33763/cdc_33763_DS1.pdf
• File Type:
  [PDF - 545.76 KB ]