Clinical Performance of the Solana Point-of-Care Trichomonas Assay from Clinician-Collected Vaginal Swabs and Female Urine Specimens from Symptomatic or Asymptomatic Women

Gayos, Charlotte A.

Thursday, September 22, 2016: 11:30 AM

Salon C

Charlotte A. Gayos, MS, MPH, DrPH¹, Jane Schwebke, MD², Julia Dombrowski, MD, MPH³, Jeanne Marrazzo, MD⁴, Barbara Silver, MS⁵, Mathilda Barnes, MS, CCRP⁶, Jenell Coleman, MD⁷, LaShonda Crane, FNP-C⁸ and Paul Fine, MD⁸, 1Div Infectious Diseases, Medicine, Johns Hopkins Univ, Baltimore, MD, 2Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, 3Div Infectious Diseases, Medicine, University of Washington, Seattle, WA, 4Infectious Diseases, School of Medicnie, Univeristy of Alabama at Birmingham, Birmingham, AL, 5Div Infectious Diseases, Medicine, Johns Hopkins University, Baltimore, MD, 6Department of Medicine, Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, 7Obstretics and Gynecology, School of Medicine, Johns Hopkins University, Baltimore, MD, 8Planned Parenthood Gulf Coast, Planned Parenthood Gulf Coast, Houston, TX

Background: Solana (Quidel) is a new rapid (<40 min.) point-of-care (POC) test for qualitative detection of Trichomonas vaginalis (TV) DNA. The assay consists of two steps: 1) specimen preparation, and 2) amplification and detection of trichomonas-target sequence using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe. The objective was to demonstrate the performance of the Solana TV-Assay for clinician-collected vaginal swabs and female urine samples in a multi-center study, based on comparison of Solana results to those by wet mount and TV culture. A secondary objective was to determine performance as compared to the Aptima-TV assay.

Methods: For each subject, 4 vaginal swab specimens were clinician-collected and used for reference (wet mount; InPouch TV Culture), Solana, and Aptima-TV testing. The 3rd polyester swab was used for Solana Assay testing. The 4^th was used for Aptima-TV. A first-catch urine was collected from each subject for testing by all 4 methods. Sensitivity/specificity calculations were based on a FDA-composite reference method (wet mount and InPouch-TV-culture). A specimen was considered positive if either test was positive.

Results: Clinician-collected vaginal swabs and urine samples (N=1044) obtained from 501 asymptomatic and 543 symptomatic women were collected. The prevalence of TV by vaginal swabs and/or urine samples was 11.5%. The Solana Trichomonas Assay demonstrated high sensitivity/specificity in clinician-collected swabs from asymptomatic (100%/98.9%) and symptomatic (98.6%/98.5%) women, and in urine samples from asymptomatic (98.0%/98.4%) and symptomatic (92.9%/97.9%) women, when compared to the FDA-composite reference method. Compared to Aptima-TV, the sensitivity/specificity performance was 89.7%/99.0% for swabs and 100%/98.9% for urine samples.

Conclusions: The combined sensitivity/specificity for swabs was 99.2%/98.7% and urines 95.0%/98.2%. Little difference was observed between asymptomatic and symptomatic women, making the Solana assay a potentially valuable POC test for use in a clinic.

3A4 Clinical Performance of the Solana Point-of-Care Trichomonas Assay from Clinician-Collected Vaginal Swabs and Female Urine Specimens from Symptomatic or Asymptomatic Women