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Clinical performance of the Solana® Point-of-Care Trichomonas Assay from clinician-collected vaginal swabs and urine specimens from symptomatic and asymptomatic women.
Expert Rev Mol Diagn. 2017 03; 17(3):303-306.ER

Abstract

BACKGROUND

Solana® (Quidel) is a new rapid (<40 min.) point-of-care (POC) test for qualitative detection of Trichomonas vaginalis (TV) DNA. The assay has two steps: 1) specimen preparation, and 2) amplification and detection using isothermal Helicase-Dependent Amplification (HDA). The objective was to demonstrate the performance of Solana for vaginal swabs and female urines based on comparison to wet mount and TV culture. Performance was also compared to the Aptima-TV assay.

METHODS

Urine and four clinician-collected vaginal swabs were collected. The first two were used for FDA composite reference (wet mount; InPouch TV Culture). The third swab was used for Solana. Sensitivity/specificity were based on the reference method. A specimen was considered positive if either test was positive. The fourth swab was for Aptima-TV.

RESULTS

Vaginal swabs and urines were obtained from 501 asymptomatic and 543 symptomatic women. Prevalence of TV by was 11.5%. For swabs, Solana® demonstrated high sensitivity and specificity from asymptomatic (100%/98.9%) and symptomatic (98.6%/98.5%) women, as well as for urines from asymptomatic (98.0%/98.4%) and symptomatic (92.9%/97.9%) women, compared to the reference method. Compared to Aptima-TV, the sensitivity/specificity was 89.7%/99.0% for swabs and 100%/98.9% for urines.

CONCLUSION

The Solana® assay performed well compared to the reference assays.

Links

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Authors+Show Affiliations

Gaydos CA
a Division of Infectious Diseases , Johns Hopkins University School of Medicine , Baltimore , Maryland , USA.
Schwebke J
b Division of Infectious Diseases , University of Alabama at Birmingham School of Medicine , Birmingham , Alabama , USA.
Dombrowski J
c Division of Infectious Diseases , University of Washington School of Medicine , Seattle , Washigton , USA.
Marrazzo J
b Division of Infectious Diseases , University of Alabama at Birmingham School of Medicine , Birmingham , Alabama , USA. c Division of Infectious Diseases , University of Washington School of Medicine , Seattle , Washigton , USA.
Coleman J
a Division of Infectious Diseases , Johns Hopkins University School of Medicine , Baltimore , Maryland , USA.
Silver B
a Division of Infectious Diseases , Johns Hopkins University School of Medicine , Baltimore , Maryland , USA.
Barnes M
a Division of Infectious Diseases , Johns Hopkins University School of Medicine , Baltimore , Maryland , USA.
Crane L
d Planned Parenthood , Houston , Texas , USA.
Fine P
d Planned Parenthood , Houston , Texas , USA.

MeSH

AdolescentAdultFemaleHumansNucleic Acid Amplification TechniquesPoint-of-Care SystemsSensitivity and SpecificityTrichomonas VaginitisTrichomonas vaginalisVaginal Smears

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

28092466

Citation

Gaydos, C A., et al. "Clinical Performance of the Solana® Point-of-Care Trichomonas Assay From Clinician-collected Vaginal Swabs and Urine Specimens From Symptomatic and Asymptomatic Women." Expert Review of Molecular Diagnostics, vol. 17, no. 3, 2017, pp. 303-306.
Gaydos CA, Schwebke J, Dombrowski J, et al. Clinical performance of the Solana® Point-of-Care Trichomonas Assay from clinician-collected vaginal swabs and urine specimens from symptomatic and asymptomatic women. Expert Rev Mol Diagn. 2017;17(3):303-306.
Gaydos, C. A., Schwebke, J., Dombrowski, J., Marrazzo, J., Coleman, J., Silver, B., Barnes, M., Crane, L., & Fine, P. (2017). Clinical performance of the Solana® Point-of-Care Trichomonas Assay from clinician-collected vaginal swabs and urine specimens from symptomatic and asymptomatic women. Expert Review of Molecular Diagnostics, 17(3), 303-306. https://doi.org/10.1080/14737159.2017.1282823
Gaydos CA, et al. Clinical Performance of the Solana® Point-of-Care Trichomonas Assay From Clinician-collected Vaginal Swabs and Urine Specimens From Symptomatic and Asymptomatic Women. Expert Rev Mol Diagn. 2017;17(3):303-306. PubMed PMID: 28092466.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical performance of the Solana® Point-of-Care Trichomonas Assay from clinician-collected vaginal swabs and urine specimens from symptomatic and asymptomatic women. AU - Gaydos,C A, AU - Schwebke,J, AU - Dombrowski,J, AU - Marrazzo,J, AU - Coleman,J, AU - Silver,B, AU - Barnes,M, AU - Crane,L, AU - Fine,P, Y1 - 2017/01/29/ PY - 2017/1/17/pubmed PY - 2017/10/11/medline PY - 2017/1/17/entrez KW - Solana KW - Trichomonas vaginalis KW - point-of-care test KW - trichomoniasis SP - 303 EP - 306 JF - Expert review of molecular diagnostics JO - Expert Rev Mol Diagn VL - 17 IS - 3 N2 - BACKGROUND: Solana® (Quidel) is a new rapid (<40 min.) point-of-care (POC) test for qualitative detection of Trichomonas vaginalis (TV) DNA. The assay has two steps: 1) specimen preparation, and 2) amplification and detection using isothermal Helicase-Dependent Amplification (HDA). The objective was to demonstrate the performance of Solana for vaginal swabs and female urines based on comparison to wet mount and TV culture. Performance was also compared to the Aptima-TV assay. METHODS: Urine and four clinician-collected vaginal swabs were collected. The first two were used for FDA composite reference (wet mount; InPouch TV Culture). The third swab was used for Solana. Sensitivity/specificity were based on the reference method. A specimen was considered positive if either test was positive. The fourth swab was for Aptima-TV. RESULTS: Vaginal swabs and urines were obtained from 501 asymptomatic and 543 symptomatic women. Prevalence of TV by was 11.5%. For swabs, Solana® demonstrated high sensitivity and specificity from asymptomatic (100%/98.9%) and symptomatic (98.6%/98.5%) women, as well as for urines from asymptomatic (98.0%/98.4%) and symptomatic (92.9%/97.9%) women, compared to the reference method. Compared to Aptima-TV, the sensitivity/specificity was 89.7%/99.0% for swabs and 100%/98.9% for urines. CONCLUSION: The Solana® assay performed well compared to the reference assays. SN - 1744-8352 UR - https://www.unboundmedicine.com/medline/citation/28092466/Clinical_performance_of_the_Solana®_Point_of_Care_Trichomonas_Assay_from_clinician_collected_vaginal_swabs_and_urine_specimens_from_symptomatic_and_asymptomatic_women_ DB - PRIME DP - Unbound Medicine ER -