Clinical Evaluation of Affirm VPIII in the Detection andIdentification ofTrichomonas vaginalis,Gardnerella vaginalis, andCandidaSpecies in Vaginitis/Vaginosis

[摘要] Objective:To compare the Affirm VPIII Microbial Identification Test for detection and identification ofCandidaspecies,Gardnerella vaginalisandTrichomonas vaginalisto clinical and microscopic criteria commonly used todiagnose vaginitis.Methods:Women that were symptomatic for vaginitis/vaginosis and asymptomatic women being seen forroutine obstetric or gynecological care were included in this study. Women treated with antibiotics orantifungals within one week or women who had douched within 24 hours were excluded. Two vaginal swabspecimens were simultaneously obtained from each patient, one swab was placed in sterile physiological salinefor immediate microscopic wet mount examination and KOH testing. The other swab was placed in the Affirmcollection tube for Affirm VPIII testing based on previously demonstrated methods.Results:The Affirm assay was significantly more likely to identifyGardnerellaandCandidathan wet mount.190 (45%) were positive forGardnerellaby Affirm compared to 58 (14%) by wet mount; 45 (11%) werepositive forCandidaby Affirm compared to 31 (7%) by wet mount; and 30 (7%) were positive forTrichomonasby Affirm compared to 23 (5%) by wet mount. Symptomatic women were significantly morelikely to be positive by Affirm only (23% vs. 10%), wet mount only (3% vs. 2%) or Affirm and wet mount(15% vs. 1%). Asymptomatic women were significantly more likely to be negative for Affirm and wet mount(43% vs. 5%).Conclusions:The Affirm VPIII test is a more sensitive diagnostic test for detection and identification ofsymptomatic vaginitis/vaginosis than conventional clinical examination and wet mount testing.

[学科分类] 妇产科学