Sexually transmitted diseases · 2026
Randomized Study of Usual Care Versus Xpert ® Xpress Multiplex Vaginal Panel at the Point-of-Care for Accurate Diagnosis and Appropriate Treatment of Vaginal Infections.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Hillier Sharon L, Macio Ingrid, Gallagher Rachel, Meyn Leslie, Beamer May, Zamborsky Tracy, Campbell Tracy, Bunge Katherine, Wiesenfeld Harold C
Аннотация
BACKGROUND: The accuracy of vaginitis diagnoses in usual care varies. This study ( clinicaltrials.gov NCT06438575) evaluated the clinical utility of Xpert ® Xpress Multiplex Vaginal Panel, a Clinical Laboratory Improvement Amendments-waived nucleic acid amplification test (NAAT), for the diagnosis of vaginal infections at the point-of-care (POC).
METHODS: Women (n = 276) seeking care for vaginal symptoms (discharge, odor, itch, irritation, and discomfort) provided self-collected vaginal samples and were randomized to usual care or POC NAAT. True positives were defined as samples positive for bacterial vaginosis (BV), Candida , or Trichomonas vaginalis (TV) by two concordant Food and Drug Administration-cleared NAATs. The primary endpoint was the proportion of women prescribed appropriate Centers for Disease Control recommended or Food and Drug Administration-approved treatment for the identified conditions within 24 hours of the visit. Groups were compared using Fisher exact test.
RESULTS: Median participant age was 33 years (range 17-76), with self-reported race of 50% Black, 41% White, and 9% other. Twenty (7%) participants were pregnant. The prevalence of BV, Candida , and TV was 44.7%, 32.0%, and 5.1%, respectively, and 36.9% of women had no pathogens detected. For women having BV, TV, or Candida , 40/77 (51.9%) of the usual care arm received appropriate treatment versus 69/77 (89.6%) of women in the POC NAAT arm ( P < 0.001). Among women without pathogens, 21/42 (50.0%) were inappropriately treated with antifungals or antibiotics in the usual care arm versus 13/48 (27.1%) in the POC NAAT arm ( P = 0.031).
CONCLUSION: POC NAATs have clinical utility for the diagnosis of women with vaginal symptoms, increasing the likelihood of appropriate treatment and reducing over-treatment of women without pathogens compared with usual care.
METHODS: Women (n = 276) seeking care for vaginal symptoms (discharge, odor, itch, irritation, and discomfort) provided self-collected vaginal samples and were randomized to usual care or POC NAAT. True positives were defined as samples positive for bacterial vaginosis (BV), Candida , or Trichomonas vaginalis (TV) by two concordant Food and Drug Administration-cleared NAATs. The primary endpoint was the proportion of women prescribed appropriate Centers for Disease Control recommended or Food and Drug Administration-approved treatment for the identified conditions within 24 hours of the visit. Groups were compared using Fisher exact test.
RESULTS: Median participant age was 33 years (range 17-76), with self-reported race of 50% Black, 41% White, and 9% other. Twenty (7%) participants were pregnant. The prevalence of BV, Candida , and TV was 44.7%, 32.0%, and 5.1%, respectively, and 36.9% of women had no pathogens detected. For women having BV, TV, or Candida , 40/77 (51.9%) of the usual care arm received appropriate treatment versus 69/77 (89.6%) of women in the POC NAAT arm ( P < 0.001). Among women without pathogens, 21/42 (50.0%) were inappropriately treated with antifungals or antibiotics in the usual care arm versus 13/48 (27.1%) in the POC NAAT arm ( P = 0.031).
CONCLUSION: POC NAATs have clinical utility for the diagnosis of women with vaginal symptoms, increasing the likelihood of appropriate treatment and reducing over-treatment of women without pathogens compared with usual care.