WebThe Solana trichomonas assay (Quidel, San Diego, California) detects T vaginalis DNA and can yield results within 40 minutes, but it requires specialized equipment for running the samples. The AmpliVue trichomonas assay (Quidel, San Diego, California) is similar to the Solana assay but it is contained within a small handheld cartridge that does not require … WebAug 18, 2016 · The Solana Trichomonas assay received CE Mark in June, and is Quidel's second molecular infectious disease diagnostic test to receive 510(k) clearance from the FDA in the scalable and versatile Solana format. Solana Group A Strep assay for the diagnosis of Group A Strep infections received 510(k) clearance from the FDA in June 2015.
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
WebSep 20, 2024 · The Solana® Trichomonas assay (Quidel, San Diego, CA) is a new rapid test for the qualitative detection of T. vaginalis DNA and can yield results within 40 minutes of specimen collection 47. WebSolana Trichomonas Assay Page 4 of 22 Only open the tubes when adding aliquots into tubes or removing aliquots from tubes. Keep the tubes closed at any other time to avoid … eager typeorm
Quidel Solana Trichomonas Starter Kit - Fisher Sci
Web41116205. Features. The Solana Trichomonas Assay is a rapid in vitro diagnostic test for the qualitative detection of nucleic acids isolated from clinician-collected vaginal swab specimens or urine specimens obtained from asymptomatic or symptomatic patients to aid in the diagnosis of Trichomoniasis. The assay utilizes helicase-dependent ... WebSep 20, 2024 · Solana® Point-of-Care Trichomonas Assay fr om clinician-collected vaginal . swabs and urine specimens from symptomatic and asymptomatic women. Expert Rev Mol Diagn. 2024; 17 (3): 303–6. WebThe Solana trichomonas assay (Quidel) is another rapid test for the qualitative detection of T. vaginalis DNA and can yield results <40 minutes after specimen collection. This assay is FDA cleared for diagnosing T. vaginalis from female vaginal and urine specimens from asymptomatic and symptomatic women with sensitivity >98%, ... cshid ultra thin hdtv antenna