Item Brochure

Clinical Performance
SL2402 | SSM304002EN00 (11/16)
Solana Trichomonas Assay – Swab – 48 Test Kit: Cat. #M304.S
Solana Trichomonas Assay – Urine – 48 Test Kit: Cat. #M304.U
Quidel Molecular Trichomonas Control Set – 80-Reaction Kit: Cat. #M119
Solana Instrument – Cat. #20278
Procedure
Performance Characteristics of the Solana Trichomonas Assay with Clinician Collected Vaginal Swabs
by Symptom Status compared to the Composite Reference Method Wet Mount and Culture
Site Symptom Sensitivity % Specificity %
Number Status N TP FP TN FN Prev % (95% CI) (95% CI)
Combined Asymptomatic 501 50 5 446 0 10.0 100 98.9
(92.9 to 100) (97.4 to 99.5)
Symptomatic 542 69 7 465 1 12.9 98.6 98.5
(92.3 to 99.7) (97.0 to 99.3)
All 1043 119 12* 911 1* 11.5 99.2 98.7
(95.4 to 99.9) (97.7 to 99.3)
Performance Characteristics of the Solana Trichomonas Assay with Female Urine Specimens
by Symptom Status compared to the Composite Reference Method
Site Symptom Sensitivity % Specificity %
Number Status N TP FP TN FN Prev % (95% CI) (95% CI)
Combined Asymptomatic 501 49 7 444 1 10.0 98.0 98.4
(89.5 to 99.6) (96.8 to 99.2)
Symptomatic 543 65 10 463 5 12.9 92.9 97.9
(84.3 to 96.9) (96.2 to 98.8)
All 1044 114 17 907 6 11.5 95.0 98.2
(89.5 to 97.7) (97.1 to 98.8)
*Of the one thousand forty-three (1043) specimens evaluated a total of thirteen (13) specimens were discordant. Of the twelve (12) discordant (Solana
Positive/Composite Reference Method Negative) specimens, four (4) were positive by an FDA-cleared Trichomonas vaginalis molecular assay. The one (1)
discordant (Negative Solana/Composite Reference Method Positive) specimen, it was negative by an FDA-cleared Trichomonas vaginalis molecular assay.
SSM304002EN00.qxp_Layout 1 11/3/16 11:35 AM Page 2