商品编号


M304.U



品牌


Quidel



公司


Quidel,inc.



公司分类


Solana



Size

48 tests

商品信息

Description:
Solana Trichomonas Assay Kit – Urine
Features & Benefits:







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 Solana Trichomonas Assay, when performed on the Solana instrument, allows for the rapid, accurate detection of Trichomonas. The assay utilizes helicase-dependent amplification (HDA) and fluorescent probe-based detection in the Solana instrument to determine assay results.

A vaginal swab specimen or a urine specimen is lysed by simple heat treatment, diluted, and added to a Reaction Tube containing the lyophilized HDA reagents including primers specific for the amplification of a T. vaginalis-specific target sequence, as well as sequence specific probes. Competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or instrument failure.

Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s five USB ports. Solana Trichomonas is supported by the power of Virena
?
.










Feature
Benefit



HDA technology
Rapid method of nucleic acid amplification that does not require thermal cycler



Lyophilized Master Mix reagent
Easy-to-use format, just add processed sample to rehydrate



Small, easy-to-use instrument
Eliminates the need for dedicated molecular space and costly capital equipment, allowing for testing in smaller labs



CLIA moderately complex
Requires minimal training



Refrigerated storage
No freezer needed, 2?C to 8?C storage



Long shelf life
Currently 12 months from date of manufacture



Multiple sample types
Kits available for vaginal swabs and urine samples



Room temperature set up
No ice or cooling block required












Product Specifications:




Product Spec Name
Product Spec Data



Sample type
Clinician-collected vaginal swabs and female urine specimens obtained from asymptomatic or symptomatic female patients



Time to results
Approximately 35 minutes



Specimen transport and storage
Transport and store the swab specimens at 2°C to 8°C for up to 7 days or room temperature (up to 30°C) for up to 48 hours prior to testing. Or transport and store urine specimens at 2°C to 8°C for 7 days or room temperature (up to 30°C) for up to 24 hours



Swab Clinical Sensitivity
Asymptomatic – 100% (95% CI 92.9% to 100%)
Symptomatic – 98.6% (95% CI 92.3% to 99.7%)
All – 99.2% (95% CI 95.4% to 99.9%)



Swab Clinical Specificity
Asymptomatic – 98.9% (95% CI 97.4% to 99.5%)
Symptomatic – 98.5% (95% CI 97.0% to 99.3%)
All – 98.7% (95% CI 97.7% to 99.3%)



Urine Clinical Sensitivity
Asymptomatic – 98.0% (95% CI 89.5% to 99.6%)
Symptomatic – 92.9% (95% CI 84.3% to 96.9%)
All – 95.0% (95% CI 89.5% to 97.7%)



Urine Clinical Specificity
Asymptomatic – 98.4% (95% CI 96.8% to 99.2%)
Symptomatic – 97.9% (95% CI 96.2% to 98.8%)
All – 98.2% (95% CI 97.1% to 98.8%)



Swab LOD
G3 – 102 trophozoite /mL
CDC888 - 306 trophozoite /mL



Urine LOD
G3 – 4 trophozoite /mL
CDC888 – 108 trophozoite /mL