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®.
Features & Benefits
| 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 | 24 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%) |
Swab Clinical Specificity | Asymptomatic – 98.9% (95% CI 97.4% to 99.5%) |
Urine Clinical Sensitivity | Asymptomatic – 98.0% (95% CI 89.5% to 99.6%) |
Urine Clinical Specificity | Asymptomatic – 98.4% (95% CI 96.8% to 99.2%) |
Swab LOD | G3 – 102 trophozoite /mL |
Urine LOD | G3 – 4 trophozoite /mL |
Ordering Information
| Catalog Number | Description | Kit Size / Case Size |
|---|---|---|
M304.S | Solana Trichmonas Assay Kit – Swab | 48 tests |
M304.U | Solana Trichomonas Assay Kit – Urine | 48 tests |
M119 | Quidel Molecular Trichomonas Control Set | 2.0 mL |
Product Documentation
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