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The Alinity m STI assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), RNA from Trichomonas vaginalis (TV), and RNA from Mycoplasma genitalium (MG) to aid in the diagnosis of urogenital disease(s) caused by infection from these organisms. The assay may be used to test the following specimens from symptomatic and asymptomatic individuals for CT, NG and TV: endocervical swab specimens, clinician-collected vaginal swab specimens, self-collected vaginal swab specimens (in a clinical setting), gynecological specimens collected in ThinPrep PreservCyt solution, female urine, and male urine. The assay may also be used to test endocervical swab specimens from symptomatic and asymptomatic individuals for MG.
ALINITY m STI ASSAY PERFORMANCE | |
Target Region |
CT = ribosomal (r) RNA NG = OPA gene DNA MG = ribosomal (r) RNA TV = ribosomal (r) RNA |
Limit of Detection (LoD) | CT= 0.5 IFU/assay; NG = 1.5 CFU/assay; TV= 0.02 TV/assay; MG = 33 genome equivalents/assay |
Carryover | 0% carryover rate [95% CI 0% to 1.4%] |
Internal Control | Yes |
Cellular Control | Yes |
Collection Device | Alinity m multi-collect specimen collection kit |
Sample Input Volume | 200 µL |
Specimen Types |
- Endocervical Swabs, Vaginal Swabs (Self-Collected and Physician Collected), male and female urine collected in Alinity m multi-collect specimen collection kit - Gynecological specimens collected in PreservCyt solution |
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