Alinity m STI Assay

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Accurate detection of sexually transmitted organisms is critical in prescribing treatment and control of sexually transmitted infections. The Alinity m STI assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the direct, qualitative detection and differentiation of RNA from Chlamydia trachomatis (CT), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), and DNA from Neisseria gonorrhoeae (NG) to aid in the diagnosis of urogenital disease(s) caused by infection from these organisms.
  • Detect all 4 organisms (CT, NG, TV, and MG) in ONE single reaction with flexible reporting to drive change in clinical practice.
  • State of the art assay design with multi-collect sample collection and flexible on-demand results reporting to support the standard of care in STI.   
  • Unique and simple collection device for easy sample collection allows for simplified workflow.
INTENDED USe
 

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.

specifications
 
 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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