Alinity m STI Assay

ONE ASSAY, MULTIPLE POSSIBILITIES
REDEFINING THE FUTURE OF STI TESTING WITH OPERATIONAL EFFICIENCY

 

Alinity m STI assay is a 4-in-1 multiplex assay to detect and differentiate CT, TV, MG, and NG to aid in the diagnosis of infection from these organisms.





Improved operational efficiency
  • A single, universal multi-collection device compatible with multiple specimens simplifies sample collection and potentially reduces human error at the collection center
  • Alinity m is a continuous and random-access molecular analyzer with a time to first result of less than 115 minutes that provides the ability to eliminate batching procedures and leads to improved laboratory workflow
IMPROVED CLINICAL CONFIDENCE
  • Independent internal and cellular controls for confidence in results
    • Internal control monitors for PCR inhibitors
    • Cellular control evaluates sample adequacy, sample extraction, and amplification efficiency
  • Gain a more holistic view of a patient's infection status with:
    • Up to four results from a single urogenital sample
    • Detection of CT and/or NG from rectal and oropharyngeal swab specimens (09N17-091 only)
  • Flexible reporting adapts to evolving changes in clinical practice

VIEW ORDERING INFORMATION

INTENDED USe
 

09N17-090

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.

09N17-091

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 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, TV, and MG: endocervical swab specimens, clinician-collected vaginal swab specimens, self-collected vaginal swab specimens (in a clinical setting), female urine, and male urine. For CT, NG, and TV, the assay may be used to test gynecological specimens collected in ThinPrep® PreservCyt® Solution from symptomatic and asymptomatic individuals. The assay may also be used to test oropharyngeal and rectal swab specimens from symptomatic and asymptomatic individuals for CT and NG.

Products not available in all countries, please verify with your local Abbott representative. 

specifications
 
 ALINITY m STI ASSAY PERFORMANCE
Technology

Multiple RT-PCR

Time to First Result

< 115 minutes

Throughput

Up to 1,080 samples in 24 hours*

Probe Design

Single-stranded probes

Target Region

 

CT = ribosomal (r) RNA

NG = OPA gene DNA

MG = ribosomal (r) RNA

TV = ribosomal (r) RNA

Specimen Type

Alinity m multi-Collect Specimen Collection Kit**:

- Endocervical swabs, 

- Vaginal swabs (self-collected and physician-collected)

- Male and female urine

- Rectal swab***

- Oropharyngeal swab***

 

Gynecological specimens collected in PreservCyt® Solution

Sensitivity

100% for all analytes across all matrices at the claimed Limit of Detection (LoD)

Limit of Detection (LoD)-Urogenital Specimens

CT= 0.5 inclusion forming units (IFUs)/assay

NG = 1.5 colony forming units (CFUs)/assay

TV= 0.02 trophozoite (TV)/assay 

MG = 33 genome equivalents/assay 

Limit of Detection (LoD)-Extragenital Specimens***

CT= 0.5 inclusion forming units (IFUs)/assay

NG = 1.5 colony forming units (CFUs)/assay

Specificity No cross-activity observed with 148 organisms
Result Reporting Detected/Not Detected; Flexible Reporting
Sample Input Volume 200 μL
Abbott Collection Device Alinity m multi-Collect Specimen Collection Kit
Carryover Rate (Overall) 0%
Internal Control (IC) Armored RNA (Pumpkin)
Cellular Control (CC) Human ß-globin gene (DNA)

 

RT-PCR = reverse transcription polymerase chain reaction

*Number of actual samples per 24-hour period may vary based on laboratory practice and workflow.

**Validated specimen types varies by product order number, please verify with your local Abbott representative.

***09N17-091 only

Ordering Info

Related Product
 


AMPLIFY YOUR IMPACT WITH ALINITY M


Alinity m is a fully integrated and automated molecular diagnostics analyzer that uses ReadiFlex technology to deliver the next level of flexibility and efficiency to your lab. 

FLEXIBILITY: True random access to perform any test, any time
TURNAROUND TIME: <115 minutes time to first result
THROUGHPUT: 300 samples in ~8 hours

Learn More

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