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Molecular
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
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
