CT/NG/TV/MG
Alinity m STI AMP Kit
For more information, contact Abbott.
For more information, contact Abbott.
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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.
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.
To learn more about Alinity m STI Assay please visit: https://www.molecular.abbott/int/en/products/infectious-disease/alinity-m-sti-assay
| ALINITY m STI ASSAY PERFORMANCE | |
| Technology | Multiplex RT-PCR |
| Time to first result | <115 min |
| Probe Design | Single stranded probes |
| Target Region | CT= ribosomal (r) RNA; NG= OPA gene DNA; TV= ribosomal (r) RNA; MG= ribosomal (r) RNA |
| Specimen type* | - 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 |
| Sensitivity | 100% for all analytes across all matricies at the claimed LoD (Limit of Detection) |
| Strains Detected | CT and TV: All strains were detected at 100% across all matrices NG: All strains were detected at >95% across all matrices MG: All strains were detected at 100% in the swab matrix |
| Specificity | No cross reactivity observed with 148 organisms |
| Result Reporting | Detected/Not Detected; Flexible Reporting |
| Sample input volume | 200μL |
| Abbott Collection Device | Alinity m multi-collect specimen collection kit |
| Carryover Rate (Overall) | 0% |
| Internal Control (IC) | Armored RNA (Pumpkin) |
| Cellular Control (CC) | Human β-globin gene (DNA) |
* The assay can be used to test all specimen types listed for CT, NG, TV, and endocervical swabs can be used for MG.
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Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.