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 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.
SPECIFICATIONS:
| ALINITY m STI ASSAY PERFORMANCE | |
| 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 |
| Cellular Control | Human ß-globin gene (DNA) |
| Internal Control (IC) | Armored RNA (Pumpkin) |
| Sample Input Volume | 200 μL |
| Carryover Rate (Overall) | 0% |
