Kit Alinity m STI

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    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%
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