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 sexually transmitted infections caused by these organisms.
Provide up to 4 results from a single sample analysis, saving reagents, reducing time-to-result compared with running multiple assays and without reducing Alinity m throughput.
The Alinity m STI Assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis (CT), DNA from Neisseria gonorrhoeae (NG), ribosomal RNA from Trichomonas vaginalis (TV), and ribosomal 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 the following analytes:
CT: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, male urine, oropharyngeal swabs, and rectal swabs
NG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, male urine, oropharyngeal swabs, and rectal swabs
TV: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, gynecological specimens in ThinPrep PreservCyt Solution, female urine, and male urine
MG: vaginal swabs (clinician-collected and self-collected in a clinical setting), endocervical swabs, and male urine
A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher clinical sensitivity compared to endocervical swabs. If endocervical swab specimens test negative, testing with a vaginal swab may be indicated if M. genitalium infection is suspected.Limitations of the procedure
The Alinity m multi-Collect Specimen Collection Kit is intended for the collection and transportation of male and female urine specimens, endocervical swab specimens, vaginal swab specimens, oropharyngeal swab specimens, and rectal swab specimens to stabilize nucleic acid for testing with the Alinity m STI Assay. Refer to the Alinity m STI Assay package insert for additional information.
The Alinity m multi-Collect Specimen Collection Kit is not intended for home use.Limitations of the procedure
|ALINITY m STI ASSAY PERFORMANCE (09N17-095)|
|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
* Collected with the Alinity m multi-Collect Specimen Collection Kit (09N19-015)
|Sensitivity||>95% for all analytes across all matrices at the claimed Limit of Detection (LoD)|
|Limit of Detection (LoD)||CT= 17.0 EB/mL
NG = 7.5 CFU/mL
TV= 0.1 TV/mL
MG = 165 genome equivalents/mL
|Specificity||Urogenital specimens: No cross-activity observed with 71 organisms
Extragenital specimens: No cross-activity observed with 56 organisms
|Result Reporting||Positive/Negative; Flexible Reporting|
|Sample Input Volume||200 μL|
|Abbott Collection Device||Alinity m multi-Collect Specimen Collection Kit (09N19-015)|
|Carryover Rate (Overall)||0.4% (2/548, 95% CI: 0.1% to 1.3%)|
|Internal Control (IC)||Armored RNA (Pumpkin)|
|Cellular Control (CC)||Human ß-globin gene (DNA)|
Standardizing to a single sample collection kit for STI testing across clinics and clinicians’ practices can simplify inventory and cost management, and improves workflow associated with managing samples at the collection sites and the laboratory.
Get it right the first time—recalling patients due to incorrect specimen collection or for add-on tests is inconvenient and contributes to increased health system costs.
Simple laboratory workflow—load Alinity m multi-Collect transport tubes when they arrive in the laboratory without the need to decap tubes or remove swabs.
A single kit for the collection of:
Designed with pierceable caps to help minimize the potential for cross-contamination
The Abbott STI Coalition Program has been developed to allow you to:
† Subject to the terms and conditions of an Abbott Product Evaluation Agreement
Understand STI prevalence and co-infection rates of potentially under diagnosed STIs in your communities to:
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
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