Alinity m STI Assay

the only 4-in-1 sti assay FDA-CLEARED in the u.s. 

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 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.





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
  • Flexibility to create add-on orders within 14 days of initial analysis without the need to find and re-run the sample
  • 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 (CT/NG/TV/MG) from a single urogenital sample
    • Detection of CT and/or NG from rectal and oropharyngeal swab specimens

VIEW ORDERING INFORMATION

INTENDED USe
 
Alinity m STI AMP Kit (09N17-095)
Intended Use

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
For in vitro diagnostic use. Rx Only.
  1. For females, 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.
  2. False negative results for Neisseria gonorrhoeae were observed from endocervical samples in the clinical study when multiple endocervical samples were collected from one patient. If multiple endocervical samples are necessary from the same patient, and the NG test result is negative, further testing may be indicated if infection with N. gonorrhoeae is strongly suspected.
  3. Performance of the assay for the detection of CT has not been established in gynecological specimens in PreservCyt or in female urine.
  4. Performance of the assay for the detection of NG has not been established in female urine.
  5. Performance of the assay for the detection of MG has not been established in gynecological specimens in PreservCyt or in female urine.
  6. Performance of the assay for the detection of TV and MG has not been established in oropharyngeal or rectal swab specimens.
  7. First-catch female urine specimens are acceptable for the detection of TV, but may detect up to 6.6% fewer TV infections when compared with vaginal swab specimens.
  8. The Alinity m STI Assay has not been evaluated for patients younger than 14 years of age.
  9. Assay interference may cause false negative or invalid results. Assay interference may be observed in the presence of seminal fluid at concentrations greater than 3.0% in PreservCyt samples.
  10. Cycle number delays were observed for mucus, seminal fluid, γ-globulin, glucose, Preparation H Hemorrhoidal Cream, feces and Sensodyne Repair & Protect Sensitive Toothpaste, which could result in interference at lower target levels (refer to Table 3 and Table 4 in the package insert 53-608012/R1).
  11. Performance with specimens collected with other collection media than those specified in this package insert has not been evaluated.
  12. Only PreservCyt specimens that have been aliquoted prior to cytology have been evaluated with the Alinity m STI Assay. The use of residual specimens post cytology has not been evaluated.
  13. A negative test result does not preclude the possibility of infection and can be caused by improper specimen collection, technical error, specimen mix-up, or target levels below the assay limit of detection (LoD).
  14. As with any diagnostic test, results from the Alinity m STI Assay should be interpreted in conjunction with other clinical and laboratory findings.
  15. Reliable results are dependent on appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the package insert 53-608012/R1).
  16. The Alinity m STI Assay has not been validated for use with vaginal swab specimens collected by patients at home. The patient-collected vaginal swab specimen application is limited to health care facilities where support/counseling is available to explain the procedures and precautions.
  17. Use of this assay is limited to personnel who have been trained in the procedure. Failure to follow the instructions given in this insert may result in erroneous results.
  18. Nucleic acid contamination from the positive controls or specimens must be monitored by good laboratory practice and careful adherence to the procedures specified in this package insert.
  19. A positive result for the presence of CT, NG, TV, and MG nucleic acids does not establish the causative agent for salpingitis or PID. A negative result for CT, NG, TV, and MG nucleic acids does not exclude related infection as a cause of ascending infection.
  20. The Alinity m STI Assay has not been evaluated with patients who are currently being treated with antimicrobial agents active against CT, NG, TV, and MG.
  21. The Alinity m STI Assay should not be used to determine therapeutic success or failure as nucleic acids may persist after appropriate antimicrobial therapy.
  22. The Alinity m STI Assay for male and female urine testing must be performed on first-catch urine specimens (defined as the first 20-30 mL of the urine stream). The effects of other variables such as first-catch vs. mid-stream, post douching, etc. have not been determined.
  23. The Alinity m STI Assay is not intended to replace other methods (eg, cervical exam) for diagnosis of urogenital infection. Patients may have cervicitis, urethritis, urinary tract infections, or vaginal infections due to other causes or concurrent infections with other agents.
  24. Use of the Alinity m STI Assay is not approved for the evaluation of suspected sexual abuse contact tracings as well as for other medico-legal indications.
  25. The effects of factors such as vaginal discharge, use of tampons, douching, or other specimen collection variables have not been determined.
  26. Though rare, mutations within the highly-conserved regions covered by the primers and/or probes of the Alinity m STI Assay may result in failure to detect the presence of the organism(s).

Alinity m multi-Collect Specimen Collection Kit (09N19-015)
Intended Use

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
For in vitro diagnostic use. Rx Only.
  • For In Vitro Diagnostic Use Only
  • Optimal performance of this kit requires appropriate specimen collection, handling, preparation, and storage (refer to the SPECIMEN COLLECTION PROCEDURES section of the package insert 53-608346/R1).
  • This kit should only be used to collect swab samples from the cervix or vagina (females), oropharynx or rectum (males and females), or urine specimens (males and females). Refer to the Alinity m STI Assay package insert for allowable specimen types and any additional information.
  • The collection of vaginal samples from pregnant women using the Alinity m multi-Collect Specimen Collection Kit should be conducted by an obstetrical provider or family physician.
  • Vaginal swab sampling is not designed to replace cervical exams for diagnosis of female urogenital infections. Patients may have cervicitis, urethritis, urinary tract infections, or vaginal infections due to other causes or concurrent infections with other agents.
  • Women who have symptoms suggesting pelvic inflammatory disease (PID) should not use a self-collected vaginal swab specimen as a replacement for a pelvic exam.
  • The self-collected vaginal swab specimen application is limited to health care facilities where support and counseling is available to explain the procedures and precautions.
specifications
 
 ALINITY m STI ASSAY PERFORMANCE (09N17-095)
Technology Multipex 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
Specimen Type  CT NG TV MG
Endovervical swab*
Vaginal swab (self-collected and physician-collected)*
Male urine*
Female urine*      
Gynecological specimen collected in PreservCyt® Solution    
Rectal swab*    
Oropharyngeal swab*    

* 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)

RT-PCR = reverse transcription polymerase chain reaction
*Number of actual samples per 24-hour period may vary based on laboratory practice and workflow.
Multi-collect kit
 


ALINITY m multi-collect specimen collection kit

A SINGLE COLLECTION KIT TO SIMPLIFY INVENTORY MANAGEMENT, SAMPLE COLLECTION AND PROCESSING
SIMPLIFY INVENTORY MANAGEMENT & STANDARDIZE OPERATIONS

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.

REDUCE PATIENT RECALL

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.

IMPROVE OPERATIONAL EFFICIENCY

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.

Alinitym_MultiCollectKit_ProductImage.png

A single kit for the collection of:

  • Male and female urine
  • Vaginal swabs
  • Endocervical swabs
  • Rectal swabs
  • Oropharyngeal swabs
 


SIMPLIFY LABORATORY PROCEDURES
  • Add Alinity m multi-Collect transport tubes alongside other routine specimens in the same Alinity m Universal Sample Rack
  • Load the Universal Sample Rack into Alinity m
  • Report results
REDUCE HANDS ON TIME AND ELIMINATE MANUAL STEPS
  • Transfer specimen to secondary tubes
  • Remove the swab
  • Decap or recap specimen tube

Designed with pierceable caps to help minimize the potential for cross-contamination

Alinitym_MultiCollectKit_PiercableCap.png

 

 
STI Coalition Program
 

JOIN THE STI COALITION

Contribute to the global efforts to stop the spread of STI
STICoalition_Icon1.png
Develop Leadership
& Advocacy
STICoalition_Icon2.png
Drive decisions
through data
insights
STICoalition_Icon3.png
Move from empirical
to etiological
management


The Challenge
  • Prevalence rates of Chlamydia trachomatis and Neisseria gonorrhoeae are published annually based on surveillance programs
  • Despite emerging interest in Trichomonas vaginalis and Mycoplasma genitalium, prevalence rates may be unknown for facilities who do not routinely screen for these pathogens
The Program

The Abbott STI Coalition Program has been developed to allow you to:

  • Leverage data-driven insights
  • Gain a better understanding of STI prevalence in the communities you serve
  • Enable the change from empirical to etiological management
How it Works
  • Agree to be part of the Abbott STI Coalition
  • Anonymized data collection
  • Monthly reporting of prevalence data

† Subject to the terms and conditions of an Abbott Product Evaluation Agreement

The Benefit

Understand STI prevalence and co-infection rates of potentially under diagnosed STIs in your communities to:

  • Justify expansion of STI menu
  • Assist in combatting the spread of STIs
  • Drive antibiotic stewardship
 
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

Learn More

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