ALINITY m STI ASSAY
Comprehensive Detection. Seamless Collection. Confident Diagnosis.
For in vitro diagnostic use. Rx only.
THE ONLY 4-IN-1 STI ASSAY FDA ‑CLEARED IN THE U.S.
Alinity m STI assay simplifies comprehensive STI testing by detecting and differentiating sexually transmitted pathogens CT, NG, TV, and MG in one streamlined test.
Benefits for HCPs
- Faster time to diagnosis
- Improved treatment initiation
- Including extragenital claims
DESIGNED FOR CLINICIAN CONFIDENCE AND PATIENT EASE—
ACCURATE RESULTS WITH MINIMAL HANDLING
MULTI-PLEX ASSAY DESIGN
- Detection of up to four pathogens from one patient sample helps reduce missed diagnosis due to co-infections and asymptomatic cases
- Holistic diagnosis helps reduce the risk of antimicrobial resistance
Confidence in Results
- Robust assay design, built with internal and cellular controls, helps ensure the test process works correctly and confirms sample adequacy for both self-collected and clinician-collected specimens
Simplified and Patient-Centered Sample Collection
- One collection kit validated for multiple sample types for in-clinic sample collection helps reduce collection errorssimpli-COLLECT home collection kits for STI, help reduce barriers to testing with self-collection in non-clinical settings
The Overlooked STIs That Could Change Your Diagnosis
New data shows TV and MG are more common than you think—are you testing for them?
Co-Infection Rate in STI Testing—Insights from a United States Cohort Study
Emerging pathogens like Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) are gaining clinical attention—but many healthcare settings still don’t routinely test for them. This gap can lead to missed diagnoses, delayed treatment, and higher health cost burden.
A recent U.S. cohort study evaluated the prevalence and co-infection rates of four key sexually transmitted infections:
- Chlamydia trachomatis (CT)
- Neisseria gonorrhoeae (NG)
- Trichomonas vaginalis (TV)
- Mycoplasma genitalium (MG)
Key findings
CT co-infections: 78% of CT coinfections tested positive for TV and/or MG
NG co-infections: 46% of NG coinfections tested positive for TV and/or MG
These findings highlight the high prevalence of multi-pathogen infections and the need for broader diagnostic coverage.
Clinical Implications
- Co-infections with TV and/or MG are common and often under-diagnosed
- Routine testing for TV and MG—alongside CT and NG—can improve patient diagnosis
- Early detection supports more targeted treatment and better patient outcomes
Why Test for All Four: CT, NG, TV, and MG?
Comprehensive Testing Matters
Sexually transmitted infections often present with overlapping symptoms yet require distinct treatments. Missing one pathogen can lead to incomplete therapy, persistent symptoms, and increased transmission risk.
Antimicrobial Resistance: A Growing Threat
- Neisseria gonorrhoeae (NG) has shown increasing resistance to fluoroquinolones, azithromycin, and even ceftriaxone in some regions
- Mycoplasma genitalium (MG) is notoriously difficult to treat due to macrolide and fluoroquinolone resistance, making resistance-guided therapy essential
- Empiric treatment without testing may contribute to resistance and treatment failure
The Case for Multi-plex Testing
The Alinity m STI assay enables simultaneous detection of up to four pathogens from a single sample, supporting:
- Faster diagnosis
- Targeted treatment
- Reduced risk of resistance development
HPV Clinical Guidelines
Confidence in Results
The cellular control (CC) feature plays a critical role in this assuring that the sample is biologically adequate and that the test process worked as intended. The CC targets an endogenous human DNA sequence, serving as a sample validity control. It confirms:
- Sample adequacy
Ensures the specimen contains sufficient human cellular material. - False negative prevention
Helps rule out false negatives due to insufficient target cells. - Extraction efficiency
Verifies that nucleic acids were successfully isolated. - Amplification integrity
Confirms that PCR process worked properly without anything interfering.
Clinical implications
Cellular Control (CC) can help:
- False negative prevention
STIs like CT and MG can be asymptomatic but still cause long-term complications (e.g., infertility, pelvic inflammatory disease). Reliable detection is essential for early intervention. - Support reliable self-collection
Enhances confidence in results from self-collected specimens, which are increasingly used in STI screening programs. Especially important in high-risk or underserved populations.
HOW DO YOU ENSURE RELIABLE STI RESULTS FOR PATIENTS WHO SELF-COLLECT ESPECIALLY THOSE AT HIGH RISK?
Streamlined STI Sample collection—
From Clinic to Home
Simplify workflows and improve access with single collection kit for clinics and home collection options.
IN HEALTHCARE SETTINGS
- A single collection kit for extragenital and urogenital samples can significantly reduce collection errors in healthcare settings
“A single sample collection device will allow for a very simplified workflow. That is what we are looking for because of lack of workforce…you can easily train people and not miss anything.”
– Public Health Laboratory Staff
Standardization for clinicians in clinical settings
Alinity m multi-collect specimen collection kit
- Male and female urine
- Vaginal swabs
- Endocervical swabs
- Rectal swabs
- Oropharyngeal swabs
Webinar: Reduce Collection Errors with Abbott’s multi‑COLLECT Specimen Collection
AT HOME
Your patients want privacy. Your practice needs reach.
You can now offer your patients a choice in STI testing. simpli-COLLECT™ STI Test from Abbott helps you reach patients who may not come into the clinic—without compromising quality.
- Home collection, lab-processed
- Clinician-ordered, patient-preferred
- Trusted results
The only FDA-cleared STI home collection kits*
simpli-COLLECT Urine Collection Kit
For male and female urine specimens
simpli-COLLECT swab Collection Kit
For female vaginal swab sample
Watch the ADLM Lab Session to discover how simpli-COLLECT Home Collection Kits are breaking down barriers to STI testing.
Talk to your Molecular sales representative to learn more about the ALINITY M STI ASSAY.
Explore
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simpli-COLLECT™ STI Test
Learn how to your lab can expand STI testing in the community without compromising lab efficiency or disrupting workflows.
REFERENCES
- Alinity m STI AMP Kit Package Insert 53-608012/R3.
- Alinity m multi-Collect Specimen Collection Kit 53-608346/R1.
- simpli-COLLECT STI Test Package Insert: 53-608395/R1.
- Parker Jayelin N., et al. Self-Collected Testing for Sexually Transmitted Infections: A National Text Message Survey of Adolescents and Young Adults, Journal of Adolescent Health, March 2025, https://doi.org/10.1016/j.jadohealth.2024.10.028
*simpli-COLLECT STI Test is the only FDA-cleared test system intended for in vitro detection of CT, NG, TV, and MG in home-collected specimens. The specimens are shipped for testing using the Alinity m STI Assay.