simpli-COLLECT™
STI Test for Home Collection
The only FDA-cleared test system intended for in vitro detection and identification of 4 common STIs.
IMPROVED ACCESS FOR YOUR PATIENTS
The simpli-COLLECT™ STI Test is a revolutionary 4-in-1 multiplex assay that lets patients collect samples privately and comfortably from their own home. Advanced molecular testing allows those living with these infectious diseases to be diagnosed correctly and can help healthcare providers determine how individuals are responding to treatment.
MODERNIZE YOUR PATIENT’S EXPERIENCE
Your patient desires a modern and discrete clinical experience when faced with the possibility of a sexually transmitted infection. A simpli-COLLECT STI Test allows your patient to collect a urine or swab sample in the comfort of their home.
Distribute directly from your office
simpli-COLLECT test kits can be handed out in clinic or mailed directly to your patient’s home.
Integrate with your EMR
We can support a user interface for creating orders, including through your EMR.
Streamline claims-based reimbursement
We can set your clinic up for claims reimbursement.
Jessica Horwitz, MPH, FNP-C
CHIEF CLINICAL OFFICER
TIA HEALTH
“At Tia – we are always looking for innovative and evidence-based ways to improve access to care and also to improve the experience for how women access care. We are excited to be partnering with MTL to be the first women’s health organization offering the Abbott simpli-COLLECT STI test.
This 4-Plex panel will allow our patients to test for STIs in the privacy of their home with an FDA cleared testing device! This is a huge step forward for access, autonomy, and prevention, and we are thrilled our patients will now have this access.”
Abbott simpli-COLLECT™ STI test system are products manufactured by Abbott.
For in-vitro diagnostic use. Rx only. Learn more from Abbott.
INTENDED USE
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home collected specimens. The specimens are shipped to a clinical laboratory for testing using the Alinity m STI Assay with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from CT, DNA from NG, ribosomal RNA from TV, and ribosomal RNA from MG to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following self-collected specimens from symptomatic and asymptomatic individuals for the following analytes:
- CT: vaginal swabs, female urine, and male urine
- NG: vaginal swabs, female urine, and male urine
- TV: vaginal swabs, female urine, and male urine
- MG: vaginal swabs and male urine
The simpli-COLLECT STI Test contains all the necessary components for the self-collection and transport of urine from male and female patients (simpli-COLLECT Urine Collection Kit) or vaginal swabs from female patients (simpli-COLLECT Swab Collection Kit) in their home, or in similar environments. The simpli-COLLECT Collection Kits may also be used to self-collect specimens in a clinic.
LIMITATIONS OF THE PROCEDURE
- Optimal performance of this kit requires appropriate specimen collection, handling, preparation, and storage. Refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the package insert for additional information.
- The simpli-COLLECT Urine Collection Kit should only be used to collect urine samples. The simpli-COLLECT Swab Collection Kit should only be used to collect vaginal swab samples. Refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS for additional information.
- 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.
- Vaginal swab samples are the preferred sample type for sexually transmitted infection testing in women. A urine sample is acceptable for women but may detect fewer infections when compared to vaginal swab samples.
- Assay interference may be observed in the presence of gel-based hand sanitizers at concentrations greater than 0.1% in simpli-COLLECT urine specimens and simpli-COLLECT vaginal swab specimens. Assay interference may also be observed in the presence of Vaseline® Intensive Care™ Deep Restore Lotion at concentrations greater than 0.5% in simpli-COLLECT urine specimens.
Refer to the Alinity m STI AMP Kit package insert for assay limitations.
WARNINGS AND PRECAUTIONS (Learn more from Abbott)
Source: FDA.gov, January 30, 2025, 510K Number: K243410, Device Name: simpli-COLLECT™ STI Test https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243410
