The test uses Abbott’s simpli-COLLECT platform to detect chlamydia, gonorrhea, trichomonas, and mycoplasma genitalium from patient-collected specimens.
Tia Health, a women’s helathcare platform, and Molecular Testing Labs have partnered to offer patients a US Food and Drug Administration-cleared home-collection kit that simultaneously detects four common sexually transmitted infections (STIs).
The test uses Abbott’s simpli-COLLECT STI Test, allowing patients to collect specimens at home and receive results through their healthcare provider. The platform can detect Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium in a single collection.
Patients access the test kit through an order from one of Tia’s clinicians, either via telemedicine or in person. After sample collection, patients ship their specimen to the laboratory for testing and receive results from a Tia provider.
“Stigma is a huge barrier to testing, and home sample collection reduces this barrier. People can now test without the fear of judgment,” says Emily Rymland, DNP, FNP, Los Angeles market medical director at Tia Health, in a release. “I often see people testing for the first time in their lives with home-based options.”
Laboratory Processing and Integration
Molecular Testing Labs provides the laboratory processing, logistics, EMR integrations, and claims reimbursement processes for the testing program. The CAP-accredited and CLIA-certified laboratory specializes in high-complexity and high-throughput diagnostic testing.
The simpli-COLLECT STI Test contains components for self-collection and transport of urine from male and female patients or vaginal swabs from female patients. Specimens are shipped to the laboratory for testing using the Alinity m STI Assay.
“By combining the FDA-cleared simpli-COLLECT STI Test with Tia’s care model, we’re making it easier for patients to get the answers they need—discreetly, quickly, and reliably,” says James York, Molecular Testing Labs’ chief commercial officer and head of government affairs, in a release.
Clinical Specifications
The simpli-COLLECT STI Test is FDA-cleared for in vitro detection of the four STIs in home-collected specimens from symptomatic and asymptomatic individuals. The collection kits may also be used for self-collection in clinical settings.
The test is contraindicated for pregnant women using the swab collection kit without first consulting their healthcare provider. The system requires a prescription and is intended for in vitro diagnostic use only.
This launch represents Tia’s entry into home testing services as part of its women’s healthcare platform that spans primary care, gynecology, mental health, fertility, and menopause support across virtual and in-clinic settings.
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