For in-vitro diagnostic use. Rx only.
National survey indicated 80.2% adolescents and young adults prefer home STI test kits mailed. simpli-COLLECT Swab and Urine Collection Kits are FDA cleared kits, enabling individuals to collect samples comfortably at home. These kits promote self-care, extend accessibility, and make high-quality STI testing more convenient and reachable. The collected samples are tested using the only FDA cleared 4-in-1 Alinity m STI assay.
-Swab and Urine kits broaden access to STI testing for both male and female populations
-A single sample supports testing for up to four common sexually transmitted infections (STIs)
-Validated self-collection kits with discreet packaging and multi-lingual patient instructions for easy sample collection
-Unique kit ID ensures sample chain of custody
-Each kit contains a primary sample tube that can be loaded directly on the Alinity m system to reduce unnecessary pre-analytical steps
-Unmask additional results for pathogens upon doctor's orders for up to 14 days without patient recall, new sample collection, or re-testing
-Sample stability of 14 days including summer and winter shipping profiles provide confidence that the sample can be processed upon receipt at labs
-Alinity m STI assay's cellular control ensures sample adequacy for reliable reporting, crucial for patients who are self-sampling
simpli-COLLECT swab or urine samples can be directly loaded on the Alinity m system to test with the Alinity m STI assay, thereby helping reduce hands on time needed for sample preparations.
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SIMPLI-COLLECT STI TEST |
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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. |
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SIMPLI-COLLECT STI TEST |
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• 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. |
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LABORATORY WARNINGS AND PRECAUTIONS: |
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• Follow all instructions in the simpli-COLLECT™ STI Test package insert. • Warnings and precautions for the Alinity m STI Assay are provided in the Alinity m STI AMP Kit package insert. |
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PATIENT WARNINGS AND PRECAUTIONS: |
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• Follow all instructions in the Instructions for Use. If you do not follow the instructions, your result could be incorrect. • Keep out of reach of children under 14 years old. • Pregnant women should not use the simpli-COLLECT Swab Collection Kit without first discussing with their healthcare provider. • Women who have symptoms suggesting pelvic inflammatory disease (PID) should not use the self-collected vaginal swab specimen as a replacement for a pelvic exam. • A negative test result does not preclude the possibility of infection with other pathogens. • The test system is not a substitute for visits to a healthcare provider. The information provided by the product should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider. • Anyone with recent sexual contact with a person known to have a sexually transmitted infection should visit a healthcare provider for treatment and evaluation as soon as possible (refer to the CDC website at www.cdc.gov/std/). • Contact a healthcare provider prior to collecting the sample if the user has a condition that makes it difficult to use the test (eg, problems with vision, handling the test components, or understanding test instructions or results). |
SIMPLI-COLLECT SWAB COLLECTION KIT | SIMPLI-COLLECT URINE | |
simpli-COLLECT Kit numbers | 09R02-001 | 09N93-001 |
Validated specimen types | Self-collected vaginal swab specimens | Self-collected male or female urine |
Dimensions (L X W X H) in | 8.625” X 4.344” X 1.312” | 8.625” X 4.344” X 2.656” |
Collection setting | Healthcare or non-healthcare settings | |
Assay | Alinity m STI Assay (09N17-095) | |
STI organisms detected and differentiated | Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) | |
Sample tracking | Unique kit ID matches sample tube and bio-hazard bag label, enabling sample tracking | |
Packaging | UN3373 Category B certified packaging for transporting biological samples. | |
Privacy | Kits are shipped in discreet shipper pouches to the patients | |
Patient instructions | Multi-language image guided collection and specimen return instructions in video and paper format | |
Patient instruction languages | English, Spanish | |
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Alinity m STI Assay
View the Alinity m STI Assay page to learn more about STI testing capabilities.
Alinity m
Learn more about the Alinity m analyzer and how it can help transform your molecular lab to achieve measurably better healthcare performance.
Simpli-COLLECT Kits for STI Testing Patient Resources
View patient resources on how to use the simpli-COLLECT Collection Kit.
1. simpli-COLLECT STI Test Package Insert: 53-608395/ R1
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