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simpli-collect™
sti test

Expanding reach
without compromising
laboratory workflow

For in-vitro diagnostic use. Rx only.

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HOW CAN YOUR LAB EXPAND STI TESTING ACCESS IN THE COMMUNITY WITHOUT COMPROMISING LAB EFFICIENCY OR DISRUPTING WORKFLOWS?

SELF-COLLECTION KITS TO SUPPORT STI TESTING

National survey indicated 80.2% adolescents and young adults prefer home STI test kits mailed.2 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.

FDA cleared

SHIPPED IN DISCREET PACKAGING

MULTI-LINGUAL PATIENT INSTRUCTIONS

TESTS UP TO FOUR COMMON STIs

THE COMPLETE STI SOLUTION THAT SUPPORTS
YOUR LABORATORY’S TESTING NEEDS

Broader Access to STI testing

-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)

ease of use

-Validated self-collection kits with discreet packaging and multi-lingual patient instructions for easy sample collection

 

-Unique kit ID ensures sample chain of custody

 

 

SEAMLESS INTEGRATION WITH ALINITY M STI ASSAY

-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

confidence in results

-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

SEAMLESS INTEGRATION WITHOUT COMPROMISING LAB WORKFLOW

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.

Intended use

SIMPLI-COLLECT STI TEST

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

SIMPLI-COLLECT STI TEST
  • 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.
  • Pregnant women should not use the simpli-COLLECT Swab Collection Kit without first discussing with their healthcare provider.
  • 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 the self-collected vaginal swab specimen as a replacement for a pelvic exam.
  • 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

LABORATORY WARNINGS AND PRECAUTIONS:
  • Follow all instructions in the simpli-COLLECT STI Test package insert.
  • Decontaminate and dispose of all specimens, reagents, and other potentially contaminated materials in accordance with local, state, and federal regulations.
  • Do not send the simpli-COLLECT Collection Kit to the patient if the kit is damaged, the kit box is open, or the kit is leaking. Discard unused, damaged, or leaking kits in accordance with local, state, and federal regulations.
  • Do not send the simpli-COLLECT Collection Kit to the patient if the kit is beyond its expiration date.
  • Do not open the kit prior to sending to patient.
  • Wear disposable gloves while handling specimens and wash hands thoroughly afterward. Use of protective eyewear is recommended.
  • Avoid touching the blue top of the Alinity m Pierceable Cap to prevent potential contamination.
  • Warnings and precautions for the Alinity m STI Assay are provided in the Alinity m STI AMP Kit package insert.

PATIENT WARNINGS AND PRECAUTIONS:
  • 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.
  • Do not use the simpli-COLLECT Urine Collection Kit or simpli-COLLECT Swab Collection Kit if the kit is damaged, the kit box is open, or if the kit is leaking. Discard unused, damaged, or leaking kits in accordance with local, state, and federal regulations.
  • Do not use the simpli-COLLECT Urine Collection Kit or simpli-COLLECT Swab Collection Kit if the kit is beyond its expiration date. Use of expired kits can lead to incorrect results.
  • Pregnant women should not use the simpli-COLLECT Swab Collection Kit without first discussing with their healthcare provider.
  • The sample tube with liquid buffer contains detergent. The liquid in the tube may cause skin or eye irritation. If the liquid comes in contact with your skin or eyes, rinse with water for several minutes. Remove contact lenses, if present and easy to do, and continue rinsing. If irritation continues, seek medical advice.
  • Protective eyewear is recommended while using this kit.
  • Wash hands thoroughly after handling.
  • Do not ingest.
  • Avoid contact with skin and eyes.
  • Only use the swab provided with the simpli-COLLECT Swab Collection Kit.
  • 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).
  • Accurate results are dependent on adequate product storage and adherence to the specimen collection and testing procedures.
  • Failure to follow test procedures can lead to incorrect results.

Specifications

 

SIMPLI-COLLECT SWAB COLLECTION KIT

SIMPLI-COLLECT URINE
COLLECTION KIT

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.
Tamper proof sleeve; prevents tampering of the final kit

Privacy

Kits are shipped in discreet shipper pouches to the patients

Patient instructions

Multi-language, image-guided specimen collection and specimen return instructions. Provided in video and written formats.

Patient instruction languages

English, Spanish

LEARN MORE ABOUT ABBOTT MOLECULAR’S SIMPLI-COLLECT
STI COLLECTION KITS

Talk to your Molecular sales representative to learn more.

contact us
explore

Alinity m STI Assay

View the Alinity m STI Assay page to learn more about STI testing capabilities.

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Alinity m

Learn more about the Alinity m analyzer and how it can help transform your molecular lab to achieve measurably better healthcare performance.

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Simpli-COLLECT Kits for STI Testing Patient Resources

View patient resources on how to use the simpli-COLLECT Collection Kit.

learn more
References

1. simpli-COLLECT STI Test Package Insert: 53-608395/ R1

2. Parker JN, Pediyakkal H, Waselewski M, Chang T, Mmeje O. Self-Collected Testing for Sexually Transmitted Infections: A National Text Message Survey of Adolescents and Young Adults. J Adolesc Health. 2025 Mar;76(3):482-487. doi: 10.1016/j.jadohealth.2024.10.028. Epub 2025 Jan 16. PMID: 39818656.

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