Supplemental Video Guide INSTRUCTIONS FOR USE

The simpli-COLLECT Urine Collection Kit allows you to self-collect urine samples at home or other settings outside a clinical setting. You will collect your urine sample and send it to a laboratory that will test for sexually transmitted infections.

This test can detect Gonorrhea (male and female urine), Chlamydia (male and female urine), Trichomoniasis (male and female urine), and M. genitalium infections (male urine). This test does not detect any other sexually transmitted infections or other infections of the genital or urinary tract that can cause similar symptoms.

Your urine sample will be tested on the Alinity m STI assay, a PCR test that can detect the presence of nucleic acids (RNA or DNA) from Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.

Males In clinical studies, the Alinity m STI Assay demonstrated 97.2% sensitivity (the test’s ability to correctly identify an individual with a disease) and 99.5% specificity (the test’s ability to correctly identify an individual who does not have a disease) for detection of Chlamydia trachomatis (CT), 100.0% sensitivity and 99.9% specificity for detection of Neisseria gonorrhoeae (NG), 98.7% sensitivity and 99.2% specificity for detection of Trichomonas vaginalis (TV), and 98.1% sensitivity and 97.5% specificity for detection of Mycoplasma genitalium (MG). Source: Abbott, Alinity m STI Assay Instructions, August 2023. Females In clinical studies, the Alinity m STI Assay demonstrated 96.7% positive agreement (the test’s ability to correctly identify a urine sample with an infection) and 99.8% negative agreement (the test’s ability to correctly identify a urine sample that does not have an infection) for detection of Chlamydia trachomatis (CT), 98.0% positive agreement and 99.9% negative agreement for detection of Neisseria gonorrhoeae (NG), and 97.7% positive agreement and 99.1% negative agreement for detection of Trichomonas vaginalis (TV). Female urine cannot be tested for Mycoplasma genitalium (MG). Source: Abbott, Alinity m STI Assay Instructions, August 2023.

Talk to your healthcare provider about sexually transmitted infections. For additional information on sexually transmitted infections, refer to the following CDC websites: Sexually Transmitted Infections (STI) www.cdc.gov/std/ Fact Sheets on STIs: www.cdc.gov/sti/communication-resources/index.html

If you do not follow the instructions, your result could be incorrect.

Do not use the kit. Use of a damaged kit can lead to incorrect results. Discard unused, damaged, or leaking kits in accordance with local, state, and federal regulations. Contact BioReference at 888-279-0967 for a new kit.

Do not use if the kit is beyond its expiration date. Use of an expired kit can lead to incorrect results. Check the simpli-COLLECT kit box for the expiration date. If expired, contact BioReference at 888-279-0967 for a new kit.

Contact BioReference at 888-279-0967 with questions regarding assistance with obtaining a new kit.

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.

Store the kit at room temperature (between 59°F to 86°F) before and after use. Before you collect your sample, check with the carrier listed on the return label to make sure that you can mail the sample within 24 hours of collection. Following this, collect your sample as soon as possible because timely testing is important to your health. After collection, mail your sample to the laboratory within 24 hours of collection.

Contact BioReference at 888-279-0967 with questions regarding collecting samples, return shipping, test results/diagnosis, or assistance with obtaining a new kit.

No. Wash your hands with soap and water. Dry your hands thoroughly. Hand sanitizer may interfere with the test result.

Mail your sample to the laboratory within 24 hours of collection.

No. Do not clean your genital area before collecting the sample.

Wait at least one hour after you last urinated before collecting your sample.

If your tube has leaked or spilled, contact BioReference at 888-279-0967 for a new kit.

When you transfer urine to the tube, it is important that the liquid level is between the MIN and MAX lines. There may be bubbles on the liquid. The top of bubbles do not count as the top of the liquid.

If the tube is overfilled (above the window), do not remove urine from the tube or your result could be incorrect. Contact BioReference at 888-279-0967 for a new kit.

Yes. Please find the sample tube label and biohazard bag label in your language and fill out both labels with first name, last name, date of birth, and date of collection. Apply one of the labels to the sample tube and the other label on the biohazard bag.

You will not receive your results.

Peel the self-adhesive tape on the box and close the lid to seal the box.

The return mailing label is in the mailing pouch your kit arrived in.

Find the return mailing label in the mailing pouch your kit arrived in. Stick the return mailing label on the bottom of the return box — do not cover UN3373 label! Return using the carrier listed on the return label.

Log in to your BioReference Patient Portal account to access your results.

A positive result means that the test detected one or more of the sexually transmitted infections tested with the Alinity m STI Test (Gonorrhea, Chlamydia, Trichomoniasis, and M. genitalium infection in the urine sample). Talk to your healthcare provider about your result and the next steps in treatment. For additional information on sexually transmitted infections, refer to the following CDC websites: Sexually Transmitted Infections (STI) www.cdc.gov/std/ Fact Sheets on STIs: www.cdc.gov/sti/communication-resources/index.html  Please note: NY Patients: NY Department of Health requires that all positive Gonorrhea, Chlamydia, Herpes, LGV, and Syphilis be reported via ECLRS electronically within 24 hours of the test result. Local or State Health Departments may contact the patients to ensure they have received treatment. Trichomonas is not a reportable disease in NY. NJ Patients: NJ Department of Health requires all positive Gonorrhea, Chlamydia, LGV, and Syphilis be reported via CDRSS electronically within 24 hours of the test result. Local or State Health Departments may contact the patients to ensure they have received treatment. Trichomonas and herpes are not reportable diseases in NJ.

A negative result means that the test did not detect the four sexually transmitted infections tested with the Alinity m STI Test (Gonorrhea, Chlamydia, Trichomoniasis, and M. genitalium infection) in the urine sample. It can take up to a few weeks from time of exposure for some of these infections to be detected in a sample. If you test during this period, you may receive a negative result even when you have the infection. Also, a urine test will not identify if you have an infection outside of the genital area – for example, oral or rectal infection. Talk to your healthcare provider about your test result and any recommendations for additional testing or follow up.