Question 1

simpli-COLLECT™ Urine Collection Kit

Accepted Answer

Supplemental Video Guide
INSTRUCTIONS FOR USE

Question 2

What is the simpli-COLLECT Urine Collection Kit?

Accepted Answer

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.

Question 3

What sexually transmitted infections will be tested using the urine sample collected with this kit?

Accepted Answer

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.

Question 4

How will the urine sample collected using the simpli-COLLECT Urine Collection Kit be tested in the laboratory?

Accepted Answer

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.

Question 5

How accurate is the Alinity m STI Assay at detecting these infections?

Accepted Answer

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.

Question 6

How can I find more information on sexually transmitted infections?

Accepted Answer

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

Question 7

What happens if I do not follow the instructions?

Accepted Answer

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

Question 8

What if the package arrives damaged, open, or is leaking?

Accepted Answer

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.

Question 9

What should I do if the kit has expired?

Accepted Answer

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.

Question 10

I received my simpli-COLLECT collection kit, but I made a mistake collecting my sample. What should I do?

Accepted Answer

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

Question 11

What should I do if the liquid in the tube gets on my skin or in my eyes?

Accepted Answer

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.

Question 12

How do I store the kit?

Accepted Answer

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.

Question 13

Who should I contact if I have questions?

Accepted Answer

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

Question 14

Can I use hand sanitizer to clean my hands before using the kit?

Accepted Answer

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

Question 15

How long do I have to mail my sample to the laboratory?

Accepted Answer

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

Question 16

Should I clean my genital area before collecting the sample?

Accepted Answer

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

Question 17

When can I collect a urine sample?

Accepted Answer

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

Question 18

What should I do if liquid has leaked or spilled from the sample tube?

Accepted Answer

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

Question 19

How do I know I transferred the correct amount of urine to the sample tube?

Accepted Answer

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.

Question 20

What if I overfill the sample tube, and the urine is above the MAX line?

Accepted Answer

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.

Question 21

Do I need to fill out both the sample tube label and biohazard bag label?

Accepted Answer

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.

Question 22

What happens if I don’t fill out the labels correctly?

Accepted Answer

You will not receive your results.

Question 23

How do I seal the box before mailing it?

Accepted Answer

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

Question 24

Where is the return mailing label?

Accepted Answer

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

Question 25

How do I return my simpli-COLLECT kit?

Accepted Answer

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.

Question 26

How do I get my results?

Accepted Answer

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

Question 27

What does a positive result mean?

Accepted Answer

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.

Question 28

What does a negative result mean?

Accepted Answer

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.

PATIENT RESOURCE CENTER

simpli-COLLECT™ STI

Frequently Asked Questions

For New York and New Jersey patients only