Clinical Genomics InSure-ONE Fecal Immunochemical Test Instructions

Clinical Genomics InSure-ONE Fecal Immunochemical Test

3 Easy Steps

InSure® ONE™ is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. The InSure ONE test is used to aid in the detection of lower gastrointestinal bleeding.

LIMITATIONS OF THIS TEST

• This test detects blood in or on your stool. There are many conditions that may cause blood in your stool so you must follow-up with your doctor if you receive a “positive” test result.
• This test does not replace a physical exam by your doctor.
• A “negative” test result means blood was not found in the sample; however, colorectal lesions may bleed intermittently and blood may not be uniformly distributed in or on the stool, so a negative test result may occur even when a gastrointestinal disease is present.
• Failure to follow the test instructions could affect the test results.

DO THE TEST

• At your next bowel movement

PLEASE READ ALL INSTRUCTIONS BEFORE BEGINNING YOUR TEST

PREPARING TO COLLECT SAMPLES

• You do not have to avoid specific foods or medications
• Eating fruits and vegetables can increase test accuracy
• Remove cleaners or bluing agents in your toilet bowl or tank then flush toilet twice

WHAT’S IN THIS KIT?

• Test card
• (2) Sampling brushes
• (2) Blue waste disposal bags
• Instructions/requisition form
• Return envelope

WARNINGS AND PRECAUTION

DO NOT DO THE TEST IF ANY OF THE FOLLOWING CONDITIONS EXIST

• The test card is expired
• The test card is damaged, dirty, or if tampering is apparent
• If any kit contents are missing.
• You have bleeding hemorrhoids
• Have blood in your urine or see blood in the toilet, contact your doctor
• It is three days before or after your menstrual cycle
• You have bleeding cuts on your hands
• Your toilet water uses salt water or is rusty

For a video demonstration on how to use this kit, please go to clinicalgenomics.com/quest

If you have questions about collecting your sample, call 800-531-3681.

STEP 1. Collect Water Sample

1. Flush toilet and have a bowel movement. Place used toilet paper in one of the blue waste bags in the kit and discard into household trash.

2.  Lift the flap on front of test card.

3. Brush the surface of the stool for 5 seconds. Tap the brush once into toilet to remove excess water (Fig. A).
   
   

4. Brush surface of square 1 with water sample for about 5 seconds (Fig. B) and repeat same process with second brush on square 2. Use second blue waste bag to discard both brushes into household trash.
   

STEP 2. Label Your Sample

1. Complete all fields on removable label (Fig. A) using a ballpoint pen.
   

2. Close flap on test card.

3. Peel off label and use it to seal the flap on the test card.
   Apply label to card as shown (Fig. B).
   

STEP 3. Return Sample

1. Complete the requisition form on the reverse side of these instructions.
2. Place completed requisition form and sealed test card into postage paid envelope.
3. Please mail your sample return envelope as soon as possible — preferably within 48 hours.
   • If your doctor printed a requisition, return it in the envelope with the test card.
   • Do not wrap bag or wrap the test card

For more information about InSure ONE, please visit clinicalgenomics.com/quest

Mail within 48 Hours of Sampling

Manufactured by
ENTERIX, A Clinical Genomics Company
236 Fernwood Ave., Edison, NJ 08837 USA

Mdi Europa GmBH Langenhagerner Str. 71 D-30855 Langenhagan Germany

References

• Quest - Clinical Genomics

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