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The BTA stat® Test Instructions for Home Use
[Part 1 of 2]

Caution: U.S.A. Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory, and use is restricted to, by or on the order of a physician.

THE CONTENTS OF THIS SITE IS FOR INFORMATION ONLY. Not to be used for performing assay. Please refer to most current package insert accompanying your test kit. 


INTENDED USE

The BTA stat test is to be used only under the guidance of a doctor and only by patients who have a history of bladder cancer. Your doctor will use the information from this test along with information from visual bladder examinations (Cystoscopy) to make decisions about your medical care.


WARNINGS AND PRECAUTIONS

  • Please read the ENTIRE brochure before starting the test.

  • Do not use after the expiration date on the label. The expiration date is located on the back of the test device pouch next to the hour glass symbol ( ). The use of an expired device could cause a wrong answer.

  • Store the BTA stat test device at room temperature (60 - 85F). Do not freeze or refrigerate the device or store above 85F as this could cause a wrong answer. 

  • For in vitro diagnostic use only (do not eat). Keep out of reach of children. 

  • Collect urine only in the plastic container provided by your doctor. 

  • Do not use paper or foam cups or any other container as this could cause a wrong answer.

  • Do not reuse the test device. Throw away after using once.

  • Do not use a test device if the package is damaged or opened.

  • Touch only the plastic part of the device. Touching any other part of the device could damage the test device or cause a wrong answer.

  • Use a new dropper (provided with each device) for each test. Reusing a dropper could cause a wrong answer.

  • The test has been designed to work with 5 drops of urine. The test will not work correctly unless 5 fully formed drops of urine are added to the sample well.


MATERIALS REQUIRED

Materials from home            

Materials from your doctor

Stopwatch, clock, or watch that measures seconds

Pen or pencil

Collection cup (Plastic only)

 BTA stat test device


CONTENTS OF THE BTA stat TEST PACKAGE         

 


Collecting and Storing Urine

Collect urine in the clean plastic container provided by your doctor. Do not use any other container for urine collection. Do not collect your first morning urine sample. Collect urine anytime of the day after your first morning urine. Test urine as soon after collection as possible. If testing can not be performed right after sample collection, cover the sample container and store urine at room temperature (60 - 85F) until tested. Store urine sample covered up to 2 days if necessary. 


Before starting the test: Record the test device lot number and expiration date before removing the device from the foil package. The lot number is located on the back of the test device package next to the symbol. The expiration date is located on the back of the test device package next to the hourglass symbol ( ). The expiration date is shown in year (Y) - month (M) format, YYYY-MM; 2002-10 indicates that the device may be used until the last day of October in the year 2002.


CLICK HERE FOR PART 2 OF INSTRUCTIONS FOR HOME USE

 

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