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Status BTA Sales

Status BTA Sales

Status BTA Sales

Product catalog summary
Overview: The document describes the Status BTA test, a rapid in vitro immunoassay for the qualitative detection of bladder tumor-associated antigen in human urine. It is designed to aid in the management of bladder cancer patients, particularly in conjunction with cystoscopy.
Specifications:
  • CLIA Waived.
  • Results available in 5 minutes.
  • Requires only 3 drops of urine; no sample preparation needed.
  • Uses monoclonal antibodies for detection.
  • Detects early-stage recurrence that cytology may miss.
Procedure:
  1. Bring test materials and urine sample to room temperature.
  2. Remove test device and pipette from packaging, discard desiccant.
  3. Fill pipette with urine and add 3 full drops to the sample well.
  4. Start timer and read results at 5 minutes, but no later than 6 minutes.
  5. Discard used materials in a biohazard container.
Interpretation of Results:
  • Positive Result: Any pink or reddish-brown line in the Test Position (T) indicates a positive result.
  • Negative Result: No colored line in the Test Position (T) indicates a negative result.
  • Invalid Test Result: No line in the Control Position (C) means the test is invalid and must be repeated.
Ordering Information:
  • Status BTA (10 tests) - Item #39010
  • Status BTA (25 tests) - Item #39025
  • Status BTA Control Kit (2 x 1.0 mL) - Item #200019
Contact Information: A PBM Group Company, 85 Orchard Road, Skillman, New Jersey, 08558. Phone: 800.526.2125, Fax: 732.246.0570, Website: www.lifesignmed.com
Additional Information: Tumor markers are substances used to help diagnose cancer, predict response to therapies, and check for recurrence. The Status BTA test is particularly useful for monitoring bladder cancer patients, offering a simple and comfortable urine sample collection method.
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Catalog excerpts

Status BTA Sales-1

A Rapid Test For the Qualitative Detection of Bladder Tumor Associated Antigen in Human Urine CLIA Waived Results available in 5 minutes Simple procedure requires only adding 3 drops of urine to test device ; no sample preparation needed Accurate test results with superior sensitivity and specificity Uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine Detects early stage recurrence cancer that cytology1 may miss 1: Cytology: a branch of pathology; the medical specialty that deals with making diagnoses of diseases and conditions through the examination of tissue or body fluid (blood, urine, etc) samples. In order for cytology examination to be carried out, the material to be examined is placed onto glass slides and stained. A physician then uses a microscope to examine the individual cells in the sample. 2: Cystoscopy: A procedure in which a lighted optical instrument called a cystoscope is inserted through the urethra to look at the bladder. A physician may perform a cystoscopy to explore the cause of many urinary conditions. Webster's New World™ Medical Dictionary, 3rd Edition (May 2008) Wiley Pub

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Status BTA Sales-2

Refer to product instructions for details. 1 Bring test materials and patient urine sample to room temperature (17 - 37°C, 1) Check the Control Position (C). A pink or reddish-brown line must appear for the test to be valid. 63 - 99°F). Gently swirl to mix patient's urine sample. 2) Positive Result: Carefully look at Test Position (T). ANY pink or reddish-brown colored line, NO MATTER HOW FAINT, in the Test Position (T) is a positive result. Neither the intensity nor the color should be compared to that seen in the Control Position (C). 2 Remove the test device and transfer pipette from foil...

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