Hemoccult Sensa Dispensapak Plus Test Kit is a rapid, qualitative method for detecting fecal occult blood, indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. Recommended for professional use, it aids in diagnosing gastrointestinal bleeding in patients with iron deficiency anemia, recovery from surgery, peptic ulcer, ulcerative colitis, and is useful in colorectal cancer screening programs when patient instructions are closely followed. Serial fecal specimen analysis is recommended for asymptomatic patients. The Hemoccult SENSA test and other unmodified guaiac tests are not recommended for use with gastric specimens.

The Hemoccult Sensa test detects abnormal bleeding associated with gastrointestinal disorders more reliably than standard guaiac tests, offering higher sensitivity but also a higher false-positive rate among non-diet compliant patients. Positive results appear as stable, intense blue color reactions, improving readability and precision. Accuracy depends on the patient's status at specimen collection and may be affected by interfering substances.

The Hemoccult Sensa test is a simplified, standardized variation of the laboratory guaiac procedure for detecting occult blood. Its formulation includes an enhancer, making it more sensitive and readable than other guaiac-based tests. It requires only a small fecal specimen, minimizing offensive odors and eliminating the need for storing or transporting large fecal specimens.

Features:

• CLIA Waived
• Results in 1 Minute
• 14-day On-slide Stability
• Built-in Test Validity Controls

Contents:

• (40) Patient Screening Kits
• (2) 15 mL Bottles of Hemoccult Sensa Developer
• Product Instructions

Precautions:

• For in vitro diagnostic use.
• Do not use after expiration date which appears on each test component.
• Because this test is visually read and requires color differentiation, it should not be interpreted by individuals with blue color deficiency (blindness).
• Patient specimens, and all materials that come in contact with them, should be handled as potentially infectious and disposed of using proper precautions.
• Keep cover flap of slide sealed until ready to use. Protect slides from heat, light, and volatile chemicals (e.g., ammonia, bleach, bromine, iodine, household cleaners). Hemoccult SENSA slides present no hazard to the user.
• Hemoccult SENSA Developer should be protected from heat and the bottle kept tightly capped when not in use. It is flammable and subject to evaporation.
• Hemoccult SENSA Developer is an irritant. Do not use in eyes. Avoid contact with skin. Should contact occur, rinse promptly with water and consult a physician.

Storage and Stability:

• Store product at controlled room temperature (15 to 30°C) in original packaging.
• Do not refrigerate or freeze.
• Protect from heat and light.
• Do not store with volatile chemicals (e.g., ammonia, bleach, bromine, iodine, household cleaners).
• The Hemoccult SENSA Slides and Developer will remain stable until the expiration dates which appear on each slide and developer bottle when stored as recommended.

Test Procedure:

Step 1. Identification:

• Using a ball-point pen, write patient name, age, address, phone number, sample collection date and physician name on front of slide in space provided.

Step 2. Preparing the Test:

• Using applicator provided, collect small fecal sample.
• Apply thin smear covering Box A.
• Reuse applicator to obtain second sample from a different part of feces. Apply thin smear covering Box B.
• Close cover flap. Dispose of applicator in waste container.

Step 3. Developing the Test:

• Slides are best developed no sooner than three days after sample application to allow for degradation of any fruit and vegetable peroxidases that may be present in the fecal sample. However, if immediate testing is required, wait 3 to 5 minutes before developing.
• Open back of slide and apply two drops of Hemoccult SENSA Developer to guaiac paper directly over each smear.
• Read results within 60 seconds. Any trace of blue on or at the edge of the smear is positive for occult blood.

Step 4. Developing the Performance Monitors Feature:

• The Performance Monitors areas must be developed on every slide.
• Apply one drop of Hemoccult SENSA Developer between the positive and negative Performance Monitors areas.
• Read results within 10 seconds. If the slide and developer are functional, a blue color will appear in the positive Performance Monitors area and no blue will appear in the negative Performance Monitors area.
• Neither the intensity nor the shade of the blue from the Positive Performance Monitors area should be used as a reference for the appearance of positive test results.
• Any blue originating from the positive Performance Monitors area should be ignored when reading the sample test results.