Hemoccult ICT Immunochemical Fecal Occult Blood Test

The Hemoccult ICT (Immunochemical Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detecting human hemoglobin in fecal samples. Fecal occult blood tests are valuable screening tools for identifying lower gastrointestinal (g.i.) disorders, such as iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers, and other g.i. lesions that may bleed. Hemoccult ICT is recommended for use by health professionals during routine physical examinations or when lower g.i. disorders are suspected.

The Hemoccult ICT operates on the principle of immunochromatography to detect human hemoglobin in fecal samples. Each test requires a Collection Card and a Test Device. A portion of feces from two different areas of the stool is thinly smeared onto the Collection Card for sample transport to the testing site. The dried sample is then transferred from the Collection Card to the Test Device using a pull-out Sample Tab and rehydrated with buffer to extract hemoglobin. Upon closing the Test Device, the sample contacts the test strip, initiating chromatographic flow. If hemoglobin is present, it forms a visible Test Line, indicating a positive result. In the absence of hemoglobin, no Test Line forms, indicating a negative result. Unbound conjugate migrates down the test strip and binds to the Control Line, confirming the test's validity.

Features:

• CLIA Waived
• Results in 5 Minutes
• 14-day On-slide Stability
• Built-in Test Validity Controls
• No Patient Dietary Restrictions
• Only Detects Human Hemoglobin

Materials:

Materials provided:

• Hemoccult ICT Test Devices containing goat anti-human hemoglobin polyclonal antibodies (Test Line), conjugate-specific polyclonal antibodies (Control Line), and goat anti-human hemoglobin conjugate (polyclonal antibodies bound to colored particles); all antibodies are from a U.S. source.
• Hemoccult ICT Buffer (8 mL) containing phosphate buffered saline, bovine serum albumin (from a U.S. source), and 0.09% sodium azide.

Materials required but not provided:

• Hemoccult ICT Collection Cards
• Timer

Precautions:

1. For In vitro Diagnostic Use.
2. CAUTION: Observe universal safety precautions and other appropriate laboratory procedures when collecting and handling patient fecal samples. All samples and materials that come in contact with them should be handled as potentially infectious.
3. Use Hemoccult ICT Collection Cards in the single card kits or Patient Screening Kits for preparing fecal samples.
4. DO NOT remove Test Devices from protective foil pouches until ready to use.
5. DO NOT use Test Devices and reagents beyond their labeled expiration dates.
6. DO NOT use any reagents from a container that appears to have leaked.
7. WARNING: The buffer contains sodium azide. Sodium azide may react with lead or copper plumbing to form highly explosive metal azides. Upon disposal, flush with large volumes of water to prevent azide buildup. Avoid reagent contact with eyes, mucous membranes or skin lesions. If contact occurs, flush affected area with water for 15 minutes and consult a physician.

Storage and Stability:

Store product at 2 to 8˚C; DO NOT FREEZE. When stored as directed, Hemoccult ICT Test Devices and components are stable until their labeled expiration dates. Alternatively, the Hemoccult ICT Test Device Kit may be stored at controlled room temperature, 15 to 30˚C for up to 90 days.

Under these storage conditions, the kit expires 90 days from the date it is placed at room temperature or the stated expiration date on the kit, whichever occurs first. If the product is stored at room temperature, the room temperature expiration date should be written on the outside of the kit box.

Patient Preparation:

No special drug or dietary restrictions are required for this test. However, patients should closely follow the Patient Instructions to assure the most accurate test results. Patients should not collect samples three days before, during or three days after their menstrual period, if they have bleeding hemorrhoids, blood in their urine, open cuts on their hands, or if they have strained during their bowel movement.

Roughage in the diet can increase test accuracy by helping uncover “silent” lesions which bleed intermittently.

Test Procedure:

Step 1:

• Bring Test Device (in sealed pouch) and Buffer to room temperature (15 to 30˚C).
• When ready, remove from pouch.
• Open Test Device, bend back and lay it flat on a level surface.

Step 2:

• From back of Collection Card, remove Sample Tab.
• Lift up blue Sample Tab from bottom.
• Pull off as shown.

Step 3:

• Place Sample Tab, blue side down in Test Device with fecal sample on top of Sample Pad.

Step 4:

• Add three (3) free-falling drops of Hemoccult ICT Buffer to center of sample on Sample Pad.

Step 5:

• With Test Device flat on surface, close device by snapping shut.
• Keeping device flat, wait 5 minutes.
• Read test Result.
• (DO NOT reopen Test Device.)

• The product warranty is applicable as per the terms and conditions provided by the product manufacturer.

Please call us for specific details.

• No returns will be accepted after 30 days from the date of shipment.
• All returns are subject to a restocking fee as per manufacturers terms and conditions.
• All returns must have an RGA number (Returned Goods Authorization), unauthorized returns will not be accepted.
• We do not guarantee fulfillment of any desired purpose or product suitability to the user and this will not be considered as a valid reason for return.
• The products must be new, unused condition, not tampered with, in original packaging and returned at the customers expense in the original packaging.
• If your return is not due to any manufacturing defect then the original shipping cost will be deducted from the total refund.
• Hygiene, bath and toilet items cannot be returned once opened or used.
• Standard manufacturer terms and conditions apply for return policy of this product.

Please call us for specific details.