Tumor Marker Faecal Occult Blood FOB Rapid Test Kit Stool Feces Sample Screening for Colorectal Cancer Evaluation
INTENDED USE
The Feacal Occult Blood FOB Rapid Test Kit (Feces) is a rapid visual immunoassay for the qualitative, presumptive detection of human hemoglobin in human fecal specimens. This kit is intended for use as an aid in the diagnosis of lower gastrointestinal (g.i.) pathologies.
INTRODUCTION
Colorectal cancer is one of the most commonly diagnosed cancers and a leading cause of cancer-related death in the United States. Screening for colorectal cancer is likely to improve the odds of detecting cancer at an early stage, reducing mortality.
Earlier commercially available FOB tests utilized a guaiac test, requiring special dietary restrictions to minimize false positive and false negative results. The FOB Rapid Test Device (Feces) is designed especially to detect human hemoglobin in fecal samples using immunochemical methods, improving specificity for the detection of lower gastrointestinal disorders, including colorectal cancers and adenomas, without the need for dietary restrictions
TEST PRINCIPLE
The FOB Rapid Test Device (Feces) detects human hemoglobin through visual interpretation of color development on the internal strip. Anti-human hemoglobin antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-human hemoglobin antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient human hemoglobin in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
MAIN CONTENTS
• Rapid test Cassette with desiccant.
• Specimen dilution tubes with buffer
• Instructions for use.
STORAGE AND STABILITY
• Store at 2 ~ 30 º C in the sealed pouch for 18 months.
PRECAUTIONS
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local regulations.
SAMPLE COLLECTION
• The FOB Rapid Test Device (Feces) is intended for use with human fecal specimens only.
• Patients should not collect samples during or within 3 days of their menstrual period if they have bleeding hemorrhoids, blood in the urine, or if they experienced strain during their bowel movement.
• Alcohol, aspirin and other medications taken in excess may cause gastrointestinal irritation resulting in occult bleeding. Such substances should be discontinued at least 48 hours prior to testing.
• No dietary restrictions are necessary before testing.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72 hours.
• Bring specimens to room temperature prior to testing.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
OPERATION
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
• Specimen collection and pre-treatment:
Unscrew and remove the dilution tube applicator. Be careful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces.
Replace the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
Shake the specimen collection tube vigorously to mix the specimen and extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.
• Testing
Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 3 drops of solution into the specimen well (S) of the test device.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
• Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes..
INTERPRETATION
POSITIVE:
Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE:
Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
INVALID:
Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
PERFORMANCE
Sensitivity 98.3%
Specificity 98.0%
FRQ:
| 1 |
What does a positive fecal occult blood test mean? |
A positive FOBT result means that blood has been found in the stool. Your doctor will have to determine the source of the bleeding, either by doing a colonoscopy or through an examination to find out if the bleeding is coming from the stomach or small intestine. |
| 2 |
What does occult blood in feces mean? |
A test that checks for occult (hidden) blood in the stool. A small sample of stool is placed in a special collection tube or on a special card and sent to a doctor or laboratory for testing. Blood in the stool may be a sign of colorectal cancer or other problems, such as polyps, ulcers, or hemorrhoids. |
| 3 |
What is the normal range for occult blood? |
Fecal Occult Blood Testing. It is normal to lose 0.5 to 1.5 mL of blood daily in the gastrointestinal tract, and melena usually is identified when more than 150 mL of blood are lost in the upper gastrointestinal tract. |
| 4 |
What is a normal fit test range? |
FIT results of more than 10 are deemed positive – patient has a 1 in 4 chance of Lower GI cancer. When FIT is less than 10 it suggests a low probability of Lower GI cancer, although these do occur. Patients with bowel cancer and a FIT less than 10 often have other symptoms. |
| 5 |
What happens if a stool test is positive? |
What does a positive fecal occult blood test mean? If your FOBT is positive, there could be bleeding in your digestive tract. It may signal colorectal cancer, but it isn't a cancer diagnosis. Typically, if the result is positive, your provider will call you to talk about next steps. |
| 6 |
Is blood in stool serious? |
Takeaways. Blood in your stool could mean you have hemorrhoids, constipation, or something more serious like inflammatory bowel disease or cancer. The blood might clear up on its own, but if it lasts over 3 weeks or the bleeding is heavy, you should see your doctor to get some answers. |
| 7 |
What is the treatment for occult blood? |
Treatment: Several nonoperative therapies are available, such as pharmacotherapy, intravascular embolization, endoscopic sclerotherapy, or banding. However, in cases of significant bleeding, surgical resection may be required. |
| 8 |
Is occult blood good or bad? |
Occult blood in the stool may indicate colon cancer or polyps in the colon or rectum — though not all cancers or polyps bleed. |
| 9 |
What causes occult bleeding? |
Although tumors and vascular anomalies are the most common causes of occult small-bowel bleeding, mucosal disease must also be considered. Celiac disease is a well-recognized cause of IDA that may result from malabsorption of iron or perhaps occult bleeding. |
| 10 |
Can piles cause a positive FIT test? |
A positive FIT test will tell your doctor that you have bleeding occurring somewhere in your gastrointestinal tract. This blood loss could be due to ulcers, bulges, polyps, inflammatory bowel disease, haemorrhoids (piles), swallowed blood from bleeding gums or nosebleeds, or it could be due to early bowel cancer. |
| 11 |
What is normal stool report? |
Normal: The stool appears brown, soft, and well-formed in consistency. The stool does not contain blood, mucus, pus, undigested meat fibers, harmful bacteria, viruses, fungi, or parasites. |
| 12 |
How serious is a positive FIT test? |
FIT cannot tell the difference between bleeding from colorectal cancer and bleeding for other reasons, such as hemorrhoids or menstruation (your period). An abnormal FIT result could mean you have colorectal cancer, even if you feel healthy or no one else in your family has the disease. |
| 13 |
Is 400 high on FIT test? |
Prioritised Urgent Suspicion of Cancer access should be given to patients with an abdominal or rectal mass or a qFIT ≥ 400gHb/g faeces. Where there is capacity, direct to test triage should be considered. |
| 14 |
What is an abnormal fit result? |
An abnormal FIT result means that blood was found in your stool (poop) sample. Abnormal FIT results are common and do NOT mean that you have cancer. On average, 10-15% of people screened with FIT have an abnormal result and need more testing. |
| 15 |
What is the most common cause of occult blood? |
Some of the more common causes include colon cancer, esophagitis, peptic ulcers, gastritis, inflammatory bowel disease, vascular ectasias, portal hypertensive gastropathy, gastric antral vascular ectasias, and small bowel tumors (eg, GI stromal cell tumor, lymphoma, carcinoid, adenocarcinoma, or polyp). |
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