【INTENDED USE】
The Faecal Occult Blood (FOB) Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of human hemoglobin in human fecal specimens. This kit for auxiliary diagnosis of digestion revealed hemorrhagic disease.
【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.
【PRINCIPLE】
The FOB Rapid Test (Feces) detects human hemoglobin through visual interpretation of color development on the internal strip. Anti-human hemoglobin monoclonal antibody are immobilized on the test region of the membrane. During testing, the specimen reacts with anti-human hemoglobin monoclonal antibody 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
• Package inser
【PRECAUTIONS】
• For professional in vitro diagnostic use only.
• Do not use after expiration date indicated on package. Do not use the test if the foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained. • Read the entire procedure carefully prior to testing.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens. Wear protective clothing, disposable gloves and eye protection when specimens are assayed.
• Humidity and temperature can adversely affect results. • Used testing materials should be discarded according to local regulations.
【STORAGE AND STABILITY】
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
【SAMPLE COLLECTION】
The FOB Rapid Test 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
.
【DIRECTION OF USE】
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Specimen collection and pre-treatment:
1) Use the specimen collection cards provided in the kit for specimen collection. Follow the instructions on the specimen collection card. Other clean, dry containers may also be used for specimen collection. For best results, performed the test within 6 hours after collection.
2) 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.
3) Replace the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.
4) 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.
2. Testing
1) 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.
2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 2 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.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
【QUALITY CONTROL】
• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
【LIMITATIONS】
• The FOB Rapid Test is for professional in vitro diagnostic use, andshouldonlybeused for the qualitative detection of human hemoglobin.
• The presence of blood in stool specimens may be due to causes otherthancolorectal bleeding, such as hemorrhoids, blood in urine or stomachirritation.
• Negative results do not exclude bleeding since some polyps and colorectal regioncancers can bleed intermittently or not at all. Additionally, bloodmaynotbeuniformly distributed in fecal samples. Colorectal polyps at an earlystagemaynotbleed.
• Urine and excessive dilution of specimens with toilet water maycauseerroneoustest results.
• This test may be exhibit decreased sensitivity for upper gastrointestinal bleeding,as blood degrades as it passes through the gastrointestinal tract.
• Not all colorectal bleeding is due to precancerous or cancerous polyps. Aswithalldiagnostic tests, a confirmed diagnosis should only be made by a physicianafterallclinical and laboratory findings have been evaluated.
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