【INTENDED USE】
The Transferrin Rapid Test (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Human Transferrin in feces. 【INTRODUCTION】
Many diseases can cause hidden blood in the feces. Transferrin, which is more resistant to the metabolism in the intestine than that of the Hemoglobin, provides the best complementary way of diagnosing the disease in the upper digestive tract. Transferrin is a blood plasma protein for iron ion delivery. Although iron bound to transferring is less than 0.1% (4 mg) of the total body iron, it is the most important iron pool with the highest rate of turnover (25 mg/24 h). Transferrin imbalance can have serious health effects for those with high serum transferring levels. A patient with an increased serum transferring level suffers from iron deficiency anemia that is one of the most important symptoms when a tumor has caused chronic occult bleeding. The Transferrin Rapid Test (Feces) is a rapid test to qualitatively detect low levels of Human Transferrin in feces. The test uses a double antibody sandwich assay to selectively detect Huma Transferrin at 4ng/ml or higher. In addition, unlike guaiac assays, the accuracy of the test is not affected by the diet of the patients.
【PRINCIPLE】
The Transferrin Rapid Test is a qualitative, lateral flow immunoassay for the detection of Human Hemoglobin and Transferrin in feces. The membrane is precoated with anti-Transferrin antibody on the test line regions of the test. During testing, the specimen reacts with the particle coated with anti-Transferrin antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-Transferrin antibody on the membrane and generate a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line regions, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
【MAIN CONTENTS】
• Rapid test cassette with desiccant.
• Specimen collection tube with Buffer
• Package insert
【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 such as laboratory coats, 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】
• Specimens should not be collected during or within three days of a menstrual period, or if the patient suffers from bleeding hemorrhoids or blood in the urine.
• 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 using the Transferrin Rapid Test (Feces).
【DIRECTION OF USE】
Bring tests, specimens, 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.
【PERFORMANCE CHARACTERISTIC】
Sensitivity Transferrin Rapid Test can detect Human Transferrin at 4ng/ml.
Precision:
Intra-Assay Within-run precision has been determined by using 10 replicates of sixspecimens: Transferrin (4ng/ml, 8ng/ml and 10µg/ml) positive specimens. Thespecimens were correctly identified >99% of the time.
Inter-Assay Between-run precision has been determined by 10 independent assays onthesame six specimens: Transferrin (4ng/ml, 8ng/ml and 10µg/ml) positive specimens. Three different lots of theTransferrin Rapid Test have beentestedusing these specimens. The specimens were correctly identified >99%of thetime.
Cross-reactivity The Transferrin Rapid is specific to human hemoglobin. Specimens containingthe following substances were diluted in the extraction buffer to a concentrationof 1.0 mg/ml, and tested on both positive and negative controls with noeffect ontest results: Bovine hemoglobin, Chicken hemoglobin, Pork hemoglobin, Goat hemoglobin, Horse hemoglobin, Rabbit hemoglobin and Turkey hemoglobin.
For further operation or performance details, please refer to final instruction manual.
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