Testsealabs Helicobacter Pylori+Fecal Occult Blood+Transferrin Combo Test
Short Description:
H.pylori Antigen/Fecal Occult Blood/Transferrin Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of H.pylori, human hemoglobin and human transferrin in feces.
 Rapid Results: Lab-Accurate in Minutes |
Lab-Grade Precision: Reliable & Trustworthy |
| Test Anywhere: No Lab Visit Required |
Certified Quality: 13485, CE, Mdsap Compliant |
| Simple & Streamlined: Easy-to-Use, Zero Hassle |
Ultimate Convenience: Test Comfortably at Home |
H.pylori Antigen/Fecal Occult Blood/Transferrin Combo Test Cassette Instruction Manual
FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY
Intended Use
H.pylori Antigen/Fecal Occult Blood/Transferrin Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of H.pylori, human hemoglobin and human transferrin in feces.
Summary
H.pylori is associated with a variety of gastrointestinal diseases including non-ulcer dyspepsia, duodenal and gastric ulcer, and active, chronic gastritis. The prevalence of H.pylori infection could exceed 90% in patients with signs and symptoms of gastrointestinal diseases. Recent studies indicate an association of H.pylori infection with stomach cancer.
Many diseases may result in hidden blood in the feces. This is known as fecal occult blood (FOB), human occult blood, or human hemoglobin. In the early stages, gastrointestinal problems such as colon cancer, ulcers, polyps, colitis, diverticulitis, and fissures may not show any visible symptoms, only occult blood.
Transferrin (TF) mainly exists in plasma, with an average content of about 1.20~3.25g/L. It is almost undetectable in the feces of healthy people. When gastrointestinal bleeding occurs, transferrin flows into the gastrointestinal tract and is excreted with feces, so it is abundant in the feces of patients with gastrointestinal bleeding.
Principle
H.pylori Antigen/Fecal Occult Blood/Transferrin Combo Test Cassette is a qualitative membrane strip-based immunoassay for the detection of H.pylori/human hemoglobin/human transferrin in human feces.
In this test procedure, H.pylori/human hemoglobin/human transferrin antibody is immobilized in the test line region of the device. After an adequate volume of test specimen is placed in the specimen well, it reacts with H.pylori/human hemoglobin/human transferrin antibody-coated particles that have been applied to the specimen pad.
This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized H.pylori/human hemoglobin/human transferrin antibody. If the specimen contains H.pylori/human hemoglobin/human transferrin antigen, a colored line will appear in the test line region indicating a positive result.
If the specimen does not contain H.pylori/human hemoglobin/human transferrin antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Reagents
The test contains H.pylori antibody, hemoglobin antibody and transferrin antibody as the capture reagent, another H.pylori antibody, hemoglobin antibody and transferrin antibody as the detection reagent. A goat anti-mouse IgG antibody is employed in the control line system.
Storage and Stability
- Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉).
- The test device is stable through the expiration date printed on the sealed pouch.
- The test must remain in the sealed pouch until use.
Materials
Materials Provided
- Test device
- Package insert
Materials Required But Not Provided
- Timer
- Specimen collection container
Precautions
- For professional in vitro diagnostic use only. Do not use after expiration date.
- 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 all procedures and follow the standard procedures for proper disposal of specimens.
- Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
- Follow standard biosafety guidelines for handling and disposal of potential infective material.
- Humidity and temperature can adversely affect results.
Specimen Collection and Preparation
- The H.pylori Antigen/Fecal Occult Blood/Transferrin Combo Test Cassette can be performed on feces.
- Remove the test device from the sealed pouch. Collect a random stool sample in a clean, dry receptacle. Open the extraction tube and use the specimen collection applicator to randomly pierce the stool sample in at least five different sites. Do not scoop stool sample as this may lead to an invalid test result. Excess stool sample may lead to an invalid test result.
- Specimen collected may be stored for 3 days at 2-8℃ if not tested within 6 hours. For long-term storage, specimens should be kept below -20℃.
- Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
Test Procedure
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30℃ or 59-86℉) prior to testing.
- Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
- Place the test device on a clean and level surface.
- Press and tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the dilution buffer.
- Holding the sample collection tube upright, remove the limiter and press the extraction tube to allow the solution to flow out, then start the timer.
- Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 15 minutes.
Interpretation of Results
- Positive: Two lines appear. One line should always appear in the control line region (C), and another apparent colored line should appear in the test line region.
- Negative: One colored line appears in the control region (C). No apparent colored line appears in the test line region.
- Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
