|Test Parameter:||H. Pylori Antibody IgG IgM||Principle:||Immunochromatography|
|Storage:||Room Temperature 2-30℃||Main Component:||Rapid Test Cassette + Buffer + Disposable Dropper + IFU|
|Sample:||Whole Blood Serum Plasma||Reading Time:||In 10 Mins|
H Pylori Antigen Test Cassette,
Immunochromatography Antigen Test Cassette,
H Pylori Antigen Rapid Test Cassette
The H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of specific IgM and IgG antibodies to Helicobacter pylori in human whole blood, serum, or plasma specimens. This kit is intended for use as an aid in the diagnosis of H. pylori infection.
Gastritis and peptic ulcers are among the most common human diseases. Since the discovery of H. pylori (Warren & Marshall, 1983), many reports have suggested that this organism is one of the major causes of ulcer diseases (Anderson & Nielsen, 1983; Hunt & Mohamed, 1995; Lambert et al, 1995). Although the exact role of H. pylori is not yet fully understood, eradication of H. pylori has been associated with the elimination of ulcer diseases. The human serological responses to infection with H. pylori have been demonstrated (Varia & Holton, 1989; Evans et al, 1989). The detection of IgG antibodies specific to H. pylori has been shown to be an accurate method for detecting H. pylori infection in symptomatic patients. H. pylori may colonize some asymptomatic people. A serological test may be used either as an adjunct to endoscopy or as an alternative measure in symptomatic patients.
The H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma) detects IgM and IgG antibodies specific to Helicobacter pylori through visual interpretation of color development on the internal strip. H. pylori antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with H. pylori antigen 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 are sufficient antibodies to Helicobacter pylori 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.
Rapid Test Cassette in Pouch
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C).
The test is stable through the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
DO NOT FREEZE.
Do not use beyond the expiration date.
Bring tests, specimens, buffer and/or controls to room temperature (1530°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2. Transfer 1 drop of whole blood or serum or plasma (approximately 25 µL) to the specimen well (S) of the device with the provided disposable pipette, then add 3 drops of buffer and start the timer.
Allow 1 drop of whole blood or fingerstick whole blood specimen (approximately 25 µL) to the specimen well (S) of the device, then add 3 drops of buffer and start the timer.
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 result area in the center of the device.
3. Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.
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.
For details, please contact Dewei staff for Instruction Manual!