H Pylori Rapid Test Blood/Serum
H Pylori Rapid Test Blood/Serum
The H pylori Antibody Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of specific 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 one of 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 fully understood yet, 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 the specific antibodies to H. pylori has been shown to be an accurate method for detection of H. pylori infection in symptomatic patients. H. pylori may colonize in some asymptotic persons. A sero-logical test may be used either as an adjunct to endoscopy or as an alternative measure in symptomatic patients.
The H. pylori Antibody Rapid Test Device (Whole Blood/Serum/Plasma) detects 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 line will form at the test region of the membrane. The presence of this colored line indicates a positive result, while its absence indicates a negative result. The appearance of a colored line at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
SET-UP OF THE TEST DEVICE
REAGENTS AND MATERIALS SUPPLIED
Individually pouched test devices. Each test contains colored conjugates and reactive reagents precoated at the corresponding regions.
Disposable pipettes. For adding specimens
Buffer. Phosphate buffered saline with Tween 20 and preservative
Package insert. For operating instructions
MATERIAL REQUIRED BUT NOT PROVIDED
Specimen collection container. For specimen collection
Timer. For timing use
Centrifuge. For preparing serum/plasma specimens
STORAGE AND STABILITY
• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Do not freeze.
• Care should be taken to protect components in this kit from contamination.
Do not use if there is evidence of microbial contamination or precipitation.Biological contamination of dispensing equipment, containers or reagents can lead to false results.
INTERPRETATION OF RESULTS
Only one colored line appears, in the control region (C). No colored line appears in the test region (T). A negative result indicates that the specimen contains no H.pyloriantibodies.
Two colored lines appear on the membrane. One line appears in the control region (C) and another line appears in the test region (T). A positive result indicates that H.pylori-antibodies were been detected.
Control line fails to appear. Results from any test which has not produced a control line at the specified reading time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and please contact the local distributor.
1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive. Please note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired
tests are the most likely reasons for control line failure.
• 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.