H pylori IgG Test
Lateral flow test to detect helicobacter pylori IgG antibody in serum/plasma sample
Catalog #:AN1001C
INTENDED USE
The H. pylori Rapid Test is a rapid lateral flow, qualitative immunoassay. It is intended for use at point of care facilities to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human serum. It provides an aid in the diagnosis of infection by H. pylori. This test has been evaluated for use with serum specimens of adults, 19 years and older.
SUMMARY AND EXPLANATION
Helicobacter pylori has been associated with a variety of gastrointestinal diseases including gastritis, duodenal and gastric ulcer, non-ulcer dyspepsia, gastric adenocarcinoma and lymphoma. The exact role that H. pylori plays in gastrointestinal disease still needs to be precisely defined. However, the prevalence rates for H. pylori infection as demonstrated by histological and bacteriological methods can approach 90% in patients who present clinical symptoms of the gastrointestinal diseases listed above. H. pylori does not appear to invade the bloodstream since no isolates yet have been detected using commercial blood culture methods. H. pylori infections occur in human populations throughout the world. In developed countries, about 50% of the population may have H. pylori infection by the age of 60 years, while only 10-20% of adults in the third decade have it.
In patients who present clinical symptoms relating to the gastrointestinal tract there are two major methods of investigation: invasive and noninvasive. Invasive methods include culture of gastric biopsy samples, histologic examination of stained biopsy specimens, or direct detection of the urease activity in the biopsy (CLO test). These methods need to obtain a biopsy sample by endoscopy, which is expensive, and usually results discomfort and risk to the patient. Noninvasive techniques include urea breath tests and serological methods. Urea breath test requires the use of a small amount of radioactivity and a mass spectrometer. Serologic tests are employed to detect antibodies as human immune response to H. pylori.
This device detects IgG antibodies specific to H. pylori infection in patient’s sera and plasma. It is a noninvasive method and does not use radioactive isotopes; the assay procedures are easy and do not require professional training; it provides a rapid result. It is a useful on-site aid in the diagnosis of H. pylori infection.
PRINCIPLE OF THE PROCEDURE
This assay is a double antigen chromatographic lateral flow immunoassay. The test strip in the device includes: 1) a burgundy-colored conjugate pad containing colloidal gold coupled with H. pylori antigens, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with H. pylori antigens, and the C line is coated with goat anti-H. pylori antibody. The antigens used in this device are from H. pylori cell lysate.When IgG antibodies specific to H. pylori are present in the specimen, the T line
will become a burgundy-colored band. If antibodies to H. pylori are not present or are present below the detectable level, no T line will develop. The C line should always appear as a burgundy-colored band regardless of the presence of antibodies to H. pylori. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred.
REAGENTS
Materials provided with the kits:
1. Test Device 25pcs
2. Instruction for use
PRECAUTION FOR USERS
1. For in-vitro diagnostic use only.
2. Must not use kit beyond the expiration date.
3. Do not mix components from kits with different lot number.
4. Avoid microbial contamination of reagents.
5. Do not pipet reagent by mouth and no smoking or eating while performing assays.
6. Wear gloves during the whole process and avoid reagents or specimen spilling-out.
7. Wipe up the spills using 5% hypochlorite solution.
8. Decontaminate all liquids or solid wastes before deposing.
SPECIMEN COLLECTION
For serum, collect blood into a container without anticoagulant. Allow the blood to clot and separate the serum from the clot. Use the serum for testing. If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer.
Bring the specimens to normal room temperature before testing. Do not freeze and thaw the specimen repeatedly.
STORAGE OF TEST KIT
The HP IgG Test can be stored at any temperature between 4-30°C. Do not freeze. The stability of the kit under these storage conditions is 24 months. Use up the reagents as soon as possible after the kit is unpacked within 3 months.
TEST PROCEDURE
1. When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.
2. Draw 0.2ml (about 4 drops) sample into the pipette, and dispense it into the sample well on the cassette.
3. Wait 5-8 minutes and read results. Do not read results after 10 minutes.
INTERPRETATION OF RESULTS
Negative: One pink line appears in control line, showing the test has been carried out correctly.There will be no line in test region
Positive: In addition to a pink colored control line, a distinct pink colored band will also appear in the test region.
Invalid: A total absence of color in both regions is an indication of procedure error and/or that the test reagent has deteriorated. The test should be repeated using a new strip.
PERFORMANCE
TDL HP IgG ELISAReference Test(Lateral Flow) / Positive / Negative
Positive / 110 / 3
Negative / 5 / 179
Specificity: 179/(179+3)=98 %
Sensitivity: 110/(110+5)= 95%
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Revision: AB200804
Manufacturer:
Biocare Diagnostics Ltd.
6F, Building B, 108 Xinghua Road
Xiangzhou, Zhuhai, China 519000
Tel: +86-756-8238560
E-mail:
Website: www.ivdbiocare.com
April 10, 2008 Revision: 03