Format
|
strip, cassette
|
Specimen
|
Whole blood/serum/plasma/Feces |
Accuracy
|
Over 99%
|
Read time
|
10-15mins
|
Expiry date
|
24-36months
|
Certificate
|
CE, FSC,ISO13485
|
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********* H.pylori Ab (Helicobacter pylori) test kit *********
Product Principle of H.pylori Ab test kit
The infection of Helicobacter pylori (H. pylori) is associated with a variety of gastro-intestinal diseases, such as stomach
ulcers,Ā chronic active gastritis and gastrointestinal adenocarcinoma.
Antibodies to H. pylori are developed in individuals infected with H. pylori as a serological response.
Detecting specific antibodies to H. pylori can be used as a qualitative assay in the diagnosis of H. pylori infection, either
as an adjunct to endoscopy or as an alternative measure in symptomatic patients.
The H. Pylori Rapid Test is a chromatographic immunoassay (CIA) for the rapid determination of antibodies to H. pylori in
serum/plasma/whole blood specimens.
The test is to be used as an aid in the diagnosis of infection due to H. pylori.
Product type
|
strip, cassette
|
Usual size
|
Strip: 2.5mm or 3.0mm Cassette: 3.0 or 4.0mm
|
Specimen
|
Whole blood, serum/plasma |
Application period
|
Primary infection period or with symptoms |
Type 1. H. pylori Ab test Strip Size: | 2.5mm 3.0mm |
Type 2. H. pylori Ab test Cassette Size: | 3.0mm 4.0mm |
Type 3. H. pylori Ag test cassette Size: | 3.0mm, 4.0mm |
Storage | Indoor temperature of 2-30 degrees |
Advantage | easy to use, fast to read result, accuracy and stable application, private usage |
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Reagent
|
Control reagent kit
Positive Negative
|
Total
|
Sensitivity: Se=100% Specificity: Sp=100%
False positive rate =0%
False negative rate =0%
Total accordance rate = 100%
|
|
Positive
|
100
|
0
|
100
|
|
Negative
|
0
|
140
|
140
|
|
Total
|
100
|
140
|
240
|
Store test device unopened at 2Ā°C-30Ā°C.Ā If stored at 2Ā°C-8Ā°C, ensure that the test device is brought to room
temperature before opening. Do not freeze the kit or expose the kit over 30Ā°C.
Specimen of H. pylori Ab test Collection and Handling
For whole blood:
Collect whole blood into a collection tube by venipuncture. If specimens are not immediately tested, they should be
refrigerated at 2-80C. Freezing is recommended if the storage periods are more than 3 days. They should be brought to
room temperature before testing. Using the specimen after long-term storage of more than three days can cause
non-specific reaction. When stored at 2-8Ā 0C, the whole blood sample should be used within three days.
For serum/plasma:
Blood should be collected aseptically into a clean tube withoutĀ anticoagulants. Separate the serum or plasma from blood
as soon as possibleĀ to avoid hemolysis. Use clear non-hemolyzed specimens when possible.
Procedure ofĀ H. pylori Ab test kit
> Step 1:Ā WhenĀ youĀ areĀ readyĀ toĀ beginĀ testing,Ā openĀ theĀ sealedĀ pouch byĀ tearingĀ alongĀ theĀ notch.Ā RemoveĀ theĀ test
fromĀ theĀ pouch.
> Step 2:Ā For Strip Test:
Immerse the strip into the container wtih the arrow end pointing towards the container.
Do not immerse past the MAX(maximum) line.
TakeĀ theĀ stripĀ outĀ afterĀ 8-10Ā secondsĀ andĀ layĀ theĀ stripĀ flatĀ onĀ aĀ clean,Ā dry,Ā nonabsorbentĀ surface
(e.g.,Ā mouth ofĀ theĀ serumĀ container).
For Cassette Test:
Drip 2 or 3 drops of specimen into the sample window.
>Step 3Ā :Ā Wait 10-15Ā minutesĀ andĀ read result.Ā DoĀ not read resultsĀ after 30Ā 15Ā minutes.
How to read the result ofĀ H. pyloriĀ test kit
>1.Ā Negative:Ā OnlyĀ oneĀ pinkĀ bandĀ appearsĀ onĀ testĀ region.
>2.Ā Positive:Ā Two pinkĀ bandsĀ appearĀ onĀ test region.
>3.Ā Invalid:Ā If without coloredĀ bandĀ appearsĀ onĀ testĀ region,Ā thisĀ isĀ anĀ indication of a possible error in
performing the test.
The test should be repeated using a new device.
WARNINGS AND PRECAUTIONS FOR Using H. pylori AbĀ test kit
ā”1.Ā MustĀ useĀ fresh specimen andĀ avoid repetitiveĀ freezing,Ā theĀ result will be invalid
ā”2.Ā Use it before expiry date.
ā”3.Ā TheĀ packageĀ ofĀ kit shouldĀ notĀ be openedĀ until itĀ reachesĀ theĀ roomĀ temperatureĀ ifĀ itĀ taken out fromĀ the refrigerator.
ā”4.Ā Old Serum can not be used. If the serum is thick, it can be used only after being separated.
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