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Product Description
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********* H.pylori Ab (Helicobacter pylori)test kit *********
Format
|
strip, cassette
|
Specimen
|
Whole blood/serum/plasma |
Accuracy
|
Over 99%
|
Read time
|
10-15mins
|
Expiry date
|
24-36months
|
Certificate
|
CE, FSC,ISO13485
|
Specification
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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, 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 |
Product Paramenters
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Example of statistical results of reagent of 240 samples
|
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
|
REAGENT PREPARATION AND STORAGE
Store test device unopened at 2°C-30°C. If stored at 2°C-8°C, ensure that the test device is brought to room
temperature before opening. Do not freeze the kit or expose the kit over 30°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 2-8 0C, the whole blood sample should be used within three days.
For serum/plasma:
Blood should be collected aseptically into a clean tube without anticoagulants. Separate the serum or plasma from blood
as soon as possible to avoid hemolysis. Use clear non-hemolyzed specimens when possible.
Procedure of H. pylori Ab test kit
> Step 1: When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test
from the pouch.
> Step 2: 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.
Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, nonabsorbent surface
(e.g., mouth of the serum container).
For Cassette Test:
Drip 2 or 3 drops of specimen into the sample window.
>Step 3 : Wait 10-15 minutes and read result. Do not read results after 30 15 minutes.
How to read the result of Dengue IgG/IgM and NS1 test kit
>1. Negative: Only one pink band appears on test region.
>2. Positive: Two pink bands appear on test region.
>3. Invalid: If without colored band appears on test region, this is an 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 Ab test kit
≡1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid
≡2. Use it before expiry date.
≡3. The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
≡4. Old Serum can not be used. If the serum is thick, it can be used only after being separated.
More rapid test products for your reference.
Packing & Delivery
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Package: go as normal package or as per clients needs.
Out carton size:63*26*49CM; Gross weight: 13KG
Shipping: by sea or by air.
Company Profile
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*Nantong Diagnos Biotechnology Co., Ltd. (Diagnos) is a professional POCT (point-of-care testing)
manufacturer in China, found in 2006, specialized in researching, developing, manufacturing and
distributing advanced medical instruments and in-vitro medical diagnostic products.
*Diagnos offers quality products in the following specialties: Fertility, Infectious Diseases, Tumor Markers,
Cardiac Markers, Substance of Drug Abuse tests and etc.
*With the strong support from the government, Diagnos has obtained ISO9001 certificate, ISO13485
certificate and CE Mark already.
*Diagnos focuses on excellent client-centered support with experienced sales and marketing team that is
fluent in both Chinese and English, in addition to strong international import - export experience.
Our Advantages
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FAQ
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1. Q: Sample available?A: Reasonable quantity free samples will be available to sent for quality evaluation.
2. Q: Do you have minimum order quantity requirements?A: Yes, but quantity can be negotiated.
3. Q: Can we visit your factory?A: sure, welcome you to visit our factory any time.
4. Q: How to ensure the cargo quality?A: A professional QC team will control the goods quality during all the mass production or a third party inspection service
could be arranged at your expense if you want. We will supply bulk sample for evaluation before shipping.
6. Q: Which certificates do you have?A: We already got CE 0123, ISO13485 and ISO 9001 certificate.
7. Q: How to pay?A: Payment can be made by paypal, western union, bank transfer, etc.