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Basic Info.
Package
Individual Package
Format
Strips/Cassette/Midstream
Accurace
99.9%
Size
3.0mm, 4.0mm, 5.0mm
ODM
Available
OEM
Available
Certificate
CE, ISO
Warranty Period
2 Years
After-Sales Service
Whole Using Lifetime
Transport Package
Wooden Case
Specification
490mmx230mmx100mm
Trademark
XINDRAY MEDICAL
Origin
China
HS Code
3822900000
Production Capacity
10000
Product Description
Home Use One Step Rapid Medical Diagnostic H. Pylori Rapid Test Kits Colloidal Gold With Best Quality
H.pylori Ab (Helicobacter pylori)test kit
| Format | strip, cassette |
| Specimen | Whole blood/serum/plasma/Feces |
| 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
| Reagent | Control reagent kit Positive Negative | Total | 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 H. pylori 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.
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 H. pylori 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.
Q1: How to buy your products?
You can place order to our company directly on online platform, or contact our salesperson for help, they will confirm order details like product configuration, shipping matters etc with you, and give you guidance for all process from purchase to arrival of your goods.Q2: What's the payment mode?
We accept payment by T/T Bank Transfer, online platform Trade Assurance Service, Western Union, Money Gram, L/C, Cash etc.Q3: What's the delivery time and shipping method?
Delivery time is upon to your ordered product and quantity, generally our lead time is within 1 week, if have stock we can ship immediately.We have long-term cooperated forwarder for worldwide shipping, we can deliver your products by express, air freight or sea freight , different shipping way the cost and time is different, we will give sincere advice according to your situation and you can decide, for many countries we even have door-to-door shipping service which include customs clearance and taxes.
Q4: What's your after-sale service?
We provide at least one year warranty for all our products (consumables exception).If there is any fault for our products, we have well-trained and passionate after-sale engineers to help you, within warranty period we will repair and change the fault parts for free; after warranty we still provide lifetime technical support, if spare parts needed just charged at cost price.
Q5: How do we secure transactions?
We Xindray Medical Group is a professional medical company owned a lot of government certificates, and also online platform verified us as Premium Supplier there. Our company is aiming to serve more and more customers in the world, providing you good quality medical products, and more safe payment ways. All transactions between you and us is 100% guaranteed, you will enjoy our whole-hearted service all the time.