in Vitro Hospital Professional Use Diagnostic Hpylori Test

• Customization: Available
• Type: IVD Reagent, Test Strips & Test Tube
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Model NO.: DGNHP-03
• Group: Adult
• Material: Plastic and Paper
• Logo Printing: OEM
• Shelf Time: 24 Months
• Specimen: Blood
• Application: Primary Infection Period or with Symptoms
• Product Type: Strip, Cassette
• Size Regular: 3.0mm, 4.0mm
• Package: Foil Bag and Box and Carton
• Payment: Tt, Paypal, Western Union
• Sample: Available to Prepare
• Certificate: CE, ISO FSC
• Packing Size: 63*26*49cm
• Gross Weight: 13kg
• Transport Package: Carton
• Specification: Standard
• Trademark: Diagnos
• Origin: Jiangsu China
• HS Code: 3822001000
• Production Capacity: 5000000 PCS/Month

Product Description

High quality; Mutual-benefit price; Fast delivery; Best service

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 

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

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.